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Architecting, designing and building medical devices in an outcomes focused Big Data world
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Architecting, designing and building medical devices in an outcomes focused Big Data world

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Keeping your medical device designs relevant in an era of value based and outcome driven care is not easy. In this talk, I cover the following topics: ...

Keeping your medical device designs relevant in an era of value based and outcome driven care is not easy. In this talk, I cover the following topics:

* “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.

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    Architecting, designing and building medical devices in an outcomes focused Big Data world Architecting, designing and building medical devices in an outcomes focused Big Data world Presentation Transcript

    • Architecting, designing and building medical devices in an outcomes-focused Big Data world Day 4 Keynote By Shahid N. Shah www.HealthcareITGuy.com
    • NETSPECTIVE Who is Shahid? • 20+ years of software engineering and multisite 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” www.netspective.com 3
    • NETSPECTIVE What’s outcomes driven care about? www.netspective.com 4
    • NETSPECTIVE What’s Big Data all about? “Normal Data” is about getting things done www.netspective.com “Big Data” is about answering big questions 5
    • NETSPECTIVE What you’ll learn in this keynote Wireless capable medical devices with significant software and data integration are the future Topics Key takeaways • 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 • “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. www.netspective.com 6
    • NETSPECTIVE Bacteria used to kill us the most… Per 100k population, Historical Statistics of the United States, Millennial Edition www.netspective.com 7
    • NETSPECTIVE Infectious diseases used to kill us… …but what’s left seem only to be “manageable” not easily “curable” Top killers in 1900 Pneumonia and influenza TB Diarrhea and enteritis Top killers today Heart disease Cancer Chronic lower respiratory diseases Per 100k population, Historical Statistics of the United States, Millennial Edition www.netspective.com 8
    • NETSPECTIVE From cures to management… …young people don’t dye of diseases often now Death by age group, 1900 Death by age group, Today http://siteresources.worldbank.org/INTHSD/Resources/topics/Health-Financing/HFRChap1.pdf www.netspective.com 9
    • NETSPECTIVE Patient populations need different devices Prevention • Education • Health Promotions • Healthy Lifestyle Choices • Health Risk Assessment Management • • Obesity Management Wellness Management • • • • • • • Assessment – HRA Stratification Dietary Physical Activity Physician Coordination Social Network Behavior Modification • • • 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 • • • 26 % of Population 35 % of Population 35 % of Population 4% of Population 4 % of Medical Costs 22 % of Medical Costs 37 % of Medical Costs 36 % of Medical Costs Source: Amir Jafri, PrescribeWell www.netspective.com 10
    • NETSPECTIVE Market trends that smart device manufacturers are following 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 PPACA ACO PCMH “Affordable Care Act” “Accountable Care Org” “Medical Home” Switch from FFS to value based payments www.netspective.com mHealth MU “Meaningful Use” PCPCC “Patient Centered Care” 11
    • NETSPECTIVE 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 www.netspective.com 12
    • NETSPECTIVE Customers are struggling with Accountable Tech Everything your device does to help answer important questions below means more sales and better margins 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 www.netspective.com 13
    • NETSPECTIVE 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 www.netspective.com 14
    • NETSPECTIVE The tech trends that must influence your device design efforts Commodity components can be put together cheaply to create new solutions using PCs, tablets, phones, and software. www.netspective.com 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 How much of what’s special in your device has or will become a commodity? Consumerization Commoditization Ignore these and you’ll be disrupted out of existence Can your device fit into agile clinical workflows? Workflows will change faster in an outcomes-focused world than in a fee for service world. 15
    • NETSPECTIVE The data trends that must influence your device design efforts Customers are seeking to build a programmable world where devices can coordinate and cooperate their data collection efforts. www.netspective.com 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 connect into the existing IT ecosystem? Connected EHRs Device Interoperability Ignore these and you’ll be disrupted out of existence 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. 16
    • NETSPECTIVE Smart buyers are evolving hardware purchase decisions Consumerization of Devices Language in new RFIs, RFPs, etc. indicate preference to purchase devices with more virtualization. Thick Devices Thin Devices Virtual Devices Sensors Only with Built-in Wireless Sensors on mobile phones, platforms www.netspective.com 17
    • NETSPECTIVE Smart buyers are purchasing more software-centric devices Consumerization of Apps Language in new RFIs, RFPs, etc. indicate preference to purchase devices with more software customization capabilities. Software for algorithms www.netspective.com Software for functionality Software for connectivity Software only 18
    • NETSPECTIVE Smart buyers require device connectivity Consumerization of IT Few people buy these when other choices exist Stand-alone and monolithic www.netspective.com Connectivity within own organization Multi-vendor connectivity System of Systems (SoS) 19
    • NETSPECTIVE Smart buyers require advanced integration Changes in Practice Models These won’t be bought if other choices exist Single-purpose devices standalone Multi-purpose standalone Multi-purpose with documentation connectivity Multi-purpose with cooperating connectivity Multi-purpose with analytical connectivity www.netspective.com 20
    • NETSPECTIVE Implications of trends Consumerization Commoditization Software Regulated IT and Systems Integration Services Workflow Automation Connected EHRs www.netspective.com Interoperability Accountable Tech DATA Evidence Based Medicine Comparative Effectiveness 21
    • NETSPECTIVE Data changes the questions we ask Simple visual facts www.netspective.com Complex visual facts Complex computable facts 22
    • NETSPECTIVE Data can change medical science The old way The new way Identify problem Identify data Ask questions Generate questions Collect data Mine data Answer questions Answer questions www.netspective.com 23
    • NETSPECTIVE Data is getting more sophisticated Social Interactions Biosensors Admin Phenotypics Since 1970, pennies per patient Since 1980s, pennies per patient • Business focused data • Retrospective • Built on fee for service models • Inward looking and not focused on clinical benefits www.netspective.com • Must be continuously collected • Mostly Retrospective • Useful for population health • Part digital, mostly analog • Family History is hard Genomics Since 2000s, started at $100k per patient, <$1k soon • Can be collected infrequently • Personalized • Prospective • Potentially predictive • Digital • Family history is easy Proteomics Emerging • Must be continuously collected • Difficult today, easier tomorrow • Super-personalized • Prospective • Predictive 24
    • NETSPECTIVE Unstructured phenotypic patient data sources Patient Source Self reported by patient Health Professional Labs & Diagnostics Medical Devices Biomarkers / Genetics Observations by HCP Computed from specimens Computed realtime from patient Computed from specimens Uncommon Uncommon 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 www.netspective.com 25
    • NETSPECTIVE Structured phenotypic patient data sources Patient Source Self reported by patient Health Professional Observations by HCP Labs & Diagnostics Specimens Medical Devices Real-time from patient Biomarkers / Genetics Specimens Errors High Medium Low Low Low Time Slow Slow Medium Fast Slow Reliability Low Medium High High High Kilobytes Kilobytes Kilobytes Megabytes Gigabytes Gigabytes Gigabytes Uncommon Uncommon Discrete size Streaming size Availability www.netspective.com Uncommon Common Somewhat Common 26
    • NETSPECTIVE The new world order General Wellness Specific Prevention Self Service Physiologics Self Service Monitoring Healthcare Professional Monitoring Care Team Diagnostics Care Team Monitoring Self Service Diagnostics Healthcare Professional Diagnostics Hospital Monitoring Hospital Diagnostics www.netspective.com 27
    • NETSPECTIVE Smart buyers looking for poly-connectivity REST DDS Option 1 (no cellular access or hospital IT integration required) Device Wireless Bluetooth, WiFi, Zibee, etc. Wired Hospital Network Corporate Gateway Could be a Home Network, too HL7 MPEG-21 External Cloud Hospital Systems X.12 Option 2 (cellular access and no hospital IT integration required) Device DDS REST MPEG-21 Wireless, Cellular www.netspective.com External Cloud 28
    • NETSPECTIVE Don’t give up data to others without a fight Software vendors, systems integrators, and others don’t have your best interest in mind Device Teaming Cloud Services Patient Self-Management Platforms SSL VPN Patient Context Monitoring BaaS Gateway (DDS, XMPP ESB) , Device Data Data Transformation (ESB, HL7) Remote Surveillance Management Dashboards HIT Integration Report Generation Device reimbursement www.netspective.com Enterprise Data RCM, Financials, EHRs Device Management Cross Device App Workflows Device Utilization Device profitability Alarm Notifications Device Inventory 29
    • NETSPECTIVE Key regulatory questions Will the FDA accept networked safetycritical 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 www.netspective.com 30
    • NETSPECTIVE Regulatory Strategy “The Device” 510(k) PMA, Class 3, Class 2, etc. 510(k) Class 2 Class 1 “Data Bridges” MDDS Unregulated EHR or others www.netspective.com “Everything else” Customer registry Patient registry Patient profile Study Management Billing 31
    • NETSPECTIVE 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 www.netspective.com 32
    • NETSPECTIVE Key marketing & product management questions Can your sales team sell it? Yes, if they’re incentivized and trained www.netspective.com Can customer manage the technology? They need a good IT and test environment to ensure reliability Does customer have the existing infrastructure? Can you deliver after you build it? Can your solutions team customize it? They need reliable power, broadband coverage, and good WiFi You need installation, provisioning, testing, and remote support infrastructure Yes, if you build for customization 33
    • NETSPECTIVE Key human capital questions You can’t go it alone, get help now 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? www.netspective.com 34
    • NETSPECTIVE Needed: diagnostic quality mHealth www.netspective.com 35
    • NETSPECTIVE Needed: predictive analytics www.netspective.com 36
    • NETSPECTIVE Needed: care team involvement PATIENT/ CONSUMER HEALTHCAR E PROVIDER Care Team FAMILY CAREGIVER CALL CENTERS AND REMOTE SUPPORT www.netspective.com HOSPITAL ALTERNATE SITE OF CARE 37
    • NETSPECTIVE Needed: automated diagnostics www.netspective.com 38
    • Visit http://www.netspective.com http://www.healthcareguy.com E-mail shahid.shah@netspective.com Follow @ShahidNShah Call 202-713-5409 Thank You