Wireless capable medical devices with significant software and data integration are the future By Shahid N. Shah

NETSPECTIVE www.netspective.com 2 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 3 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 • 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. What you’ll learn in this briefing Wireless capable medical devices with significant software and data integration are the future

NETSPECTIVE www.netspective.com 4 Life expectancy is increasing… …but the rate of growth is slowing

NETSPECTIVE www.netspective.com 5 Bacteria used to kill us the most… Per 100k population, Historical Statistics of the United States, Millennial Edition

NETSPECTIVE www.netspective.com 6 We’ve got most infections beat… …except the flu and pneumonia Per 100k population, Historical Statistics of the United States, Millennial Edition

NETSPECTIVE www.netspective.com 7 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 8 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 9 The new realities of patient populations • 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 10 Healthcare industry / market trends PPACA “Affordable Care Act” ACO “Accountable Care Org” PCMH “Medical Home” MU “Meaningful Use” Health Home mHealth PCPCC “Patient Centered Care” 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

NETSPECTIVE www.netspective.com 11 Implications of healthcare trends PPACA ACO MU PCMH Health Home mHealth DATA Evidence Based Medicine Comparative Effectiveness Software Regulated IT and Systems Integration Services

NETSPECTIVE www.netspective.com 12 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 13 Wireless BAN Ecosystem Source: Qualcomm

NETSPECTIVE www.netspective.com 14 Key regulatory questions Will the FDA accept wireless in safety- critical 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

NETSPECTIVE www.netspective.com 15 Key design questions Choose a radio or develop one? Antenna Design? Provisioning & Support? Choose off the shelf (OTS) multi- radio chips with extended support Follow mobile phone designs 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

NETSPECTIVE www.netspective.com 16 Wireless Protocols Comparison http://acamp.ca/alberta-micro-nano/images/docs/Technology-Presentations/Ken-Fyfe-HealthMedical-Dec09.pdf

NETSPECTIVE www.netspective.com 17 ANT+ is winning ULP protocol battle http://acamp.ca/alberta-micro-nano/images/docs/Technology-Presentations/Ken-Fyfe-HealthMedical-Dec09.pdf

NETSPECTIVE www.netspective.com 18 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

NETSPECTIVE www.netspective.com 19 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 20 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 21 Needed: diagnostic quality mHealth

NETSPECTIVE www.netspective.com 22 Needed: predictive analytics

NETSPECTIVE www.netspective.com 23 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 24 Needed: automated diagnostics

NETSPECTIVE www.netspective.com 25 Data changes the questions we ask Simple visual facts Complex visual facts Complex computable facts

NETSPECTIVE www.netspective.com 26 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

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