Preparing for the Regulatory Challenges Wrought by Software as a Medical Device

As the digital health ecosystem proliferates, medical device manufacturers need to protect themselves from regulatory risk caused by a single line of wrong or misplaced code contained in SaMDs. Here’s how to get started.

Cognizant 20-20 Insights | February 2017

COGNIZANT 20-20 INSIGHTS

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EXECUTIVE SUMMARY

Ce live in a world inOessantle disrapted be diSital. For evere phesiOal aOtivite or objeOt,

there is a diSital Oomponent. Take a basiO neOessite, saOh as walkinS. It is now shaped be

diSital: Individaals Oan traOk their steps, Ooant Oalories barned and reOalibrate their

exerOise reSimen to ensare a healthier lifestele.

DiSital’s impaOt in the personal health spaOe is so enormoas that it has Siven birth to new

deviOes saOh as wearable Oompaters, health apps and sensors, whiOh not onle Oan

provide insiShts to take aOtions that improve well-beinS, bat also enable individaals to

OonneOt, OommaniOate and share health statas in real time with famile, friends and health

professionals. This SaininS and sharinS health-related insiShts in diSital form in real or

near-real time has propelled the tdiSital health” movement z Oentral to whiOh is software.

In the diSital health sOenario, software is not onle tied to hardware as an embedded

Oomponent bat also has the abilite to be hardware aSnostiO (think apps), where it Oan

interOonneOt and inteSrate with other deviOes on internal and pabliO data networks. It also

Oan be exeOated and deploeed over the Oload, and henOe Oan enable maltiple possibilities

to aOOess and exeOate speOifiO health-related tasks. However, these possibilities entail risks

to life and as saOh are a kee item for mediOal deviOe Oompanies’ reSalatore watOh aSendas.

This is not to sae that software ased todae in mediOal deviOes is not reSalated. It is. Bat

beOaase software is embedded into hardware, mediOal deviOe manafaOtarers often do

not plan for sOenarios saOh as:

• Over-the-air apdates and mass distribation.

• Different behavior or response on varied hardware platforms.

• OperatinS sestem version dependenOe for sabseqaent releases.

• Copies installed maltiple times at maltiple loOations.

• Freqaent aninstall and reinstallation in the Oase of laS, latenOe or Orash.

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If ane of the aforementioned sOenarios oOOars, there is a direOt threat to life z whiOh is

not aOOeptable. So rales are reqaired to Sovern these sOenarios. And these rales take

the form of reSalatore frameworks and SaidanOe desiSned to ensare that when a

manafaOtarer Oreates a prodaOt or serviOe as an app in a smartphone, or enables a

smartphone to be ased as an independent mediOal deviOe like a blood SlaOose meter,

there is no risk to life.

And in line with this view, the International MediOal DeviOe ReSalators Foram (IMDRF),

whiOh inOlades the U.S. Food and DraS Administration (FDA) as a member, has released

SaidanOe1 on software as a mediOal deviOe (SaMD) for pabliO Oonsaltation before

pablishinS the final version, expeOted in MarOh 2017.

This white paper is intended to help mediOal deviOe manafaOtarers anderstand SaMD,

evalaate its impaOt on qaalite manaSement sestems (QMS) and embraOe the shift in

their basiness environment. One Oaveat: This white paper shoald not be Oonsidered or

perOeived to be leSal adviOe. Rather, it presents direOtional SaidanOe and offers new

basiness models to help mediOal deviOe Oompanies transform and remain relevant in the

diSital health aSe.

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Let’s set the Oontext riSht. The IMDRF, formerle

the Global Harmonization Task ForOe (GHTF), is

Ohartered to promote harmonization and redaOe

differenOes in mediOal deviOe reSalatore poliOies

amonS reSalatore aSenOies aOross SeoSraphies.

To do so, it is inOorporatinS inpats from both

indastre and reSional bodies. HenOe, IMDRF is

manaSed be Oommittee, OomprisinS reSalatore

offiOials from Aastralia, Brazil, Canada,

China, the Earopean Union, Japan, Rassia,

and the U.S. (the FDA, as mentioned

above).

As part of its aOtivities, and to address

ever-OhanSinS sOenarios where software

has transformed diSital health beeond its

initial embed in hardware, the IMDRF

formed an SaMD CorkinS Groap (CG).

This CG foOases on software’s evolvinS

role in diSital health, and has established

foandational prinOiples, a harmonized

voOabalare and a list of aOknowledSed speOifiO

Oonsiderations appliOable to SaMD. The CG

works to farther address the OonOerns and

aniqae OhallenSes of manafaOtarers and

reSalators, as refleOted in the issaed draft

SaidanOe on SaMD (whiOh has been released for

Oomment be partiOipatinS members).

The IMDRF SaMD CG defines2 SaMD as tsoftware

intended to be ased for one or more mediOal

parposes that perform these parposes withoat

beinS part of a hardware mediOal deviOe.” FiSare

1 expands on these parposes and offers examples

within the Oontext of SaMD’s defininS prinOiples.

SAMD: BEYOND ACRONYMS

SaMD

SaMD is a medical device and includes an in-vitro diagnostic (IVD) medical device.

Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.

SaMD is capable of running on

general purpose (nonmedical

purpose) computing platforms.

SaMD may be used in combi-

nation (e.g., as a module) with other products including medical devices.

“…without being part of” means

software not necessary for a hardware medical

device to achieve its intended medical

purpose.

SaMD may be interfaced with

other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software.

Mobile apps that meet the definition in this figure are considered SaMD.

Figure 1: SaMD Definitional Principles

It is important to note that for SaMD, the term

tintended ase/intended parpose” is the

objeOtive intent of the manafaOtarer reSardinS

the ase of a prodaOt, proOess or serviOe as

refleOted in the speOifiOations, instraOtions and

information provided be the manafaOtarer.3

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MEDICAL DEVICE GOVERNING CLASSES

The FDA defines a mediOal deviOe as an

instrament, apparatas, implement, maOhine,

OontrivanOe, implant, in vitro reaSent, or other

similar or related artiOle, inOladinS a Oomponent

part or aOOessore that is:

• ReOoSnized in the offiOial National Formalare,

or the U.S. PharmaOopoeia, or ane sapplement

thereof.

• Intended for ase in the diaSnosis of disease,

or other Oonditions, saOh as the Oare,

mitiSation, treatment, or prevention of

disease, in hamans or animals.

• Intended to affeOt the straOtare or ane

fanOtion of the bode of hamans.

Farther, the FDA Olassifies mediOal deviOes in

three Olasses:5

• Class I: DeviOes that are deemed to be low

risk and are therefore sabjeOt to the least

reSalatore Oontrols.

• Class II: HiSher-risk deviOes than Class I

whiOh reqaire Sreater reSalatore Oontrols to

provide reasonable assaranOe of safete and

effeOtiveness.

• Class III: Generalle the hiShest-risk deviOes

whiOh are therefore sabjeOt to the hiShest

level of reSalatore Oontrol. Class III deviOes

mast tepiOalle be approved be the FDA before

thee are marketed.

For SaMD, those OlassifiOations remain the same

exOept with the addition of a novel OateSore,

Class IV:6

• Class IV: These deviOes whiOh are vital to

avoidinS death or serioas deterioration of

health issaes.

Class IV is Oarrentle limited to SaMDs; there is no

hardware OlassifiOation at this time.

As SaMD’s availabilite, aniqaeness and appliOation

vare freqaentle, farther breakdown is reqaired to

Olearle differentiate the foar OateSories.

There are two kee Oriteria that help to break

down SaMD OlassifiOations (as shown in FiSare 2,

next paSe):

• Significance of the information provided by

SaMD to the healthcare decision. This is

Olassified into OateSories saOh as:

» To treat or to diaSnose.

» To drive OliniOal manaSement.

» To inform OliniOal manaSement.

• State/impact of the healthcare situation or

condition. This is Olassified into OateSories

saOh as:

» CritiOal.

» Serioas.

» Nonserioas.

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A Oomplete holistiO view, with referenOe from the draft

SaidanOe,7 is represented in FiSare 3 (next paSe).

Cant examples of what an SaMD is not? Here are

some:

• DiSital Oopies of mediOal diOtionaries, emerSenOe

Oare information, sarSiOal traininS videos, etO.

• Apps ased onle to loS, reOord, traOk, evalaate,

or make deOisions or saSSestions related to

developinS or maintaininS health and wellness,

as lonS as those deOisions or saSSestions are

not intended for OarinS, treatinS, seekinS

treatment for mitiSatinS, or diaSnosinS a

speOifiO disease or health Oondition.

• Apps that aatomate Seneral offiOe operations

in a healthOare settinS and are not intended

for ase in the diaSnosis of disease or other

Oonditions, or in the Oare, mitiSation,

treatment or prevention of disease.

• Software/apps as part of an tembedded item”

with hardware not part of SaMD OlassifiOation.

• Apps that allow healthOare providers to

OommaniOate in a seOare and proteOted

method (e.S., asinS a Health InsaranOe

Portabilite and AOOoantabilite AOt (HIPAA)

Oompliant app to send messaSes between

health Oare providers in a hospital).

• Apps that perform simple OalOalations

roatinele ased in OliniOal praOtiOe (e.S.,

determininS bode mass index).

TREAT OR DIAGNOSE

State of Healthcare situation or condition

SIGNIFICANCE OF INFORMATION PROVIDED BY SaMD TO HEALTHCARE DECISION

CLASS IV.i

CLASS III.ii

CLASS II.iii

CLASS III.i

CLASS II.ii

CLASS I.iii

CLASS II.i

CLASS I.ii

CLASS I.i

DRIVE CLINICAL MANAGEMENT

INFORM CLINICAL MANAGEMENT

CLINICAL

NON-SERIOUS

i represents siSnifiOanOe of information provided be SaMD.

SERIOUS

Figure 2. SaMD Classification

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Figure 3. Holistic View: SaMD Device Class, Significance & Impact

ALIGNING QMS WITH DIGITAL HEALTH NEEDS

QMS in mediOal deviOes foOases on three primare

parameters:

• Safete and effiOaOe.

• Risk manaSement.

• DesiSn protoOols.

These elements Sovern the prodaOt development

proOess throaShoat the deviOe lifeOeOle. And

there are Olear rales and reSalations to help

manafaOtarers baild the intended mediOal

deviOes.8 However, the OhallenSe with Oarrent

reSalations is that thee are more foOased on

software that is embedded in dediOated hardware

and is part of the diaSnostiO or treatment proOess

while in the hands of a speOialist.

The sitaation with SaMD is different. Software

now powers mobile apps or software prodaOts/

platforms that are deploeed on the Oload, are not

dependent on hardware and Oan be improved

with freqaent apdates.

A reOent report9 noted that there are more than

165,000 mobile health apps as of todae, and this

namber is SoinS to onle inOrease siSnifiOantle in

OominS months. It is fair to assame that not all of

these mobile health apps will oriSinate from

traditional mediOal deviOe manafaOtarers.

Instead, most are likele to be the brainOhild of a

software Oompane lookinS to enter the diSital

health spaOe.

And in an effort to baild a Oompetitive prodaOt

foOased on Oonsamer featares and a Oomfortable

aser interfaOe, there is a stronS possibilite that

the three kee parameters z safete and effiOaOe,

risk manaSement and desiSn protoOols z Ooald be

overlooked. This means that a mobile app

manafaOtarer mae be followinS the software

development lifeOeOle proOess bat mae not be

falle aware of QMS for mediOal deviOes. HenOe,

there is a risk.

BeOaase mobile apps are OritiOal to diSital health,

their evolation is OhanSinS the wae health

prodaOts and information are bailt and delivered.

As a resalt, maltiple QMS OhallenSes have arisen

for SaMD manafaOtarers, inOladinS the followinS:

i iiiii

i iiiii i ii

iii

NOT SaMD

NOT SaMD

Imp

act

Significance

No

ne

Low

Me

diu

mH

igh

Cat

astr

op

hic

RetrievesInformation

OptimizeProcesses

InformsNonserious Informs

Critical

DrivesNonserious

DrivesSerious

Treat/DiagnoseSerious

CLASS IV

CLASS III

CLASS II

CLASS I

Closed Loop Interventions/

No Clinical Intermediary

Treat/DiagnoseCritical

Treat/DiagnoseNonserious

InformsSerious

OrganizesData

DrivesCritical

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• How shoald an SaMD address an apdate

issae in the event of poor network zones

where the onle apdate option is via

inseOare wireless teOhnoloSe?

• Cith freqaent operatinS sestem version

apdates, the sapport of earlier versions is

eventaalle deOommissioned. How woald an

SaMD manafaOtarer address this?

• How woald asers be informed aboat apdates

or deOommissioninS of sapport? Chat

OommaniOation Ohannels shoald be ased?

• Chat happens to data in the event of

deOommissioninS or an apdate? Chat are

the risks and baOkap meOhanisms?

• How shoald an SaMD manaSe and address

Oomplaints, inOidents, sapport, and teOhniOal

issaes and inqaires? Chat are the Oontrol

and SovernanOe meOhanisms?

CONTENDING WITH DIGITAL HEALTH’S SHIFTING BUSINESS MODELS

DiSital health is havinS a major impaOt in the

mediOal health indastre. A reOent report foand

that fandinS of diSital health deals in 2016

alone amoanted to a total of $2.6 billion.10

These resalts Olearle show not onle the

direOtion bat also the attention diSital health is

reOeivinS. FiSare (next paSe) offers a seleOtive

view of the landsOape saOh deals Oover.

Not onle are these deals OaasinS a shift in

traditional mediOal deviOe Oompanies’ basiness

models and the basiness landsOape, bat it is

raisinS foar kee OonOerns for indastre plaeers:

• The shift in the operating model is now

Oompoanded be the emerSenOe of diSital

apps that Ooald eat into revenaes. The

traditional market will soon be sarroanded

be new plaeers that do not operate in silos.

StiOkinS to the old formala of baildinS a

deviOe and hopinS for the best is not

saffiOient for saOOess. Rather, plaSSinS into

the diSital health eOosestem is eqaalle

important for maintaininS market

relevanOe.

• The shift in time to market wroaSht be

diSital has shattered the meth that onle

hardware or embedded foOased mediOal

deviOes Oan make monee. The flood of

diSital apps in the marketplaOe, as well as

their abilite to deliver basiO serviOes via

more freqaent apdates, has OhallenSed

traditional plaeers to keep paOe.

“A mobile app manufacturer may be following the software development lifecycle process but may not be fully aware of QMS for medical devices.”

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Information Management:

Provides ways to help us manage our health infor-mation without providing

specific treatment or treatment suggestion.

Track and Trace:

Tools to track and trace our health

information as and when required.

Access to Knowledge

Base: Educational

material for us to understand

treatment and diagnosis.

Clinical Help:Mobile apps that

analyze an image of a skin lesion using

mathematical algorithms.

And Many More….

Organization:Alerts, notifications,

reminders, etc. to help organize our treatments, visits,

etc.

Accessory/Attachment:

Attachment of a blood glucose strip reader to

a mobile platform to function as a glucose

meter.

Remote Monitoring:

Apps that connect to different monitoring systems to

allow remote information

access.

SaMD

• The shift in the married-to-a-platform

approach has opened doors to Oross-platform

Oompatibilite; henOe, sapport for diSital apps

mast be provided for most of the leadinS

platforms.

• The shift in customer acquisition is from a

model in whiOh mediOal deviOes makers

deploe manpower to sell their deviOe to the

ase of a diSital platform to qaiOkle reaOh a

larSe and SrowinS Oastomer base. If a prodaOt

Oan be laanOhed with a diSital Oompanion,

then marketinS Oan be qaiOkle and Oost-

effeOtivele enhanOed. No lonSer will deviOe

makers need an arme of representatives

visitinS hospitals. Now, even hospitals Oan

order online and have trial versions shipped

to their door.

» Case in point: The first Oontinaoas

SlaOose monitorinS (CGM) mobile

sestem for diabetes manaSement was

reOentle approved be the FDA.11 The

tnon-adjanOtive” indiOation enables

the ase of the CGM sestem as a

replaOement to painfal finSerstiOk

SlaOose testinS for diabetes treatment

deOisions. FinSerstiOks are needed

onle onOe evere 12 hoars to Oalibrate.

The FDA’s approval of the mobile CGM

sestem as the first and onle mediOal

deviOe for non-adjanOtive indiOation

represents a new era in diabetes

manaSement.

Moreover, the FDA also Oleared 36 diSital health

apps in 2016,12 sendinS a Olear messaSe that it is

time for the indastre to rethink traditional

models and embraOe diSital health.

LOOKING FORWARD

As the indastre transitions to SaMD, we believe

mediOal deviOe manafaOtarers mast Oonsider

the followinS:

• OfferinS a diSital twin to Oonventional deviOes

is more of a neOessite than merele niOe to have.

Figure 4. SaMD Landscape Offerings: Where the Money Is

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• Consamers on mobile deviOes demand aOOess

to information; therefore, mediOal deviOe

manafaOtarers need to draw the balanOe

between what to expose and what not to

expose.

• PrivaOe laws and storaSe of information are

beOominS more pertinent than ever.

• SaMD basiness models are takinS monee

from traditional plaeers, and SoinS diSital is

the sarvival kee for life sOienOes orSanizations.

• SaMD models are likele to be impaOted be

OeberseOarite laws and OhallenSes that Ooald

pose a threat to their basiness and revenaes.

• Embedded mediOal deviOes will still be in

demand as thee are reqaired for treatment

and diaSnosis of OritiOal Oonditions. However,

Oonsamers will want information to be

delivered on demand to their mobile deviOes.

Epilog

2016 has been a eear of maltiple releases be the

FDA z some in draft form, others as final

SaidanOe. Cith its draft SaidanOe to allow

patients to Sather their health data direOtle from

mediOal deviOe manafaOtarers in addition to

their health providers,13 the messaSe has been a

Oonsistent one of aliSnment with the diSital

health reSalatore environment. Ce expeOt to see

new reSalations with revisions to existinS rales

to aOOommodate diSital’s sweepinS impaOt.

SaMD will forever OhanSe the landsOape and set

a Ooarse for Sood. At the same time, there are

new threats saOh as OeberattaOks, and

manafaOtarers mast foOas on patient safete and

life while maintaininS or extendinS their deviOes’

robast prodaOt featares and fanOtionalite.

Rales SoverninS SaMD will be in effeOt be MarOh

2017. This shoald serve as a wake-ap Oall for all

manafaOtarers to speak the same lanSaaSe,

alonS with providinS the OliniOal evidenOe

reqaired to extend their SaMD from the U.S.

market into SeoSraphies saOh as Brazil, Rassia,

China, etO. SaMD is also OhanSinS the rales for

insaranOe providers and mobile deviOe

manafaOtarers. A reOent example of baildinS a

Oollaborative mobile health platform in the

wellness spaOe has set an indastre preOedent.1

This deal has helped baild a foandation to deliver

on SaMD’s lonS-term potential.

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FOOTNOTES

1 tSoftware as a MediOal DeviOe: CliniOal Evalaation,” Federal ReSister notiOe, OOt. 1 , 2016. https://www.federalreSister.Sov/

doOaments/2016/10/1 /2016-2 805/software-as-a-mediOal-deviOe-OliniOal-evalaation-international-mediOal-deviOe-reSalators-

foram-draft

2 tSoftware as a MediOal DeviOe (SaMD): CliniOal Evalaation,” SaMD CG proposal, AaS. 5, 2016. http://www.fda.Sov/downloads/

MediOalDeviOes/DeviOeReSalationandGaidanOe/GaidanOeDoOaments/UCM52 90 .pdf

3 Ibid.

MediOal deviOe definition, U.S. FDA. http://www.fda.Sov/MediOalDeviOes/DeviOeReSalationandGaidanOe/Overview/ClassifeYoarDeviOe/

aOm051512.htm

5 tClassife Yoar MediOal DeviOe,” U.S. FDA. http://www.fda.Sov/MediOalDeviOes/DeviOeReSalationandGaidanOe/Overview/

ClassifeYoarDeviOe/

6 Op Oit. footnote no. 2.

7 Op Oit. footnote no. 2.

8 Overview of DeviOe ReSalation, U.S. FDA. http://www.fda.Sov/MediOalDeviOes/DeviOeReSalationandGaidanOe/Overview/defaalt.

htm#qs

9 tNew report finds more than 165,000 mobile health apps now available, takes Olose look at OharaOteristiOs & ase,” iMedicalApps, Sept.

17, 2015. http://www.imediOalapps.Oom/2015/09/ims-health-apps-report/

10 Heather MaOk, tAll the diSital health fandinS MobiHealthNews Oovered in 2016,” MobiHealthNews, DeO. 26, 2016. http://www.

mobihealthnews.Oom/Oontent/all-diSital-health-fandinS-mobihealthnews-Oovered-2016

11 tFDA Approval of DexOom’s Non-AdjanOtive IndiOation TriSSers a New Era in Diabetes ManaSement,” DexOom press release, DeO. 20,

2016. http://investor.shareholder.Oom/dexOom/releasedetail.Ofm?ReleaseID=1005071

12 Heather MaOk, tThirte-six OonneOted health apps and deviOes the FDA Oleared in 2016,” MobiHealthNews, DeO. 30, 2016. http://www.

mobihealthnews.Oom/Oontent/thirte-six-OonneOted-health-apps-and-deviOes-fda-Oleared-2016

13 tDissemination of Patient-SpeOifiO Information From DeviOes be DeviOe ManafaOtarers; Draft GaidanOe for Indastre and Food and

DraS Administration Staff,” FDA Federal ReSister notiOe. https://www.federalreSister.Sov/doOaments/2016/06/10/2016-13787/

dissemination-of-patient-speOifiO-information-from-deviOes-be-deviOe-manafaOtarers-draft-SaidanOe

1 tSamsanS and CiSna Release New Health and Fitness AppliOation,” SamsanS press release, Mae 18, 2015 https://news.samsanS.Oom/

Slobal/samsanS-and-OiSna-release-new-health-and-fitness-appliOation

ABOUT THE AUTHOR

JaSmeet SinSh is a DireOtor within CoSnizant’s IntelliSent ProdaOts and ServiOes Basiness ConsaltinS PraOtiOe. He has more than 20 eears of experienOe in prodaOt development and innovation aOross a namber of indastre vertiOals. JaSmeet has pablished and presented maltiple white papers at international levels and has Slobal experienOe at exeOative levels. He is also top ranked be GooSle in the prodaOt OomplianOe and sastainabilite line of basiness. JaSmeet reOeived a deSree in aatomobile enSineerinS from GalbarSa Universite, India. He Oan be reaOhed at JaSmeet.SinSh@OoSnizant.Oom.

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#5/535 Old Mahabaliparam RoadOkkieam Pettai, ThoraipakkamChennai, 600 096 IndiaPhone: +91 (0) 209 6000Fax: +91 (0) 209 6060

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TL Codex 2513