Architecting, designing and building medical devices in an outcomes-focused Big Data world Day 4 Keynote By Shahid N. Shah www.HealthcareITGuy.com 

NETSPECTIVE www.netspective.com 3 Who is Shahid? • 20+ years of software engineering and multi- site healthcare system deployment experience • 12+ years of healthcare IT and medical devices experience (blog at http://healthcareguy.com) • 15+ years of technology management experience (government, non-profit, commercial) • 10+ years as architect, engineer, and implementation manager on various EMR and EHR initiatives (commercial and non-profit) Author of Chapter 13, “You’re the CIO of your Own Office” 

NETSPECTIVE www.netspective.com 4 What’s outcomes driven care about? 

NETSPECTIVE www.netspective.com 5 What’s Big Data all about? “Normal Data” is about getting things done “Big Data” is about answering big questions 

NETSPECTIVE www.netspective.com 6 Topics • Things that kill and harm human beings today are very different than just 100 years ago • Health policy and payments are shifting to deal with new realities (move from 20 percent to 50 percent of payments will be value-based within the next 3-5 years) • Marketplace and industry challenges for device vendors • How consumerization of devices will disrupt you and what to do about it Key takeaways • “Connected EHRs”, device interoperability, and “Accountable Tech” are the future of med devices • Hardware, sensors, and software are transient businesses but data lives forever. He who owns, integrates, and uses data wins in the end. • Data from devices is too important and specialized to be left to software vendors, managed service providers, and system integrators. What you’ll learn in this keynote Wireless capable medical devices with significant software and data integration are the future 

NETSPECTIVE www.netspective.com 7 Bacteria used to kill us the most… Per 100k population, Historical Statistics of the United States, Millennial Edition 

NETSPECTIVE www.netspective.com 8 Top killers today Heart disease Cancer Chronic lower respiratory diseases Top killers in 1900 Pneumonia and influenza TB Diarrhea and enteritis Infectious diseases used to kill us… …but what’s left seem only to be “manageable” not easily “curable” Per 100k population, Historical Statistics of the United States, Millennial Edition 

NETSPECTIVE www.netspective.com 9 Death by age group, 1900 Death by age group, Today From cures to management… …young people don’t dye of diseases often now http://siteresources.worldbank.org/INTHSD/Resources/topics/Health-Financing/HFRChap1.pdf 

NETSPECTIVE www.netspective.com 10 Patient populations need different devices • Obesity Management • Wellness Management • Assessment – HRA • Stratification • Dietary • Physical Activity • Physician Coordination • Social Network • Behavior Modification • Education • Health Promotions • Healthy Lifestyle Choices • Health Risk Assessment • Diabetes • COPD • CHF • Stratification & Enrollment • Disease Management • Care Coordination • MD Pay-for-Performance • Patient Coaching • Physicians Office • Hospital • Other sites • Pharmacology • Catastrophic Case Management • Utilization Management • Care Coordination • Co-morbidities Prevention Management 26 % of Population 4 % of Medical Costs 35 % of Population 22 % of Medical Costs 35 % of Population 37 % of Medical Costs 4% of Population 36 % of Medical Costs Source: Amir Jafri, PrescribeWell 

NETSPECTIVE www.netspective.com 11 Market trends that smart device manufacturers are following PPACA “Affordable Care Act” ACO “Accountable Care Org” PCMH “Medical Home” MU “Meaningful Use” Switch from FFS to value based payments mHealth PCPCC “Patient Centered Care” Major market and regulatory trends that are causing customers to buy differently and competitors to shift designs You must learn and be able to talk to customers about all these terms 

NETSPECTIVE www.netspective.com 12 Customers are struggling with interoperability and filling EHRs Everything your device does to make their life easier will mean more sales and better margins Source: Jan Whittenber, Philips Medical Systems 

NETSPECTIVE www.netspective.com 13 Customers are struggling with Accountable Tech Cost per patient per procedure / treatment going up but without ability to explain why Cost for same procedure / treatment plan highly variable across localities Unable to compare drug efficacy across patient populations Unable to compare health treatment effectiveness across patients Variability in fees and treatments promotes fraud Lack of visibility of entire patient record causes medical errors Everything your device does to help answer important questions below means more sales and better margins 

NETSPECTIVE www.netspective.com 14 Opportunities for incremental or new revenue Fill clinical documentation into EHRs Improve alarm notification Review and perform complex event processing Add signal/data processing for new parameters Remotely upgrade and service equipment Automate clinical workflows Remote surveillance Gateways and interoperability appliances 

NETSPECTIVE www.netspective.com 15 The tech trends that must influence your device design efforts Commoditization How much of what’s special in your device has or will become a commodity? Commodity components can be put together cheaply to create new solutions using PCs, tablets, phones, and software. Consumerization Can your device be replaced a mobile phone or other consumer device? Sensors built into next generation phones will be clinically useful and may not require FDA approvals due to broad intended use. Workflow Automation Can your device fit into agile clinical workflows? Workflows will change faster in an outcomes-focused world than in a fee for service world. Ignore these and you’ll be disrupted out of existence 

NETSPECTIVE www.netspective.com 16 The data trends that must influence your device design efforts Device Interoperability Can your device connect into the existing IT ecosystem? Customers are seeking to build a programmable world where devices can coordinate and cooperate their data collection efforts. Connected EHRs Can your device fill electronic health records (EHRs)? Billions are being spent for these software systems and buyers are looking to connect their devices to them. Accountable Tech Can your device pay for itself based on diagnostic, therapeutic or other outcomes? Customers in new outcomes-based payment models needs ways of proving efficacy of treatments. Ignore these and you’ll be disrupted out of existence 

NETSPECTIVE www.netspective.com 17 Smart buyers are evolving hardware purchase decisions Thick Devices Thin Devices Virtual Devices Sensors Only with Built-in Wireless Consumerization of Devices Sensors on mobile phones, platforms Language in new RFIs, RFPs, etc. indicate preference to purchase devices with more virtualization. 

NETSPECTIVE www.netspective.com 18 Smart buyers are purchasing more software-centric devices Software for algorithms Software for functionality Software for connectivity Software only Consumerization of Apps Language in new RFIs, RFPs, etc. indicate preference to purchase devices with more software customization capabilities. 

NETSPECTIVE www.netspective.com 19 Smart buyers require device connectivity Stand-alone and monolithic Connectivity within own organization Multi-vendor connectivity System of Systems (SoS) Consumerization of IT Few people buy these when other choices exist 

NETSPECTIVE www.netspective.com 20 Smart buyers require advanced integration Single-purpose devices standalone Multi-purpose standalone Multi-purpose with documentation connectivity Multi-purpose with cooperating connectivity Changes in Practice Models Multi-purpose with analytical connectivity These won’t be bought if other choices exist 

NETSPECTIVE www.netspective.com 21 Implications of trends Consumerization Commoditization Workflow Automation Interoperability Connected EHRs Accountable Tech DATA Evidence Based Medicine Comparative Effectiveness Software Regulated IT and Systems Integration Services 

NETSPECTIVE www.netspective.com 22 Data changes the questions we ask Simple visual facts Complex visual facts Complex computable facts 

NETSPECTIVE www.netspective.com 23 Data can change medical science The old way Identify problem Ask questions Collect data Answer questions The new way Identify data Generate questions Mine data Answer questions 

NETSPECTIVE www.netspective.com 24 Data is getting more sophisticated Proteomics Emerging •Must be continuously collected •Difficult today, easier tomorrow •Super-personalized •Prospective •Predictive Genomics Since 2000s, started at $100k per patient, <$1k soon •Can be collected infrequently •Personalized •Prospective •Potentially predictive •Digital •Family history is easy Phenotypics Since 1980s, pennies per patient •Must be continuously collected •Mostly Retrospective •Useful for population health •Part digital, mostly analog •Family History is hard Admin Since 1970, pennies per patient •Business focused data •Retrospective •Built on fee for service models •Inward looking and not focused on clinical benefits Biosensors Social Interactions 

NETSPECTIVE www.netspective.com 25 Unstructured phenotypic patient data sources Patient Health Professional Labs & Diagnostics Medical Devices Biomarkers / Genetics Source Self reported by patient Observations by HCP Computed from specimens Computed real- time from patient Computed from specimens Errors High Medium Low Time Slow Slow Medium Reliability Low Medium High Data size Megabytes Megabytes Megabytes Data type PDFs, images PDFs, images PDFs, images Availability Common Common Common Uncommon Uncommon 

NETSPECTIVE www.netspective.com 26 Structured phenotypic patient data sources Patient Health Professional Labs & Diagnostics Medical Devices Biomarkers / Genetics Source Self reported by patient Observations by HCP Specimens Real-time from patient Specimens Errors High Medium Low Low Low Time Slow Slow Medium Fast Slow Reliability Low Medium High High High Discrete size Kilobytes Kilobytes Kilobytes Megabytes Gigabytes Streaming size Gigabytes Gigabytes Availability Uncommon Common Somewhat Common Uncommon Uncommon 

NETSPECTIVE www.netspective.com 27 The new world order General Wellness Specific Prevention Self Service Physiologics Self Service Monitoring Self Service Diagnostics Care Team Monitoring Care Team Diagnostics Healthcare Professional Monitoring Healthcare Professional Diagnostics Hospital Monitoring Hospital Diagnostics 

NETSPECTIVE www.netspective.com 28 Smart buyers looking for poly-connectivity Device Hospital Network Corporate Gateway External Cloud Hospital Systems Option 1 (no cellular access or hospital IT integration required) Device External Cloud Option 2 (cellular access and no hospital IT integration required) DDS REST HL7 X.12 DDS REST MPEG-21 MPEG-21 Could be a Home Network, too Wired Wireless Bluetooth, WiFi, Zibee, etc. Wireless, Cellular 

NETSPECTIVE www.netspective.com 29 Don’t give up data to others without a fight Software vendors, systems integrators, and others don’t have your best interest in mind Cloud Services Management Dashboards Data Transformation (ESB, HL7) BaaS Gateway (DDS, XMPP , ESB) Enterprise Data RCM, Financials, EHRs Device Inventory Cross Device App Workflows Alarm Notifications Patient Context Monitoring Device Teaming Device Management Report Generation HIT Integration Remote Surveillance Device Data SSL VPN Patient Self-Management Platforms Device Utilization Device reimbursement Device profitability 

NETSPECTIVE www.netspective.com 30 Key regulatory questions Will the FDA accept networked safety- critical systems? Are connected devices safe enough for medical devices? Yes Yes but you must prove it The best regulatory strategy is to abstract design specifications to minimize sustaining engineering: • Intended use • Predicate device(s) • Design approach and how OTS • components are used • Design input specifications • Risk and hazard analysis Abstract Specifications: • Remove dynamic characteristics • Manufacturer, model, version • Performance specifications • Clock speed • Memory • Storage • Industry standards • Third party certifications Source: Tim Gee, MedicalConnectivity.com 

NETSPECTIVE www.netspective.com 31 Regulatory Strategy 510(k) PMA, Class 3, Class 2, etc. Unregulated EHR or others 510(k) Class 2 “Data Bridges” “Everything else” Customer registry Patient registry Patient profile Study Management Billing “The Device” Class 1 MDDS 

NETSPECTIVE www.netspective.com 32 Key design questions Regulatory approach? Wait for standards? Hardware Design? Software Design? IT Infrastructure Design? Component based separation and task-based approach No, use what’s available and make yours the standard Follow mobile phone designs Buy or build a BaaS, M2M, or IOT Solution Interface-based flexibility over defined certainty 

NETSPECTIVE www.netspective.com 33 Key marketing & product management questions Can your sales team sell it? Can customer manage the technology? Does customer have the existing infrastructure? Can you deliver after you build it? Can your solutions team customize it? Yes, if they’re incentivized and trained They need a good IT and test environment to ensure reliability They need reliable power, broadband coverage, and good WiFi You need installation, provisioning, testing, and remote support infrastructure Yes, if you build for customization 

NETSPECTIVE www.netspective.com 34 Key human capital questions Do we have strategy expertise? Do we have development expertise? Do we have unit and internal testing expertise? Do we have systems and customer environment testing expertise? Do we have regulatory expertise? Do we have certification expertise? You can’t go it alone, get help now 

NETSPECTIVE www.netspective.com 35 Needed: diagnostic quality mHealth 

NETSPECTIVE www.netspective.com 36 Needed: predictive analytics 

NETSPECTIVE www.netspective.com 37 Needed: care team involvement HEALTHCAR E PROVIDER PATIENT/ CONSUMER HOSPITAL FAMILY CAREGIVER ALTERNATE SITE OF CARE Care Team CALL CENTERS AND REMOTE SUPPORT 

NETSPECTIVE www.netspective.com 38 Needed: automated diagnostics 

Thank You Visit http://www.netspective.com http://www.healthcareguy.com E-mail [email protected] Follow @ShahidNShah Call 202-713-5409