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Architecting, designing and building medical devices in an outcomes

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Information about Architecting, designing and building medical devices in an outcomes
Science-Technology

Published on February 17, 2014

Author: ShahidNShah

Source: authorstream.com

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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 Day 4 Keynote By Shahid N. Shah www.HealthcareITGuy.com PowerPoint Presentation: This and many of my other presentations are available at http://www.SpeakerDeck.com/shah @ ShahidNShah shahid@shah.org Who is Shahid?: 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” What’s outcomes driven care about?: What’s outcomes driven care about? What’s Big Data all about?: What’s Big Data all about? “Normal Data” is about getting things done “Big Data” is about answering big questions What you’ll learn in this keynote: 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 Bacteria used to kill us the most…: Bacteria used to kill us the most… Per 100k population, Historical Statistics of the United States, Millennial Edition Infectious diseases used to kill us…: 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 From cures to management…: 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 Patient populations need different devices: 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 Well Patient At Risk Chronic Care Acute Treatment 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 Market trends that smart device manufacturers are following: 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 Customers are struggling with interoperability and filling EHRs: 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 Customers are struggling with Accountable Tech: Customers are struggling with Accountable Tech Everything your device does to help answer important questions below means more sales and better margins Opportunities for incremental or new revenue: Opportunities for incremental or new revenue The tech trends that must influence your device design efforts: The tech trends that must influence your device design efforts Ignore these and you’ll be disrupted out of existence The data trends that must influence your device design efforts: The data trends that must influence your device design efforts Ignore these and you’ll be disrupted out of existence Smart buyers are evolving hardware purchase decisions: Smart buyers are evolving hardware purchase decisions Consumerization of Devices Sensors on mobile phones, platforms Language in new RFIs , RFPs, etc. indicate preference to purchase devices with more virtualization. Smart buyers are purchasing more software-centric devices: 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. Smart buyers require device connectivity: Smart buyers require device connectivity Consumerization of IT Few people buy these when other choices exist Smart buyers require advanced integration: Smart buyers require advanced integration Changes in Practice Models Multi-purpose with analytical connectivity These won’t be bought if other choices exist Implications of trends: Implications of trends DATA Evidence Based Medicine Comparative Effectiveness Software Regulated IT and Systems Integration Services Data changes the questions we ask: Data changes the questions we ask Simple visual facts Complex visual facts Complex computable facts Data can change medical science: Data can change medical science The old way The new way Old New Data is getting more sophisticated: Data is getting more sophisticated Biosensors Social Interactions Unstructured phenotypic patient data sources: 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 Structured phenotypic patient data sources: 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 The new world order: The new world order Smart buyers looking for poly-connectivity: Smart buyers looking for poly-connectivity Option 1 (no cellular access or hospital IT integration required) 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 Don’t give up data to others without a fight: 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 Key regulatory questions: Key regulatory questions 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 Regulatory Strategy: 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 Key design questions: Key design questions Key marketing & product management questions: Key marketing & product management questions Key human capital questions: Key human capital questions You can’t go it alone, get help now Needed: diagnostic quality mHealth: Needed: diagnostic quality mHealth Needed: predictive analytics: Needed: predictive analytics Needed: care team involvement: Needed: care team involvement HEALTHCARE PROVIDER PATIENT/ CONSUMER HOSPITAL FAMILY CAREGIVER ALTERNATE SITE OF CARE Care Team CALL CENTERS AND REMOTE SUPPORT Needed: automated diagnostics: Needed: automated diagnostics Thank You: Thank You Visit http://www.netspective.com http :// www.healthcareguy.com E-mail shahid.shah@netspective.com Follow @ ShahidNShah Call 202-713-5409

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