MDDI WirelessMedDev.com East Keynote: Wireless capable medical devices with significant software and data integration are the future
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This keynote was presented at MD+DI Wireless Connectivity in Medical Devices Conference East (WirelessMedDev.com) on November 28, 2012. Topics discussed: * 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 * Marketplace and industry challenges for device vendors * Why wireless connectivity is good business * Why wireless connectivity is a disruptive innovation Key takeaways: * Wireless is a business enabler but there’s a lot to consider. * 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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MDDI WirelessMedDev.com East Keynote: Wireless capable medical devices with significant software and data integration are the future
- 1. Wireless capable medical devices with significant software and data integration are the future By Shahid N. Shah
- 2. 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 2
- 3. NETSPECTIVE What you’ll learn in this briefing 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 • Marketplace and industry challenges for device vendors • Why wireless connectivity is good business • Why wireless connectivity is a disruptive innovation • Wireless is a business enabler but there’s a lot to consider. • 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 3
- 4. NETSPECTIVE Life expectancy is increasing… …but the rate of growth is slowing www.netspective.com 4
- 5. NETSPECTIVE Bacteria used to kill us the most… Per 100k population, Historical Statistics of the United States, Millennial Edition www.netspective.com 5
- 6. NETSPECTIVE We’ve got most infections beat… …except the flu and pneumonia Per 100k population, Historical Statistics of the United States, Millennial Edition www.netspective.com 6
- 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 7
- 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 8
- 9. NETSPECTIVE The new realities of patient populations 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 9
- 10. NETSPECTIVE Healthcare industry / market trends Major market and regulatory trends that are causing customers and competitors to shift 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” Health Home www.netspective.com mHealth MU “Meaningful Use” PCPCC “Patient Centered Care” 10
- 11. NETSPECTIVE Implications of healthcare trends PPACA ACO Software Regulated IT and Systems Integration Services MU Health Home www.netspective.com PCMH mHealth DATA Evidence Based Medicine Comparative Effectiveness 11
- 12. 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 12
- 13. NETSPECTIVE Wireless BAN Ecosystem Source: Qualcomm www.netspective.com 13
- 14. NETSPECTIVE Key regulatory questions Will the FDA accept wireless in safetycritical systems? Is wireless 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 14
- 15. NETSPECTIVE Key design questions Choose a radio or develop one? Choose off the shelf (OTS) multiradio chips with extended support Antenna Design? Follow mobile phone designs Provisioning & Support? Buy or build a BaaS, M2M, or IOT Solution OTS Selection Criteria: • Frequency of changes • Frequency of patches • Adherence to standards • Potential to strip out features • Suitable suppliers Appropriate Frequency: • Medical Implant Communications Service (MICS) 402-405 MHz • Wireless Medical Telemetry Service (WMTS) 608-614 MHz, 1,395-1,400 MHz, and 1,429-1,432 MHz • Medical Body Area Network (MBAN) 2,360-2,390 MHz secondary basis, 2,390-2,400 Source: Tim Gee, MedicalConnectivity.com www.netspective.com 15
- 17. NETSPECTIVE ANT+ is winning ULP protocol battle http://acamp.ca/alberta-micro-nano/images/docs/Technology-Presentations/Ken-Fyfe-HealthMedical-Dec09.pdf www.netspective.com 17
- 18. NETSPECTIVE Key marketing & product management questions Can customer manage the technology? Does customer have the existing infrastructure? Can you deliver after you build it? 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 Infrastructure Considerations: • Interoperability, coexistence • Shared or dedicated infrastructure • System and device level security • Capacity/bandwidth • WMTS: 16 MHz bandwidth • Wi-Fi: >450 MHz bandwidth • MBAN: 40 MHz bandwidth • Manageability Source: Tim Gee, MedicalConnectivity.com www.netspective.com 18
- 19. 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 19
- 20. 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 20
- 21. NETSPECTIVE Needed: diagnostic quality mHealth www.netspective.com 21
- 23. 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 23
- 25. NETSPECTIVE Data changes the questions we ask Simple visual facts www.netspective.com Complex visual facts Complex computable facts 25
- 26. 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 26