International Edition
RegulatoRy Notice
this annual Report (“annual Report, international and investor edition”) presents Masimo features and/or products that are marketed outside of the united States
and for the global investor audience.
See the “annual Report, u.S.” for Masimo features and/or products that are FDa-cleared for the united States market.
at the time of printing, not all Masimo features and/or products profiled in the “annual Report, international and investor edition” have worldwide regulatory
clearances and/or approvals.
For example, the following profiled features and/or products are pending clearances as of February 12, 2015:
• europe ce Marking: animal Health products, iSpo2, and iSpo2 Rx for infant & neonatal use and MightySat Rx
• canada MDl: iSa aX+, iSa oR+, iSpo2 Rx for infant & neonatal use, Radius-7 and oRi.
To the many who have helped shape, guide, inspire, and innovate the first 25 years of Masimo,
thank you.
table oF
coNteNtS
Timeline
6
ceo leTTer
18
THankS
28
SeT®
62
Hemoglobin
76
rooT
92
rainbow®
expanSion
FuTure
leaderSHip
appendix
FinancialS
110
120
134
142
144
152
4
5
tHe FiRSt
25 yeaRS
1989
Founding of masimo
company founded by
Massi Joe e. Kiani and
soon after Mohamed Diab
and Mary Kiani joined
1995
High-Fidelity
pleth waveform
First true diagnostic-
quality pleth waveform
1995
mS-1™ board
First commercially available
Set® oeM board
1995
masimo SeT®
pulse oximetry
First Measure-through
Motion and low Perfusion™
pulse oximetry – debuts at
the Society for technology
in anesthesia™ and wins
excellence in technology
innovation award
PI
1995
perfusion index
First accurate quantification
of amplitude of the pleth
waveform to 0.02%
First
Implementation
with Masimo SET®
1996
kontron
multi-parameter
First Masimo Set® mulit-
parameter implementation
1996
lnop® Sensors
High signal-to-noise ratio
sensor with non-absorbent
material, rejuvenating
adhesive, and replaceable
tapes – minimizing waste
1998
iVY biomedical 2000
First Masimo Set®
standalone device
implementation in the u.S.
First Standalone
with Masimo SET®
1997
nec
First Masimo Set®
standalone device
implementation
Breakthrough
Study
1998
breakthrough study shows
masimo lnop® sensors
last nearly twice as long
as the market-leading
adhesive disposable
sensors
thomas a et al. Respir Care.
1998;43(10):860.
6
7
tHe FiRSt 25 yeaRS
Measure-through
Motion
510(k)
1998
First FDa 510(k) clearance
for Measure-through
Motion pulse oximetry
SmarTone
1998
SmarTone™
ability to maintain
saturation tones with
variable pitch during low
signal-to-noise conditions
1998
SofTouch™
First Masimo sensor
designed for sensitive
skin of neonates
Max
1998
max Sensitivity Setting
allowing reliable
measurement in the most
challenging conditions of
low perfusion
1998
datascope
Datascope, along with
other oeMs, brings
commercialization of
Masimo Set® in to their
patient monitors
Measure-through
Low Perfusion
510(k)
1999
First FDa 510(k) clearance
for Measure-through low
Perfusion pulse oximetry
2000
radical® pulse oximeter
First 3-in-1 pulse oximeter
standalone device for
bedside monitoring with
detachable handheld unit
for portable monitoring,
SatShare ® interface to
upgrade conventional pulse
oximetry in multi-parameter
patient monitors to Masimo
Set®, and first monitor
to have an automated
rotational screen
2000
Signal iQ®
First to quantify
measurement quality
and give clinicians a way
to know when to have
confidence in the Spo2
values during motion
and low perfusion
FastStart
2000
FastStart™
Spo2 value in less than 10
seconds from the time the
instrument is turned on
2000
FastSat ®
enabling accurate tracking
of rapid saturation changes
Award-winning
Breakthrough
Study
2000
Study shows masimo SeT®
helps increase caregiver
efficiency
Durbin c.g. et al. Anesthesiology.
2000; 93(3a): a-556.
Breakthrough
Study
2002
Study shows masimo
SeT® helps wean patients
from the ventilator faster,
reduce Fio2 levels, and
reduce arterial blood gas
measurements
Durbin c.g. et al. Crit Care Med.
2002 aug;30(8):1735-40.
8
9
tHe FiRSt 25 yeaRS
Breakthrough
Study
2002
breakthrough study shows
masimo SeT® linked to
reduced medical errors in
critical care medicine
Hay W.W.et al. J Perinatol. 2002
Jul-aug;22(5):360-6.
APOD
2003
adaptive probe off
detection® (apod®)
Reducing false display of
values by 83% when the
probe is not on the patient,
compared to competing
pulse oximeters
Breakthrough
Study
2003
breakthrough study shows
masimo SeT® linked to
reduced retinopathy of
prematurity in neonatal
patients
chow l.c. et al. Pediatrics. 2003
Feb;111(2):339-45.
2004
lncS ® Sensors
low noise cable
sensor design
2005
blue ® Sensor
First sensor for accurate
measurements in cyanotic
infants and children
2004
rad-5 ® Handheld
pulse oximeter
First handheld incorporating
Masimo Set®
2004
newborn Sensor
First sensor designed
for newborn monitoring
during resuscitation
2005
rainbow® SeT® in
mx-1® board
First noninvasive blood
constituent platform
100%
Desat Index
Alarm Limit 93%
Low SpO2
Alarm Limit 90%
2
O
p
S
Time (in minutes)
20
40
60
80
2005
3d desat index alarm™
First alarm to alert
clinicians to patterns of
transient desaturation
that may predict
respiratory depression
2005
rad-57®
First handheld capable of
noninvasively measuring
carbon monoxide levels in
the blood
SpCO
2005
Spco®
First noninvasive
carboxyhemoglobin
measurement
x
e
d
n
I
n
o
i
s
u
f
r
e
P
1.0
0.9
0.8
0.7
0.6
0.5
0.4
PI Baseline determined by the Radical-7
PI Delta % Change = 25
(within a 1 hour period)
Time
Alarm triggered
2005
3d perfusion index
delta alarm™
First alarm to alert
clinicians of changing
peripheral perfusion
status that may indicate
worsening condition
10
11
tHe FiRSt 25 yeaRS
SpMet
2006
Spmet ®
First noninvasive
methemoglobin
measurement
2005
radical-7®
First bedside rainbow Set®
Pulse co-oximeter®
Breakthrough
Study
2005
breakthrough study shows
assessment with masimo
SeT® improves screening
for congenital heart
disease in newborns
de-Wahl granelli a. et al. Acta
Paediatr. 2005 Nov;94(11):1590-
1596.
2007
patient Safetynet™
First remote notification
system capable of rainbow®
measurements – with
optional central monitoring
based on 802.11 abg
PVI
2007
pleth Variability
index (pVi)
First noninvasive
and continuous fluid
responsiveness
measurement
2008
national Fire protection
association Standard
NFPa 1584 releases
fire rehab standards
and includes carbon
monoxide assessment
during fire rehab
Breakthrough
Study
2008
breakthrough study
shows pVi® predicts
fluid responsiveness
during surgery
cannesson M. et al. Br J Anaesth.
2008 aug;101(2):200-6.
2008
neopt-500
First sensor for extremely
low birth weight babies
2008
rad-87®
First Pulse co-oximeter
with integrated 802.11
abg wireless radio
SpHb
2008
SpHb®
First noninvasive
and continuous
total hemoglobin
measurement
Breakthrough
Study
2008
breakthrough study
shows Spco® identifies
unsuspected co poisoning
in the eR
Suner S. et al. J Emerg Med. 2008
May;34(4):441-50.
2009
rainbow reSposable ®
Sensor System
featuring performance
of adhesive sensors with
green Designed in™, which
reduces both landfill and
carbon footprint
12
13
tHe FiRSt 25 yeaRS
RRa
2009
rainbow® acoustic
monitoring (ram™)
First noninvasive and
continuous respiration
rate (RRa®) monitor with
acoustic sensor
Breakthrough
Study
2010
Study shows masimo
SeT® and masimo patient
Safetynet improve
outcomes in adults on the
med-surg unit – fewer rapid
response activations, icu
transfers, and icu days
taenzer a.H. et al. Anesthesiology.
2010 Feb;112(2):282-7.
Fluid
Management
Study
2010
Study shows pVi helps
clinicians improve
fluid management and
decrease lactate levels
in surgical patients
Forget P. et al. Anesth Analg. 2010
oct;111(4):910-4.
Breakthrough
Study
2010
Study shows pVi helps
assess which patients will
become hemodynamically
unstable with the addition
of PeeP
Desebbe o et al. Anesth Analg.
2010;110:792-798.
Foundation for Ethics,
Innovation, and Competition
in Healthcare
2010
masimo Foundation for
ethics, innovation, and
competition in Healthcare
created with a
$10 million gift
2010
radical-7
Featuring touch screen
display, wireless capability,
and external display
functionality
Halo
Index
2011
Halo index™
cumulative trending
assessment of the global
patient status. increases
in Halo index suggest
physiologic deterioration
and may indicate a need for
clinicians to more closely
assess the patient
Breakthrough
Study
2010
SpHb
breakthrough study shows
SpHb monitoring helps
clinicians optimize blood
management
ehrenfeld J.M. et al. American
Society of Anesthesiologists.
2010;lb05.
RRp
2011
respiration rate from
the pleth (rrp™)
First noninvasive and
continuous respiration
rate measurment from
the pulse oximeter signal
2010
pronto® and pronto-7®
First noninvasive spot
checking of hemoglobin,
Spo2, pulse rate, and
perfusion index
Adaptive
Threshold
Alarm
2010
adaptive
Threshold alarm
First dynamic physiologic
alarm threshold based
on changes from each
patient’s baseline value
2012
capnography and
gas monitoring
Masimo begins offering
innovative, multispectral
technologies for measuring
respiratory gases and
anesthetic agents
14
15
tHe FiRSt 25 yeaRS
SpfO2
2012
Spfo2™
the first noninvasive
fractional oxygen
saturation monitor
measurement
2013
iSa™ capnography
the iSa capnography
Moc-9 module for Root
features high sidestream
performance and offers
cost-effective disposables
through the innovative
Nomoline™ adapter with
extended monitoring time
and use of generic cannulas
2013
root ® patient
monitoring and
connectivity platform
First device to integrate:
> rainbow® measurements
> iris™ connectivity for
third party devices
> Masimo open
connect™ (Moc-9™) for
measurement expansion
2013
iSpo2 ® pulse oximeter
the first pulse oximetry
for both ioS (apple) and
android™ mobile devices
2013
Sedline ® brain
Function monitoring
the Sedline Moc-9
module for Root features
4 simultaneous channels
of high-quality eeg
data; Sedline provides
continuous information
about both sides of the brain
and provides information
about a patient’s response
to anesthesia
2014
o3™ regional oximetry
the o3 Regional oximetry
Moc-9 module for Root
features near-infrared
spectroscopy (NiRS) and
reflectance pulse oximetry
to enable simultaneous
monitoring of tissue
oxygen saturation (rSo2)
in the brain and arterial
blood oxygenation (Spo2)
2014
radius-7™
Radius-7 for Root is the
first and only wearable,
wireless monitor with
Masimo’s breakthrough
rainbow Set® technology
2014
eve™ newborn
Screening application
animated tutorial for
the Radical-7 specifically
designed to help clinicians
more effectively and
efficiently screen
newborns for critical
congenital heart
disease (ccHD)
2014
TFa-1™
Single-patient-use
forehead sensor for
Masimo Set®
2014
rainbow® dci®-mini
the first and only reusable
spot check hemoglobin
sensor for infant and
pediatric patients from
3 to 30 kg
ORI
2014
ori™
the first noninvasive and
continuous parameter
to provide insight
into oxygen reserve
in patient’s receiving
supplemental oxygen
2015
mightySat™
First fingertip pulse oximeter
with Masimo Set® Measure-
through Motion and low
Perfusion™ technology
For sports and aviation use only
in the u.S.
16
17
letteR FRoM tHe
cHaiRMaN & ceo
2014 marked the 25th anniversary of Masimo. i would like to thank everyone, from our employees and customers to our investors
and advisors, who has helped Masimo achieve its mission of improving patient outcomes and reducing cost of care by taking
noninvasive monitoring to new sites and applications.
We believe that Masimo Set® pulse oximetry now
helps clinicians monitor more than 100 million
patients a year and is the primary pulse oximetry technology
for eight of the top 10 hospitals on the u.S. News & World
Report best Hospitals Honor Roll for 2014-2015. that’s a long
way from 1989, when we started with a $40,000 loan on my
condominium and the dream that one day we could fulfill our
Mission stateMent
Improve patient outcomes and reduce the cost of care by taking noninvasive monitoring
to new sites and applications.®
mission, make a contribution to society, reward the investors
So even as i take humble pride in Masimo’s achievements,
current market needs and, more importantly, anticipating
who believed in us, and achieve financial stability.
i can tell you we are all committed to achieving even greater
future market expectations. a few of the highlights include:
accomplishments in the years to come. this is one reason why
Since its introduction, Masimo Set® Measure-through Motion
we worked so hard to put in place a plan several years ago to
and low Perfusion™ pulse oximetry has helped prevent at least
produce a product a month during 2014, our 25th anniversary.
25,000 potential cases of retinopathy of prematurity (RoP) in
this was more than just flexing our innovation might. by
1 ce Marking of o3 regional oximetry* for Root. o3 regional
oximetry uses near-infrared spectroscopy (NiRS) through
Moc-9 with up to two sensors per Moc-9 module. each sensor
newborns worldwide, and has impacted the quality of care for
producing clinically significant products at a pace unmatched
contains four light-emitting diodes (leDs) and two detectors to
millions of patients of all ages, including babies born with critical
by anyone else in the medical technology industry, we
continuously and simultaneously measure both organ oxygen
congenital heart disease, and adults in post surgical wards.
demonstrated that Masimo is more than capable of addressing
saturation (rSo2) and arterial blood oxygenation (Spo2). Root
*o3 regional oximetry is pending FDa 510(k). Not available in the u.S.
Joe kiani
Chairman & CEO, Masimo
1818
19
reVenueS // 200 5-2014
In mIllIons of d oll ars
Product revenues //
royalty revenues
allows either one or two o3 Moc-9 modules
to be connected, enabling monitoring with as
3 FDa 510(k) clearance of the Root
patient monitoring and connectivity
few as one and as many as four sensors. organ
platform. Root can be a hub at the bedside,
oximetry, also known as regional oximetry
enable Masimo’s breakthrough noninvasive
and cerebral oximetry, enables the continuous
measurements to be used by experts
innovative and cost-effective Nomoline
offering patients continuous monitoring
sampling line
> Wireless functionality – capable of
transmitting information through
assessment of the oxygenation of the organ
and novices with trend and analog views,
bluetooth and Wi-Fi.
beneath the sensor. o3 helps clinicians detect
take advantage of a rich set of additional
cerebral hypoxemia that pulse oximetry alone
measurements, and provide other companies
can miss. in addition, the Root monitor can
a robust platform on which to develop other
automate the differential analysis of regional
innovative measurements via Moc-9. High-
4 later, Masimo also announced iSa oR+
multigas monitoring, a Masimo open
connect (Moc-9) Module for Root. During
to central oxygen saturation. o3 monitoring
impact innovations in Root that are now
general anesthesia, the iSa oR+ monitors
is as simple as applying o3 regional oximetry
available in the u.S. include:
the inhaled and exhaled concentration of five
sensors to the forehead and connecting the o3
Moc-9 module to any Root through one of its
three Moc-9 ports.
2 iSpo2 Pulse oximeter for android. With
the release of iSpo2 in the popular
android operating system, more consumers
than ever have access to Masimo Set®
anesthetic gas agents (Sevoflurane, isoflurane,
> iris – built-in connectivity gateway through
iris for verified standalone devices such as
Halothane, Desflurane, enflurane), carbon
dioxide (co2), nitrous oxide (N2o), and oxygen
iV pumps, ventilators, hospital beds, and
(o2), in addition to respiration rate. When
other patient monitors to eMR
technology modules are connected with Root,
> Moc-9 – Flexible measurement expansion
through Masimo open connect (Moc-9)
including Masimo Set® pulse oximetry,
noninvasive and continuous hemoglobin
multiple additional parameters are available
Measure-through Motion and low Perfusion™
with Moc-9 modules from Masimo or third-
(SpHb), PVi, Sedline brain function monitoring,
pulse oximetry – the same technology used in
party measurements from other companies
and o3 regional oximetry.
leading hospitals worldwide. iSpo2 provides
to expand the platform’s measurements
accurate, real-time oxygen saturation
and capabilities. New Moc-9 modules may
(Spo2), pulse rate (PR), and perfusion index
require new 510(k) clearances
(Pi) readings – ideal for anyone who desires
5 another amazing technology for Root
that we’re very proud of is Radius-7, the
first and only wearable, wireless monitor with
access to accurate health data through their
> capnography – iSa co2 sidestream module
Masimo’s breakthrough Masimo Set® and
mobile devices.
featuring fast warm-up time and the
rainbow acoustic Monitoring™ technology,
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
total revenues
Product revenues
royalty revenues
2005
107.9
---
---
2006
224.3
155.5
68.8
2007
256.3
200.2
56.1
2008
307.1
259.6
47.5
2009
349.1
300.1
49.0
2010
405.4
356.4
49.0
2011
439.0
406.5
32.5
2012
493.2
464.9
28.3
2013
547.2
517.4
29.8
2014
586.6
556.8
29.8
*the use of the trademarks Patient SafetyNet and PSN is under license from university Health System consortium.
with freedom of movement. Radius-7, which
received FDa 510(k) clearance in 2014, can alert
clinicians – at the bedside or remotely, through
our Patient SafetyNet* remote monitoring
system – of critical changes in a patient’s
oxygen saturation and pulse rate – even during
states of motion and low perfusion – as well as
GuidinG
PrinciPles
> Remain faithful to your promises
and responsibilities
> thrive on fascination and
accomplishment and not on
greed and power
> Strive to make each year better
than the year before, both
personally and for the team
> Make each day as fun as possible
> Do what is best for patient care
20
2121
respiration through acoustic respiration rate
color screen that can be rotated for real-time
its name to the daughter of annamarie
prolonged intubation.4 the study was among
(RRa). lightweight at only 0.34 lbs. (155g), the
display of the pleth waveform as well as
Saarinen, co-founder and ceo of the Newborn
12 selected from more than 1,000 as one of
Radius-7 attaches to the patient’s arm, allowing
measurements. optional bluetooth wireless
Foundation. eve was diagnosed at 48 hours
the best abstracts at the american Society
untethered monitoring while they are in bed or
functionality enables measurement display via
old with ccHD, and annamarie has made it
of anesthesiologists (aSa) annual Meeting
out. With no need to disconnect and reconnect
a free, downloadable app on ioS and android
her life’s mission to make sure all newborns
in New orleans, the largest gathering of
the cable to get out of bed, the Radius-7
mobile devices as well as the ability to trend
are screened. We hope our eve software
anesthesiologists in the world.
reduces the need for nursing assistance.
and communicate measurements. and for
feature will help professionals accomplish
and the Radius-7’s wireless communication
those who want to use their pulse oximeter
their mission to help save the lives of babies
functionality – either short-range via bluetooth
to evaluate another physiologic dimension,
and spare families from heartbreaking loss.
back to Root or with upgradeable WiFi‡ for
MightySat is the only fingertip pulse oximeter
long-range communication – ensures the
available with the optional Pleth Variability
patient can be continuously monitored and
index (PVi), a measure of the dynamic changes
connected to caregivers wherever they are
in Pi that occur during one or more complete
8 oxygen Reserve index (oRi™†). With ce
Mark and limited market release, oRi
became the first noninvasive and continuous
hemoglobin (SpHb) spot-check sensor for
infants and small children (weight 3 to 30
kg). Paired with Masimo’s handheld Pronto
9 ce Mark, clearance in Japan, and
limited market release of the rainbow®
Dci-mini™¥. Dci-mini is the first noninvasive
in the hospital. Radius-7 allows clinicians to
respiratory cycles.2
parameter of its kind to provide insight into
device, the rainbow® Dci-mini sensors are
continuously monitor their patients when
they are mobile, and studies have shown that
patient mobility is a key factor in more rapid
patient recovery.1
a patient’s oxygen reserve when they are
designed to help clinicians quickly and easily
7 ce Mark of eve™*, a newborn screening
application for the Radical-7. Masimo
gained its first commercial foothold in the
receiving supplemental oxygen. With oRi,
spot-check hemoglobin levels. Dci-mini allows
Masimo’s rainbow Set® Pulse co-oximeters
clinicians and public health programs around
with the latest MX-5 circuit board can now
the world to expand hemoglobin assessment
Nicu, so this new technology holds a special
measure an unprecedented 11 parameters3
to vulnerable populations who need a
6 MightySat, the first fingertip pulse
oximeter with Masimo Set®. MightySat,
for sports and aviation use, is available in
place for us. eve is an intuitive software
through noninvasive optical rainbow® sensor
noninvasive and convenient method. We hope
feature to help clinicians more effectively
technology. a clinical study at the university
that the new rainbow® Dci-mini will help more
screen for critical congenital heart disease
of texas Southwestern and children’s Medical
infants and small children, along with their
three versions – each of which provides
(ccHD). eve automates the screening steps
center in Dallas evaluating oRi showed
moms, around the globe to receive timely
oxygen saturation (Spo2), pulse rate (PR),
with animated instruction, including sensor
that oRi can provide advanced warning of
assessment and treatment, which will benefit
and perfusion index (Pi) measurements in a
application, measurement selection, and
potential hypoxia and may help clinicians
their long-term health, as well as the health of
compact, battery-powered design with a large
screening result determination. eve owes
optimize oxygenation before and during
our society.
470,000
449,000
342,000
inSTalled baSe // 2005-201 4
estImated unIts
excludes handhelds
1,313,000
1,205,000
1,088,000
979,000
855,000
640,000
567,000
‡ the configuration for long-range communication is not yet released. * eve ce Marked. currently not available in the u.S. † oRi is ce Marked. currently not available in the u.S. ¥ rainbow® Dci-mini is ce Marked. currently not available in the u.S.
1 Needham D, Korupolu R, Zanni J, Pradhan P, colantuoni e, Palmer J, brower R, Fan e. “early Physical Medicine and Rehabilitation for Patients With acute Respiratory Failure: a Quality improvement Project.” Archives of Physical Medicine and Rehabilitation Vol 91, issue 4, PP 536–542, april 2010.
2 the utility of PVi is unknown at this time and requires further clinical studies. technical factors that may affect PVi include probe position and patient motion. 3 eleven parameters include: 1) oxygen saturation (Spo2); 2) Pulse rate; 3) Perfusion index (Pi); 4) Pleth Variability index (PVi);
5) Respiration Rate from the pleth (RRp); 6) total hemoglobin (SpHb); 7) oxygen content (Spoc); 8) carboxyhemoglobin (Spco); 9) Methemoglobin (SpMet); 10) Fractional oxygen saturation (Spfo2); 11) oxygen Reserve index (oRi). 4 Szmuk P, Steiner J, olomu P, Dela curuz J, Sessler D. oxygen
Reserve index - a New, Noninvasive Method of oxygen Reserve Measurement” Proceedings of the american Society of anesthesiologists, oct.14, 2014, New orleans, boc12, Room 275-277.
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2222
23
earningS per SHare daTa For annual reporT // 2008-2014
FY2010
year ended
January 1, 2011
FY2012
year ended
december 29, 2012
FY2011
year ended
december 31, 2011
FY2008
year ended
January 3, 2009
FY2009
year ended
January 2, 2010
FY2013
year ended
december 28, 2013
e
r
a
h
S
r
e
p
s
g
n
n
r
a
e
d
e
t
u
i
l
i
d
$1.21
$0.88
$1.05
$1.07
$1.02
$0.53
FY2014
year ended
January 3, 2015
$1.30
10 ce Mark of the tFa-1*
transflectance forehead adhesive
sensor. tFa-1, a single-use sensor for adult
While we are happy that we fulfilled the
expectations of everyone who invested
in Masimo up until we went public, we are
before. that included product revenue of
lifesaving breakthrough products become
$556.8, million – up 8% from $517.4 million.
ubiquitous in healthcare settings and beyond.
Since 2007, we have focused on building
our technology will expand and evolve to
and pediatric patients, offers clinicians
restless in fulfilling the expectations of our
a strong and knowledgeable worldwide
meet the future needs of healthcare, by
the power of Masimo Set® pulse oximetry
investors, post our iPo. i am grateful for the
sales and marketing organization, capable
helping improve surgical and post-surgical
on an alternative monitoring site for rapid
patience that our investors have exhibited
of expanding both our Masimo Set® and
outcomes with shorter lengths of stay. by
detection of oxygen saturation changes
while we work through the 10-year plan we
rainbow® businesses. While we continue to
better assessing patients we can help reduce
during low perfusion. tFa-1 also offers
established in 2007. the good news for those
make strategic investments in our worldwide
the cost of care.
pulse rate, perfusion index, and PVi
who remained patient over the past 7 years
organization, we believe that we have now
measurements. tFa-1 gives clinicians yet
is that we expect all of the planning and
reached the level of staffing needed for our
We’ve set in motion the “consumerization” of
another way to leverage the breakthrough
execution of the past 7 years will begin to pay
sales, marketing, engineering, and other
our core technologies with the iSpo2 pulse
measurement capability in Masimo Set®
off in not only the lives we improve and save,
organizations to support higher product
oximeter for smartphones, and more recently
pulse oximetry. by continuing to take
but the increase we expect in our earnings
revenue growth.
Masimo’s breakthrough technologies to
and hopefully our stock price.
MightySat, the world’s first fingertip pulse
oximeter with Masimo Set® pulse oximetry.
new sites and applications, we are helping
it is not hubris to envision that within the
elite athletes such as an olympic silver
improve patient outcomes and safety while
For fiscal year 2014, total revenue rose 7% to
next 3 years, Masimo will reach new heights
medal cyclist and a four-time free diving
reducing cost of care.
$586.6 million from $547.2 million the year
with our customers and shareholders, as our
champion and guinness World Record holder
2008
2009
2010
2011
2012
2013
2014
*tFa-1 is ce Marked. currently not available in the u.S.
first masimo set® technology board
dr. Peter cox testing masimo pulse
oximeter while breathing nitrogen
first test patient using masimo set® technology
one year anniversary of
masimo listing on nasdaQ
one millionth oximeter shipped
executive team helps millionth oximeter on its way
24
25
25
it is humbling and profoundly motivating to
think that the technology we have created
– and continue to create – is saving and
improving lives around the world.
are using our technologies to help improve their training
stop us from getting our breakthrough technologies in the
and recovery regimens. throughout most of Masimo’s
hands of clinicians for the safety and care of patients.
history, our medical devices have been designed to help
patients recuperate. Now, we’re also helping healthy
it is humbling and profoundly motivating to think that the
people improve their lives.
technology we have created – and continue to create – is
saving and improving lives around the world. this is a
Since its beginning, Masimo has confronted and overcome
great honor, and a great responsibility. on behalf of all of
obstacles – a real-world David versus goliath story, only
us at Masimo, we look forward to rising to the challenges
with sequels. it has been a wonderful journey, with many
of this millennium, driven by the mission to improve
successes and challenges, and undoubtedly many more yet to
patient outcomes, while reducing the cost of care by taking
come. but we stand alert and ready and will not let anything
noninvasive monitoring to new sites and applications.
Joe kiani
Chairman & CEO
26
26
27
Joe Kiani and mohamed diab solved the “unsolvable”
– inventing pulse oximetry that was accurate when
patients moved or had low perfusion.
ouR StoRy,
FRoM tHoSe
WHo liVeD it
28
28
29
The Early Years
as told by Mohamed diab, Mary Kiani,
Walt Weber, Bob smith, and ammar al-ali
Mohamed diab
“it’s mixed in-between. if you’re not shaking your hand, then you
on physiology that helped us better understand the problems we
get a good reading. as the late Dr. Swan characterized it, “Pulse
were facing.
oximetry has been, at best, a fair weather friend.” What DSt gives
> At Masimo, we learned from the beginning that if it could be imagined, Mohamed could make
you is a map; it says this is the good number and here are some of
“wHen maSimo STarTed, i wanted to help my brother, because
it become reality. That’s how good he is. From figuring out how to make adaptive filters work in
the bad numbers. it just breaks things up and shows a total map.
he was working full time and doing Masimo at the same time with
noninvasive monitoring, to figuring out the discrete saturation transform, he has always been
that enabled us to extract the correct arterial saturation even
no help from anyone. i was a licensed dentist, and working full time
from the 1975 debut of the nihon Kohden olv-5100, the world’s first pulse oximeter,
a core of technical ability and integrity that allowed our company to attract many other amazing
under motion conditions, and that’s the power of it. that changed
at an office in brea, but my work was at night and Saturdays which
the science of pulse oximetry was plagued by unreliability when it was needed most
engineers because they love working around Mohamed.
– during patient motion and low perfusion. the industry had given up and considered
the problem “unsolvable.” clinicians were forced to live with the results – excessive
false alarms, delayed notification due to long averaging times, inaccurate data, and
an inability to obtain data on the most critical patients.
When Joe Kiani and mohamed diab looked at pulse oximetry signals differently
than anyone had before, they created new possibilities. By employing advanced
signal processing techniques – including parallel engines and adaptive filters –
they believed they could find the true arterial signal that would allow accurate
monitoring of arterial oxygen saturation and pulse rate, even during the most
challenging conditions. after six years of dedicated and focused research and
development, masimo set ® debuted in 1995 at the society for technology in
anesthesia and won the prestigious excellence in technology Innovation award.
everything for us because we knew that there was at least one
gave me all day to help him. i did secretarial duties, answered
Joe Kiani
solution to the motion artifact problem!
the phones, and handled the mail, did library searches, whatever
“wHen we STarTed Masimo, medical device manufacturers assumed that ‘motion
was needed. i was also Director of Medical affairs, being the only
artifact’, in pulse oximetry was an ‘unsolvable’ problem and that the best a pulse oximeter
“We solved the low perfusion problem –measuring blood oxygen
degreed person on staff with anything like a physician’s license.
could do was detect the presence of motion and freeze the number on the screen until the
saturation at extremely low blood flow – by properly designing
i conducted early patent searches at the los angeles public library.
motion subsided. in fact, even the slightest hand motion generates extraneous signals,
our hardware and sensors and by using advanced digital signal
When professional copies needed to be made of the business plan
many times the size of the arterial pulse, and hence it can easily corrupt the measured
processing techniques. this enabled us to reliably extract
that Joe had developed or logo graphics for publications,
arterial signal, which causes conventional pulse oximeters to display false low or high Spo2
extremely small signals under a wide range of patient conditions.
i would go to the printers. i helped our mom cook for the christmas
and pulse rates – resulting in false alarms as high as 90%. i recall a meeting with Joe Kiani
parties, and to provide food for the investor and director meetings.
in late 1989 where he told me that if we were to build a successful pulse oximeter company
“by the summer of 1992 bob Smith, Rex Mccarthy and Walt
basically, i took care of whatever he needed to free him to work
we had to solve two fundamental problems: Motion artifact and low Perfusion.
Weber had joined Masimo. they have tremendously contributed
on the prototype, develop the business plan, find investors, go to
to the hardware, software and algorithm development. bob’s
various business conventions, and all other things that he did to
“We started with motion artifact knowing well that adaptive filters were the way to go –
work on a very low-noise platform was crucial in extracting very
make the company happen – which were endless.
but how? No book or paper had a solution for the problem. our first breakthrough came
low signals. Walt and Rex further developed the DSt as well as
in May 1990 when we figured out a way to mathematically extract a signal that described
newer techniques for extracting the arterial signal under motion
“When Masimo first gained ample funding, we had about 60 people
the noise using a conventional sensor with only two leDs. However, that solution
condition. in 1995 ammar al-ali joined us and quickly became
on staff. Joe asked me to resign, as he had people who were more
required a quiet period, at the beginning, where a clean arterial signal could be sampled.
the leader of Masimo’s pulse oximetry development with major
qualified to be members of the board of directors of the company
mohamed diab
unsatisfied with that solution, the second breakthrough came when i was on a plane
contributions to the algorithms, software and system design.”
by that time. Joe always did what was best for the company. that
coming back from Syria. i ended up calling it DSt, the discrete saturation transform.
“Here’s a simple explanation: imagine you’re moving to los angeles and want to buy
a house. you ask what the median price of a home is, but there’s a huge difference in
Mary Kiani
meant having the right people for the right job at the right time,
and i was no longer what the company needed. i was happy to do
it, as my intention all along had been to help until i was no longer
needed. i had my own career and a growing family. He made sure
prices in different areas. So, what if someone gives you a map of each city in the area: the
> Mary was a full-time dentist and recently married, yet she knew
that i had plenty of shares in our then still-private company. He
median price in Palos Verdes is this, in beverly Hills it’s this much, in compton this much,
her brother was also working a full-time job while trying to build
always took care of people. i didn’t realize what the stock might
a distribution of prices. you can look at the full picture and more easily see where you can
what became Masimo. With no expectations of any stock or value,
mean, and i wasn’t the only one who found out about the rewards
afford to buy. With a conventional pulse oximeter, when you shake your hand, you get a
merely to help out, she drove to the L.A. Public Library to conduct
of helping Joe. a friend of his, barry Miller, loaned Masimo a top-
false reading that is kind of the average between the venous and the arterial saturations.
patent searches and to UCSD and UC Irvine to do library searches
of-the-line Macintosh computer at a time when we couldn’t easily
30
mary Kiani
31
afford one, so Joe could do the business plan; because of being
i wanted to do. What i was doing initially was showing what
monitoring products. this continuity within the company has
so gracious about the computer, Joe gave him 30,000 shares,
was achievable by conceptualizing and developing algorithms
been rewarding and wonderful to be a part of.
which later with all the stock splits became much more shares.
together with a system for processing data. one of the things
barry passed away before Masimo went public, but his wife
that really opened up my eyes, back then, was a journal
“it’s been quite a journey, 25 years now as a company, and
and daughter made a lot of money with those shares. at the
by the institute of electrical and electronics engineers on
it was well worth it. We’ve shipped over 1 million Signal
first annual shareholder meeting after 2007, barry’s widow
biomedical signal processing. the biomedical signal processing
extraction technology® pulse oximeters. We believe over 100
found Joe and said, ‘Joe, we felt like barry sent us money from
state of the art was primitive compared to the state of other
million people are monitored with them each year. every time
heaven.’ Helping people can pay off in ways you don’t expect.
applications of signal processing. i thought, you can really
someone turns on that pulse oximeter, that thing is running
it’s all about your heart.”
improve biomedical signal processing – because it was really in
my algorithms. isn’t that cool?”
sales and engineering “debate”
whether product is ready to ship
Bob smith
Walt Weber
its infancy – if you remove noise from signals and give a vital
sign that’s indicative of a noise-free type of environment.
Bob smith
“in the early 90’s, journal articles would often cite problems
masimo’s first incarnation
was vital signals Inc, or vsI
Walt Weber
> When Walt joined our company in the very early days, we had
with pulse oximeter devices to include such items as patient
> A great engineer with a heart of gold, Bob came to the company
the technology of solving the pulse oximeter motion problem, but
motion, low perfusion, ambient light as well as the effects of
at a time when we didn’t know how to make a product. None of us
implementation of it was unstable. The signal processing portion
dyshemoglobins among others. We would use these papers as
before him had ever built a product – we simply had ideas about
had to be re-done. Walt figured out how to solve that problem
a basis to create a list of items that we would find solutions to.
how to make technologies better. Bob brought in unbelievably
and that allowed us to jump forward with the development of the
these were not treated as problems but rather opportunities
great hardware design skills and created an environment for
commercial product. He has continued to be an incredible and
to improve and create new products.
development of design, keeping track of the details that, at the
honest mathematical sounding board for us ever since.
end of the day, have continually helped our manufacturing people
“i believe that, one of the keys to our success has been
create every generation of our groundbreaking products.
“i Joined maSimo on marcH 24, 1992. i had three
engineering’s employee retention. everything that we have
interviews over a few months. they were looking for somebody
built is based on expertise that has been developed over time.
“i Joined maSimo in June oF 1992. What i remember
to do some signal processing. Mohamed gave me a demo of
therefore, part of the team that developed our pulse oximetry
about those early days was there was always a struggle to
some of the stuff they were doing on a computer system called
products was utilized to develop our rainbow® products.
keep 10 people on the payroll. that was a magic number
the comdisco, which kind of impressed me. i had another job
and part of the team that developed our pulse oximetry and
because if you dropped below 10, it was difficult to get
offer, but i wanted to take the Masimo job because it’s what
rainbow® products were utilized to develop our brain function
health insurance for everybody. at the same time, we
32
32
33
didn’t have a whole lot of money. So we had to make sure
the first Masimo SET® board to the market. SatShare,® the
floor one night with Joe and Mohamed at about 10 PM –
that everyone was contributing mightily to the company.
Radical,® and continual innovations followed. He’s been invaluable.
our normal going home time – talking about plans. our oeM
there were no sales, no marketing, no FDa submissions. it
prototype board, which was running at 4.5 watts at that
was all about the engineering and trying to get something
“i waS inTroduced To maSimo through Mohamed Diab
time and cost us about $500, ran very hot, and was basically
together that showed people what we had really did work and
in 1995. at that time, there was more work than people.
unusable. i told them that the board could be taken down to
was important. it was all about pushing the commercially
i worked with Walt Weber on developing and optimizing
100 milliwatts and cost under $100, and we made a goal.
available electronics to the limit of what was possible, and
algorithms for Spo2.
applying it in new ways. it was all about pushing ourselves
“but we didn’t try to go for that all at once. i developed a
beyond what we thought we could do, and being part of
“i came in as a software engineer, and was running the
step plan so we could use each step as an improvement in
something greater than the sum of the individuals.”
engineering department after about a year and a half.
technology. the first commercial board, MS-1, was 2.4 watts.
ammar al-ali
over the years, i went from Vice-President, to executive VP,
the MS-3 was 1 watt. our MS-5 was 500mw, MS-7 was 250mw,
to chief technical officer, and now i’m focused on technical
and MS-11 was 125mw. Now we have the MS-2000 family, which
work. i managed our group for 15 years, when Masimo was
is 100mw, and the MS-2040, which is < 45mw. it took us 10
mostly engineers. We now have more than 120 engineers
years to get there, but we got several useful boards out of it.
> When Ammar arrived, we assigned him a huge challenge that
in our irvine facility. i’ve hired a lot of people and
we had not been able to conquer, which was how to make an
i have a rule about it. i look for two properties: (1) high iQ;
“Now our business is much more complex and there are
optical simulator so that we could simulate in the engineering
(2) good attitude. if someone has those two things, you
so many products, it can feel like maybe we’re spread too
lab very low signals to test out our perfusion capability. No one
can do anything together.
else had been able to do it. Ammar did it one day on his own
thin. after many successful product introductions, many
new technologies that make a difference in people’s lives,
hours. Soon after, he became our head of engineering. Sharing
“the biggest challenge i’ve faced during the time i’ve been
a strong iP portfolio with 162 patents to my name, and
Mohamed’s brilliance of inventiveness, he also had the discipline
here was getting all Masimo efforts moving in a unified
considering where we started from and where we are now,
of system engineering and managed engineers to help us deliver
direction, on a long-term plan. i remember sitting on the
we’re doing extremely well.”
34
35
The Early Investors
as told by abbas Bolandgray, ron nessim
(for Jose nessim), Harish Patel, Bobby Yazdani,
omid Kordestani, and robert Feibusch
When Joe Kiani first proposed building an “impossible” pulse oximeter to mohamed
diab, the idea of leaving a steady job was not too palatable to mohamed. the
company mohamed worked for, however, was moving to colorado and mohamed
loved southern california. so he told Joe if he could raise $75,000 he would work
with him. Joe came up with $50,000 within two months, and mohamed gave five
months’ notice to his employer.
they named their company vital signals, Inc.; it was founded february 1989
when Joe Kiani had just turned 24 years old. By the summer of 1989, their first
prototype was ready. all of this was possible due to some singularly visionary
doctors and engineers.
abbas Bolandgray
“about a year ago, i met with Joe and thanked him for his vision,
i bought shares, too, early on – 1990, 1991, 1992, 1993. and as
hard work, and persistence and not only for helping others but
happened with many Masimo investors from those early years,
helping change my humble retirement to a comfortable level.
the investments paid off very well.”
> Dr. Bolandgray was our first investor, with a check for $5,000. A man who would always give his best
advice to any young person who would sit and listen, he championed our company when it was only a
“as a Farsi expression goes, i told him: ‘if you ever have some
one-page idea to doctor friends who provided the bulk of the $80,000 in funds that launched us.
shares and don’t know what to do with them and are going to
Harish Patel
Through him came Dr. Jose Nessim and then Dr. Jeremy Swan, both of whom lent us great credibility.
donate them to charity, i know somebody who would like to have a
He didn’t just put in his money – he called everyone that he knew who might help, and help they did.
couple more. His name is abbas bolandgray and he prays for you.’”
> As Joe Kiani’s friend and fellow field applications engineer before Masimo
abbas Bolandgray
“mY FamilY and i came from iran to the ‘land of opportunity’ – the united States –
permanently in 1982. through mutual friends, i got to know a recently graduated iranian-
american student, Joe Kiani. one day, he came to our house with one piece of paper in
ron nessim (for Jose nessim)
began, Harish knew about the idea for the company very early in planning
stages. He initially helped by providing an introduction to three doctor
friends who contributed $10,000 each to our initial $80,000. And all of
them, though not related, shared the last name of Patel. Harish remained a
his hand, telling me he was going to make a pulse oximeter. i knew he had a degree in
> Given his initial skeptical views and negative advice he received
great friend of the company, helping us with, among other things, including
electronics, but he did not have much knowledge about medicine. Without hesitation,
from a world-renowned doctor friend, Jose Nessim was a physician
support from Analog Devices, whose DSP chip we use in our products.
however, i gave him all the encouragement i could and told him he would make it without
who seemed highly unlikely to become a Masimo advocate, much
any doubt, particularly in the land of opportunity.
less an investor. But he did both, and much more. Once he was sold
“i FirST meT Joe in 1988 when we were both working as field
on our technology, he became a tireless advisor and champion. At
application engineers, me at PMi as a Staff Fae for the Southwest
“then the critical question came up. He asked me if i could invest in this future company.
a time when investors wanted 60% of the company for a very small
region and Joe a Fae at bell industries, a distributor of PMi. We
i gave it a great deal of thought, considering my position at the beginning of our migration
investment and we decided to walk away, Dr. Nessim wrote a check
hit it off the first time we met and became really good friends.
(we had arrived below zero financially). i decided to invest very minimally with this young,
for $134,000 that allowed us to continue. We are forever grateful.
We worked together on many customer design opportunities
reliable, intelligent person and told him that i could give him $5,000.
in orange county. Joe’s technical strength, willingness to learn,
“mY FaTHer, JoSe neSSim, met Joe Kiani and they really hit it
enthusiasm, and great communications skills were highly
“later on, while i was on-call at cedars-Sinai Medical center in los angeles, i discussed Joe’s
off. Dad was a practicing ob/gyN. He really liked the Masimo pulse
regarded by our customers and the PMi Southwest sales team.
venture with a few colleagues and a couple of them invested $5,000. Dr. Jose Nessim wanted to
oximeter and he really liked Joe, and we invested very early. My
Jose nessim
meet Joe, so i gave him Joe’s phone number. apparently, Dr. Nessim was a well-known gentlemen
father introduced Joe to other people at cedars-Sinai, the main
“about mid-1989, Joe had moved to anthem, another PMi distributor.
and influential with people, and he invested $10,000 at first, and $130,000 subsequently. later
hospital my Dad was affiliated with, and introduced him to Dr.
We discussed medical and other market opportunities in a meeting,
on, i invested another $5,000 for a friend who did not want to keep the investment, so i took it
Jeremy Swan, a famous cardiologist who co-invented the Swan-
and he said he would like to show me a product he and his friend
and had $10,000 invested in the company, which gave me 20,000 shares.
ganz heart catheter that revolutionized heart surgery. We have
Mohamed had been working on that had great market potential. We
a place in laguna beach where Joe would visit talking business.
went over to Mohamed’s apartment to see their invention – the pulse
“Many years passed and Masimo increased my number of shares three times. i divided the
i also remember Joe coming to the house in beverly Hills and
oximeter! this product was a 19-inch rack size Pc board. Mohamed
60,000 shares among my daughters and kept some for myself. More years passed and
making a presentation as part of raising money early on. My dad
and Joe gave me a demo. until then i did not really understand
one day i received a letter from Masimo saying they were paying dividends. Here came
was a bit of a risk taker who believed in people and new things, and
how a pulse oximeter worked, or its life-saving benefits for patients
$200,000. in another year’s time, $100,000. then another year, and $90,000. i was quite
he would jump on innovative products if they hit him right. With
resulting from accurate measurement of blood oxygen levels. i was
surprised to count that amount of money!
Masimo, that happened repeatedly; he invested several times.
very impressed with the demo on the kitchen table. i asked Joe, what
36
Harish and Gita Patel
37
would be the next step. He mentioned finishing off some fixes,
“i am very proud of Joe, and what he has accomplished, at such
that i knew in Silicon Valley. i was based in San Francisco.
that has gone into making Masimo what it is today. i think
may confront in life, with a positive attitude and a winning
refining it over the next few months, and finding investors so
a young age. thank you, Joe and family, for your friendship. on
i introduced Joe to Val Vaden, who brought major financial
Joe has demonstrated that ultimately by having a vision,
spirit. Joe Kiani and the story of Masimo embody all the the
robert Feibusch
they could launch, at which time he would leave anthem.
Masimo’s 25th anniversary, i wish you even more success, health
investment to Masimo.
putting your energy and your hard work behind it, and
traits that i talked proudly about that day.
and happiness, and many more anniversaries in the future. Keep
remaining a high integrity individual who always tries to
> Bob had been a successful entrepreneur, sold his company for
“over the next couple of weeks Joe asked me if i would be
up your great work.”
willing to invest. Regrettably, i could not, as my wife had just
started a travel agency which had consumed my savings. but
i approached some of my friends and sold the idea to three
indian doctors. these friends asked to see the product and
Bobby Yazdani
“in addition to my involvement as a small investor, and in
making introductions to Joe, one summer i went to orange
county and helped Joe and Mo with some of the software
that they were trying to write for their system. these were
very, very early versions of Masimo Set. Mohamed had a two-
do the right thing for other people, you can do very well.”
“i had the pleasure of being a small contributor to Masimo’s
$100 million, and then set up a small investment group with a
omid Kordestani
success through a chance introduction from a close friend
friend of his who had been his board member. When an associate
of mine who i went to school with from first grade in iran.
made him aware of Masimo, Bob not only invested an initial
bobby yazdani was an advisor and friend of Joe. in the
$500,000, he became a mentor to Joe. Bob and his partner
early days of Masimo, bobby invited me to make a small
spent a lot of time providing advice any time Joe needed to visit
meet Joe. So there was another demo on Mohamed’s kitchen
> Shortly after Masimo began, Bobby, a very good software
bedroom apartment, and one of the bedrooms was his lab.
> Introduced to us by Bobby Yazdani (who was a childhood
investment in the company and become a friend of Joe and
them. They helped 26 year-old Joe in thinking through company
table. after a little more convincing, the doctors decided to
developer, brought object-oriented software development into
i had a software background, so i tried to share some of my
friend), Omid brought a savvy aspect to our company in the way
Masimo and the journey they were about to embark on.
planning, and even helped out in meetings with OEM customers.
invest $10K each. both Joe and Mo were ecstatic. So was
Masimo so that we didn’t create spaghetti code. He would
experience in terms of production quality software. i advised
of advice, along with his own investment. He had been involved
at the time, i was busy growing this small startup called
i, as these doctors providing the money were very tough
fly down from the San Francisco Bay Area on weekends and
them on software practices for their devices.
in several high-flying startups that failed, but those failures didn’t
google that i had joined as its first business executive
“i belieVe we were THe FirST non-private financial investor
customers and they asked a lot of searching questions!
brainstorm with us about software. He introduced us to a big
faze him, he would go on to become the first business person
and employee number 11! i had invited my friend bobby to
in Masimo. at the time i met Joe, we were active investors.
angel investor that invested initially half a million and then
“Since that time, Joe has been a great friend and he
hired by a new company called Google. Omid offered to help any
make an investment in google and he invited me to do the
Val Vaden was working at our company and introduced us
“in January 1990, Joe called and mentioned he had left
later another half million. Bobby helped us bridge between
supported me with my company, Saba, when i founded it and
way he could, and described Joe as the epitome of what a CEO
same in Masimo. the relationship evolved from there and
to Joe and Mohamed through a mutual friend. i remember
anthem, and that he and Mo had founded VSi (Vital Signals
the small family friend investors to venture capitalists.
when we took it public. He helped me as a board member of
should be like. He pushed Masimo to major investors.
i introduced my Stanford business School classmate Val
very clearly our first meeting with them. they put their first
inc.). He also had secured some office space and a couple
That changed the paradigm.
my company and gave me a lot of advice as i was developing
Vaden, who was a successful investor and Vc, to Masimo.
prototype on my finger to demonstrate how it worked. Well,
of engineers, bob Smith being one of them. initially, i had
Saba and also through its growth years. He helped me
“aT a commencemenT SpeecH at my undergraduate
Val in turn invested in Masimo at a critical time in Masimo’s
it didn’t! During the test Joe couldn’t even get a signal and i
reservations about Joe’s very aggressive timeline for going to
“i waS inTroduced to Joe Kiani through a common
build my business. Joe is a high integrity guy, and he’s very
school, i had the privilege of imparting some of my life
evoluation.... and the rest is history!
thought he was going to panic. then he said to Val, ‘Well of
production with the first pulse oximeter due to various FDa
family member, and Joe told me what he was trying to
humble. Nothing gets to his head, and he’s no different
lessons to the graduating class of 2007 at San Jose State
course it couldn’t work. bob is obviously a regular venture
requirements. Still, i had a strong hunch that Joe with his
accomplish. at that time i was a new software engineer at
than he was 20-some years ago. the industry really hasn’t
university. the key theme of my talk was the ‘immigrant
“great individuals with a heart of gold, a great smile, and
capitalist; he has no heart.’ We all cracked up, and to my
vision, optimism, drive to succeed, and his trust in the people
oracle. and i got very interested in the project – i got very
changed him much, in terms of his empathy for people.
attitude’ and how i believe it can be a key ingredient for
winning immigrant attitude like Joe Kiani, make the world
great pleasure, i invested anyway. years later, i told Joe that
he worked with would allow him to lead a successful company
interested in the space. i was an early investor and i tried
i think of Joe’s vision of how ultimately technology can
success for everyone. i talked about the singular focus to
a better place! i am proud and honored to have a small
i decided i had to invest in him. it’s how you overcome those
that would be a leader and envy of the medical field.
to put Joe and his vision in front of some of the people
evolve this category of life science. it’s a lot of hard work
succeed and breaking through any and all barriers that one
part in their success.”
obstacles and deal with them that matters most.”
manizheh Kiani
Bobby yazdani
mohamed diab
38
38
Pre-thanksgiving lunch catered
by manizheh Kiani, Joe’s mother
omid Kordestani
39
39
Early Advocates
as told by the late Jeremy swan, steve Barker,
Mitchell Goldstein, Peter cox, and augusto sola
starting with a relatively small amount of financing, and no marketing department,
the creation of masimo was a continuous uphill climb. When they invented set® –
signal extraction Pulse oximetry technology – in 1989, they managed to separate
the arterial signal from the non-arterial noise (e.g. venous blood movement during
motion). this gave the company the first and only pulse oximetry technology
scientifically and clinically proven to be accurate during challenging conditions
of patient motion and low perfusion. Great news, but how do you sell a pulse
oximeter in a market dominated by one company? simple – you get the thought
leaders in medicine to review it, hoping that you can prove you’ve built a much
better technology as promised. that approach takes courage because bad results
from respected medical authorities can result in the demise of a fledgling company
with limited assets. approaching the problem fearlessly, Joe Kiani and his team
sought out tough but highly respected experts to study and test masimo products.
speaking to the true quality of their innovative technology, masimo won the day
and in some cases, saved precious young lives.
Jeremy swan
steve Barker
“Sometimes the truth hurts, but it’s the best course. i was an expert
witness in the first Nellcor patent-infringement trial. i was on the
witness stand being cross-examined by the Nellcor attorney. i had
> H.J.C. “Jeremy” Swan (June 1, 1922 – February 7, 2005) was an Irish cardiologist who was
> Dr. Barker had done more studies on pulse oximetry than anyone
been talking about how in our clinical study we found that Nellcor
a president of the American College of Cardiology, and Chairman Emeritus of Cedars-Sinai
when he came to our attention. He always published the truth. In
pulse oximeters failed quite often during motion. the guy said, ‘Well
Medical Center’s Division of Cardiology.
fact, his study on the first company that made reflectance pulse
tell me, isn’t the Nellcor pulse oximeter correct some of the time?’
oximetry showed its limitations and put that company out of
Without hesitating, i replied, ‘yes, and a broken clock is right twice a
As the co-inventor of the Swan-Ganz catheter, Dr. Swan was a rock star among doctors.
business. That’s when we knew he was the clinician-researcher that
day.’ i could hear the titters from the jury.
dr. steve Barker
When no one knew who Masimo was, his presence made everyone pay attention. With
we wanted to have studying our pulse oximetry technology. When
Dr. Swan’s encouragement, Masimo developed Halo Index,™ which provides a cumulative
Joe walked him through how Discrete Saturation Transform worked,
“When i met Joe he was just a kid, about 23 or 24. i sometimes
trending assessment of the global patient status. Dr. Swan was the founding Chairman of
because he’s an engineer as well as a doctor, he loved it. He never
think of him as an adopted son; he’s about the same age as my
our Scientific Advisory Board and was invaluable to Masimo’s evolution.
asked for any money for any study he did. If it weren’t for Steve
oldest child. He called me when he and his partner were starting
Barker, clinical people might never have believed in us. Now we’re
this new company, called Masi-something. i had published a
When our company was no more than two young engineers in a garage, Dr. Swan
very proud to say he’s the chairman of our Scientific Advisory Board.
number of pulse oximetry papers and consulted with companies
generously gave his time and moral support. As the founding Chairman of our Scientific
like Datascope, Novametrix, and even Nellcor. i believed in his
Advisory Board, he made our goals very clear when he urged us to: “deliver the highest
“i conSulTed once For a STarT-up companY called Sentinel.
product early on and helped with studies. i watched the company
fidelity signal possible and let the clinicians decide on how to use the newly available
they were the first company that commercially marketed
grow from the startup in Joe’s apartment to what it is today.
information.” From that time forward, we did just that.
reflectance pulse oximetry, with a sticky pulse oximeter probe
through it all, he has kept that wonderful, child-like curiosity
He lived a long and productive life, and was a friend we hated to lose. Dr. Swan made great
rather than transmitted light. i did some work with them,
curiosity and the desire to always make things better – that’s
medical contributions and triggered other developments that helped mankind. It was
including a small clinical trial, and i finally said, ‘look, i have to
what has made Masimo different. they’re always exploring new
wonderful for us all to have lived in a time that Dr. Swan was among us.
be honest with you guys. it doesn’t really work, and here’s why.’
technologies. they’re constantly looking at new stuff and when
that you slapped on the forehead. it measured reflected light
about him, which i often tell him, don’t ever lose. that constant
“conventional pulse oximeters are a fair-weather
friend. Masimo Set® is a foul-weather friend.”
Jeremy Swan, md
Former chairman of Masimo’s Scientific advisory
board and chairman, emeritus cedars-Sinai
Medical center’s Division of cardiology
it had a very high failure rate due to venous pulsation in the
i give him my own ideas – and i come up with a lot of hare-
forehead with a patient in the supine or trendelenburg position.
brained ideas – they always listen and some of them actually get
they were very nice people, but i published a study that basically
developed. For example, i was pushing Masimo for years to look
put their company out of business. So, when Joe Kiani came to
into multi-wavelength pulse oximetry. Now they have become
me for advice, he knew that just because i like the people that
the pioneers and dominating force in that whole market. they’re
have asked me to do a study, it didn’t mean i would change my
the only company today that makes a multi-wavelength pulse
standards. in fact, years later, he told me that is exactly the
oximeter that can not only measure carboxyhemoglobin and
reason he came to me. i had proven that i would be scientifically
methemoglobin but now it can even measure total hemoglobin.
honest. When i did my first study, i couldn’t believe the results,
so i wanted to find out why it worked. When Joe explained the
“i often remind Joe that Masimo is the embodiment of the
technology, i said, ‘that’s incredible, why didn’t i think of that?’
american Dream, and i kid him about it, too. but his story truly is
dr. Jeremy swan and Joe Kiani
40
Party for shipment of
first masimo set® board
41
dr. mitchell Goldstein
dr. augusto sola
the american Dream. He started with new ideas and brains, skill
‘i have this new oximeter that we’ve been trialing. it is not FDa-
at that time. there was: ohmeda; Nellcor; and HP (the bedside
ucla and division director at cedars-Sinai. When i arrived there in
and a lot of determination, and then guided it forward to where it
approved. We’ve been using it to read saturations at times when
monitoring system we were using), which eventually was acquired
1997, i was interested in improving neonatal outcomes based on data
is today – a thriving, leading company with a bright future ahead.”
we wouldn’t otherwise be able to get a reading.’ the dad consented
by Philips. None of these companies would agree to include the
and implementation of actions into clinical practice. When reviewing
Mitchell Goldstein
moments, i had a saturation that improved from initially 10-15% as
our patients needed a robust, read through-motion system that
available data could not be accurate. So i started to look deeper into
we continued our therapy. if we hadn’t had that oximeter, we would
was able to accurately measure saturations below 95% (we deal
that area, while building a new Nicu and asking for newer equipment.
for the baby to be on study. this was Masimo technology. Within
Masimo technology. it was clear to us in the pediatric world that
data i was struck by several issues, one of them being RoP. the
have stopped. this baby was Joshua Diaz, the first life saved with
with a large congenital heart disease population). and, through
dr. Peter cox testing masimo pulse
oximeter while breathing nitrogen
> When Joe gave Dr. Goldstein a demo of our pulse oximeter, he was
Masimo technology. in addition to being featured in the New york
testing in our own institution, Masimo was the only one that met
“at that time, i read two abstracts of pulse oximetry technology,
so impressed by its ability to read through motion, he called every
times article, Joshua was invited to the Society of critical care
those criteria. to get Masimo technology, we had to change the
one by Dr. Steven barker. all of the technology existing then had a
doctor and nurse in the hospital to come see it, and they were all just
Medicine meeting to see Joe receive the technology excellence
patient monitoring company we used. i believe we were one of the
lot of false alarms and nurses were very frequently turning them
10th anniversary party
blown away by it. One day, he called about saving baby Joshua Diaz’s
award, the same technology that saved his life. Without Masimo,
first institutions to implement standardized monitoring across
off. i read these abstracts, and i started to contact people. With
life and that story became the lead in the New York Times exposé on
Joshua would have been dead before he was even a month old.”
the institution. We adopted Masimo technology hospital-wide and
some difficulty i was able to get the Masimo technology into that
Group Purchasing Organizations. Mitch testified at the Senate hearing
about GPOs despite pressures that he not, and has always been one of
our greatest friends.
Peter cox
“in 1995, i waS on call when i heard from the emergency room.
> After a completely unnecessary death due to poor monitoring at
we’ve been satisfied with our choice ever since.”
hospital, and we also changed the clinical protocols using Spo2
augusto sola
from the minute after birth.
“after two or three years, we published the first prospective paper
on Spo2 targeting, which was a breakthrough. We showed for
i was told, ‘We’ve got a baby here who doesn’t look so great, and
Toronto’s Hospital for Sick Children in the mid-1990s, Dr. Cox and
> Joe met Dr. Sola for the first time after he read the The New York Times
the first time that with the breakthrough accuracy of Set pulse
we’d like to send him up to you in the Nicu.’ i was told he was a
a hospital team searched everywhere for the most reliable pulse
article on the GPOs that came out in 2002. He had a hypothesis that the
oximetry even during motion and with good protocols, many
few weeks old, was breathing kind of hard, and he looked kind of
oximetry and contacted Masimo. He tested the equipment personally,
high levels of oxygen given to premature babies and the back and forth
more babies with birth weight under 1,500 grams could go home
blue. Five minutes later, he was there in the Nicu, and he looked
fought to replace the hospital’s Philips equipment with GE who had
jockeying of levels was contributing to retinopathy of prematurity (ROP).
without severe retinopathy, and they and their families could lead
in extremis. We started doing everything we could. We placed a
integrated Masimo SET® (they’d been with Philips for 30 years),
He was right. To test his hypothesis, he needed a pulse oximeter that
normal lives without the emotional and economic burden of a
breathing tube with no response. We had the baby on an N200
completed the first installation of continuous Masimo monitoring on
was accurate even during motion and low perfuison. Masimo, of course,
life with blindness. that was a lifesaver. but this was not only an
pulse oximeter that could not obtain a signal. the baby was not
any general floor, and has been a huge advocate ever since.
was it. He fought to get Masimo pulse oximetry into use at the Neonatal
individual issue for babies and families. it was also a large societal
moving. We had an electrical tracing of the heart rate, but the
Intensive Care Unit (NICU) and lost his job over it. Eventually, he won the
contribution made by the then new Masimo technology leading
nurses and the respiratory therapist thought it was obvious that
“an inQueST in 1999 set our team at the Hospital for Sick
war, his ground-breaking study proved that proper titration of oxygen
to a significant decrease in health care costs related to the care of
the baby was going to die. they asked me to stop. We sent off a
children, toronto, canada on a plan to monitor every bedside in
using Masimo’s pulse oximetry can reduce ROP dramatically, and Dr. Sola’s
blinded individuals for life.
blood gas but the lab was a half an hour prospect because it was
the hospital. i first met Joe Kiani in 1999, and then again a couple
work has saved thousands of babies from blindness.
downstairs in the basement. a respiratory therapist had to come
of times in 2000. We were searching for an integrated monitoring
“according to lao tse, gratitude is the memory of the heart. it is
get the blood, go downstairs, run the tests, and then run it back
system that was both centralized and could be spread out through
“wHen i waS a clinical direcTor at the university of california
with heartfelt memory that i thank and congratulate everyone who
to us so that we could confirm the reading. So i told the parents,
the institution. there were a number of monitors on the market
San Francisco, i was offered the position of Professor of Pediatrics at
made that advancement possible.”
reception desk
at madero office
42
42
43
43
The Venture
Capitalists
as told by Jack lasersohn, robert coleman,
Jonathan osgood, Jim scopa, and
lawrence saper
When masimo set® technology was first perfected, Joe, mohamed, and the team
naturally wanted to get the technology in use for patients asaP. they calculated that
to do that, they should license their invention to market leader nellcor or another
company. they also discussed creating a standalone device, but other ideas came
from the first major investors, who came to masimo by way of silicon valley. the
route to robert feibusch, Jack lasersohn, and other venture capitalists over the years
turned a small path into a medical technology super company. one investor wanted
Joe and mohamed to merely create ideas and license them. others wanted to replace
Joe as ceo – the reasoning being that almost no one was good at both innovating
new products and running a company, too. the investors who lasted and profited the
most, however, saw kindred spirits in Joe Kiani and mohamed diab, people who like
themselves were willing to risk it all to make a major difference in the quality of life
and health in the world.
Jack lasersohn
robert coleman
loses its innovative energy and momentum. i think that is the
silent battle. When all is said and done, Masimo’s biggest victory
may actually be its constant stream of innovation. and then, there
> Jack came to us as a co-investor with Warburg Pincus in the mid-1990s. He was one of the
> A born entrepreneur, Bob had been CEO of another company, sold it,
are the unstated scenarios of having management leadership –
smartest people who had ever come in contact with Masimo. At one point, he led a charge
and became very wealthy. He was asked to join the Masimo board at
specifically, Joe – that manages to stay ahead of all the growth
to take over the company but once he had a change of heart, he became one of the biggest
a time when the board kept second-guessing everything Joe was doing.
challenges. Masimo has done that.”
contributors to the board and a great company friend. When we were having a tough time with
Bob had so much credibility he was able to convince other members
the patent litigation, he spent many days helping us strategize and has been offering great
of the board to let Joe run the company as he saw fit. When Warburg
advice for decades.
Pincus tried to take over, Bob found the way out of that. With great
comprehensive advice for years, he has always been a wonderful support.
Jonathan osgood
oem adopters of
masimo technology
“our companY THe VerTical group is one of the leading medical device venture
> Jon Osgood had a huge brand name as an analyst in the days of
capitalists. there’s a myth that Vcs make financing decisions on the basis of personalities,
“in 1996 edward caHill, who has now been a fellow Masimo
our initial attempt at going public in 1996. When market situations
the people running things. While it is true that we always try to get the best management
board member for 15 years, told me he had received a copy of a
proved to be less than fruitful for an initial public offering, he led us
team, it’s actually a myth that venture capitalists make personalities the #1 item. the
fundraising document from Joe Kiani. He asked me if i would mind
into private deals that helped us raise tens of millions, crucial dollars
important factor is usually the strength of the technological idea. the reason for the myth
traveling to california to meet with Joe and advise him on the
to help us go from an R&D company to a fully commercial one. He was
is that usually most of the people who start companies are not the people who are going to
merits of a Masimo investment. i had just completed 21 years as
always a staunch supporter, and much appreciated.
be able to run them when they get larger. and the reality is that the management is often
a medical device ceo at the time, and i had just sold a company
changed from the first time you make an investment in the company to the time it goes
called MediSense to abbott laboratories. Joe and i formed a
“wHen i waS inTroduced, i was head of the Healthcare
from a few people to be 50 to 100 people.
relationship and in 1997, i joined the board. i’ve been a member
Research group at alex. brown & Sons, inc., and i was also the
ever since. before Masimo became public, Joe and i went off to
research analyst responsible for the medical technology industry.
“in my career, i have usually had the greatest success with companies with a great
a trade show event in Hawaii. We were sitting at a shrimp shack
My partner in alex. brown’s investment banking division, Donald
technological idea that’s been well executed. there have only been two exceptions to
getting lunch at a rustic place in oahu. Joe looked at me and said,
Notman, had discovered Masimo and Joe Kiani and thought it was
that rule, where i have invested even when i did not think the business was a great idea,
‘bob, what’s it going to be like to run a public company?’
a promising company. Masimo was looking to raise a private round
but where i thought the entrepreneur was so extraordinary that i wanted to back him no
of financing and wanted alex. brown to act as agent. but for alex.
robert coleman
and Joe Kiani
matter what. Masimo was one of those cases. When i met Joe Kiani and Mohamed Diab, i
“i said, ‘Joe, i have just recently finished a tour of doing that myself.
brown to sign on, both investment banking and research had to
thought that this was one of the most extraordinary entrepreneurial teams of my career.
First of all, i would rather own the shrimp shack, broken down picnic
agree to do the deal, and that required customary due diligence
their business idea, however, was to try to solve an almost impossible technological
tables, and some chickens scratching on the ground underneath
and meeting the company. Joe and the company left an indelible
problem and then compete head to head with a monopolist – Nellcor – and i thought that
the tables. and the second thing i have to tell you, as ceo of a
impression with me.
was really a terrible business plan. i told Joe, ‘i really hate this idea. i wish i could convince
public company, is you’d better start thinking about what it might
you to do something more reasonable, but i’m going to back you anyway because i think
feel like to be the only fire hydrant in a town full of dogs.’ that said,
“the only time that Joe and his team’s schedule aligned with mine
you and Mohamed are two of the most talented young guys i’ve met in my life.’ that’s
the biggest hurdle that an emerging company has to overcome is
was an evening in chicago. i was flying in from a week in europe,
how i came to invest in Masimo. Sometimes you just need to have guts and go with your
what i call the one trick Pony Syndrome. that is when you have
and Joe was flying from Southern california. i arrived on time in
instincts about people. obviously, that bet paid off.”
your bright ideas, you get a company going, and then the company
the evening, but i soon learned that Joe’s flight was delayed. and
44
technician at Hospital for sick
children in toronto, canada
45
the delay kept getting longer. at about 7:00 PM chicago time Joe’s
flight had still not taken off from orange county, and i called Joe
Jim scopa
to tell him that we should postpone. it was the equivalent of about
“We made another attempt in 2001 to get the company public,
“mY companY, Datascope, had the objective of having a comprehensive
but it just wasn’t to be. the market went south on us again, as
physiological monitoring apparatus. the variable of pulse oximetry,
lawrence saper
part of the dotcom bust. by the time Masimo went public in
measuring a concentration of oxygen in a patient’s blood, was an essential
1:00 aM for me, having just been in europe. i was tired, and i was
> Jim Scopa was the banker whose involvement with Masimo blended
2007, i had already changed careers and come to MPM capital
component in making up a complete physiological profile. at some
sure Joe would rather just go home and reschedule. but Joe, in that
in beautifully with the advice we got from Jonathan Osgood. Jim
to do venture capital. So when Masimo’s initial public offering
point, we considered do we make it ourselves, or do we see what’s out
calm, smooth voice, assured me that the time wasn’t a problem, that
became a great friend and assisted us with great financial advice at
ultimately happened, i felt like a proud father, but i wasn’t there
there. i clearly wanted to see what was out there, and the best thing
nothing was more important than this meeting, and that the pilot
every step of the way. Eventually, he became a venture capitalist so we
at the birth. Nevertheless, as everybody is aware, that iPo turned
that we found was Masimo. i discovered that my motivation for
had assured him that they would fly.
couldn’t work with him as a banker any more, but the total support he
out to be more than a 10X return for the investors we brought
getting into business and the way i do business was very consistent
gave us in every way possible will never be forgotten.
in, and for some, an approximately 200X return, even before the
with that of Joe Kiani. We both pretty much look at the world – the
“i hung up, and went to bed, sure that he would never make it to
legal settlement with tyco/Nellcor. So it was a happy day and well
technology world, the business world – in the same way.
chicago, or if so, we’d meet in the morning. about 2:00 aM i was jarred
“wHile i waS aT the former alex. brown, we made a valiant
worth the wait.”
awake by a loud knocking on my hotel door. a thin, very young, dark-
attempt to take Masimo public in June of 1996. the window
haired guy stood at the door smiling at me. i thought it was someone
closed before we could get there. given what happened in the
from room service who had gotten the wrong room. but i soon realized
market after that to early medical device company valuations,
that i was standing face-to-face with Joe Kiani, who was there to have
the company was probably better off private. even though we
lawrence saper
“i take a measure of a person depending on a number of elements.
i get a picture of somebody: either i like them or am neutral or i
dislike them. it’s rare that i dislike someone, but it’s also rare that
i find someone who’s working for the same reasons as i do. and
our meeting. i was incredulous, and a bit sour for being wakened at
couldn’t get the company public, we immediately went into a
> As founder and CEO of Datascope, Larry seemed angry at our first
who talks straight, thinks straight, and has a sense of humor,
celebrating one
year on nasdaQ
2:00 in the morning. For the next three hours Joe talked passionately
private placement process and generated $10 or $15 million. it
meeting because he wished he had learned about Masimo sooner.
which Joe Kiani has. We looked outside and discovered Joe’s pulse
about Masimo, its technology, and his strategy for competing with
was 11 years from the time that the company first attempted to
He loved what we were doing. When none of the major OEMs in
oximetry abstract, which was very good for us, so we made an oeM
Nellcor. by the time he was finished, the sun was coming up and
go public in 1996 to when it actually did in 2007. that is probably
the U.S. were putting Masimo in their products due to GPO/Nellcor
deal where we bought instrumentation from Joe’s company and
he had me convinced that Masimo would be successful and worth
a record. usually, such efforts die a natural death in that amount
blockage, Larry put Masimo into his products and by promoting that
incorporated it in various forms in our monitoring apparatus. later,
backing. Joe’s persistence, passion, patience and salesmanship were all
of time. and it was unclear how the company would best get to
action, basically forced all other OEMs to sign up. Later, he made a
Masimo had developed to a point where Joe needed capital, and we
displayed at that meeting and in the hours that led up to it. i knew we
market with its technology. Nevertheless, i would say we raised
major investment in our company at a very crucial time, making him
invested. it was unique for us because we never did that before or
had a winner because i knew Joe would never give up, ever.”
something like $50 million for the company privately over time.
one of our favorite people, ever.
since. We were never in the business of lending people money.”
46
46
forbes names masimo one of the best
small public companies in america in 2011
47
47
Taking on the GPOs
as told by seth Bloom, sen. Herb Kohl,
and Walt Bogdanich
By 2002, masimo was engaged in a legal battle with pulse oximetry industry
leader nellcor. despite occasional breakthroughs like cook county Hospital in
chicago, that the famed er tv show was about which completed a system-wide
conversion to masimo set®, the company was in essence shut out of 95% of
american hospitals due to the monopolistic practices of dominant companies like
nellcor with Group Purchasing organizations who got paid by them. When nellcor
not only manipulated GPos to keep masimo out of the u.s. hospitals, but also
attempted to co-opt masimo technology, there was no choice but legal action.
to break up the group purchasing organization oppression of small innovative
companies trying to break in with better technology, government intervention
was necessary. that came about via a senate panel chaired by sen. Herb Kohl
of Wisconsin and sen. mike deWine of ohio, bolstered by a series of new york
times articles, the first one tiitled “medIcIne’s mIddlemen; Questions raised
of conflicts at 2 Hospital Buying Groups.” that piece began with the story of
how baby Joshua diaz was saved in the hospital as a newborn due to use of a
masimo monitor. Walt Bogdanich, the times reporter, wrote about Joe Kiani,
“he still cannot sell his oximeter, regardless of the price, to many american
hospitals, even though medical experts say it helps the most fragile of patients –
premature infants.” the articles were devastating indictments of the GPo
payoff schemes and monopolies, and after reviewing the situation and hearing
voluminous testimony, sen. Kohl’s committee drafted legislation and persuaded
the offending GPos to voluntarily change their ways. subsequently, masimo
received its first contract with Premier (one of the two major GPos), and other
med tech innovators soon found entrée to american hospitals to be much easier.
> our cruSading HeroeS: Masimo had technology that was 30 to 100 times better than
any other pulse oximeter available, yet we could not sell it to hospitals in the U.S. due to the
GPO monopoly. So we concentrated on small NICUs and non-GPO based hospitals, which
were few. Then we noticed that Medical Device Manufacturers Association (MDMA), a new
group representing medical companies, publicly said there was a problem with this whole
GPO setup. That led us to Seth Bloom, an aide to Senator Herb Kohl, who was conducting his
own relentless investigation.
MDMA told us we had to come to Washington to visit Sen. Kohl’s people, specifically Seth, a
true idealist. Sen. Kohl was wealthy and didn’t need to raise money to become elected. He
held hearings on the issue and thanks to him and Seth, we were able to sell our products in
the U.S. and save countless lives and the eyesight of thousands of premature babies. We all
owe Seth and Sen. Kohl copious thanks.
When we contacted 60 Minutes about our issues, they gave us Walt Bogdanich’s name.
Walt, while previously at ABC News, broke the controversial story about tobacco companies
manipulating nicotine to make cigarettes more addictive. Walt said the story was so big he
was willing to go to The New York Times with it. Since a 15 minute segment wouldn’t do it
justice, he got an agreement from them to do a whole series on the GPOs if Joe was willing
to step up and speak up, and he certainly did. About a year and a half after Joe assisted Walt
on his investigation, the story was shelved in the wake of 9/11, but when the story finally
launched in March 2002, it helped change the healthcare industry for the better.
seth Bloom
“THe group purcHaSing organizaTion iSSue and how innovative medical devices were
being prevented from reaching patients first came to my attention at the end of December 2000.
there was a meeting, i believe, sponsored by the Medical Device Manufacturers association.
there was a group of maybe 10 or 15 people around the table in my office and i was in a sort of
shock about the situation. it caught my attention in particular because it affected patient health
and safety. i couldn’t imagine a more important competition issue. after having this meeting,
i brought it up with Sen. Kohl, whom i worked for at the time, and who was the senior Democrat
on the antitrust Subcommittee. i didn’t meet Joe Kiani until sometime in 2001.
“When the New york times stories on gPos appeared in 2002, we were already planning
our hearing where Joe testified, but the first times story definitely attracted Sen. Kohl’s
attention. He was appalled by the kinds of things the paper was writing about. the
Senator felt the most effective use of the bully pulpit of a congressional hearing was to
get the gPos, and their trade association, to agree to change their ways voluntarily. Joe’s
testimony was vitally important at the first hearing.
“those testifying all told the same story – how the gPo system
prevented crucial, in many cases potentially life-saving,
devices from reaching patients and helped entrench the
market positions of the large vendors.
“this hearing led to the gPos establishing codes of conduct, which
they did only after Sen. Kohl turned the spotlight on them and
we threatened legislation to remedy the situation. among other
things, the leading gPos and their trade association agreed to
end some of their worse practices – for example, ethical abuses
and conflicts of interests where gPo executives would have
investments in companies that obtained gPo contracts. and
many of gPo-negotiated contracts were five to seven years. the
gPos agreed, for clinical preference products, to limit the length
of the contract to three years, which obviously gives competitors
a better shot at getting in. and they agreed to end exclusive, sole
source and bundling contracts for medical devices. Sen. Kohl was
very directly involved in negotiating with the two largest gPos to
get them to use these voluntary codes of conduct. it was quite an
achievement. We had our first hearing in 2002 in the spring.
“by the summer of 2003, we had these agreements in place.
So that was a major accomplishment of these hearings.”
sen. Herb Kohl
“i waS VerY impreSSed by Masimo and its ceo, Joe Kiani.
in my view, Masimo was exactly the kind of company we
wanted to encourage, an upstart company, founded by
immigrants, taking on the industry’s incumbents with a
better product. and this product was a basic medical device
key to helping prevent blindness in premature babies. i was
quite disturbed to learn that hospital gPos, acting at the
behest of dominant suppliers, were effectively preventing
Masimo’s devices from reaching physicians and patients. that
patients – particularly premature babies – could be denied
access to these critical devices was shocking to me. the
experience of Masimo and other similarly situated medical
device manufacturers led me to conclude that something had
to be done to end the stranglehold on the market of the large
incumbent suppliers resulting from the gPo system.
he needed to obtain contracts. i don’t know whether we could
have achieved the reforms to the gPo system that we got the
gPos to agree to without Mr. Kiani’s testimony.”
Walt Bogdanich
“i HaVe a cloSe Friend who worked in the medical device
arena and he had complained many times about the out-
sized influence of group Purchase organizations. i always
thought of gPos as inherently good. the story he told me
painted a very different picture of them.
“i recall that Mitchell goldstein, a physician from a Southern
california hospital, offered compelling testimony at our first
hearing in 2002 about being denied access to Masimo’s
devices, and the dangers that posed to his patients, including
premature infants.
“our interest in the gPo system was to insure that patients
received access to the best medical devices at the best prices.
While we did not get involved in this issue to benefit any
one company or group of companies – we were just acting to
promote competition and help patients get access to needed
medical devices – Joe Kiani’s testimony was crucial to our
efforts. i recall how sincere he was in seeking reforms and
how courageous he was in coming to testify. His testimony
exposed the shortcomings of the gPo system, and yet he
testified next to representatives of the very gPos from whom
“i can recall with great clarity my first meeting with Joe Kiani.
We were sitting and talking at a nice New york restaurant. For
some reason, i remember the sun streaming in through the
window. i had heard the outlines of Joe’s story, but i needed
him to fill in the blanks. i also needed to assess his credibility
in person. Needless to say, he passed with flying colors.
“the gPo story was a difficult one to tell. and, to be absolutely
honest, our editors did not immediately see the value in spending
a great deal of time learning about the dark side of gPos. but
we kept at it. We followed the money and it led us to an incredibly
important series of discoveries. the result was a compelling
series about the hidden hand of gPos in the marketplace.
the best part of that series – hands down – was the opening
anecdote which dealt with Joe’s product. Without that, i’m not
sure anyone would have read beyond the first few paragraphs.”
48
seth Bloom
senator Herb Kohl
Walt Bogdanich
49
The Legal Warriors
as told by Joe re and steve Jensen
as 2004 began, the patent trial was on everyone’s mind, but despite advancing in
the marketplace, masimo was $5,000,000 in debt to its law firm, Knobbe, martens,
olson & Bear. attorney steve Jensen believed in the masimo mission and urged
his partners to continue with the case, fearing that if the company did not win, it
could literally mean a great many unnecessary deaths in the future. the Knobbe
firm assembled a small army of personnel on a floor of a hotel in downtown los
angeles. mohamed diab thought it looked like a war room, with an It specialist,
computers everywhere, and steve Jensen writing the trial strategy like a field
general. to reassure his clients, attorney Joe re told masimo that it had many
legal “smoking guns” with which to go after nellcor and its parent company at the
time, mallinckrodt, while in most trials of this kind, there was only one. this was
a prescient comment. on friday, march 26, 2004, the 27-day trial was over and
masimo won to the tune of $270 million overall, with a 14.8 percent royalty to be
paid to masimo by nellcor each year for use of masimo technology. everyone at
masimo was hugely relieved, but it was too early to celebrate; with appeals, it might
be years to collect. through appeals and another trial, however, masimo persisted,
and nellcor lost. a med tech david had brought down a med tech Goliath, and
masimo showed the world that “right is might” and no just fight was impossible to
win, if you had enough determination, persistence, and truth on your side.
> our legal Team: As a lawyer, we think of Joe Re as bigger than life. He’s King Kong. He
doesn’t leave anything behind. Together with Steve Jensen, they formed a simply unstoppable
team. During our patent litigation, Steve was detail oriented, found all the facts, did all the
discovery work, and came up with the legal strategy along with Joe. And when Joe Re went in
front of that jury and displayed his mastery, our ultimate success was assured, no matter how
much trepidation we had going in and during the trial.
The patent trial victory was cleansing and healing, and the wonderful result was heavily dependent
on Steve, who was literally tireless. He would work all night leading up to and during the weeks of the
trial. At 4:00 or 5:00 in the morning he’d hand off the questions that Joe would ask the witnesses
the next day. And then Steve would go take an hour nap, shower up and come back to court with us.
He lost 30 pounds during that 4- to 5-week period, and he and Joe won us our life as a company.
Joe re
“wHaT an Honor it was for me and my partners at Knobbe to present the Masimo story to
eight strangers, a jury. as each day passed during that six-week patent infringement trial,
the contrast between Masimo and Nellcor became more and more evident. While Nellcor
was struggling to preserve its market dominance, Masimo was fighting to introduce its Set®
technology to improve healthcare for everyone.
“as the truth prevailed, the jury easily saw the stark difference
“i didn’t want to withdraw, and believed we would win the case.
between the two companies, one focused on themselves, and
i believed that patient care would forever suffer if Masimo’s
“the trial revealed that Nellcor’s executives had been telling Joe Kiani that his dream of
the other focused on the patient.”
expanding pulse oximetry was unrealistic, that he should pursue something else, or maybe
get some experience as a VP first.
“When Masimo offered its technology for Nellcor to introduce, Nellcor’s pride got in
steve Jensen
technology did not make it to the market. and if we didn’t win this
patent case, i didn’t believe Masimo’s revolutionary technology
would ever make it to patients in a meaningful way because the
much larger competitor was infringing its patents.
the way. its executives could not stomach that two young engineers, Joe Kiani and
“wHen THe nellcor paTenT lawSuiT was filed, Masimo was
“For patients to benefit, Masimo needed to be able to protect
Mohamed Diab, solved problems that had long plagued the pulse-oximetry industry.
a very small company and not yet profitable. Nellcor had a large
its innovations. and if i withdrew, i think that may have been
Nellcor refused to agree to implement Masimo’s technology immediately because it
legal team. Masimo did not have the funds to keep up and just
the end of Masimo.
wanted to keep Set®, which they referred to as that ‘killer app,’ on the shelf until its
got further and further in debt to my law firm. at one point, the
own sensor patents expired, regardless of how that plan would harm patients. guided
debt owed to my firm was so significantly impacting the firm’s
“the first bank wire Masimo received after we won was over
by his self-determination and integrity, Joe had Masimo introduce its Set® technology
financial situation that my partners wanted me to withdraw
$300 million, and Masimo’s revolutionary technology began
on its own.
from the case.
to be adopted rapidly.”
Joe re
steve Jensen
50
51
International
Advocates
as told by Katsuyuki Miyasaka, christian Poets,
and atsuhiro sakamoto
masimo’s international reach was expanded in february of 1998 with deals with
datascope corp. and Invivo research. datascope put the company in front of a
worldwide market when it agreed to integrate masimo set® into its monitors. But
before that, Japanese companies, nec medical and atom, had agreed to introduce
masimo to Japan, and a uK company, Kontron, agreed to do so in europe. this was
quickly followed by Gs electromedical, a German company whose primary products
were defibrillators and monitors used in emergency medical applications. Gunter
stemple, President of Gs electromedical, called masimo technology a “quantum leap
in performance and reliability,” which was quite a recommendation for the rest of
the european market. With the Group Purchasing organization structure in the u.s.
hindering market expansion for so long, masimo’s necessary outreach to international
markets turned into a blessing long-term, and some special champions of our work
made a big difference with their support, encouragement, and advice.
Katsuyuki Miyasaka
> Dr. Miyasaka was an anesthesiologist in the National Children’s Hospital in Japan. He did
original studies for us in Japan when NEC was implementing Masimo SET® into their products.
His data gave us a clue that eventually helped us figure out how to make a pulse oximeter that
was good even on cyanotic patients. Even better, he pushed us to complete rainbow,® which was
major, by telling Joe over dinner, “If you don’t do it, no one else will!”
“mY inTereST in pulSe oximeTrY began over 30 years ago, particularly regarding its use
in clinical settings for neonates, and in pediatric anesthesia and critical care. i was one of the
first to promote the use of pulse oximetry in Japan through my involvement in conferences
on oximetry use and publication of scientific and clinical papers from the late 1980s. My
scientific and clinical association with Masimo started in 1993 when Mr. Joe Kiani visited
Japan, from which time i became involved in Masimo pulse oximeter product development.
clinical data from physicians in the field provided important feedback to Masimo and led to
suggestions for product improvement.
“there was little interest in pulse oximeter use at the beginning because in adult anesthesia
the monitor always showed 100%, but the situation was quite different in pediatrics as
patients were always labile and fragile.
“My focus on such issues as the influence of venous pulsation on motion artifact during
poor perfusion in pediatric patients and the use of clinical data analysis contributed
to the improvement of Masimo Set® technology. the reduction of false alarms due to
motion artifact was of utmost importance in establishing clinician acceptance of pulse
oximetry. i believe its use in adult medicine was based in part upon its success in pediatric
medicine. i find many other issues, such as the importance of noninvasive measurement of
hemoglobin and dyshemoglobins, to be of great interest.
“as a physician researcher specializing in pediatric anesthesia and critical care, i have been
aware of the importance of pulse oximetry in pediatric anesthesia and Nicus and have
tried to deepen understanding of the issues involved through clinical studies that provide
information to the medical community, both in Japan and overseas. i look forward to further
development of products by Masimo in the future.”
christian Poets
> Christian rolled up his sleeves, tested our product (when it was in a little blue box) on babies
in his care, collected a lot of great data, and challenged us to make it better. He urged us to
improve pulse rate algorithm, and we did. Because of his help, data,
prodding, and then his publications, he showed our competitor’s
product not only gave false readings but they also missed true
alarms. None of this ever showed us as perfect but all of a sudden
we were seen as much better than whatever was out there.
these recordings (including the raw red-to-infrared data),
which apparently helped the Masimo team a great deal
to improve their software. i did this because i saw the
potential: there was never any money involved.
“i waS conTacTed in late 1993 by trevor Jones, a senior
manager from a british Monitor company, Kontron (Watford,
uK). they had supported us by designing a transcutaneous
Po2 monitor for home use in infants (to notify parents
of severe hypoxemia potentially leading to sudden infant
death syndrome (SiDS)). We had chosen transcutaneous
monitoring because pulse oximetry was nowhere near
suitable as a home monitor at that time. trevor told me
he had had contacts with a person called Joe Kiani, who
had developed a new, motion resistant pulse oximeter,
and asked whether i was interested in meeting this guy –
which i certainly was, as i had never liked the idea of using
transcutaneous oxygen monitors in the home environment,
and was thus keen to meet somebody who promised he had
solved its main problem, i.e., motion artifact!
“Joe walked into my office a few weeks later, and was proud
to present me his pulse oximeter. However, when i tested
this device in our patients on the neonatal intensive care
unit, i saw its potential, but in my opinion, there were still
far too many false alarms due to motion. i told him that,
and he asked me whether i would be willing to record
saturation data in some really difficult infants on our Nicu
(with a lot of motion, but also recurrent true hypoxemia),
which i was. Masimo sent equipment, and i then started
“What struck me already during our first encounter was Joe’s
determination to really improve pulse oximetry, not just to
make money. He was burning to make a potentially extremely
helpful technology better, more user-friendly and reliable, and
he could accept/respond to critique. i gave him a really hard
time in 1993, when he was so proud about his new invention,
and it was certainly not easy for him to swallow my rather
blunt statement: ‘it’s better than what i have seen from your
competitors, but not what i expect from a really good device.’
He did not ignore my critique, but took it as a challenge that
ultimately helped Masimo to become better.”
atsuhiro sakamoto
> Dr. Sakamoto met Joe Kiani in Tokyo in 2007 and provided Joe
with information about the style of Japanese medical practice and
about the Japanese medical business. Dr. Sakamoto also helped
study noninvasive hemoglobin and rainbow acoustic monitoring
as the head of the Masimo Japan Working Group (MJWG) and has
been instrumental in helping us better shape our products for
assisting patients in Japan.
“in Japan, since 2008, i have been a leader in reviewing
over 1,000 clinical data on SpHb® while collaborating with
15+ key medical institutes. i organized an SpHb study
group called MJWg with 35+ key teaching hospitals on the
subject of SpHb. MJWg shares its clinical study data with
those key teaching hospitals, and this collaboration has
contributed to a greatly improved product. MJWg not only
contributed to various clinical studies on SpHb, but also to
the penetration of Masimo SpHb into the Japanese market.
We consider this to be a great asset to the health of our
country’s people.
“i also have a strong interest in enhancing patient safety. For that
purpose, i am working on a project for our hospital to improve
patient respiratory management. i find Masimo RRa® and Spo2
greatly contributes to increasing patient safety at clinical sites.
“our hospital resources, rather than being abundant, are
limited. therefore, it is important for us to know how to
manage patient safety in critical care and in the general ward
with our limited number of medical staff. Just applying a
monitor to a patient on the general ward is not enough. Vital
signs should be monitored continuously and collected in real
time and should be closely observed and analyzed at a central
Station for the best patient care.
“the greatest importance is how quickly our staff members
grasp a patient’s medical condition and how quickly we
can take necessary actions for a patient. i am assured
that Masimo products with Spo2, RRa, Hb, and a central
monitoring system maximizing our hospital laN network
system are powerful tools for our medical staff to increase
patient safety throughout our hospital.”
52
the Kianis with _____ and dr. Katsuyuki miyasaka
dr. christian Poets
Joe Kiani and dr. atsuhiro sakamoto
53
The Researchers
masimo has been fortunate to build partnerships with some of the most renowned
researchers in the world. these collaborations are based on the fundamental desire
nitin Kumudchandra shah
> Professor of Anesthesiology at Loma Linda University;
Chief of Surgical ICU at Long Beach VAHS
to improve patients’ lives more significantly. In recognition of these individuals
dr. SHaH’S 1997 study was the first to show that Masimo Set® pulse oximetry had
for their commitment to evidence-based research, and hence to the evolution
higher sensitivity and specificity than competitive pulse oximetry during motion and
of noninvasive monitoring technologies, we have provided highlights of their
low perfusion conditions. Dr. Shah went on to complete several additional studies with
individual contributions.
similar results, including a 2010 study that showed Masimo Set® continued to have higher
sensitivity and specificity than to the latest generation of competitive pulse oximetry.
charles G. durbin
> Professor of Anesthesiology and Surgery,
University of Virginia Health System
dr. durbin’S 2000 study in post-coronary artery bypass graft (cabg) surgery found that
when comparing Masimo Set® vs. non-Masimo Set® pulse oximetry, icu clinicians weaned
patients from their ventilator faster while administering fewer arterial blood gas draws.
david drover
> Associate Professor of Anesthesiology, Perioperative and Pain Medicine,
Stanford University Medical Center
dr. droVer’S 2002 study was the first to show that Sedline® brain function monitoring
with Patient State index resulted in faster emergence and recovery from propofol-
alfentanil-nitrous oxide anesthesia, compared to standard practice without brain
function monitoring.
William W. Hay, Jr.
> Scientific Director of the Perinatal Research Center;
Director, Neonatal Clinical Research Center;
Scientific Director, Perinatal Research Center,
University of Colorado, Denver;
Professor of Pediatrics (Neonatology)
in addiTion to Dr. Hay’s clinical research in early postnatal
intravenous nutrition of the extremely low birth weight infant,
he is a global expert in the research of neonatal applications of
pulse oximetry in newborn infants. in 2002, Dr. Hay’s research
showed significantly fewer false Spo2 and PR alarms when
using Masimo Set® pulse oximetry versus conventional and
new-generation pulse oximeters in the Nicu.
Maxime cannesson
> Associate Professor of Clinical Anesthesiology,
University of California, Irvine, CA
in 2008, Dr. cannesson was the first researcher to show
that Masimo’s noninvasive pleth variability index (PVi®)
was significantly better than traditional measures used to
help clinicians assess fluid responsiveness in mechanically
ventilated patients during general anaesthesia. after Dr.
cannesson’s study, over ten studies have been published on
PVi showing similar results as well as the impact of PVi on
in addition, PVi has now been recommended in both France
surgery was the first to show that using noninvasive and
and the united Kingdom for use during surgery to perform
continuous hemoglobin (SpHb) monitoring helped clinicians
goal-directed fluid management.
reduce the frequency of intraoperative red blood cell transfusions
and the average units of blood transfused per patient.
andreas H. taenzer
> Associate Professor of Anesthesiology and Pediatrics,
Director, Pediatric Acute Pain Service,
Dartmouth-Hitchcock Medical Center;
Director of the Dartmouth Patient Deterioration
Prediction Laboratory (DP2L)
dr. Taenzer’S 2010 study with Masimo Set® pulse oximetry
and Patient SafetyNet™ was the first to show that pulse oximetry
and remote monitoring could reduce rescue activations and icu
transfers in post-surgical patients. after Dr. taenzer’s study, the
anesthesia Patient Safety Foundation and Joint commission
recommended that all patients on opiods be continuously
monitored with pulse oximetry.
Jesse ehrenfeld
> Associate Professor of Anesthesiology,
Surgery, and Biomedical Informatics;
Director of the Anesthesiology &
Perioperative Informatics Research Division;
Director of the Center for Evidence-Based Anesthesia,
Medical Director for Perioperative Quality
Michael a.e. ramsay
> Chairman, Department of Anesthesiology,
Baylor University Medical Center;
President, Baylor Research Institute
dr. ramSaY’S 2013 study was the first to show that acoustic
respiration rate (RRa) detected the cessation of breathing
faster than traditional capnography, providing a well-tolerated
solution for patients at risk of respiratory depression.
dominik roth
> Medical University of Vienna,
Department of Emergency Medicine
dr. roTH’S 2014 study showed that adding noninvasive
carboxyhemoglobin (Spco®) assessment to the standard
emergency department assessment revealed nearly twice
as many more cases of carbon monoxide poisoning being
detected than reported previously. co poisoning accounts
for an estimated 50,000 eD visits in the u.S. annually.
Dr. Roth’s study means that an additional 34,500 patients
goal-directed fluid management decisions and patient risk.
dr. eHrenFeld’S 2010 study in patients undergoing orthopedic
may have carbon monoxide poisoning, but are undiagnosed.
54
dr. nitin Kumudchandra shah
dr. charles d. durbin
dr. david drover
dr. William W. Hay, Jr.
dr. maxime cannesson
dr. andreas H. taenzer
dr. Jesse ehrenfeld
dr. michael a. e. ramsay
dr. dominik roth
55
The Masimo
Foundation
as told by Jim Bergman
the masimo foundation for ethics, Innovation and competition in Healthcare is a
non-profit organization we formed to facilitate our corporate philanthropy. during
the first quarter of 2010, we provided a monetary gift and an in-kind contribution
of pulse oximetry equipment and supplies to support the foundation’s efforts. our
$10 million gift to the foundation represented a portion of the multi-million dollar
payment received in January 2010 from the antitrust victory against nellcor/tyco
Healthcare. the foundation’s established purpose was to encourage and promote
various activities, programs, and research opportunities designed to improve
patient safety and deliver advanced healthcare to people worldwide that may not
otherwise have access to lifesaving technologies.
In addition, the foundation is meant to support third-party research, development
initiatives, and clinical studies designed to expand the healthcare industry’s ability
to provide better and more cost-effective solutions and protocols for healthcare
delivery throughout the world. finally, the foundation is intended to provide special
attention to those causes whose ultimate goals are ethical – focused on doing the
right thing for the right reasons – and designed to create healthy competition,
which masimo believes is the ultimate answer to lower health care costs in the
u.s. and throughout the world. the masimo foundation is dedicated to improving
patient care through philanthropic programs and research initiatives that foster
an environment of robust and honest competition, and enhance caregiver access
to cost-effective and innovative healthcare solutions. the masimo foundation is
also a family affair with sarah, mrs. Joe Kiani, serving on the board.
as we look back over the past quarter century and consider our struggles along
the way, we feel particularly blessed to have made it this far because there were
many times when the future seemed shaky, as the following story from a masimo
foundation board member illustrates.
Jim Bergman
> When we walked away from our first venture capital deal, Jim Bergman’s firm was one of the
a great idea and just managed to persevere basically through everything
companies involved. Despite our departure, Jim came forward and said he and his firm really
with the guts to keep trudging ahead, and they finally won. and i can’t say
like us and wanted to invest. He felt that Masimo’s valuation was six times higher than investors
there’s any better story that i can think of than that.
offered less than a year before. He not only became our first real venture capital investor, he has
always reminded us about fairness. He was our very first choice to be involved with the Masimo
“For over 30 years, i was a general Partner of firms that provided capital
Foundation, and is still onboard.
and management assistance to emerging companies primarily in high
technology, particularly those technologies associated with electronics,
“rigHT aFTer we had raised several million dollars in a round of investment, a couple of
communications, biotechnology and health care. i’ve served on the
new people joined the board of Directors. this created a board of four outsiders and three
boards of more than thirty-five companies, and i was a director of the
insiders, and there were three outside people who wanted to bring in a new ceo. they
National Venture capital association from 1985 to 1990.
wanted to move Joe over to marketing manager or engineering manager. We had
a vote, it was 4 to 3, and thank goodness, we didn’t do it. i mean, had i voted the other
“but my real love is the charitable sector. i’ve been on the boards of
way, Joe wouldn’t be the ceo.
Micro Finance banks and organizations in africa and have served on
numerous other church and charitable boards and committees. My
“When we were battling Nellcor, normally, the little guy never can outlast the big guy, in
wife and i have taken more than forty field trips to Developing World
terms of spending money. We probably spent $15 million. For a company that was not
countries with World Vision, church Resource Ministries, opportunity
making much money, that was a lot of money to spend, but we somehow persevered.
international, and other organizations.
in my experience in venture capital, i don’t think i’ve ever seen or been aware of anyone
winning that big a lawsuit when it was sort of David vs goliath.
“because i love helping others, i feel perfectly at home being on the
board of the Masimo Foundation, whose humanitarian outreach and
“Masimo is the great story of the american dream, two hardworking young guys who went
scope has been worldwide in its emphasis since the organization’s
to San Diego State rather than Harvard or yale or even Stanford or ucla and came up with
beginning. Here’s to another quarter century of success!”
rescue medical team
in Haiti using donated
masimo technology
the Kiani family at fundraiser
for Juvenile diabetes research
fund (Jdrf) with the mayor of
Irvine, steven choi
56
57
The Patient
Safety Movement
as told by President William Jefferson clinton
President William Jefferson clinton
> In the summer of 2012, Joe Kiani spent over a week with President Clinton in Africa. It was part
of a commitment Joe had made to help the President with his work for the Clinton Global Initiative
(CGI). They became friends, and Joe told President Clinton something that was fascinating but
horrifying – that three million people die worldwide every year from deaths that are preventable.
More than 200,000 of those deaths occur in the U.S. The two agreed that the goal of healthcare
in the new millennium should be more than simply providing people access to healthcare, but also
advancing a healthcare system that assures patient safety and dignity.
“i’ve been impressed by Joe’s commitment to end all deaths due to preventable
medical circumstances. i believe that the goal of the Patient Safety Movement can be
accomplished--and because it can it has to be done.
“i know big goals can be achieved. Since 2005, members of the clinton global
initiative, with their thousands of commitments to action, have had a positive
impact on more than 400 million people in 180 countries. being a cgi member entails
making a commitment and doing your best to keep it. the cgi staff works year round
to help our members develop and keep their commitments. they draw upon each
other’s strengths and create new partnerships to put their ideas into action. We call it
‘mobilizing for impact.’
“this is exactly what Joe Kiani has demonstrated in building Masimo, and in creating
the Patient Safety Movement. on their 25th anniversary, i’d like to congratulate Joe
and the people at Masimo for helping us achieve a healthier world, and commit to doing
my part until the goal of zero preventable deaths becomes a reality.”
Joe Kiani and President clinton
58
President clinton as keynote speaker
at inaugural Patient safety summit
President clinton in africa on tour
59
masimo team on 20-year anniversary
In Memoriam
It is never easy to say goodbye to a masimo team member, and doubly difficult
when someone from the masimo family passes. thankfully, there have not been
many such instances over the quarter century of our existence, but we would like
to remember here some people who gave us great service and fond memories in
their time with us all.
Scott barnhouse
Philip bonwell
Jeffery Dempsey Jr.
Patricia Jasion
Joseph Mueller
cynthia Nelson
Sue Nevill
Jennifer Nibarger
ashley chuck Smith
James Van Slochteren
Sari Wheaton
60
61
SolViNg tHe
uNSolVable
62
62
63
SigNal eXtRactioN
tecHNology®
twenty-five years ago, two young engineers asked why pulse
oximetry wouldn’t work during patient motion and low perfusion.
in doing so, they started a revolution in patient monitoring.
oVercoming THe limiTaTionS oF
pulse and normalizing the pulsating signal
conVenTional pulSe oximeTrY
over the non-pulsating signal, oxygen
Pulse oximetry had always been unreliable
saturation (Spo2) can be obtained. although
when it was needed most – during patient
this was a big step forward in pulse oximetry’s
motion and low perfusion. the industry
evolution, this core assumption has major
considered the problem “unsolvable” and
flaw – it assumes that the only pulsating
clinicians were forced to live with the
component is arterial blood.
consequences – excessive false alarms,
delayed notification due to long averaging
unfortunately for conventional pulse
times, inaccurate data, and an inability to
oximetry, venous blood moves every time
obtain data on the most critical patients.
the patient moves or breathes. this causes
Something had to change.
conventional pulse oximeters to display false
low or high Spo2 readings and pulse rates –
conventional pulse oximetry works under
causing false alarm rates as high as 90% in
the assumption that by looking at only the
icus and recovery rooms.
conventional pulse oximetry uses the standard red over infrared algorithm to provide Spo2, while Masimo Set® uses that conventional
algorithm but has added four other algorithms that all run in parallel. these algorithms allow the distinction between arterial and venous
signal during motion and low perfusion by identifying and isolating the non-arterial and venous noise Spo2 (left peak shown in blue) from
the true arterial Spo2 components (right peak shown in red) in the signal. the plot peak on the right is then chosen as the Spo2 value, since
the physiologically higher Spo2 value within the measuring site will always be arterial signal.
64
65
65
unleaSHing breakTHrougH perFormance
Joe Kiani and Mohamed Diab approached pulse oximetry
from a completely different perspective.
in doing so, they opened up a whole set of
MSt™ – to separate the arterial signal from
exciting new possibilities. Masimo Set®
sources of noise (including the venous signal)
acknowledges that both the arterial and
to measure Spo2 and pulse rate accurately,
venous blood can move and uses parallel signal
even during the so-called challenging
processing engines – DSt®, FSt®, SSt™, and
conditions of motion and low perfusion.
ValidaTed bY independenT and obJecTiVe reSearcH
over 100 independent and objective studies have shown that Masimo Set® outperforms all other pulse
oximetry technologies, providing clinicians with the sensitivity and specificity required to make critical
patient care decisions.
after six years of dedicated and focused
thereafter, skeptical clinicians around the
of Masimo Set® consistently resulted in
detection was shown to be over 97% –
research and development, Masimo Set®
world sought actively to compare Masimo
significantly fewer false alarms and improved
even during motion and low perfusion.1
debuted in 1995 at the Society for technology
Set® to pulse oximetry technologies offered
detection of true alarms. With Masimo Set®,
in anesthesia and won the prestigious
by other companies. but in study after
clinical studies have shown false alarms can
excellence in technology innovation award.
study, the breakthrough signal processing
be reduced by over 95%, while true alarm
1 Shah N., Ragaswamy H.b., govindugari K., estanol l. J Clin Anesth.
2012 aug;24(5):385-91.
miSSed True alarmS and SenSiTiViTY during cHallenging condiTionS
FalSe alarm raTeS and SpeciFiciTY during cHallenging condiTionS
mIssed true alarms //
sensItIvIty
f alse alarms //
sPecIfIcIty
43%
3%
In this hospital-based study,
investigators measured spo2 in
10 subjects during motion and low
perfusion conditions and calculated
the false alarm rate during 120 full
oxygenation events (specificity)
and true alarm rates during 40
de-oxygenated events (sensitivity).1
97%
28%
5%
nellcor n-600
masimo SeT®
Sensitivity
nellcor n-600
masimo SeT®
In this hospital-based study,
investigators measured spo2 in
10 subjects during motion and low
perfusion conditions and calculated
the false alarm rate during 120 full
oxygenation events (specificity)
and true alarm rates during 40
de-oxygenated events (sensitivity).1
95%
Specificity
66
66
67
67
induSTrY-leading
pulSe oximeTrY SoluTion
Masimo Set® is the world’s leading pulse oximetry technology,
demonstrated by both independent and objective research
and the real-world success of our customers and partners.
THe cHoice oF clinicianS in THe
timelier detection of true events, clinicians
world’S leading HoSpiTalS
can intervene earlier for better patient
because of its unmatched reliability during
outcomes and improved patient safety.1
challenging conditions of motion and low
perfusion,1 clinicians at thousands of hospitals
inTegraTed in more induSTrY-leading
around the world count on Masimo Set® every
producTS THan anY oTHer pulSe
day to help them care for patients. and while
oximeTrY TecHnologY
many leading hospitals have already integrated
Masimo Set® is integrated in more industry-
Masimo Set®, more are converting every day.
leading multiparameter monitors than any
other pulse oximetry technology – more
leading hospitals and clinicians choose
than 100 monitors from 50 leading brands.
Masimo Set® to help them deliver effective
in many of these monitors, Masimo Set® is
and efficient patient care. With fewer false
the only pulse oximetry technology offered.
alarms,2 clinicians can focus on the patients
in addition, more and more of our original
who need the most attention. With more
equipment manufacturer (oeM) partners are
accurate measurements,1 clinicians can more
enhancing the capabilities of their monitoring
tightly control oxygenation levels. and with
solutions by integrating our rainbow® technology.
1 Shah N et al. J Clin Anesth. 2012 aug;24(5):385-91. 2 barker SJ. Anesth Analg. 2002 oct;95(4):967-72.
leading hospitals and clinicians choose Masimo Set® to help
them deliver effective and efficient patient care.
Physio-control®
with rainbow®
ZOll®
with rainbow®
masimo set® is
integrated in more
industry-leading products
than any other pulse
oximetry technology
Ge® with Masimo seT®,
rainbow® integration underway
Ms-2040™
Very low power seT® OeM Board
dräger®
with rainbow®
perFormance during
moTion and low perFuSion
True Alarm Detection – Sensitivity (%)
100
90
80
70
60
50
40
30
20
10
0
Masimo SET®
Philips 24C
Philips CMS-B
Datex-Ohmeda 3740
Nellcor N-395
Datex-Ohmeda AS-3
Datex-Ohmeda 3800
Datex-Ohmeda 3900
Nellcor N-200
Philips CMS
Nellcor N-295
GE 8000
Novametrix MARS
Nellcor NPB-190
Nellcor NPB-180
Novametrix 520A
Spacelabs 90308
Nonin 8600
BCI 3304
Criticare 5040
0 10
20
30
40
50
60
70
80
90
100
False Alarm Rate – 100 - Specificity (%)
a total of 70 volunteers were tested with motorized hand motions. each
motion was studied during both room air breathing and hypoxemia. Pulse
oximeters on the stationary hand were used to provide control measurements
for comparison. sensitivity was defined as ability to detect a true spo2 <90%.
specificity was defined as the ability to detect a true spo2 >90%.2
“masimo set® is advantageous because even
though it significantly reduces false alarms, it
doesn’t do that by ignoring physiological changes.”
Philips® with
Masimo seT®, rainbow®
integration underway
Ms-2013™
low power seT® OeM Board
Mx-5™
low power rainbow® OeM Board
Welch allyn®
with rainbow®
christian poets, md
director, neonatal Intensive care medical school, Hanover, Germany
68
69
69
Helping clinicianS Screen For criTical congeniTal
HearT diSeaSe and preSerVe babieS’ eYeSigHT
From the very beginning, infants and
children have been at the heart of our
research and development. as a result,
Masimo leads the industry in solutions
designed exclusively for these most
vulnerable patients.
enabling newborn Screening For
criTical congeniTal HearT diSeaSe
(ccHD),1,2 spurring the uS Secretary of Health and Human
Services to add “motion-tolerant” pulse oximetry to the
the breakthrough performance of Masimo Set® is often most
Recommended uniform Screening Panel for newborns.3 Masimo
appreciated by clinicians caring for fragile newborns. up to
Set® pulse oximeters and sensors meet the recommended
30% of all congenital heart disease (cHD) deaths occurring in
criteria for newborn screening, were exclusively used in the two
the first year of life are unrecognized at post-natal discharge.
studies that were the basis for the ccHD workgroup decision to
Helping clinicianS reduce
reTinopaTHY oF premaTuriTY
beTTer care For cYanoTic paTienTS
opTimal newborn reSuSciTaTion
in cyanotic infants, Masimo Set® with the blue Sensor
every second matters during newborn resuscitation.
Masimo Set® pulse oximetry has been shown to reliably assist
recommend newborn screening, and were the first to receive
Premature infants requiring neonatal intensive care need
is the only pulse oximeter shown to enable accurate
the Masimo Newborn Sensor ensures the fastest response
clinicians in screening for critical congenital heart disease
FDa 510(k) clearance with labeling for ccHD screening.
enough oxygen to preserve vital organ function, but too
maintenance of targeted oxygen saturation levels.5 and for
time with maximum sensitivity – allowing clinicians to focus on
1 ewer aK et al. Lancet. 2011 aug 27;378(9793):785-94. 2 de-Wahl granelli aD et al. BMJ. 2009;338. 3 Secretary of Health & Human Services letter to the Secretary’s advisory committee on
Heritable Disorders in Newborns and children (SacHDNc); dated September 21, 2011. 4 castillo a et al. Acta Paediatr. 2011 Feb;100(2):188-92. 5 cox PN et al. Anesthesiology. 2007;107:a1540.
(abstract).
much oxygen can cause severe eye damage from retinopathy
very low birth-weight babies, only the Masimo NeoPt-500
real-time patient management instead of the device. in addition,
of prematurity (RoP). Masimo Set® is the only pulse oximetry
Sensors are designed for both size and performance in
Masimo Set® is being used by hospitals to supplement the
shown to help clinicians dramatically reduce RoP.4
infants as small as 500 grams.
standard aPgaR score to assess general newborn health.
newborn Screening
wiTH maSimo SeT®2
n = 39,821 BaBies
physical
exam alone
physical exam + masimo SeT®
pulse oximetry Screening2
Sensitivity for
ccHd detection
Specificity for
ccHd detection
63%
98%
83%
99.8%
reducTion oF rop
wiTH maSimo SeT®5
seVere reTinOPaThy Of PreMaTuriTy (rOP) raTe
center
period 1
(pre-policy change)
period 2
(post-policy change)
period 3
(post-policy change)
a
b
12% with Nellcor
5% with Masimo
4% with Masimo
13% with Nellcor
13% with Nellcor
6% with Masimo
spo2 screening was conducted on 39,821 newborn babies, preductally (palm of right hand) and postductally (either foot)
before routine physical examination. the baby was considered to be screening positive if: 1) either preductal or postductal
spo2 measurement was <90%; 2) if in three repeat measurements, both preductal and postductal spo2 were <95%, or the
difference between the two measurements was >3%.
In period one, the baseline rate for severe roP in two centers, both using nellcor pulse oximetry, is established.
In period two, the oxygen targeting policies, caregivers, and patient characteristics were the same at both centers,
but only center a switched to masimo set®, which led to a significant reduction in roP (from 12% to 5%). In period
three, center B switched to masimo set® and experienced a reduction in roP from period two (from 13% to 6%).
* eve is pending ce Mark. Not currently available in the u.S.
Masimo’s latest innovation in pulse oximetry,
eve,* is an intuitive application that transforms
the Radical-7® into a simple yet powerful
newborn screening tool designed for improved
accuracy and efficiency.
70
70
71
addreSSing THe number one TecHnologY Hazard
in HoSpiTalS TodaY–alarmS
proViding earlier noTiFicaTion oF poTenTial riSk
wiTH adVanced alarmS
core TecHnologY adVanTageS oF maSimo SeT®
significant events. Masimo Set® broke through past barriers and
alarm paradigms of the past to notify clinicians when
While standard Spo2 and pulse rate alarms can
> 3d desat index alarm™ helps clinicians detect multiple transient desaturation events that may identify patients at risk for
the Joint commission, the ecRi institute, the anesthesia Patient
reduced false alarms by over 95%. in an area like the icu where
significant changes in physiology have occurred.
sometimes provide a signal of deteriorating
respiratory failure.5
Safety Foundation, and numerous other leading industry bodies
up to 90% of all alarms used to be false, Masimo has helped
have repeatedly cited alarm fatigue among the most pressing
reduce the false alarm incidence to just 5%.4
adaptive threshold alarm helps clinicians reduce alarms
patient conditions, Masimo’s advanced
3D alarms give you another dimension of
• low Spo2 alarm limits are typically set too low to spot multiple transient desaturations that could indicate patient distress.
3D Desat index Delta alarm signals after five desaturations below 93% over a period of 60 minutes or less (Figure 2).
patient safety hazards.1-3 conventional approaches to alarm
and reduces the time required to set patient-specific alarms
advanced notification of parameter conditions
management were developed mainly to address the problems
auTomaTed, paTienT-cenTric approacH wiTH
by automatically adjusting the audible alarm to the patient’s
that may precede clinically significant events.
> 3d perfusion index delta alarm helps clinicians quickly detect critical changes in peripheral perfusion.6, 7
of conventional pulse oximetry’s inability to measure through
adapTiVe THreSHold alarm*
baseline (Figure 1).
motion. Fixed alarm thresholds and delays sometimes reduce non
We designed adaptive threshold alarm to help clinicians
actionable alarms, but with potentially delayed notification of
manage the frequency of alarms, improving on the limited
* adaptive threshold alarm is ce Marked. currently not available in the u.S.
• changes in peripheral perfusion can reflect significant underlying cardiovascular changes. 3D Perfusion index Delta alarm
notifies clinicians when there is a 25% change in Perfusion index (Pi) within a period of 60 minutes or less (Figure 3).
Figure 1: adaptive Threshold alarm example
Figure 2: 3d desat index alarm example
Figure 3: 3d pi delta alarm example
SpO2
100%
Desat Index
Alarm Limit 93%
Low SpO2
Alarm Limit 90%
alarm frequency of fixed
threshold alarm and
adaptive Threshold alarm,
both with 10-second delay.
Baseline
SpO2
Fixed Threshold Alarm Event
Adaptive Threshold Alarm Event
Adaptive Threshold
Fixed Threshold
Alarm sounds after five desaturations below
93% over a period of 60 minutes or fewer
0
20
40
60
80
Time (in minutes)
Perfusion Index
1.0
0.9
0.8
0.7
0.6
PI Baseline determined by the Radical-7
PI Delta % Change = 25
(within a 1 hour period)
Alarm triggered
100
150
200
250
300
Time (in minutes)
1 The Joint commission Sentinel event alert. 2012;49. 2 ecri institute. 2012. 3 Stoelting rk et al. APSF. 2011. 4 Shah n et al. J Clin Anesthesiology. 2012. 5 wong mw et al. J Trauma Inj Infect Crit Care. 2004; 56(2):356-362. 6 de Felice et al. Pediatr Crit Care Med. 2008;(9)2:203-208.
7 ginasar et al. Acta Anaesthesiol Scand. 2009; 53:1018-1026.
SpO2
100
98
96
94
92
90
88
86
84
82
80
72
72
1 Hour
Time
73
73
adVancing
pulSe oximeTrY
x-cal™ TecHnologY For
enHanced paTienT SaFeTY
Masimo’s newest innovations demonstrate that our commitment to pulse oximetry technology has never been stronger.
x-cal TecHnologY For enHanced paTienT SaFeTY
poor quality and performance of system components:
cable and sensor. monitors equipped with X-cal-enabled
FirST eVer noninVaSiVe FracTional Spo2 meaSuremenT
until now, pulse oximeters could only measure and display
functional oxygen saturation (Spo2). So, when patients had
elevated carboxyhemoglobin (from carbon monoxide poisoning)
and/or elevated methemoglobin (adverse reaction to more than 30
common drugs used in hospitals, like caines, nitrates, and Dapsone),
the displayed functional oxygen saturation overstated the actual
oxygen saturation value.
Masimo Spfo2™* is the first truly fractional, noninvasive oxygen
saturation measurement. Spfo2 allows more precise arterial
oxygenation assessment in patients with elevated dyshemoglobins
– common throughout the hospital and pre-hospital settings – as
compared to functional oxygen saturation (Spo2). as a result, Spfo2
should enable earlier interventions and more timely therapeutic
decisions. For example, in a patient who is a smoker with an Spo2
of 97%, carboxyhemoglobin level of 12%, and methemoglobin of
1%, if Spfo2 were available, it would be displayed at 84%. it is well
accepted that clinicians would frequently make different diagnostic
and therapeutic decisions at an oxygenation of 84% versus 97%.
TFa-1™ diSpoSable ForeHead SenSor*
expanding its versatility of sensors, Masimo now offers the tFa-1
transflectance forehead adhesive sensor as an alternative to
traditional digit sensors. the forehead provides rapid detection of
saturation changes compared to digit sites during low perfusion and
offers easy access during surgery, resuscitation, and in patients with
finger deformities or when the digit is not accessible.
utilizing more than seven wavelengths of light
and breakthrough signal processing, Masimo
rainbow® Pulse co-oximeters can measure and
display oxygen content (Spoc™), along with its
components, hemoglobin and fractional arterial
oxygen saturation (Spfo2).
and improVed clinician eFFiciencY
masimo has implemented a new technology called X-cal in
its sensors, cables, and monitors to enhance patient safety
and improve clinician efficiency. all masimo components
1) imitation Masimo sensors and cables
2) cables and sensors used far beyond
their expected life
circuit boards will not function with imitation cables and
sensors and will display a message to replace cables and
sensors that have been used beyond their useful life.
work together as an integrated system to measure through
3) third-party reprocessed pulse
the indication to change a sensor or cable only occurs
challenging conditions including motion and low perfusion.
oximetry sensors
When all components are fully functioning, the system works as
intended. In contrast, when any of these system components is
How x-cal workS
outside of active patient monitoring to avoid disruption
to clinical practice. for example, if the end of a single-
patient-use sensor’s expected life is reached while actively
compromised, erroneous measurements can occur.
X-cal is seamlessly integrated into masimo sensors, cables
monitoring a patient, the sensor will continue to operate
and circuit boards and is provided at no additional cost to
until monitoring with that sensor is stopped. at the next
X-cal is designed to address three common factors that can
end-users. X-cal can detect imitation cables and sensors
re-application of the same sensor, the monitor will display
impact measurement accuracy and patient safety due to
and measures the active patient monitoring time of each
a message to advise the clinician to replace the sensor.
1
SenSor
2
cable
3 moniTor
Masimo Set® Measure-through Motion and
low Perfusion™ pulse oximetry has three
system components: 1) the sensor that
connects to the patient; 2) the patient cable
that connects the sensor to the Masimo
circuit board in the monitor; 3) the Masimo
circuit board (Set® Spo2 or rainbow® Pulse
co-oximetry) installed in a multiparameter
patient monitor or Masimo pulse oximeter.
Patient Monitor or Masimo oximeter
* SpfO2 and TFA-1 are CE Marked. Currently not available. in the U.S.
74
75
See MoRe
Do MoRe
76
76
77
HelPiNg cliNiciaNS oPtiMiZe
blooD MaNageMeNt
With the rainbow® measurement platform – including noninvasive total hemoglobin (SpHb®) –
Masimo supports some of the most common, costly, and critical decisions made in healthcare.
riSkS and coSTS oF
in which significantly lower hemoglobin
red blood cell TranSFuSionS
triggers are used to determine need for
Red blood cell (Rbc) transfusion is one of the
transfusion – are safe.3 in addition, the
most frequent procedures performed in u.S.
cost of each Rbc unit is estimated between
hospitals, with one in ten inpatients receiving
$522 and $1,183 per unit, without including
one or more blood units.1 While blood loss
morbidity-associated costs.4 beyond the cost
during surgery is a known risk factor, Rbc
of transfusion, each Rbc unit transfused is
transfusion overuse can increase patient risk
associated with increased cost of care and
and the cost of care.2 Meta-analysis of pooled
transfusions that occur at higher hemoglobin
results from multiple observational studies,
levels increase the cost of care more than
each of which adjusts for risks between
those given at lower hemoglobin levels.5 With
patients, shows that patients receiving Rbc
the growing recognition of the need to reduce
transfusions have a 69% higher mortality, 88%
transfusions, noninvasive and continuous
higher infection rate, and 250% higher rate of
hemoglobin (SpHb) can be a key tool to help
acute respiratory distress syndrome (aRDS).2
clinicians overcome the limitations of existing
Multiple randomized controlled trials indicate
approaches, although SpHb monitoring is not
that restrictive transfusion practices – those
intended to replace blood draws.
1 aHRQ. inpatient Sample. 1997-2007. 2 Marik Pe et al. Crit Care Med. 2008;36(9):2667-74. 3 carson et al. Cochrane Database Syst Rev. 2012 apr
18;4:cD002042. 4 Shander a et al. Transfusion. 2010;50(4):753-765. 5 Murphy g J et al. Circulation. 2007;116:2544-2552. Prior to using this device,
the user should read and understand the operator’s Manual and Directions for use. laboratory diagnostic tests using blood samples should be
conducted prior to clinical decision making to completely understand the patient’s condition. comparisons between SpHb measurements and
laboratory diagnostic hemoglobin measurements may be affected by sample type, collection technique, physiological, and other factors.
“Deciding to transfuse based on a single static
measurement more often results in patients
receiving unnecessary transfusions with
increased risks, costs, and the depletion of
an already scarce blood supply. New medical
technologies and devices that continuously
monitor hemoglobin, oxygen, and perfusion will
become essential for transfusions.”
dr. aryeh Shander
chief, Department of anesthesiology, Pain Management and Hyperbaric Medicine,
icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New york
78
78
79
oVeruSe oF blood TranSFuSionS
growing recogniTion oF THe need
limiTaTionS wiTH exiSTing approacHeS
assists in better decision-making. While SpHb monitoring is
To reduce TranSFuSionS
To aSSeSS TranSFuSion need
not intended to replace blood draws, it nonetheless identifies
Many transfusions are unnecessary. a systematic, expert
the most universally available information about whether a
significant changes in hemoglobin trends and lack of
review of 494 studies for positive impact on health outcomes
transfusion is needed during surgery is estimated blood loss,
significant changes in hemoglobin between invasive blood
showed that 59% of Rbc transfusions are “inappropriate.”1
which is often overstated. Visible blood and fluid loss appears
sampling and laboratory analysis.5
given the risks and costs of Rbc transfusions, there is a growing
to indicate how much blood has been lost, but in a recent study
recognition of the need to implement strategies to reduce Rbc
at Duke university, anesthesiologists estimated blood loss at
continuous hemoglobin means clinicians have real-time visibility
transfusions. the Joint commission has introduced Patient
40% more than it actually was.4 the implication is that the need
to the directional trend of hemoglobin – whether it is stable, rising,
blood Management Measures that encourage hospitals to
for transfusion may appear to exist, when in fact it does not.
or falling. this can help clinicians avoid unnecessary transfusions
evaluate appropriateness of transfusions as a continuous quality
when the SpHb trend is stable even though the clinician may
indicator.2 the american Medical association and the Joint
How SpHb moniToring HelpS wiTH
otherwise perceive hemoglobin to be dropping. likewise, when the
commission also recently identified Rbc transfusions as one of
TranSFuSion deciSionS
SpHb trend is rising but the clinician may otherwise believe that
the top five overused procedures in medicine, defining overuse
Masimo’s SpHb measures hemoglobin noninvasively and
it’s not rising fast enough. inside and outside the operating room,
as “circumstances where the likelihood of benefit is negligible or
continuously. the noninvasive aspect makes the technology
a declining SpHb trend may also allow clinicians to identify internal
zero, and the patient is exposed to the risk of harm.” 3
easy to apply to the patient, and the continuous aspect
bleeding and permit earlier interventions.
a systematic, expert review of 494 studies for positive impact on health
outcomes showed that 59% of Rbc transfusions are “inappropriate.”
appropriaTe uSe oF TranSFuSion
InaPProPrIate //
aPProPrIate //
uncertaIn
(cid:127) 12%
59% (cid:127)
(cid:127) 29%
the american medical association and the Joint
commission also recently identified rBc transfusions
as one of the top five overused procedures in
medicine, defining overuse as “circumstances where
the likelihood of benefit is negligible or zero, and the
patient is exposed to the risk of harm.”3
494 studies were evaluated by an expert panel in a systematic method
to assess appropriateness of rBc transfusion, revealing a significant
opportunity to reduce unnecessary transfusions.1
1 Shander et al. TransMed Rev. 2011. 232-246. 2 Joint commission Perspectives.
the Joint commission continues to Study overuse issues. Volume 32,
(Radical-7) Number 5, 2012: 4-8(5). 3 http://www.jointcommission.org/
patient_blood_management_performance_measures_project/ 4 Hill SJ et al.
ASA. 2011 (abstract). 5 Frasca D et al. Crit Care Med. 39(10); 2011; 2277-2282.
Hemoglobin
continuous hemoglobin trending between invasive blood
sampling provides a real-time indication of whether:
> hemoglobin is stable when it may appear
to be dropping
> rising when it may not appear to be rising
> or dropping when it appears to be stable.
SpHb
Lab hemoglobin
Time
80
80
81
SpHb Helped clinicians reduce Transfusion Frequency in
lower blood loss Surgery1
SpHb Helped clinicians reduce the amount of blood Transfused
in Higher blood loss Surgery2
Frequency of Intraoperative Blood Transfusions
Average RBC Units Transfused Per Patient
reducing blood TranSFuSionS and coST
5%
4%
3%
2%
1%
0%
4.5%
0.6%*
Standard Care Group
SpHb Group
87%
Reduction in Blood
Transfusion Frequency
2.5
2.0
1.5
1.0
0.5
0.0
1.9
47%
reduction
1.0**
0.9
Average RBC Units
Reduced Per Patient
Standard Care Group
SpHb Group
randomized controlled trial in 327 orthopedic patients. * p=0.03 vs Standard care group
prospective cohort study in 106 neurosurgery patients. ** p<0.001 vs Standard care group
SpHb Helped clinicians decrease the Time to Transfusion,
when a Transfusion is Truly indicated2
range of potential blood cost Savings per patient with
SpHb monitoring3
Time to Transfusion Start After Need Established (min)
50
40
30
20
10
0
50.2
9.2***
Standard Care Group
SpHb Group
41min
Reduction in Time
to Transfuse
proJecTed SpHb SaVingS
range of rbc Transfusion
cost estimates
low blood
loss Surgery1
High blood
loss Surgery2
$522
$1,183
$47
$106
$470
$1,065
clinical eVidence THaT SpHb moniToring
to reduce the percent of patients receiving three or more
in lower blood loss surgery, the 0.09 lower Rbc units per
HelpS reduce TranSFuSionS
Rbc units from 73% to 32% and reduce the average number
patient with SpHb monitoring is projected to reduce Rbc
there are now two studies showing that SpHb monitoring
of Rbc units transfused by 47% (from 1.9 to 1.0 units per
costs by $47 to $106 per patient monitored.1 in higher
helps clinicians reduce Rbc transfusions.
patient).2 in this study, the researchers also showed that
blood loss surgery, the 0.90 lower Rbc units per patient
SpHb monitoring has been shown in a randomized controlled
received them sooner by 41 minutes on average.
$470 to $1,065 per patient monitored.2 these estimates
trial in lower blood loss surgery (orthopedic) to reduce the
do not take into account the expense of SpHb monitors
frequency of intraoperative blood transfusions by 87%
proJecTed coST SaVingS From SpHb moniToring
or sensors, or the other costs associated with over-
(from 4.5% to 0.6%) and the average number of Rbc units
To reduce TranSFuSionS
transfusion or delayed interventions.
with SpHb monitoring, patients who needed Rbc units
with SpHb monitoring is projected to reduce Rbc costs by
transfused by 90% (from 0.1 to 0.01 units per patient).1
to project the potential savings from SpHb monitoring,
SpHb monitoring has also been shown in a prospective
estimates for Rbc transfusions ($522 to $1,183) by the
cohort study in higher blood loss surgery (neurosurgery)
expected reduction in Rbc transfusions per patient.3
we can simply multiply the range of published cost
prospective cohort study in 106 neurosurgery patients. *** p<0.001 vs Standard care group
1 ehrenfeld Jm et al. ASA. 2010. lb05. (abstract). 2 awada wn et al. J Clin Monit Comput. 2015 Feb 4. [epub ahead of print] pubmed pmid:
25649717. 3 Shander et al. Transfusion. 2010;50(4):753-765.
82
83
riSk and coST oF
undeTecTed bleeding
in addition to assisting with transfusion management,
continuous SpHb can also help clinicians inside and outside
the operating room identify changes in hemoglobin that may
be associated with internal bleeding.
bleeding affects up to 35% of patients in
childbirth, clinical estimation of blood loss
surgery, intensive care, and obstetric care
is inaccurate and changes in standard vital
areas.1 bleeding is considered a significant
signs can occur long after the bleeding has
risk factor for patients, and late detection
begun. low hemoglobin identifies bleeding
further increases risk and cost.2 Surveys
over 90% of the time, but is only assessed
show that the majority of u.S. hospitals have
intermittently and requires a blood draw
multiple patients per year with serious injury
and laboratory analysis.4 in some parts
or death due to late detection of bleeding.3
of the world, laboratory testing is simply
not available.
limiTaTionS oF currenT approacHeS
To deTecT bleeding
by measuring hemoglobin continuously,
a significant number of injuries or deaths
clinicians can become aware of real-time
due to bleeding are preventable. Prevention
drops in hemoglobin that may be indicative
requires identifying that a patient has
of bleeding. identification of low or falling
experienced significant bleeding and then
hemoglobin levels allows interventions
intervening to stop the bleeding and improve
that may prevent preventable death and
the patient’s condition. identifying bleeding is
disability. SpHb monitoring is not intended
challenging because even during surgery and
to replace blood draws.
1 Hebert Pc. Crit Care. 1999: 3(2):57-63. 2 Herwaldt la. Infect Control Hosp Epidemiol. 2003; 24(1):44-50. 3 HRa Research of Hospital executive.
2012. 4 bruns b et al. J Trauma. 2007; 63(2):312-5.
poTenTial For earlier idenTiFicaTion oF
Falling Hemoglobin ValueS
Hb Value (g/dL)
9.0
8.5
8.0
7.5
7.0
6.5
6.0
Lab tHb ordered early due to
declining SpHb values
Patient transported to
OR for splenectomy
Standing lab order
10
11
12
13
14
15
16
17
18
tHb lab test
Masimo SpHb (unblinded)
Blood transfusion initiated
19
Hours
“Masimo SpHb helped prevent a potentially life-threatening event. i am
now using it for all my major craniofacial procedures and can’t see doing
a surgery without it.”
Jeffrey Fearon, md
Physician for 8-year-old girl who had just completed craniofacial surgery in which SpHb signaled undetected bleeding through a dramatic drop in
hemoglobin over a 5-minute period.
84
85
85
Single Hemoglobin measurement comparison between Three devices
and the central laboratory Hematology analyzer2, 3
SpHb (g/dL)
CO-Oximeter Hb (g/dL)
HemoCue Hb (g/dL)
18
16
14
12
10
8
5
4
SpHb
1.0
g/dl (armS)
Bias + Standard Deviation = 0.0 + 1.0 g/dL
18
16
14
12
10
8
5
4
CO-Oximeter
1.1
g/dl (armS)
Bias + Standard Deviation = 0.9 + 0.6 g/dL
18
16
14
12
10
8
5
4
HemoCue
accuracY oF noninVaSiVe and conTinuouS Hemoglobin
moniToring compared To common inVaSiVe meTHodologieS
1.3
g/dl (armS)
Bias + Standard Deviation = 0.3 + 1.3 g/dL
While hemoglobin is one of the most common laboratory tests performed, most
clinicians are unaware of variation that should be expected when comparing
hemoglobin measurements – both within and between various device models.
this is because clinicians do not typically measure hemoglobin more than once
in the same patient at the same time. Variation is induced by physiology, blood
sampling technique, device methodology, and individual device calibration.1
4
6
8
10
12
14
16
18
4
6
8
10
12
14
16
18
4
6
8
10
12
14
16
18
Hematology Analyzer tHb (g/dL)
Hematology Analyzer tHb (g/dL)
Hematology Analyzer tHb (g/dL)
Trended Hemoglobin measurement comparison between Three devices
and the central laboratory Hematology analyzer2, 3
Difference in Consecutive Hemoglobin
Values (SpHb) (g/dL)
Difference in Consecutive Hemoglobin
Values (HbABG) (g/dL)
Difference in Consecutive Hemoglobin
Values (HbCAP) (g/dL)
SpHb
R=0.64
18
16
14
12
10
8
5
4
CO-Oximeter
R=0.60
18
16
14
12
10
8
5
4
HemoCue
R=0.39
4
6
8
10
12
14
16
18
4
6
8
10
12
14
16
18
4
6
8
10
12
14
16
18
Difference in Consecutive Hemoglobin Values (tHb) (g/dL)
Difference in Consecutive Hemoglobin Values (tHb) (g/dL)
Difference in Consecutive Hemoglobin Values (tHb) (g/dL)
18
16
14
12
10
8
5
4
86
the results of an independent study
conducted in a surgical intensive care
unit illustrate the variation that can
be expected between hemoglobin
device methods. a total of 471
hemoglobin measurements were
evaluated from 62 patients.
the results of an independent study conducted in a surgical
intensive care unit illustrate the variation that can be
expected between hemoglobin device methods. a total of
471 hemoglobin measurements were evaluated from 62
patients. Noninvasive and continuous hemoglobin (SpHb),
a satellite laboratory co-oximeter (Siemens RapidPoint
405), and a point-of-care device (Hemocue 301) were
all compared to reference hemoglobin from the central
laboratory hematology analyzer (Sysmex Xt2000i).
in this study, the absolute accuracy and trending accuracy
of SpHb was similar to the two widely used invasive
methods2 when all three methods were compared to the
central laboratory hemoglobin analyzer, both in single-
measurement comparisons as well as trended measurement
comparisons. only SpHb provides hemoglobin noninvasively
and continuously – for real-time visibility to hemoglobin
changes, or lack of changes, in-between invasive blood
sampling and laboratory analysis.
1 berkow l. J Clin Monit Comput. 2013 Mar 26. 2 Frasca D et al. Crit Care Med. 2011 oct;39(10):2277-82. 3 aRMS was calculated as defined by the iSo 80601-2-61.
Some independent researchers have conducted their own testing and obtained similar results, while other researchers have reported larger differences when comparing SpHb
measurements to laboratory measurements.
87
aiding clinician aSSeSSmenT oF Fluid reSponSiVeneSS
and Fluid managemenT wiTH pVi®
Fluid administration is one of the most common hospital interventions. although it is critical to improving patient status
and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality.1
While commonly used, traditional “static” measurements such as central venous pressure are not reliable to predict whether
a patient will respond to volume administration with an increase in blood flow (stroke volume or cardiac output) and therefore
are not effective to guide fluid management decisions.
clinical and Financial beneFiTS oF
dYnamic moniToring TecHnologieS
Helping aSSeSS Fluid reSponSiVeneSS wiTH pVi
decisions and patient outcomes in two randomized controlled
Masimo Set® pulse oximetry technology has the unique ability to
trials.17,18 in a study of colorectal surgery patients managed with
New “dynamic” monitoring technologies that measure stroke
also provide a dynamic fluid responsiveness variable called pleth
the enhanced Recovery after Surgery (eRaS) protocol including
volume variation (SVV), pulse pressure variation (PPV), or
variability index (PVi) that is similar to SVV and PPV but PVi is
goal-directed fluid therapy guided by PVi, 30-day hospital costs were
stroke volume response (∆SV) are effective at predicting
fluid responsiveness and enabling goal-directed fluid
noninvasive. PVi is displayed on the same monitor and obtained
reduced by $2,867 and median length of stay was reduced by 2 days.19
with the same sensors as are used for Masimo Set® pulse oximetry
also, PVi has also been shown to help assess which patients will
management. a meta-analysis of 32 randomized controlled
or rainbow® monitoring – with no incremental procedural cost. PVi
become hemodynamically unstable with the addition of Positive end
operating room8
Fluid Responder Detection – Sensitivity (%)
100
90
80
70
60
50
40
30
20
10
0
intensive care unit9
masimo pVi has been
shown to help clinicians
assess fluid responsiveness
as reliably as new invasive
parameters, and better
than traditional invasive
parameters.
Pleth Variability Index (PVI)
Arterial Pulse Pressure Variation (PVV)
Cardiac Index (CI)
Pulmonary Capillary Wedge Pressure (PCWP)
Central Venous Pressure (CVP)
Sensitivity
1.0
0.8
0.6
0.4
0.2
0.0
PVI, AUC = 0.97
CVP, AUC = 0.56
SVV, AUC = 0.99
0 10
20
30
40
50
60
70
80
90
100
Fluid Non-Responders Detection – 100 - Specificity (%)
0.0
0.2
0.4
0.6
0.8
1.0
1-Specificity
This observational study evaluated 25 surgical patients before and after volume expansion, with fluid responders (sensitivity) defined as a cardiac index
increase of >15% and fluid non-responders (specificity) defined as a cardiac index increase of <15%.
This study has shown pVi to be an effective alternative indicator for accurate, noninvasive, and continuous fluid responsiveness
in mechanically ventilated patients undergoing major surgery.
trials showed that goal-directed fluid management
has been shown to help clinicians assess fluid responsiveness in
expiratory Pressure (PeeP), which may allow clinicians to more carefully
Lactate Levels (mMoIL-1)
with dynamic monitoring technologies reduces surgical
mechanically ventilated patients under general anesthesia during
select ventilator settings and monitor effects more closely.20
complications by 32% and shortens length of stay by 1.2
surgery,8,9,10,11 in the icu in adults and children,12,13 and in septic
days.3 Depending on the morbidity rate of the patient
patients in early stages of shock in the emergency department.14
incluSion in Fluid managemenT guidelineS
population, goal-directed fluid management with dynamic
the positive and expanding evidence for PVi has led to its inclusion
monitoring technologies is estimated to save between
Helping improVe Fluid managemenT wiTH pVi
in guidelines and best practices for fluid management. in 2012,
$808 to $7,000 per patient.4 While these technologies have
PVi has also been shown to improve fluid management compared
the united Kingdom’s National Health Service (NHS) included PVi
been shown to improve clinical and cost outcomes, they are
to standard care in two randomized controlled trials, reducing
in its intra-operative Fluid Management Pack, which serves as a
invasive and/or complicated and therefore are underutilized
intraoperative fluid infused and intraoperative and postoperative
guide for hospitals implementing fluid responsiveness monitoring
and still only justified for the highest risk patients.5,6,7 as a
lactate levels.15,16 in addition, compared to goal-directed therapy
to improve patient outcomes.21 in 2013, the French Society for
result, many patients who could benefit from goal-directed
fluid management are not receiving it.
with invasive dynamic monitoring technologies (PPV and ∆SV),
goal-directed therapy with PVi showed similar fluid management
anaesthesia and intensive care (SFaR ) added PVi to its guidelines
for optimal hemodynamic management of surgical patients.22
1 bundgaard-Nielsen M et al. Acta Anaesthesiol Scand. 2007; 51(3):331-40. 2 Michard F et al. Chest. 2002. 3 grocott et al. Br J Anaesth. 2013. 4 Simon t et al. Critical Care. 2013. 17(2):196. 5 benes J et al. Critical Care. 2010, 14:R118. 6 Miller t et al. aSa. 2013. #4293. 7 gan tJ et al. IARS. 2013. 8 cannesson M et al.
Br J Anaesth. 2008;101(2):200-6. 9 Zimmermann M et al. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. 10 Fu Q et al. Biosci Trends. 2012 Feb;6(1):38-43. 11 Haas S et al. J Anesth. 2012 oct;26(5):696-701. 12 loupec t et al. Crit Care Med. 2011;39(2);294-299. 13 byon HJ et al. BJA. 2012 Dec;Doi 10.1093/bja/aes467.
14 Feissel M et al. J Crit Care. 2013 May 14. 15 Forget P et al. Anesth Analg. 2010;111(4):910-4. 16 yu y et al. J Clin Monit Comput. 2014 Feb 21. 17 Delaporte a et al. ESA. 4aP3-9. 2014. 18 bahlmann H et al. ESA. 3aP5-5. 2014. 19 thiele RH et al. Journal of the American College of Surgeons (2015), doi: 10.1016/j.
jamcollsurg.2014.12.042. 20 Desebbe o et al. Anesth Analg. 2010;110:792-798. 21 http://www.ntac.nhs.uk/Newsandevents/ioFM_technology_adoption_Pack_Published.aspx. 22 Vallet b et al. SFAR. 2013.
2.5
2.0
1.5
1.0
0.5
0.0
This randomized study
of 82 abdominal surgery
patients found that pVi-
based, goal-directed fluid
management reduced the
volume of intraoperative
fluid infused and reduced
intraoperative and post-
operative lactate levels.9
Financial benefits of using enhanced recovery after Surgery
(eraS) protocol including pVi for goal-directed Therapy
outcome
conventional approach
without pVi
enhanced recovery after
Surgery approach with pVi
30-day hospital costs
$18,017
median length of stay
5 days
$15,150
3 days
most recently and as part of a multi-modal perioperative
management approach called enhanced recovery after Surgery
(eraS), pVi was shown to help reduce 30-day hospital costs by
$2,867 per patient and reduce median length of stay by 2 days.
PVI Group
Control Group
Start
At 24 Hr
At 48 Hr
Intraoperative Surgery
88
89
pao2 range and aVailable
moniToring meTHodS
PaO2 (mmHg)
Hyperoxia
Oxygen
Reserve
Normoxia
Hypoxia
SpO2/SaO2
ORI with SpO2
PaO2
in utilizing oRi the researchers noted mean of 40 sec advance alarm
before Spo2 reached 98% and about 52 seconds advance alarm before
the patients reached 90% Spo2.
oxygen reserve index: a new noninvasive method of oxygen reserve measurement.
Szmuk p., Steiner J., olomu p., dela cruz b.S., Sessler d.
Proceedings of the american Society of anesthesiologists, october 14, 2014. New orleans; boc12.
FirST noninVaSiVe &
conTinuouS parameTer To
proVide inSigHT inTo oxYgen
reSerVe in paTienTS receiVing
SupplemenTal oxYgen
Pulse oximetry (Spo2) provides noninvasive
approximately 100 to 200mmHg). oRi is
and continuous visibility to arterial blood
intended to supplement, not replace, Spo2
oxygenation in hypoxia (less than normal
monitoring and Pao2 measurements. as
oxygenation) and normoxia (normal
an “index” parameter with a unit-less scale
oxygenation). During supplemental oxygen
between 0.00 and 1.00, oRi can be trended
administration, clinicians often use the
and has optional alarms to notify clinicians of
partial pressure of oxygen (Pao2), which is
changes in a patient’s oxygen reserve.
invasive and intermittent, to monitor levels of
hyperoxia (higher than normal oxygenation).
in patients receiving supplemental oxygen
between invasive sampling, changes in Pao2
such as those in surgery, conscious sedation,
can go unnoticed and lead to unexpected
or the intensive care unit, oRi may provide an
hypoxia or unintended hyperoxia.
advance warning of a pending hypoxic event.
in addition, oRi may provide an indication of
oxygen Reserve index (oRi™) provides
an unintended hyperoxic state. in this way, oRi
real-time visibility to oxygenation status
may enable proactive interventions to avoid
in moderate hyperoxic range (Pao2 of
hypoxia and unintended hyperoxia.
90
90
91
at tHe Root oF
tRaNSFoRMiNg
PatieNt caRe
92
92
93
WHy
Root?
From Masimo’s inception, the root of our inspiration has been unwavering – patients, their families,
and their caregivers.
this inspiration guides us every time we set
Root is a powerful new patient monitoring
Root includes a dock for the Radical-7® or
out to solve a previously “unsolvable” problem,
and connectivity platform that enhances
Radius-7,™ an instantly interpretable display,
in every new measurement we create, and
our breakthrough rainbow® and Set®
and iris™ connectivity ports for third-party
in every new software, hardware, or systems
measurements with multiple additional
devices such as iV pumps and ventilators. Root
innovation we have developed. all our
parameters – including Sedline® brain
integrates multiple streams of data and simplifies
innovations are designed for one purpose –
function monitoring, o 3™ regional
patient care workflows, empowering caregivers
to enable clinicians to get to the root of better
oximetry,* and capnography and gas
to help make quicker patient assessments,
care for their patients. that’s why we called our
monitoring – in an integrated, clinician-
earlier interventions, and better clinical decisions
latest innovation Root.®
centric platform.
throughout the continuum of care.
“Root integrates rainbow® measurements so at any moment i can see what i want to
see and how i want to see it—a great advantage to the anesthesiologist in a data-
rich operating room. Root makes it easy to use SpHb and PVi together to optimize
transfusions and fluid management.”
dr. keith ruskin
Professor of anesthesiology at yale-New Haven Hospital in New Haven, ct
94
94
* o3 regional oximetry is ce Marked. currently not available in the u.S.
95
geTTing To THe rooT oF rooT®
inSTanTlY inTerpreTable, HigH-ViSibiliTY diSplaY
With the Radical-7 handheld inserted in its dock, Root enables
instant interpretation of Masimo’s breakthrough noninvasive
measurements. the brilliant, high-resolution, adaptive display
is designed to aid clinicians’ rapid assessment of patient status
in three distinct ways:
> “Trend” view in which each measurement value is
displayed alongside its graphical trend
> “analog” view for quick assessment through gauges
showing measurement values in relation to alarm ranges
When docked with Root, the Radical-7’s screen can transform into
an alarm status visualizer, with a three-dimensional, anatomical
image that associates device measurements with alarm status.
trend view
inTuiTiVe ToucHScreen naVigaTion For eaSY and
adapTable uSe in anY HoSpiTal enVironmenT
With a simple tap, swipe, or drag-and-drop, screen views
and parameter sizing can be customized to suit any hospital
environment, workflow, clinician preference, or patient-specific
need. this allows Root to be used across a wide variety of care
areas with disparate clinical and operational requirements –
from the operating room to the intensive care unit to the
medical-surgical floors.
analog view
alarm STaTuS ViSualizer
eaSilY cuSTomizable ToucHScreen
a three-dimensional, anatomical image
that associates device measurements
with alarm status.
Screen views and parameter sizing are
easily customized with a simple tap,
swipe, pinch, or drag-and-drop.
no alarm
approaching alarm
alarm state
96
96
97
97
THe power oF maSimo
breakTHrougH meaSuremenTS
in a paTienT-worn moniTor
untethered, continuous monitoring with Radius-7™ allows
patient mobility without the hassle of disconnecting and
reconnecting from traditional monitoring devices.
THe mobiliTY oF paTienT moniToring
unlock breakTHrougH
and aSSeSSmenT
rainbow SeT® meaSuremenTS
Studies have shown that patient mobility is a key
Radius-7 is the first and only wearable, wireless
factor in more rapid patient recovery.1 However,
monitor to leverage breakthrough Masimo
continuously monitoring mobile patients
rainbow Set® technology to enable the
presents challenges. Radius-7* is the first rainbow
continuous monitoring of:
Set® noninvasive wearable, wireless monitor
for the Root Patient Monitoring Platform.
Radius-7 is designed to allow patient mobility
along with continuous monitoring, enabling early
identification of clinical deterioration.
opTimize workFlowS and eFFiciencieS
Radius-7 is designed to promote greater
patient comfort and independence while
reducing nurse time to disconnect the
monitor each time the patient moves.
Radius-7 utilizes a standard wireless short-
> oxygen saturation (Spo2) and pulse rate
monitoring with Masimo Set® Measure-
through Motion and low Perfusion™
pulse oximetry for reliable detection of
desaturation and accurate pulse rate while
dramatically reducing false alarms2, 3
> Respiration rate monitoring through either
rainbow acoustic Monitoring™ for acoustic
respiration rate (RRa®) or through the
plethysmograph waveform (RRp™*) to
identify respiratory depression or tachypnea3
range communication to Root via secured
> Noninvasive and continuous hemoglobin
bluetooth with upgradeability to WiFi†
(SpHb) monitoring with rainbow® Pulse co-
for direct communication throughout the
oximetry may help clinicians detect bleeding
hospital to the Patient SafetyNet™¥ remote
earlier, avoid unnecessary blood draws, and
monitoring system.
optimize transfusion decisions.
1 Needham D. et al. Archives of Physical Medicine and Rehabilitation. Vol 91, issue 4, PP 536–542, april 2010. 2 taenzer a.H. et al. Anesthesiology.
2010 Feb;112(2):282-7. 3 Pyke Joshua et al. Patient Safety & Quality Healthcare. May/June 2009.*Radius-7 and RRp are ce Marked. currently not
available in the u.S. † the configuration for long-range communication is not yet released. ¥ the use of the trademarks Patient SafetyNet and
PSN is under license from university Health System consortium.
one Radius-7 battery charges
while the other is being worn
by the patient, making battery
exchange quick and convenient.
98
99
Flexible meaSuremenT expanSion in rooT
wiTH maSimo open connecT
With Root, Masimo is providing an open invitation to other companies,
from small to large, to develop and commercialize their innovations and
deliver them via the Root platform.
expanding maSimo meaSuremenTS
Root offers expanded measurement capability through software upgrades and Masimo open connect™
(Moc-9™) modules. Sedline brain function monitoring monitoring, Masimo capnography and gas
monitoring, and o3 regional oximetry are all provided as Moc-9 modules.
Moc-9 modules expand
Root’s capability via third-
party development of
additional measurements.
deSigned To STimulaTe THird-parTY innoVaTion*
Moc-9 is designed to spur third-party development of additional
measurements by companies other than Masimo. Market
barriers and development costs often keep small, innovative
companies from delivering products to the clinicians and patients
who need them most. With Root, Masimo is providing an open
invitation to other companies, from small to large, to develop
and commercialize their innovations and deliver them to market
via the Root platform. We anticipate a whole new ecosystem of
third-party measurements to spring from Root – seeding whole
new fields of innovation in patient monitoring.
100
101
* Root with third party expandability and O3 are CE Marked. Currently not available in the U.S.
rooT wiTH
brain FuncTion moniToring
Featuring 4 simultaneous channels of high-quality eeg data, Sedline® provides continuous information about both sides
of the brain and provides information about a patient’s response to anesthesia.
THe rooT oF beTTer daTa
FaciliTaTing indiVidualized TiTraTion
Patients respond differently to anesthetics,
Sedline enables individualized titration
which can mean over- or under-administration
of sedation and faster emergence, while
during surgery and conscious sedation
offering reliable monitoring during challenging
procedures. Sedline brain function monitoring
conditions such as electrocautery.
provides continuous information about a
patient’s response to anesthesia. Sedline
use of Sedline and its Patient State index
enables monitoring of both sides of the brain
(PSi) has been shown to help clinicians manage
simultaneously. the Density Spectral array (DSa)
patients to significantly faster emergence from
enables immediate recognition of asymmetrical
anesthesia and recovery.1
activity, identification of the specific frequency
in which most eeg activity is occurring, and easy-
to-see display of burst suppression events.
“Sedline gives me a better idea of where i stand at each
phase of anesthesia. the PSi number helps guide me
to make subtle changes in my anesthetic appropriate
for the patient’s heart rate and blood pressure, and thus
arrive at the end where i want to be.”
david drover, md
Stanford university Hospital, Stanford, ca
1 Drover DR et al. Acta Anesthesiology. 2002; 97:82-89.
102
103
103
rooT wiTH regional oximeTrY*
o3™ regional oximetry uses near-infrared spectroscopy (NiRS) and reflectance pulse oximetry to enable simultaneous
monitoring of tissue oxygen saturation (rSo2) in the brain and arterial blood oxygenation (Spo2).
THe rooT oF beTTer brain
oxYgenaTion moniToring
utilizing regional oximetry during surgery to
better monitor cerebral oxygenation.
Regional oximetry – also known as tissue
oximetry or cerebral oximetry – enables
a powerFul combinaTion
continuous assessment of the oxygenation
o3’s combination of highly accurate regional
“Masimo o3 Regional oximetry will have the unique ability to
measure both rSo2 and Masimo Set® Spo2 pulse oximetry
simultaneously from the same forehead sensor. this may provide
of the tissue beneath the sensor. o3 helps
oximetry measurements and onboard pulse
the anesthesiologist or perfusionist for the first time with a
clinicians detect regional hypoxemia
oximetry enables continuous assessment of
that pulse oximetry alone can miss.1 For
deviations between rSo2 and Spo2, taken from
this important reason, more and more
either the o3 sensor or from the Radical-7
anesthesiologists and perfusionists are
docked in Root.2
differential analysis of regional to central oxygen saturation
monitoring that could help the clinician in maintaining brain
oxygenation and safe cerebral perfusion during cardiac procedures.”
1 Redford D et al. Absolute and Trend Accuracy of Masimo O3 regional oximetry in Healthy Volunteers During Controlled Hypoxia 2014 STA Annual
Meeting. January 15-18, orlando, Fl. abs#46. 2 if regulatory approval has been obtained in your country and Root has the relevant software update.
* o3 regional oximetry is ce Marked. currently not available in the u.S.
michael a.e. ramsay, md
chief of the Department of anesthesiology and Pain Management, baylor university Medical center, Dallas
o3 moniToring
every root offers plug and
play monitoring with all
moc-9 modules.
104
105
105
rooT wiTH capnograpHY and
gaS moniToring
changes in expired respiratory gas can be an early indicator of an adverse respiratory event. Hypoventilation, hyperventilation,
airway obstruction, and other potentially life-threatening conditions can be rapidly detected with capnography – enabling
clinicians to intervene as early as possible. capnography and gas monitoring also provide insight into the effectiveness of the
anesthesia breathing circuit, aiding clinicians in maintaining proper gas concentrations and ventilation levels.
nomoline™ – no moiSTure Sampling line
Nomoline technology eliminates common problems associated with conventional
sidestream gas analysis. incorporating a special polymer and a hydrophobic bacterial
filter, the Nomoline allows water in the sampling line to evaporate into the surrounding
air, while leaving oxygen, carbon dioxide, and anesthetic gases unaffected. Specially
designed for low-flow applications and functional in any orientation, Nomoline technology
can be used in any clinical application for all types of patients from neonates to adults.
Nomoline is designed to extend the product life in single-use applications, such as high
humidity environments. Nomoline’s innovative design also allows multi-patient use as a
resposable solution, along with the use of generic cannulas.
Root with capnography and gas monitoring
measurements delivered through either
complements our breakthrough noninvasive
mainstream or sidestream options, Masimo
portfolio with innovative, multispectral
customers can now benefit from end-tidal co2,
technologies for measuring respiratory
Fico2, RR, N2o, o2, and inhalation anesthetic
gases and inhalation anesthetic agents.
agent monitoring in a range of hospital
the solutions range from integrated oeM
environments—from the operating room to
solutions to external “plug-in and measure” gas
intensive care to the medical-surgical floors.
analyzers to handheld devices. With multiple
irma™ – a compleTe moniTor in a probe
Single-patient-use cannula
and Nomoline adapter
Single-patient-use cannula and multi-
patient-use Nomoline adapter
iSa™ – HigH perFormance in a SideSTream analYzer
enabled by state-of-the-art spectrometer technology that utilizes nine different wavelengths of
light and powerful signal processing algorithms, iSa provides the clinician with precise capnography
and gas measurements with crisp waveforms that help depict the clinical situation for adults and
neonates, from the operating room to the general floor. additionally with virtually no warm-up time
and full accuracy performance in ten seconds iSa saves time in critical situations. iSa is factory
calibrated and does not require field calibration, minimizing maintenance efforts for hospital
biomedical engineering departments. iSa sidestream analyzers are available as standalone or easy-
Designed with the latest advancements in miniaturized components and
to-integrate oeM modules.
microprocessor technology, the iRMa mainstream analyzer weighs less
than 1 ounce and fits in the palm of your hand. this versatile, complete
mainstream capnography and gas monitoring system can be utilized with
adult, pediatric, or infant patients.
iSa co2 with Nomoline attached to the back of the
Root, enabling quick disconnect and movement
to any Root in which capnography and gas
monitoring is desired
Irma aX+
etcO2, rr, n2O, inhalation anesthetic
agent identification
Irma co2
etcO2, ficO2, rr
Isa or+
etcO2, rr, n2O, O2, inhalation
anesthetic agent identification
Isa co2
etcO2, ficO2, rr
Isa aX+
etcO2, rr, n2O, inhalation anesthetic
agent identification
106
107
keeping clinicianS and
paTienTS connecTed
inTegraTing meaSuremenTS To enable meaningFul
uSe oF HealTH inFormaTion TecHnologY
keeping clinicianS and paTienTS connecTed
clinicians spend their time caring for patients, not recording data.
two-way, Hl7-based connectivity to the eHr. ace significantly
new standards for hospitals require meaningful use of the
masimo’s pulse oximeters also feature a built-in wireless radio
reduces the time and complexity to integrate and validate custom
electronic health record (eHr) by charting changes in vital signs
for communication through a hospital’s wireless network—with
Hl7 implementations, and demonstrates masimo’s commitment
as well as documentation of interventions. masimo enables
seamless integration to the eHr. Patient safetynet incorporates
to innovation that automates patient care with open, scalable,
automatic recording and transmission of key data into the eHr so
the masimo adaptive connectivity engine (ace), which enables
and standards-based connectivity architecture.
today’s challenging hospital environment subjects clinicians to mountains of information and multiplying documentation
requirements. Masimo simplifies and automates this process, streamlining workflows and improving patient safety by
empowering clinicians to focus on patients rather than technology.
Through iris, root is designed
to provide built-in integration
to multiple standalone devices,
including iV pumps, ventilators,
beds, and other patient monitors.
third-party
device
iris icon
root
device icons
Patient safetynet
view
Wireless 802.11 or
wired connection
Patient safetynet
appliance
connectivity to electronic
health record & central
monitoring stations
notifications
iriS™ inTegraTion plaTForm*
be remotely viewed with Patient SafetyNet,
Despite huge advances in medical technology,
transmitted through notification systems or
the lack of device communication and
to electronic health record (eHR) systems to
integration creates risks to patient safety
facilitate better patient care and meaningful
in hospitals around the world. existing
use, and eventually displayed on Root at the
approaches for device interoperability require
point of care to facilitate decision support.
separate hardware, software, and/or network
infrastructure, which can clutter the patient
iris offers a built-in connectivity
gateway that can integrate
multiple standalone devices.
room, burden it management, and increase
Device connectivity with iris is designed to
the complexity and cost of care. Root with iris
leverage existing network infrastructures and
offers a built-in connectivity gateway that can
reduce costs while enhancing workflows and
integrate multiple standalone devices such as
decision support to improve patient safety,
iV pumps, ventilators, beds, and other patient
whether the clinician is at the bedside, down
monitors. iris allows device information to
the hall, or across the globe.
* iris is ce Marked. currently not available in the u.S.
108
108
109
eNHaNciNg
PatieNt SaFety
tHRougHout
tHe HoSPital
110
110
111
Helping proTecT paTienTS From Hidden dangerS wiTH Spmet®
Monitoring for unintended consequences of drugs commonly
given in hospitals and during certain procedures.
addreSSing THe riSk oF dangerouS
that reduces the delivery of oxygen to the
drug reacTionS
tissues. While methemoglobinemia can
Many drugs commonly used in hospitals
occur in all care areas and patients, it is
– such as lidocaine, benzocaine, dapsone,
often unrecognized and undiagnosed. if not
and nitrates – cause a dangerous reaction
detected and treated immediately, it can
known as acquired methemoglobinemia
result in avoidable injury or death.
Masimo noninvasive methemoglobin (SpMet) helps clinicians
assess for methemoglobinemia, facilitating earlier detection
and immediate treatment to reduce patient risk
enabling Quick TreaTmenT wiTH Spmet
Masimo noninvasive methemoglobin (SpMet) helps
clinicians assess for methemoglobinemia especially in
care areas where drugs that cause methemoglobinemia
are used most often, such as procedure labs and the
operating room. this enables them to quickly adjust
exposure to the dangerous drug and initiate potentially
life-saving treatment.
1 ash-bernal Ra et al. Medicine. 2004;83:265-273.
“ acquired methemoglobinemia is fairly common and
causes morbidity and mortality in both the inpatient
and outpatient settings. acquired methemoglobinemia
is often unrecognized and thus untreated.”
rachel ash-bernal, md
and other researchers at Johns-Hopkins Hospital,
Baltimore, md
medicaTionS known To cauSe
meTHemoglobinemia
Benzocaine, cetacaine, chloroquine, dapsone, emla topical, flutamide, lidocaine,
metoclopramide, nitrates, nitric oxide, nitroglycerin, nitroprusside, nitrous oxide,
Phenazopyridine (Pyridium), Prilocaine, Primaquine, riluzole, silver nitrate, sodium
nitrate, sulfonamides
preValence oF
meTHemoglobinemia
number of
methemoglobinemia cases
patient age
care areas
Fatalities
138
(2.5 cases per hospital per month)
4 days to 86 days
surgery, intensive care, outpatient
clinics, pediatrics, emergency
department, cardiac cath lab
1 fatality
3 near fatalities
results from a retrospective study at two Johns Hopkins Hospitals over a 28-month period, using laboratory co-oximeter results, and patient electronic medical records.1
112
112
113
113
proTecTing more paTienTS
bY moniToring eVerY breaTH
to expand the rainbow® platform’s promise of breakthrough noninvasive
measurements, we have grown beyond our optically based technologies
to include clinical measurements derived from sound.
rainbow acoustic monitoring™ noninvasively and
continuously measures respiration rate using an innovative
adhesive cloth sensor with an integrated acoustic transducer
that is easily and comfortably applied to the patient’s neck.
rainbow acouSTic moniToring™
While we offer standard capnography
allowing more paTienTS To be moniTored,
continuous monitoring of respiration rate is
solutions, we believe rainbow acoustic
more SaFelY THan eVer beFore
especially important for post-surgical patients
Monitoring™ is better suited for post-surgical
When rainbow acoustic Monitoring™ is
receiving patient-controlled analgesia for
monitoring and conscious sedation.
used in conjunction with rainbow® Pulse
pain management.
co-oximetry and the Patient SafetyNet
Masimo’s rainbow acoustic Monitoring™
system, clinicians can follow key indicators
the anesthesia Patient Safety Foundation
now provides noninvasive and continuous
of oxygenation with industry-leading
(aPSF) and the Joint commission
respiration rate that has been shown to be
Masimo Spo2; ventilation with breakthrough
recommend continuous oxygenation and
accurate, easy-to-use, and enhances patient
acoustic respiration rate (RRa); circulation
ventilation monitoring in all patients
compliance.2 acoustic Respiration Rate (RRa)
with Masimo Measure-through Motion
receiving opioid-based pain medications.1
may help clinicians reliably and continuously
pulse rate (PR); and hemoglobin levels
conscious sedation can induce respiratory
assess breathing – facilitating earlier detection
with Masimo’s continuous and noninvasive
depression and place patients at considerable
of respiratory compromise and patient distress
hemoglobin (SpHb) – enabling clinicians to
risk of serious injury or death. However,
– offering a breakthrough in patient safety for
monitor more patients, more safely than
current methods for respiration rate
post-surgical patients on the general floor and
ever before.
monitoring are limited by patient tolerance.
for procedures requiring conscious sedation.
1 Stoelting RK et al. APSF Newsletter. 2011. (www.apsf.org). 2 Macknet MR et al. Anesthesiology. 2007;107:a84. (abstract). 3 Ramsay M et al. Anesth Analg. 2013;Doi: 10.1213/aNe.0b013e318290c798. 4 Patino M et al.
Paediatr Anaesth. 2013 Dec;23(12):1166-73.
abiliTY To deTecT
reSpiraTorY pauSe3
resPiraTiOn raTe MeThOd
oridion
capnostream
Sara v4.5
masimo
rainbow acoustic
monitoring™ v7804
Sensitivity
(respiratory pause detected when
actual respiratory pause occurs)
62%
81%
retrospective analysis of 33 pacu subjects. reference respiration rate determined by expert observer.
a total of 21 episodes of respiratory pause were identified, defined as 30 seconds with no breathing activity.
paTienT Tolerance4
capnography
(oridion capnostream 20)
rainbow acoustic
monitoring™
Fifteen of 40 pediatric patients removed the nasal cannula while only one removed rainbow® acoustic sensor.
114
115
115
Helping improVe ouTcomeS on medical-Surgical FloorS
wiTH maSimo paTienT SaFeTYneT
in august 2012, the Joint commission Sentinel event alert on the safe use of opioids in hospitals recommended
implementation of better dosing along with continuous oxygenation and ventilation monitoring (instead of spot checks)
in post-surgical patients.1 Patient SafetyNet – combined with Masimo Set® pulse oximetry and rainbow acoustic
Monitoring™ or standard capnography – offers a clinically proven, cost-effective approach to continuous postoperative
monitoring with high nursing satisfaction and patient compliance.
0Patients Suffered Brain
Damage or Died Over
a 5-year Period†
%
65Reduction in Rapid
Response Team
Activations
%
48Reduction in
ICU Transfers
reducing reScueS and icu TranSFerS
Set® and Patient SafetyNet remote monitoring
the general floor, clinicians can be confident their
For many years, clinicians have understood the
and wireless notification system in a post-surgical
patients are being watched even when they aren’t
risks of not continuously monitoring patients
floor where only intermittent spot-checking
at the bedside, while families can be assured their
on the general floor. However, excessive false
was used before, Dartmouth-Hitchcock Medical
loved ones are receiving maximum protection.
alarms due to patient motion made improving
center reduced rapid response activations by
the safety of these patients an elusive goal. in
65% and icu transfers by 48%,2 and saved $1.48
proVen coST-eFFecTiVeneSS
the last decade, Masimo Set® has been shown
million annually. in addition, there were zero brain-
When translated into financial impact,
in multiple studies to improve the process of
damaged patients over a 5-year period.3 Just as
the Dartmouth-Hitchcock study showed
Significant reductions in rapid response team activations
and icu transfers were observed in an 11-month evaluation
of Patient SafetyNet on a post-surgical unit. Rescue events
decreased 65%, from 3.4 to 1.2 per 1,000 patient discharges,
and icu transfers decreased 48%, from 5.6 to 2.9 per 1,000
patient days after implementation. the financial impact
resulted in annual opportunity cost savings of $1.48 million.
Results drove expansion of the use of Patient SafetyNet to
other care areas.2, 3
care in neonates and pediatric patients due to
pulse oximetry has become a standard of care
that implementing Masimo Set® and
reducing costs associated with emergency
its Measure-through Motion and low Perfusion™
in the oR, Pacu, and icu, we now believe that
Patient SafetyNet to more safely monitor
rescue events.3 With both the clinical and
performance. However, a landmark study in 2010
Measure-through Motion and low Perfusion™
post-surgical patients could also have a
financial rationale now in place, hospitals
showed that Masimo Set® also improves clinical
pulse oximetry will become a standard of care on
significant impact on the hospital’s bottom
are increasingly implementing general floor
outcomes in adults. after implementing Masimo
the general floor. With Masimo technologies on
line by increasing icu bed availability and
monitoring with Masimo technologies.
Halo index™* enableS aSSeSSmenT oF paTienT STaTuS
Halo index is a new indicator for cumulative trending assessment of the
global patient status. Physiologic deterioration often occurs long before a
patient crisis and manifests through subtle and often undetected changes
in multiple physiologic parameters. Masimo designed Halo index to mimic
the systematic approach that expert clinicians use in assessing patient
physiologic deterioration – analyzing the patient history and extracting key
vital sign parameter characteristics to assess global patient status. Halo
index currently uses available Masimo parameters but is scalable to include
additional information from the patient data repository. each parameter’s
significance is weighted and combined into the Halo index, a single
displayed number with a range from 0 to 100 that provides a cumulative
trending assessment of global patient status. increases in Halo index
suggest physiologic deterioration and may indicate a need for clinicians
to more closely assess the patient.
1 the Joint commission Sentinel event alert. 2012;49. 2 taenzer aH et al. Anesthesiology. 2010;112(2):282-287.
3 taenzer aH et al. anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
* Halo index is ce Marked. currently not available in the u.S.
Patient SafetyNet can display actual
parameter values (above) or color-coded alarm
states (left), which allows more patients to
be viewed simultaneously on screen.
in this example, Halo index indicates a
declining patient condition while displaying
parameter trends and their contribution
(the size of the bubbles below the
parameter) to the Halo index.*
116
† Since expansion, no patients suffered irreversible, severe brain damage or died as a result of respiratory depression from opioids over a 5-year period.
117
clinician-cenTric moniToring wiTH mYView™
MyView empowers clinicians to see things their way.
the level of information required can change
clinician, patient, and care area to provide
dramatically by clinician and care area, but
the parameters, waveforms, and trends that
medical devices historically function in a
clinicians want to see and what their patients
static manner with the same parameters,
and family see. While a physician may want to
waveforms, and trends displayed the same
see all parameters and waveforms, a medical
way. While Masimo measurements and
assistant may only want to see Halo index*
display flexibility continue to expand, this
or a few parameters and no waveforms. if no
doesn’t mean that all clinicians need to
clinician is in the room, the patient and family
see all of the information in the same way.
may be best served with no specific device
MyView technology – featured in Masimo
information, but rather a visual indicator with
Patient SafetyNet – is being expanded
a green, yellow, or red color indicating device
to allow wireless sensing of the device,
alarm status.
MyView in Patient
SafetyNet automatically
senses when the
physician approaches
and highlights his or her
patients for easy viewing.
When no clinicians are in the room, the clinician
may select a device display that is entirely green,
yellow, or red—depending on the alarm status.
this eliminates a common distraction for the
patient and family while limiting unnecessary
concerns or questions for caregivers.
When the clinician re-enters the room, MyView
recognizes the clinician and displays the measurements
that interest the particular clinician.
* Halo index is ce Marked. currently not available in the u.S.
clinician-centric view with the use of a presence
tag or smartphone allows caregivers to see
the customized information most important
to them upon approach to a patient.
118
118
119
eXPaNDiNg
ouR iMPact
beyoND tHe
HoSPital
120
120
121
aS HealTHcare conTinueS
To grow ouTSide THe
HoSpiTal, So do we
industry-leading Masimo technologies are increasingly
being used to enhance the quality of patient care
outside the hospital.
a new leVel oF care in THe Home
For pediatric patients requiring continuous monitoring at home, Masimo Set®
offers advantages for parents caring for special needs children – dramatically
reducing false alarms during motion and low perfusion that can complicate an
already difficult situation.
adding a SaFeTY neT in poST-acuTe care
as hospital costs rise, more patients are receiving care in long term acute care and
skilled nursing facilities. a major challenge in these facilities is weaning patients off
ventilator care, which can put patients at increased risk of adverse events. Post-acute
care facilities integrating Masimo Set® bedside pulse oximeters and Patient SafetyNet
remote monitoring and notification systems have experienced considerable reduction
in rapid response activations as well as emergency “transfer outs.”
“the sensitivity and motion artifact rejection
characteristics of the non-Masimo Set® pulse
oximeters we tested were not adequate for a
pediatric sleep laboratory setting.”
bob brouillette, md
Montreal children’s Hospital, Montreal, canada
reliable Sleep lab moniToring
During sleep lab monitoring, conventional pulse oximetry fails to provide
the fidelity and accuracy required to help clinicians detect clinically
relevant physiologic events. Masimo Set® technology is integrated in
leading sleep lab monitoring systems, enabling clinicians and patients to
benefit from its unmatched reliability in this challenging environment.
“ Masimo technology has raised the
bar in the quality of care that can be
delivered in a post-acute setting –
the right thing to do for patient safety.”
gene gantt, rrT
linde Respiratory Support Services
122
123
Quick and noninVaSiVe SpHb and Spo2 aSSeSSmenT
the Pronto-7® is designed specifically for faster noninvasive
total hemoglobin (SpHb) spot-check testing, along with Spo2,
pulse rate, and perfusion index.
a reVoluTionarY deVice For a
5” x 3” x 1” and weighing just 11 ounces –
VarieTY oF clinical SeTTingS
puts the power of noninvasive hemoglobin
Hemoglobin is one of the most commonly ordered
spot-check into any clinician’s hands in
tests in both the hospital and non-hospital
almost any environment, including hospitals,
setting; however, traditional laboratory testing
clinics, blood donation centers,* and
and processes involve delayed results. the
emergency medical services.
Pronto-7 represents a breakthrough solution
for noninvasively measuring hemoglobin and
operation is easy and intuitive with the
oxygen saturation together, in under a minute.
Pronto-7’s touchscreen interface. embedded
802.11 b/g and bluetooth® capability enable
SpHb is not intended to replace lab testing
wireless printing or emailing of test results,
but it can provide immediate and additional
as well as transmission to eHR systems. in
information to aid patient assessment.
addition, new spot-checks can be downloaded
the palm-sized Pronto-7 – approximately
directly to the device.
1 de benoist b et al. Worldwide prevalence of anemia 1993-2005 WHo global Database on anaemia geneva. World Health Organization. 2 adams
PF et al. current estimates from the National Health interview Survey, 1996. Vital Health Stat. 10.1999:1-203. * use in blood donation settings is
ce Marked. Prior to using this device, the user should read and understand the operator’s Manual and Directions for use. laboratory diagnostic
tests using blood samples should be conducted prior to clinical decision making to completely understand the patient’s condition. comparisons
between SpHb measurements and laboratory diagnostic hemoglobin measurements may be affected by sample type, collection technique,
physiological, and other factors.
124
124
125
immediaTe capnograpHY aT THe poinT oF paTienT conTacT
emma™ – emergencY mainSTream analYzer
seconds. the continuous capnograph allows for confirmation
capnographs measure carbon dioxide (co2) concentrations
and continuous monitoring of endotracheal tube placement,
in expired gases. they are used during anesthesia,
enables clinicians to assess the depth and effectiveness of
emergency care, and intensive care—where capnography is
compressions, and allows clinicians to recognize return of
often used as a substitute for blood gas measurement or to
spontaneous circulation (RoSc).1 its primary use is short-
monitor the performance of assisted ventilation. eMMa is a
term monitoring of end-tidal co2 and respiration rate in
compact, portable, lightweight mainstream capnograph that
adults, pediatric, and infant patients.
requires virtually no warm-up time with full accuracy in 15
1 Neumar RW et al. Circulation. 2010;122:S729-S767.
eMMa fits onto a breathing
circuit, facilitating cPR
“Monitoring respiratory rate and end-tidal carbon dioxide
in the positive-pressure ventilated patient represents
the greatest opportunity to avoid harm and improve
clinical outcomes in all of resuscitation.”
daniel davis, md
Professor of clinical emergency Medicine, Director, center for Resuscitation Science,
ucSD emergency Medicine, San Diego, ca
126
126
127
127
Helping clinicianS idenTiFY
carbon monoxide poiSoning
wiTH Spco®
carbon monoxide (co) poisoning is the most common
cause of poisoning in industrialized countries,1 but is often
misdiagnosed because its symptoms are similar to the flu,
and moderate poisoning is possible with no symptoms at all.2
a deadlY poiSon reVealed wiTH Spco
our first rainbow® measurement was noninvasive carboxyhemoglobin (Spco), helping
clinicians identify and assess co levels in the blood. a recent study at Medical
university Vienna in austria assessed 32,396 emergency Department patients with
Spco by Pulse co-oximetry. of 32 patients with a diagnosis of co poisoning, 22
(69%) would not have been identified without an elevated Spco measurement.2
in another study, researchers examined data from the undersea Hyperbaric Medicine
Society’s co poisoning surveillance system (supported by the centers for Disease
control) and found that patients who were initially measured using Pulse co-oximetry
had an almost one-hour reduction in time from the end of co exposure to treatment.3
“We believe that all 50-plus people in the hotel
would have been dead at dawn if it were not for this
lifesaving intervention from Masimo.”
Skip kirkwood, mS, Jd, emT-p
chief, eMS Division, Wake county Dept. of emergency Services , Raleigh, Nc
SaVing liVeS eVerY daY
in emergency medical services, Spco is helping protect both victims and first
responders from the dangers of co poisoning. Spco helps paramedics and emergency
medical technicians to identify and assess co levels in the blood. Spco is also helping
firefighters reduce the risk of co poisoning that they face every day. Just one severe
co poisoning nearly doubles the risk of premature death, and consistent co exposure
may cause long-term heart and brain damage.4,5
When even mild levels of co are circulating in the blood, the heart and brain are robbed of
critical oxygen. this can cause mental confusion that leads to poor decision making and
also increases the risk of heart disease or stroke – two conditions already accounting
for nearly 50% of on-duty firefighter deaths.6 these factors are why industry-leading
organizations have lined up to support co education, and the National Fire Protection
association (NFPa) recently released an updated Fire Rehabilitation Standard (NFPa
1584) requiring firefighters exposed to smoke at incident scenes and during training to be
assessed for carbon monoxide (co) poisoning.
1 unintentional non-fire-related carbon monoxide exposures - united States, 2001-2003. MMWR Murb Mortol Wkly Rep. 2005;
54:36-39. 2 Roth D, et al. Int J Clin Pract. 2014; 10.1111/ijcp.12432. 3 Hampson Nb. J Emerg Med. 2012 May 23. 4 Hampson Nb et al.
Crit Care Med. 2009; 37(6): 1941-47. 5 bledsoe be. JEMS. 32:54-59, 2007. 6 bledsoe be. FireRescue Magazine. September 2005.
“there is nothing more important in our profession
than firefighter safety. the new 1584 standard builds on
the older standard and more comprehensively addresses
medical monitoring and carbon monoxide poisoning of the
firefighter. i am excited to see this updated standard and
that Masimo is at the forefront of making sure firefighters
go home at the end of their shifts.”
gary ludwig
Fire chief of the champaign (ill.) Fire Department
128
129
leading THe
mHealTH reVoluTion
We are witnessing an exciting convergence of medical device
until now no fingertip pulse oximeter has been available with Masimo Set® Measure-through
and mobile device technology that promises to utterly
Motion and low Perfusion™ pulse oximetry – the same technology used on more than 100 million
transform healthcare.
patients a year in leading hospitals worldwide.
iSpo2® iS THe world’S FirST pulSe oximeTer
For ioS and android mobile plaTFormS
combining a Masimo “board-in-cable,” reusable
or disposable sensor, and an application running
on a smart phone or tablet device, iSpo2* feature
Masimo’s proven Measure-through Motion and
low Perfusion™ pulse oximetry – Spo2, pulse rate,
and perfusion index.
* For sports and aviation use only in the u.S.
“this pulse oximeter is without a doubt the best one
available for the consumer market. Masimo uses
impressive digital signal processing combined with
proprietary leD technology. if you need a serious pulse
oximeter, this is the one to get.”
kirk Shelley, md, phd
Professor of anesthesiology, yale university
New Haven, ct
MightySat™* is available in three versions – each of which provides oxygen saturation (Spo2),
pulse rate (PR), and perfusion index (Pi) measurements in a compact, battery-powered design
with a large color screen that can be rotated for real-time display of the pleth waveform as well
as measurements. optional bluetooth wireless functionality enables measurement display via
a free, downloadable app on ioS and android mobile devices as well as the ability to trend and
communicate measurements. and for those who want to use their pulse oximeter to evaluate
another physiologic dimension, MightySat is the only fingertip pulse oximeter available with
the optional Pleth Variability index (PVi), a measure of the dynamic changes in the Pi that
occur during one or more complete respiratory cycles.
* For sports and aviation use only in the u.S.
“i would recommend Masimo’s MightySat to anyone
interested in health and fitness – understanding what
goes on inside your body is paramount to improving
performance.”
Stig Severinsen
Ph.D. in medicine, four-time World champion freediver and owner of multiple guinness World Records,
including history’s longest breath-hold of 22 minutes
130
130
131
Taking noninVaSiVe moniToring To
all creaTureS greaT and Small
We ramped up our animal Health business in 2013, offering
veterinarians the same industry-leading monitoring solutions
that have helped so many human patients.
Masimo Set® monitors and sensors*
at risk – during anesthesia-induced operating
greatly enhance the accuracy of arterial
procedures and post-operative recovery.
oxygen saturation (Spo2) and pulse rate
(PR) monitoring, particularly in the most
innoVaTiVe capnograpHY proTecTS
challenging conditions of motion and
paTienTS From THe operaTing room
low perfusion.1 Masimo Set® supports
To recoVerY
veterinarians in providing the highest level
up to 60% of all post-surgical animal deaths
of care – especially when their patients are
occur in the post-operative setting. and 74%
up to 60% of all post-surgical animal deaths occur in the
post-operative setting. and 74% of these deaths are
related to cardiovascular or respiratory problems.
of these deaths are related to cardiovascular or respiratory
m-lncS™ proVideS more SenSor opTionS THan
problems.2 the eMMa capnograph is Masimo’s most
anY SenSor and cable SYSTem
cost-effective method for monitoring end-tidal co2 and can
With multiple designs to serve the needs of all patient
be used to help identify animals needing an intervention in
types, M-lNcS sensors offer flexibility for improved
cPR/resuscitation, during surgical procedures, and in post-
patient monitoring from the operating table to the
operative recovery. the water-resistant durable capnograph
recovery room. the M-lNcS tc-i tip-clip ear Sensor
also meets american animal Hospital association (aaHa)
is suited for animals over 30 kg.
guidelines for end-tidal co2 monitoring.
With multiple designs to serve the
needs of all patient types, M-lNcS
sensors offer flexibility for improved
patient monitoring from the
operating table to the recovery room.
1 Shah N et al. J Clin Anesth. 2012 aug;24(5):385-91. 2 brodbelt D et al. Vet Ane and Anal. 2008; 35: 365-373. * animal Health products are pending Masimo quality system release.
132
133
SenSor
Masimo provides a full line of
reusable sensors for various
clinical applications
cable
Rugged, durable design
with reliable connectors
for better performance
TecHnologY
look for Masimo Set® – the market leader in
pulse oximetry – for accurate measurements
during challenging conditions
looKiNg
FoRWaRD
to tHe NeXt
25 yeaRS
134
134
135
perSpecTiVeS on THe FuTure From
THe Founder and ceo, Joe kiani
When Masimo was a garage start-up, more than two
Masimo is well positioned for
decades ago, i never imagined it would become a
a future where healthcare and
global company with more than half a billion dollars in
medical technologies get pushed
annual revenues and more than 3,000 employees.
to home and mobile devices.
as i reflect on the past 25 years, i am proud
Masimo technologies also will be seen to a
as people increasingly use at-home and
even further with measurements from
or “revolution via evolution” – has the
of our accomplishments, yet i can’t help but
greater extent outside clinical settings, as
mobile devices to monitor themselves,
other potential developers through
ability to help unleash innovation that
think: Maybe i should have dreamed bigger.
the role of the “empowered patient” evolves.
they’ll send results to their clinicians from
Masimo open connect™ or Moc-9.
will improve patient outcomes and safety,
one of my core values is to never be content
People are becoming more accountable for
wherever they happen to be. Healthcare of
while reducing the cost of care.
with “good enough.” i’m always striving to
their own healthcare, driven by policy and
the future will be contextualized by almost
Disruptive technologies that improve
fix my sights higher, to set more challenging
technology changes. Fortunately, Masimo is
constant biofeedback, with wireless networks
patient care don’t always come from large,
i remember others in the medical device
goals for my team and myself to accomplish
well positioned for a future where healthcare
and consumer devices for health monitoring
well established companies. yet market
industry – i won’t name names – literally
more than before.
and medical technologies get pushed to home
creating a richer connection between patients
barriers and development costs often
laughed at me when i proposed this concept.
it is not hubris to envision that within the next
and mobile devices.
and their caregivers.
keep small, innovative companies from
i’m mindful that proprietary mindsets had
delivering their products to the clinicians
essentially blocked Masimo from much of
five to 10 years, Masimo technologies will be
leveraging our well-earned reputation for
in keeping with the theme of connectivity
and patients who need them most.
the uS market years ago. closed systems
monitoring more than 200 million patients
unprecedented performance and quality, we
and empowerment, we will witness the
With Root, Masimo is providing an open
that fence off creative, more effective
a year, as our products become ubiquitous
will be unveiling more consumer and mobile
Root® patient monitoring and connectivity
invitation to other companies, from small
technologies are marked relics.
in healthcare settings and beyond. our
monitoring technologies. armed with these
platform continue to evolve and realize its
to large, to develop and commercialize
technology will expand and evolve to meet the
and other devices, consumers will become
full potential. Root is already available with
their innovations through Masimo’s “open-
by doing something like Root, Masimo
future needs of healthcare, by helping improve
more attuned to their physiology. We’ll see
Masimo Set® pulse oximetry, capnography,
innovation” Moc-9 platform.
is lowering the hurdle for innovative
surgical and post-surgical outcomes with
people playing a larger, more proactive role
noninvasive rainbow® parameters, brain
technologies to get to the healthcare
shorter lengths of stay. by better assessing
with their healthcare, rather than merely
function monitoring, and rainbow acoustic
this seemingly incremental functionality
market, lowering the cost of these monitors,
patients we can help reduce the cost of care.
being passive spectators of their “sick care.”
Monitoring™. yet Root is designed to expand
– part of a concept i call “microfixing”
and in the end, saving even more lives.
136
137
i’m reminded of the personal computer saga. before the Pc,
innovation is key to the future of healthcare. Without
For example, you can dramatically improve patient safety
computers were cold, massive, institutional machines housed
innovation, we won’t find the cure to cancer or heart disease
with today’s technologies. you don’t need new technology to
in antiseptic rooms where only geniuses or highly specialized
or alzheimer’s. We won’t have the solutions we hope will be
eliminate the 200,000 preventable patient deaths in u.S.
technicians were allowed to touch them. With the advent of the
there for our kids. However, we need more than technology.
hospitals—you need the will.
Pc, computers became something everyone could play with. We
see a compelling analogy with our Root platform. the thinking
was that someone needed to do for patient monitoring what
was done for computing. that is, make it accessible for other
developers, create an open architecture to speed innovation,
and deliver technologies at a lower cost. that’s why
we were able to price Root at about the
level someone would pay for a Pc –
a couple thousand dollars instead
of $10,000 or $15,000 – so it can
become truly ubiquitous.
Root also allows us to address
interoperability in a more meaningful
way. More than a dozen medical
devices can be connected to
a patient, but those devices
are handicapped if they can’t
communicate with each other. up to
80% of medical errors in hospitals
involve communication problems
between healthcare professionals.
i believe many of these errors could be
avoided if devices could “talk” to each other,
and even shut each other off or alarm when a
measurement on another product is approaching a
dangerous level.
Restrictive business agreements are a barrier to interoperability
therapeutic devices, and it infrastructure all together
and, again, an outdated strategy for med tech companies
with intelligent, predictive algorithms in this Patient Data
to make more money. information-blocking practices harm
Superhighway, then physicians, along with patients and their
patients. We can envision a day, hopefully soon, when providers
families, could be informed of dangerous trends; more lives
only buy devices that share data, particularly when taxpayer
could be saved; and the process of care could be improved
dollars are involved.
substantially, further reducing cost.
likewise, data accessibility is the companion of device
once again evoking the empowerment of patients, they
interoperability – and both are essential to create a Patient
should also be able to access their own health information
Data Superhighway. this highway would securely house a
from medical devices. the Health information technology for
patient’s complete electronic medical history and would
economic and clinical Health (HitecH) act of 2009 states
be populated with real-time information from vital-signs
that eligible professionals “provide patients with an electronic
monitors, labs and other sources. if we bring monitors,
copy of their health information upon request.” it’s a laudable
innovation is key to the future of healthcare. improving
patient safety can be done with today’s technologies.
you don’t need new technology to eliminate the
200,000 preventable patient deaths in u.S. hospitals.
138
139
Human warmth, tenderness, and
understanding are key ingredients
to a more humane and more
effective healthcare system.
requirement. but it should be done as a matter of course and should include
empathy and love are not just for doctors and nurses. Medical technology
easy-to-understand data from medical devices.
executives, engineers, health insurance providers, even the orderlies, those
who deal with hospital linens, and, of course, patients, need to find room
We know that a lack of meaningful communication and information sharing
in their hearts for love. the best medical treatment comes when those
among medical technologies, clinicians and patients contributes to poor
providing care love what they do and for whom they do it.
patient outcomes. Patients who know in layman’s terms how their devices
are programmed, function and interact with their healthcare would be better
if we are to reach a goal of mine – articulated through the Patient Safety
able to communicate with caregivers. greater communication throughout
Movement Foundation we created in 2012 – to eliminate preventable patient
the healthcare ecosystem is key. implicit in that is something that too often
deaths by 2020, then innovative technologies, open engineering architecture,
is neglected in healthcare discussion and debates. and that is empathy and
data accessibility and the Patient Data Superhighway, and last but not least,
love. i disagree that empathy and emotion do not have a place in healthcare.
love, will have to become part of our healthcare system of the future.
Human warmth, tenderness and understanding are key ingredients to a more
humane and more effective healthcare system.
Masimo is here to help make that happen. that’s what i mean by dreaming big.
Joe kiani
Chairman & CEO
140
140
141
141
SeNioR
MaNageMeNt
teaM
From left to right: Tetsuro maniwa, President, Masimo Japan; Stacey Taggart,
President, europe, Middle east & africa; mark de raad, executive
Vice President & chief Financial officer; paul Jansen, executive
Vice President, business Development; Jon coleman, President,
Worldwide Sales, Professional Services & Medical affairs;
rick Fishel, President, Worldwide oeM business and blood
Management; Joe kiani, chief executive officer; Yongsam
lee, executive Vice President, chief information officer; Tom
mcclenahan, executive Vice President, general counsel;
anand Sampath, executive Vice President, engineering & chief
operating officer; robert zyzanski President, Masimo Sweden
board of directors
(not pictured):
Joe kiani, chairman of the board of Directors; Steven barker,
MD, PhD; robert coleman, PhD; Sanford Fitch; Jack lasersohn;
craig reynolds
142
143
aPPeNDiX
6
coNtiNeNtS
HaVe MaSiMo
tecHNologieS
OEM
OEM
masimo is integrated in more
masimo is integrated in more
industry-leading products than any
industry-leading products than any
other pulse oximetry technology
other pulse oximetry technology
144
144
145
TecHnologieS and producTS
MoNitoRS
eXteRNal MeaSuReMeNt
tecHNologieS
PatieNt SaFetyNet™
SySteM
iSpo2®
Spo2, PR, Pi
uSpo2®
Spo2, PR, Pi
mightySat™
Spo2, PR, Pi, PVi
emma™
Portable mainstream
capnometer
pronto-7®
rainbow® 4D with
SpHb® spot-check
with wireless
communication
rad-5v®
Masimo Set®
radius-7™
Patient-worn monitor
radical-7®
complete rainbow® Pulse co-oximetry,
rainbow acoustic Monitoring™,
upgradeable, color touchscreen display,
standard wireless radio, MyView™
root®
complete rainbow® Pulse co-oximetry and rainbow acoustic
Monitoring™, upgradeable, touchscreen, standard wireless radio,
MyView™, Moc-9™, iris™
Shown with Radius-7™
rad-8®
Masimo Set®,
leD display
pronto®
rainbow Set® with
SpHb® spot-check
rad-57®
rainbow Set®
Pulse co-oximetry
iSa™
Sidestream
capnography and
gas Monitoring
Sedline®
brain Function
Monitoring
o3™
Regional
oximetry
patient Safetynet remote monitoring and notification System
> Direct alarms to nurse via pager
> MyView™ for clinician-centric monitoring > iRiS for 3rd party device integration
> open architecture with Hl7 interface to hospital eHR
tecHNologieS aND PaRaMeteRS
ciRcuit boaRDS
SeNSoRS
Measure-through Motion and low Perfusion™
pulse oximetry
Noninvasive blood constituent and
fluid responsiveness monitoring
Noninvasive respiratory monitoring
> end-tidal carbon Dioxide (etco2)
> acoustic Respiration Rate (RRa®)
> Fractional concentration of inspired carbon
rainbow® pulse co-oximetry
rainbow acoustic monitoring™
capnography and gas monitoring
> Functional oxygen Saturation (Spo2)
> Pulse Rate (PR)
> Perfusion index (Pi)
> Pleth Variability index (PVi®)
> Respiration Rate from the Pleth (RRp™)
> carboxyhemoglobin (Spco®)
> Methemoglobin (SpMet®)
> total Hemoglobin (SpHb®)
> oxygen content (Spoc®)
> Fractional oxygen Saturation (Spfo2™)
> oxygen Reserve index (oRi™)
> Plus all Masimo Set® measurements
brain Function monitoring
Noninvasive depth of sedation monitoring
> Patient State index (PSi)
See Regulatory Notice
146
Dioxide (Fico2)
> Respiration Rate (RR)
> Nitrous oxide (N2o)
> oxygen (o2)
mS-2011
mS-2040
> inhalation anesthetic agent identification
(agent iD)
mS-2013
mx-5
masimo SeT® Sensors
Spo2, PR, Pi, PVi®
rainbow® SeT Sensors
SpHb®, Spoc®, Spco®, Spfo2™,
SpMet®, Spo2, PR, Pi, PVi®
rainbow®
acoustic Sensor
RRa®
Sedline® Sensor
PSi
nasal cannula
mainstream adapter
147
caNNulaS aND aDaPteRS
nomoline™
low humidity Multi-
patient use adapter
o3™ Sensor
rSo2 and Spo2
nomoline™
High humidity
Multi-patient
use adapter
naTional and inTernaTional awardS For excellence
SelecT oem parTnerS
masimo set® is integrated in more than 100 oem monitors from 50 leading brands. In addition, more and more of our oem partners are enhancing the capabilities of their monitoring solutions
by integrating rainbow® technology.
BECKER’S
Hospital Review
2000
technology
excellence
2013
best clinical application of
technology award for SpHb
2014
top 50 leaders
in Patient Safety
2014
Hubert H. Humphrey
“Dawn of life” award
1995 excellence in technology innovation for Measure-
through Motion and low Perfusion Pulse oximetry
2006 Medical Design excellence
2009 Zenith award
American Association for Respiratory Care
2000 outstanding Medical Device company
2007 excellence in technology innovation for
Noninvasive total Hemoglobin Monitoring
2001 innovative Product and technology
2007 groundbreaking innovation of rainbow® Set
2001 Distinguished leadership
2001 Medical Design excellence
2003 New Standard of care
2003 technology of the year in Patient Monitoring
2003 Platform abby for innovations in Healthcare
2005 innovative Product and technology
2006 application of technology for
Noninvasive Methemoglobin and
carboxyhemoglobin Monitoring
2007 Patient Monitoring technology
leadership of the year
2008 excellence in Medical technology
2008 outstanding growth
2008 outstanding Medical Device company
2008 best in class
2008 Zenith award
American Association for Respiratory Care
2009 Patient Monitoring ceo of the year
2009 Masimo Set® and Patient SafetyNet help
Dartmouth-Hitchcock Medical center win the
4th annual Health Devices achievement award
2010 Respiratory Product best-in-class award
2011 Product Design award for the Pronto-7
2011 WINNER
2011 Medical Design excellence gold for the Pronto-7
2011 High-tech innovation for the Pronto-7
2012 National entrepreneur of the year
life Sciences award Winner
2012 gold “Stevie” award for best New Health Product
for the Pronto-7
OEM
OEM
masimo is integrated in more
masimo is integrated in more
industry-leading products than any
industry-leading products than any
other pulse oximetry technology
other pulse oximetry technology
2009 best in class
2013 Hot Product award for eMMa and iSpo2
148
149
149
maSimo’S global reacH
Masimo is committed to improving patient care globally, with over
3,000 talented people worldwide and operations in North america,
europe, latin america, the Middle east, asia, and australia.
HeaDQuaRteRS
iNteRNatioNal oPeRatioNS
MaNuFactuRiNg ceNteRS
corporaTe HeadQuarTerS
52 Discovery
irvine, ca 92618
uSa
tel: 949 297 7000
inTernaTional HeadQuarTerS
Puits-godet 10
2000 Neuchâtel
Switzerland
tel: +41 327201111
couNtRy oFFiceS
ThE AMERICAS
canada
4878 levy
Saint-laurent
Qc H4R 2P1
canada
tel: 888 336 0043
laTin america / mexico
Paseo de la Reforma 404
Piso 6 – 602
edificio Moncayo
col. Juárez
México, D.F. 06600 México
Delegación cuauhtémoc
tel: +5255 5511-2799
ASIA
aSia paciFic
31 ubi Road 1
#04-05
Singapore 408694
tel: +65-6521-6700
cHina
Room 502, Suite e
triumph tower bldg. 6
170 beiyuan Rd
beijing 100101
china
tel: +86 1058236155
india
70/2 Miller’s Rd
Miller’s boulevard, 2nd Floor
bangalore 560052
Karnataka State
india
tel: + 1 800 425 MaSiMo
Japan
Sumitomo Fudosan
Korakuen bldg. 17F
1-4-1, Koishikawa, bunkyo-ku
tokyo 112-0002
Japan
tel: +81 338685201
AuSTRALIA
auSTralia
abN 71 124 372 701
Suite 3, bldg. 7
49 Frenchs Forest Rd
Frenchs Forest, NSW 2086
australia
tel: +61 294523763
EuROPE
auSTria
Meldemannstr. 18
1200 Wien
austria
tel: +43 (0) 1 533 73 61
uM
u.S. manuFacTuring
40 Parker
irvine, ca 92618
uSa
mexico manuFacTuring
calzada Del oro No. 2001
Modulo-6,
Mexicali, 21395
Mexico
6
coNtiNeNtS
HaVe MaSiMo
tecHNologieS
uM
France
espace européen d’ecully
bat g
15 chemin du Saquin
69130 ecully
France
tel: +33 0472 179370
germanY
Niederlassung
Deutschland
lindberghstr 11
82178 Puchheim
germany
tel: +49 89800658990
iTalY
Via Filzi 33
20124 Milano
italy
tel: +39 0245076308
neTHerlandS
Hart van brabantlaan
12-14-2016
5038 Jl tilburg
Netherlands
tel: +31 135832479
Spain
Ronda de Poniente
12 2F
28760 tres cantos
Madrid
Spain
tel: +34 918049734
TurkeY
Mustafa Kemal Mah.
2125. Sok
Kolbay is Mrk c blok No:6/10
Sogutozu
ankara
turkey
tel: +90 312 219 54 38
uk
unit Q, loddon
Matrix House, basing View
basingstoke. Hants.
Rg21 4DZ
united Kingdom
tel: +44 (0)1256 479988
MIddLE EAST
middle eaST
offices 505-508
Manhal center
Manhal Square, Jubaiha
amman
Jordan
tel: +962 7 9701 1135
SubSiDiaRieS
maSimo SemiconducTor
25 Sagamore Park Rd
Hudson, NH 03051
uSa
tel: 603 595 8900
134
couNtRieS HaVe
Masimo Set®
maSimo Sweden ab
Svärdvägen 15,
182 33 Danderyd
Sweden
tel: +46 8 544 98 150
tHiRD PaRtieS
maSimo diSTribuTorS
maSimo oemS
59
oeM PaRtNeRS
WoRlDWiDe
21
couNtRy oFFiceS
WoRlDWiDe
oVeR
330
DiStRibutoRS
WoRlDWiDe
3,000
MaSiMo eMPloyeeS
WoRlDWiDe
150
151
2014
FiNaNcialS
Financial perFormance
condensed consolidated Statements of income (unaudited) (in thousands, except per share information)
reVenue
Product
Royalty
total revenue
cost of goods sold
gross profit
operating expenses:
Selling, general and administrative
Research and development
litigation award and defense costs
total operating expenses
operating income
Non-operating expense
income before provision for income taxes
Provision for income taxes
Net income including noncontrolling interest
Net income (loss) attributeable to noncontrolling interest
Net income attributable to Masimo corporation stockholders
Net income per share attributable to Masimo corporation stockholders:
basic
Diluted
Weighted-average shares used in per share calculations:
basic
Diluted
YEAR EndEd:
January 3, 2015
december 28, 2013
$556,764
29,879
586,643
195,864
390,779
241,016
56,581
(10,331)
287,266
103,513
1,472
102,041
27,678
74,363
1,845
$72,518
$1.33
$1.30
54,708
55,571
$517,429
29,816
547,245
188,418
358,827
215,469
55,631
8,010
279,110
79,717
3,991
75,726
20,005
55,721
(2,660)
$58,381
$1.03
$1.02
56,690
57,480
152
152
153
Financial perFormance
condensed consolidated balance Sheets (unaudited) (in thousands)
aSSeTS
current assets:
cash and cash equivalents
accounts receivable, net
inventories
Prepaid income taxes
other current assets
Deferred income taxes, current
total current assets
Deferred cost of goods sold
Property and equipment, net
intangible assets, net
goodwill
Deferred income taxes, noncurrent
other assets
total assets
January 3, 2015
december 28, 2013
liabiliTieS and eQuiTY
January 3, 2015
december 28, 2013
$134,453
$95,466
accounts payable
current liabilities:
71,017
69,718
417
21,471
18,065
315,141
67,485
101,952
27,771
20,979
24,193
7,485
76,759
56,813
3,740
19,384
19,636
accrued compensation
accrued liabilities
income taxes payable
Deferred revenue
current portion of capital lease obligations
271,798
total current liabilities
61,714
Deferred revenue
24,866
long term debt
28,104
other liabilities
22,793
total liabilities
22,565
commitments and contingencies
6,822
equity:
$565,006
$438,662
Masimo corporation stockholders’ equity:
common stock
treasury stock
additional paid-in capital
accumulated other comprehensive
(loss) income
Retained earnings
total Masimo corporation
stockholders’ equity
Noncontrolling interest
total equity
total liabilities and equity
$38,045
33,600
24,541
6,562
21,067
79
123,894
453
125,145
7,773
257,265
52
(185,906)
288,686
(2,093)
205,260
305,999
1,742
$307,741
$565,006
$28,004
29,486
23,028
2,406
20,755
111
103,790
566
225
7,680
112,261
57
(83,454)
273,129
3,995
132,742
326,469
(68)
$326,401
$438,662
condensed consolidated Statements of cash Flows (unaudited) (in thousands)
YEAR EndEd:
YEAR EndEd:
caSH FlowS From
operaTing acTiViTieS
January
3, 2015
december
28, 2013
caSH FlowS From
inVeSTing acTiViTieS
Net income including noncontrolling interest
$74,363
$55,721
Purchases of property and equipment
borrowings under revolving line of credit
125,000
adjustments to reconcile net income including noncontrolling
interest to net cash provided by operating activities:
Depreciation and amortization
Share-based compensation
loss on disposal of property and equipment
Provision for doubtful accounts
benefit from deferred income taxes
income tax benefit from exercise of stock
options granted prior to January 1, 2006
excess tax deficit from share-based
compensation arrangements
changes in operating assets and liabilities:
Decrease (increase) in accounts receivable
increase in inventories
increase in deferred cost of goods sold
Decrease (increase) in prepaid income taxes
increase in other assets
(Decrease) increase in accounts payable
increase in accrued compensation
increase in accrued liabilities
increase (decrease) in income taxes payable
increase in deferred revenue
increase (decrease) in other liabilities
12,818
11,005
368
583
(320)
264
396
4,862
(13,434)
(5,888)
3,316
(2,619)
(1,375)
4,948
1,837
3,909
199
227
increase in intangible assets
Net cash used in investing activities
caSH FlowS From
Financing acTiViTieS
11,421
11,674
249
728
(8,613)
Debt issuance costs
693
Repayments on capital lease obligations
Proceeds from issuance of common stock
excess tax deficit benefit from share-based
compensation arrangements
Repurchases of common stock
Repurchases of equity by noncontrolling interest, net
of equity issued
Net cash provided by (used in) financing activities
effect of foreign currency exchange rates on cash
Net increase (decrease) in cash and cash equivalents
cash and cash equivalents at beginning of period
cash and cash equivalents at end of period
1,308
(9,576)
(9,453)
(9,594)
(1,660)
(756)
1,238
4,557
6,406
(381)
1,467
(842)
Net cash provided by operating activities
95,459
54,587
January
3, 2015
(75,061)
(3,353)
(78,414)
december
28, 2013
(9,360)
(3,926)
(13,286)
(436)
(111)
4,680
(396)
(102,453)
(38)
26,246
(4,304)
38,987
95,466
$134,453
–––
–––
(132)
3,289
(1,308)
(19,790)
–––
(17,941)
552
23,912
71,554
$95,466
154
155
Forward-looking STaTemenTS
all statements other than statements of
our dependence on Masimo Set® and Masimo
of intangible assets we have recorded; the
any obligation to update, amend or clarify
historical facts included in this document that
rainbow® Set® products and technologies
maintenance of our brand; the amount and
these forward-looking statements, whether
address activities, events or developments
for substantially all of our revenue; any
type of equity awards that we may grant
as a result of new information, future events
that we expect, believe, or anticipate will or
failure in protecting our intellectual property
to employees and service providers in the
or otherwise, except as may be required under
may occur in the future are forward-looking
exposure to competitors’ assertions of
future; our ongoing litigation and related
applicable securities laws.
statements. Forward-looking statements
intellectual property claims; the highly
matters; and other factors discussed in the
include statements which are predictive
competitive nature of the markets in which
“Risk Factors” section of our most recent
noTe regarding THiS annual reporT
in nature, which depend upon or refer to
we sell our products and technologies; any
periodic reports filed with the Securities and
Please note that this annual report does not
future events or conditions, which include
failure to continue developing innovative
exchange commission (“Sec”), including our
constitute the company’s “annual report
words such as “expects,” “anticipates,”
products and technologies; the lack of
most recent annual Report on Form 10-K,
to security holders” for purposes of the
“intends,” “plans,” “believes,” “estimates” or
acceptance of any of our current or future
Quarterly Reports Form 10-Q and current
requirements of the Sec. For a copy of the
similar expressions. these forward-looking
products and technologies; obtaining
Reports on Form 8-K, all of which you may
company’s annual report to security holders
statements are based on management’s
regulatory approval of our current and future
obtain for free on the Sec’s website at
required under Rule 14a-3 of Regulation 14a
current expectations and beliefs and are
products and technologies; the risk that
www.sec.gov. although we believe that the
of the Securities exchange act of 1934, as
subject to uncertainties and factors, all
the implementation of our international
expectations reflected in our forward-looking
amended, please refer to the company’s annual
of which are difficult to predict and many
realignment will not continue to produce
statements are reasonable, we do not know
Report on Form 10-K for the fiscal year ended
of which are beyond our control and could
anticipated operational and financial benefits,
whether our expectations will prove correct.
January 3, 2015, which you may obtain for free
cause actual results to differ materially
including a continued lower effective tax
you are cautioned not to place undue reliance
on the Sec ‘s website at www.sec.gov.
and adversely from those described in the
rate; the loss of our customers; the failure
on these forward-looking statements, which
forward-looking statements. these risks
to retain and recruit senior management;
speak only as of the date hereof, even if
include, but are not limited to, those related
product liability claims exposure; a failure to
subsequently made available by us on our
to: actual foreign currency exchange rates;
obtain expected returns from the amount
website or otherwise. We do not undertake
156
157
VEnIMuS, VIDIMuS, VICIMuS
Masimo • 52 Discovery • irvine, ca 92618 • tel: +41 32 720 1111
© 2015 masimo. masimo, set, rainbow, rainbow acoustic monitoring, rainbow 4d, rainbow resposable, 3d desat Index alarm, adaptive Probe off detection, aPod, Blue, dcI-mini, dos, dst, e1, emma, eve, fastsat, fst, Halo Index, Iris, Irma, Isa, ispo2, ispo2 rx, lncs, lnoP,
masimo open connect, masimo Patient safetynet, measure-through motion and low Perfusion, mightysat, m-lncs, moc-9, ms-1, ms-2011, ms-2013, ms-2040, mst, mX-1, mX-3, mX-5, myview, nomoline, o3, orI, Phasein, Pronto, Pronto-7, Pulse co-oximeter, Pulse co-
oximetry, PvI, rad-5, rad-57, rad-5v, rad-8, rad-87, rad-9, radical, radical-7, radius-7, ram, ras, root, ros, rra, rrp, satshare, sedline, signal extraction technology, signal I.Q., smartone ,softouch, spco, spfo2, spHb, spmet, spoc, sst, tfa-1, uspo2, X-cal, Improve patient
outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and new applications, and closer to the Heart are trademarks, registered trademarks, or service marks of masimo corporation. all rights reserved. apple, iPhone, iPad, iPod, and iPod touch
are registered trademarks of apple Inc. registered in the u.s. and other countries. Ios is a trademark or registered trademark of cisco in the u.s. and other countries and is used under license. android is a trademark of Google Inc. all other products, logos, or company names
mentioned herein may be trademarks and/or registered trademarks of their respective companies.
6800-8752a-0215