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

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.

Transcript

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

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2. NETSPECTIVE
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   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”
   

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3. NETSPECTIVE
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   What’s outcomes driven care about?
   

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

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5. NETSPECTIVE
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   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
   

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

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7. NETSPECTIVE
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   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
   

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8. NETSPECTIVE
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   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
   

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9. NETSPECTIVE
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   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
   

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10. NETSPECTIVE
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    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
    

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11. NETSPECTIVE
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    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
    

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12. NETSPECTIVE
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    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
    

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13. NETSPECTIVE
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    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
    

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14. NETSPECTIVE
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    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
    

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15. NETSPECTIVE
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    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
    

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16. NETSPECTIVE
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    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.
    

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17. NETSPECTIVE
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    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.
    

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18. NETSPECTIVE
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    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
    

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19. NETSPECTIVE
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    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
    

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20. NETSPECTIVE
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    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
    

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21. NETSPECTIVE
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    Data changes the questions we ask
    Simple visual facts Complex visual facts Complex computable
    facts
    

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22. NETSPECTIVE
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    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
    

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23. NETSPECTIVE
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    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
    

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24. NETSPECTIVE
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    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
    

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25. NETSPECTIVE
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    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
    

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26. NETSPECTIVE
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    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
    

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27. NETSPECTIVE
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    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
    

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28. NETSPECTIVE
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    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
    

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29. NETSPECTIVE
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    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
    

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30. NETSPECTIVE
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    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
    

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31. NETSPECTIVE
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    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
    

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32. NETSPECTIVE
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    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
    

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33. NETSPECTIVE
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    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
    

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34. NETSPECTIVE
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    Needed: diagnostic quality mHealth
    

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35. NETSPECTIVE
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    Needed: predictive analytics
    

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

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37. NETSPECTIVE
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    Needed: automated diagnostics
    

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38. 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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