Life Sciences. White Paper. The Internet of Things for Medical Devices - Prospects, Challenges and the Way Forward

Transcription

1 Life Scieces White Paper The Iteret of Thigs for Medical Devices - Prospects, Challeges ad the Way Forward

2 About the Authors Ashok Khaa Busiess Head UK, EU ad Major Accouts, Life Scieces (EIS) Global Head, Presales ad Solutios for Life Scieces (EIS) Ashok Khaa has over 19 years of idustry experiece i the field of healthcare, hi-tech ad telecom. As a busiess leader, his expertise spas multiple medical ad pharmaceutical domai areas icludig ew product developmet, product lifecycle maagemet, maufacturig operatios maagemet, R&D ad quality, regulatory ad product susteace. Prateep Misra Research Area Maager, TCS Iovatio Labs With over 21 years of experiece i the IT idustry i areas such as software developmet, research, techology cosultig ad software quality assurace, Prateep Misra leads the developmet of platforms for Iteret-of-Thigs applicatios. Misra's curret focus areas iclude IT ifrastructure architecture ad desig, IT trasformatio, storage systems, large scale ad real time aalytics platforms, ad cloud computig.

3 With the icreasig use of sesors by medical devices, remote ad cotiuous moitorig of a patiet s health is becomig possible. This etwork of sesors, actuators ad other mobilecommuicatio devices, referred to as the Iteret of Thigs for Medical Devices (IoT-MD), is poised to revolutioize the fuctioig of the healthcare idustry. Coected health techologies have gaied promiece as a result of the widespread occurrece of chroic diseases ad the striget eed to cotrol healthcare costs of a agig populatio. A coected healthcare eviromet promotes the quick flow of iformatio ad eables easy access to it. Improved home care facilities ad regular health updates to cliicias reduce the chaces of redudat or iappropriate care, improve patiet care ad safety, ad reduce overall costs of care. Coected health solutios ca also be used to track lifestyle diseases such as hypertesio, diabetics ad asthma which eed cotiuous moitorig. The IoT-MD provides a eviromet where a patiet s vital parameters get trasmitted by medical devices via a gateway oto secure cloud based platforms where it is stored, aggregated ad aalyzed. It helps store data for millios of patiets ad perform aalysis i real time, ultimately promotig a evidece-based medicie system.

4 Cotets 1. Itroductio 5 2. Diverse Applicatios of IoT - MD 6 3. Ulockig the Potetial of IoT - MD 7 4. Addressig Emergig Challeges I IoT - MD 7 5. Maximizig Results with A Platform-Based Approach 9 6. Beefits of IoT - MD Coclusio 11

5 1. Itroductio The Iteret of Thigs (IoT) is icreasigly beig recogized by researchers ad aalysts as oe of the most sophisticated techologies that has the potetial to ot oly affect the health, safety ad productivity of billios of people but also has a major ecoomic impact. It primarily cosists of physical objects that are embedded with sesors, actuators, computig devices ad data commuicatio capabilities. These are liked to etworks for data trasportatio. Imagie a sceario where a patiet s medical profile, vital parameters, ad dialysis machie iputs are captured with the help of medical devices attached to his body. The patiet does ot eve have to move from facility to facility to receive treatmet. Rather, he ca get his dialysis doe with the help of a portable/home machie desiged for the purpose. Data gathered from this device is aalyzed ad stored, ad the aggregatio from multiple sesors ad medical devices helps make iformed decisios i a timely maer. Caregivers ca moitor the patiet from ay locatio ad respod appropriately, based o the alert received. Advaced treatmet of this ature ca drastically improve a patiet s quality of life. Big Data Framework Ehaced Remote Moitorig Ceter VSAT Coectivity Or RTU Gateways Or Eterprise Historia Wired Coectivity Or Big Data Aalytics Predictive Model/ Rule Base Egie Cotrol System & Local Historia Visualizatio GSM/GPRS Coectivity Reportig Figure 1. Remote Moitorig of a Real Patiet 5

6 Health ad welless is oe of the most promisig applicatio areas of IoT techology. Remote health maagemet, maagig lifestyle-related diseases ad coditios, fitess programs, care at home, chroic diseases ad care for the elderly are some of the importat use cases. Other use cases iclude improvig a patiet s compliace to treatmet ad medicatio i hospitals, cliics ad other care facilities. Medical devices such as persoal home-use diagostic devices or low-ed diagostic ad imagig devices that are used by mobile health workers are oe of the key techology compoets. Backed systems exist for data aggregatio, storage, aalytics, visualizatio ad host user-cetric services. I the IoT, physical objects moitor their surroudigs ad participate i daily activities, helpig create ew products, services ad busiess models, to improve efficiecy ad optimize busiess operatios. Additioally, mobile phoes ca be used for may physiological moitorig ad examiatio tasks. The potetial ecoomic impact of IoT i healthcare aloe could ru ito trillios of dollars of aual savigs. I this paper, we idetify potetial applicatio use cases as well as the challeges caused by the IoT o medical devices. Further, we aalyze how a service orieted platform based approach ca address these challeges. 2. Diverse Applicatios of IoT-MD Coected healthcare programs utilize scarce resources to provide a improved quality of care, leadig to better cliical outcomes. Measureable beefits of coected medical devices iclude reductio i mortality rates, reduced cliic visits, emergecy admissios, ad hospital admissios, icludig reductio i bed days of care ad legth of stay i hospitals. The major use cases i this domai iclude: Care for the pediatric ad the aged: Coected health programs are desiged to improve existig healthcare systems for pediatric ad agig populatios. The key idea is to allow the care to be admiistered i the patiet s home. Pediatric patiets eed attetio ad specialized care. Most aged patiets, o the other had, have multiple chroic diseases. Their physiological parameters, activities ad home eviromet eed costat supervisio. Aother class of devices detects mood ad emotio which is used to moitor the psychological state of the patiet. Devices Vital Sig Moitors Activity Moitors Safety Moitors Medicatio Moitors Weight measurig device Walkig time measurig device Fall detectio device Medicatio adherece systems Blood pressure measurig device Step coutig device Persoal safety ad trackig devices Smart Pill Dispeser ECG Blood glucose measurig device Heart rates measurig devices Pulse Oximeters Speed measurig device Calorie spet measurig device Time spet i rest or sleepig measurig device Figure 2. Versatile Offerigs of Coected Medical Devices 6

7 Chroic disease maagemet: Chroic ailmets such as cardiovascular disease, diabetes, high cholesterol, hypertesio, obesity, pulmoary problems ad other diseases affect billios of people worldwide. Chroic disease maagemet ivolves maagig the lifestyle of the patiet via cotiuous egagemet, to help the patiet adhere to a persoalized care pla ivolvig specific treatmet, medicatio ad diet regimes. Persoal health ad fitess maagemet: This class of applicatios is iteded for people who are selfmotivated ad take steps to stay healthy ad fit. These users moitor their daily exercise ad fitess regimes ad use a app or web based applicatio to store the data ad keep track of their progress. These apps are also used to track adherece to schedules created by traiers. Sesors ad devices used i this case iclude weight sesors, activity moitors, heart rate ad blood pressure moitors, coected treadmills ad other fitess equipmet. 3. Ulockig the Potetial of IoT-MD Coected medical devices ad associated IoT techologies will primarily be used to achieve the followig capabilities: Access real time visibility of the patiet's coditio, his/her activities, cotext ad physiological parameters Moitor compliace to prescribed treatmet, diet ad exercise regimes Provide feedback ad cues to patiets, family members, doctors ad caregivers i order to implemet corrective actio Leverage high performace computig for real time feedback ad use evidece-based medicie for better patiet outcome Remote moitorig of patiets leads to more effective ad timely treatmet, leadig to better maagemet of health. I additio, patiets (ad their relatives) are empowered by gettig greater visibility ito their actual health coditios, eablig them to play a active role i cotrollig ad ifluecig their treatmet. 4. Addressig Emergig Challeges i IoT-MD The itegratio ad maagemet of IoT-MD is ot without sigificat bottleecks ad challeges. Maagig device diversity ad iteroperability: I the coected health domai, a variety of devices, istrumets ad equipmet from device vedors ad OEMs, located i homes ad cliics, will coect to backed databases via aggregatio devices located at the site. Aggregatio devices are dedicated device gateways, home routers, smartphoes ad PCs, ad their etwork is ofte referred to as the Peripheral Area Network (PAN). Commoly accepted stadards of etwork iterface are required betwee the devices ad the aggregatio device. Similarly, the iterface betwee the aggregatio device ad backed medical records will be govered by regulatios that madate the use of certai approved stadards ad certificatio. Examples of stadards i use i PANs iclude Cotiua Alliace Bluetooth Profiles ad the ISO/IEEE Optimized Exchage protocol¹. A emergig problem today is that there are still may vedors who do ot support these stadards i their products, thus leadig to sigificat iteroperability issues ad icreased system itegratio costs. [1] Rady Carroll et. al, IEEE Pervasive Computig Magazie, Cotiua: A Iteroperable Persoal Healthcare Ecosystem, Oct Dec

8 Data itegratio: I order to build itelliget, cotext-aware health ad welless applicatios that geerate relevat patiet-specific cues ad alerts, there is a eed to itegrate data from multiple sources. These sources iclude differet types of medical devices such as blood pressure moitors, weighig scales, thermometers, pulse-oximeters, glucose meters, ECG moitors, imagig systems as well as equipmet such as fitess ad stregth machies. Apart from devices ad equipmet, there is a eed to itegrate with other sources of patiet-specific cotextual data icludig mobile devices, social etwork feeds ad other web resources. Device iterfacig ad data collectio will ot yield results uless the structure ad sytax of data ad its meaig is properly uderstood. It is oly whe the sematics is uderstood that itelliget applicatios or mashups ca be built, usig techiques such as correlatio, complex evet processig ad automated reasoig with sematics techology. The sematics of the data must be part of the data itself ad ot be locked up withi the applicatio logic i differet applicatio silos. Scale, data volume ad performace: As the quality ad accuracy of medical devices improve, more applicatios will be developed for a expadig user base. The amout of data that eeds to be igested, stored ad aalyzed will also icrease expoetially. Some medical devices will eed to store high resolutio data, ad some will geerate multimedia output such as high resolutio images ad videos. This will lead to a typical Big Data problem where the sheer volume ad velocity of data igested will make stadard architectures ad platforms iadequate. I other cases, some applicatios may demad more striget real-time performace tha what is ordiarily possible usig stadard iteret techologies. Applicatios ad the database backed must be seamlessly scaled up as operatios become more complex. Flexibility ad evolutio of applicatios: As ewer aalytics, techiques, algorithms, use cases ad busiess models evolve, advaced medical devices with improved capabilities will be created. Newer applicatios ad software compoets eed costat upgrades by specialists with specific techology ad medical domai skills. May of the applicatios will be i the form of dedicated purpose-built apps that are developed usig a crowdsourced model ad dowloaded by ed users from a app marketplace. The ability to quickly develop ad deliver apps with miimal effort is a key requiremet. There is a eed to create ecosystems ad platforms that sustai such a crowdsourced applicatio developmet ad cosumptio model. Data privacy: Data collected from medical devices is sesitive ad must be protected from uauthorized access. It should be used oly for the specific purpose for which the patiet/user allowed that data to be collected. Policies to share medical data with authorized persos ad applicatios must be strictly followed, ad data securitizatio be give utmost importace. Need for medical expertise: The diagosis ad trasmissio of medical data to healthcare providers is govered by regulatios. The iability to iterpret data captured by medical devices, with patiets tryig to diagosis themselves based o a icorrect uderstadig, ca lead to major risks². Every diagosis ad progosis bases itself ot oly o curret observatios made by devices, but o the history ad the health profile of the idividual patiet. Diagosis ad detectio of alert coditios is aided by automated decisio support systems where rules/decisio trees are provided by traied physicias, customized for each coditio ad patiet. [2] Alex Wright, Commuicatios of the ACM, Patiet, Heal Thyself, August

9 5. Maximizig Results with a Platform-Based Approach To meet the challeges of the IoT-MD, we recommed usig a service-orieted platform. The platform, followig a service-orieted architectural (SOA) approach, should be modular ad made available as services that are callable from exteral applicatios by meas of Applicatio Programmig Iterfaces (APIs). The APIs should be ope, welldocumeted ad be made part of a developer portal, together with a example code ad a testig eviromet. Device ad data maagemet A critical aspect that the platform eeds to address is the set of challeges posed by device diversity. Simplifyig the iterfacig with multiple devices, seamless data collectio ad device maagemet will go a log way i eablig IoT. A set of backed cloud coector libraries will be provided for both stadards compliace ad proprietary devices. Moreover, it will be easy to add support i the form of plug-is for ew kids of devices as they become available. The platform should support itegratio of data from multiple sources amely, may differet types of medical sesors as well as o-sesor sources such as data from diagostic equipmet, pathology lab istrumets, data from hospital maagemet systems ad web sources amog others. The data layer should ideally be supported by a sigle commo iformatio model that will be able to describe ay sesor or sesor observatio ad provide commo schemas for capture ad query trasactios. The iformatio model ad schemas ca be made ope so that ay software applicatio ruig o the platform ca easily uderstad ad query the data captured from ay source. Separatio of the data layer from ay applicatio specific processig creates a platform that is flexible ad oe that allows ewer applicatios to be created at differet poits i time by differet sets of developers. Real-time ad batch aalytics Coected health applicatios eed to support both real time aalytics o streamig data as well as aalytics o stored historical data. Examples of real time data maagemet iclude complex evet processig to detect evets of iterest/sigificace, miig sesor evet streams for iterestig patters ad rule-based processig of icomig data i sesor streams. O stored historical data, aalytics should ru usig batch jobs ad it should iclude tasks such as data miig, traiig of machie learig algorithms for predicatio ad filterig ad statistical processig. Itegratio of data from multiple sources also requires the ability to uderstad the sematics of the data ad perform automated reasoig based o the data. The support to describe devices ad observatio data with rich metadata should be available o the platform. Data privacy Privacy of patiet ad user data is a critical requiremet. The platform should defie policy-based access cotrols to medical device data. The patiet should be i cotrol of what is beig accessed by whom ad the platform will allow him to view ad set the access cotrol policies, maitaiig aoymity ad maskig of data wherever possible. 9

10 High scalability From a architecture viewpoit, the platform should be highly scalable. Horizotal scalability allows resources to be added to the commo resource pool as ad whe the umber of devices ad users icrease. Services will be made available i the form of easy-to-use ad well-documeted APIs. A multi-teated approach allows differet applicatios ad users to be supported o the same platform, while providig separatio of data ad resources betwee the teats. Ideally, the platform should be able to ru o both public ad private clouds. Support for applicatio developmet ad deploymet The platform must support developmet ad deploymet of applicatios by users/teats. Web applicatios as well as backed services, batch programs ad sesor stream processig programs should be supported. It is desirable that may differet types of programmig laguages ad applicatio rutimes be supported. Fially, a desired capability of the platform is that it will allow a model-drive approach to coected health applicatio developmet. I this approach, the applicatio developer simply defies the model of the applicatio, the rules of data processig, ad istatiates the devices ad the data processig rules usig a GUI based tool. The platform the geerates the ecessary code ad scripts eeded to ru the applicatio backed ad the data visualizatio iterfaces. 6. Beefits of IoT-MD The key beefits of IoT-MD applicatios i healthcare are as follows: Lowered cost of care: By leveragig IoT-MD systems, the health of patiets ca be moitored o a real time basis, avoidig uecessary doctor visits. Home care is possible, further reducig hospital stay. Caregivers ca address commo use cases ad reach out to doctors oly whe eeded. Improved patiet outcomes: By referrig to a comprehesive kowledge base compiled from previous disease outbreaks ad prove research, caregivers ad doctors ca use evidece-based medicie for improved patiet outcomes. The real-time iformatio ca help provide timely care ad address issues at a early stage. Real time disease maagemet: I a coected healthcare eviromet with cotiuous remote moitorig, patiets ca get treated proactively before their coditio worses. This ot oly helps patiets' health, but also reduces the cost of care. The focus is shifted from 'treatmet' to 'welless'. Improved quality of life: For the critically ill, pediatric ad aged populatios, IoT-MD offers a easier life. The elderly ca live idepedetly at ay locatio of their choice while gettig their medical coditio moitored. Improved user experiece: For patiets as well as caregivers, IoT-MD makes it possible to have a richer ad more itimate egagemet with each other. Automatio of data collectio makes it possible to collect data accurately, o time ad with miimal huma itervetio. All stakeholders receive better visibility with respect to the patiet's coditio, progress ad outcomes of treatmet. Automatio of egagemet also allows better compliace to prescribed treatmet regimes. A platform based approach makes it easy to develop coected health applicatios, eables creatio of smart/itelliget applicatios, allows ewer applicatios to evolve over a period of time ad supports ew devices as they become available. 10

11 7. Coclusio IoT-MD will drastically chage the face of healthcare moitorig ad treatmet outcomes. By providig persoalized ad optimized services, it will promote a better stadard of livig. Natios across the world are strugglig to improve patiet care ad IoT-MD provides a timely ad cost-effective respose to this critical imperative. Moreover, recet developmets i sesor, iteret, cloud, mobility ad big data techologies have led to affordable medical devices ad coected health programs, vastly icreasig the potetial of IoT-MD to ifluece further chages. 11

12 About TCS' Life Scieces Busiess Uit With over two decades of experiece i the life scieces domai, TCS offers a comprehesive portfolio i IT, Cosultig, KPO, Ifrastructure ad Egieerig services as well as ew-age busiess solutios icludig mobility ad big data caterig to compaies i the pharma, biotech, medical devices, ad diagostics idustries. Our offerigs help cliets accelerate drug discovery, advace cliical trial efficiecies, maximize maufacturig productivity, ad improve sales ad marketig effectiveess. We draw o our experiece of havig worked with 7 of the top 10 global pharmaceutical compaies ad 8 of the top 10 medical device maufacturers. Our commitmet towards developig ext-geeratio iovative solutios ad facilitatig cuttig-edge research - through our Life Scieces Iovatio Lab, research collaboratios, multiple ceters of excellece TM ad Co-Iovatio Network (COIN ) - have made us a preferred parter for the world's leadig life scieces compaies. Cotact For more iformatio about TCS Life Scieces Busiess Uit, visit: [email protected] or visit Subscribe to TCS White Papers TCS.com RSS: Feedburer: About Tata Cosultacy Services (TCS) Tata Cosultacy Services is a IT services, cosultig ad busiess solutios orgaizatio that delivers real results to global busiess, esurig a level of certaity o other firm ca match. TCS offers a cosultig-led, itegrated portfolio of IT ad IT-eabled ifrastructure, egieerig ad TM assurace services. This is delivered through its uique Global Network Delivery Model, recogized as the bechmark of excellece i software developmet. A part of the Tata Group, Idia s largest idustrial coglomerate, TCS has a global footprit ad is listed o the Natioal Stock Exchage ad Bombay Stock Exchage i Idia. For more iformatio, visit us at IT Services Busiess Solutios Cosultig All cotet / iformatio preset here is the exclusive property of Tata Cosultacy Services Limited (TCS). The cotet / iformatio cotaied here is correct at the time of publishig. No material from here may be copied, modified, reproduced, republished, uploaded, trasmitted, posted or distributed i ay form without prior writte permissio from TCS. Uauthorized use of the cotet / iformatio appearig here may violate copyright, trademark ad other applicable laws, ad could result i crimial or civil pealties. Copyright 2014 Tata Cosultacy Services Limited TCS Desig Services I M I 07 I 14