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

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In the rapidly evolving digital health ecosystem, software as a medical device (SaMD) plays an increasingly critical role for medical device manufacturers and other stakeholders, and understanding regulatory policies covering such software is key for determining QMS requirements.
  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  2 Preparing for the Regulatory Challenges Wrought by Software as a Medical Device | Cognizant 20-20 Insights gu   EXECUTIVE SUMMARY e live in a world inessantl disrpted b diital. For ever phsial ativit or objet, there is a diital omponent. Take a basi neessit, sh as walkin. It is now shaped b diital: Individals an trak their steps, ont alories brned and realibrate their exerise reimen to ensre a healthier lifestle. Diital’s impat in the personal health spae is so enormos that it has iven birth to new devies sh as wearable ompters, health apps and sensors, whih not onl an provide insihts to take ations that improve well-bein, bt also enable individals to onnet, ommniate and share health stats in real time with famil, friends and health professionals. This ainin and sharin health-related insihts in diital form in real or near-real time has propelled the diital health” movement  entral to whih is software.In the diital health senario, software is not onl tied to hardware as an embedded omponent bt also has the abilit to be hardware anosti (think apps), where it an interonnet and interate with other devies on internal and pbli data networks. It also an be exeted and deploed over the lod, and hene an enable mltiple possibilities to aess and exete spei health-related tasks. However, these possibilities entail risks to life and as sh are a ke item for medial devie ompanies’ relator wath aendas.This is not to sa that software sed toda in medial devies is not related. It is. Bt bease software is embedded into hardware, medial devie manfatrers often do not plan for senarios sh as: ã Over-the-air pdates and mass distribtion. ã Different behavior or response on varied hardware platforms. ã Operatin sstem version dependen for sbseqent releases. ã Copies installed mltiple times at mltiple loations. ã Freqent ninstall and reinstallation in the ase of la, laten or rash.    3 Preparing for the Regulatory Challenges Wrought by Software as a Medical Device | Cognizant 20-20 Insights gu   If an of the aforementioned senarios ors, there is a diret threat to life  whih is not aeptable. So rles are reqired to overn these senarios. And these rles take the form of relator frameworks and idane desined to ensre that when a manfatrer reates a prodt or servie as an app in a smartphone, or enables a smartphone to be sed as an independent medial devie like a blood lose meter, there is no risk to life. And in line with this view, the International Medial Devie Relators Form (IMDRF), whih inldes the U.S. Food and Dr Administration (FDA) as a member, has released idane 1  on software as a medial devie (SaMD) for pbli onsltation before pblishin the nal version, expeted in Marh 2017.This white paper is intended to help medial devie manfatrers nderstand SaMD, evalate its impat on qalit manaement sstems (QMS) and embrae the shift in their bsiness environment. One aveat: This white paper shold not be onsidered or pereived to be leal advie. Rather, it presents diretional idane and offers new bsiness models to help medial devie ompanies transform and remain relevant in the diital health ae.  4 Preparing for the Regulatory Challenges Wrought by Software as a Medical Device | Cognizant 20-20 Insights Let’s set the ontext riht. The IMDRF, formerl the Global Harmonization Task Fore (GHTF), is hartered to promote harmonization and rede differenes in medial devie relator poliies amon relator aenies aross eoraphies. To do so, it is inorporatin inpts from both indstr and reional bodies. Hene, IMDRF is manaed b ommittee, omprisin relator ofials from Astralia, Brazil, Canada, China, the Eropean Union, Japan, Rssia, and the U.S. (the FDA, as mentioned above). As part of its ativities, and to address ever-hanin senarios where software has transformed diital health beond its initial embed in hardware, the IMDRF formed an SaMD orkin Grop (G). This G foses on software’s evolvin role in diital health, and has established fondational priniples, a harmonized voablar and a list of aknowleded spei onsiderations appliable to SaMD. The G works to frther address the onerns and niqe hallenes of manfatrers and relators, as reeted in the issed draft idane on SaMD (whih has been released for omment b partiipatin members). The IMDRF SaMD G denes 2  SaMD as software intended to be sed for one or more medial prposes that perform these prposes withot bein part of a hardware medial devie.” Fire 1 expands on these prposes and offers examples within the ontext of SaMD’s denin priniples. SAMD: BEYOND ACRONYMS SaMD is a medical device and includes an in-vitro diagnostic (IVD) medical device. Software does not meet the denition 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 denition in this gure are considered SaMD. Figure 1: SaMD Denitional Principles It is important to note that for SaMD, the term intended se/intended prpose” is the objetive intent of the manfatrer reardin the se of a prodt, proess or servie as reeted in the speiations, instrtions and information provided b the manfatrer. 3
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