MDDI WirelessMedDev.com East Keynote: Wireless capable medical devices with significant software and data integration are the future

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.

Transcript

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

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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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   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
   

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

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5. 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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6. NETSPECTIVE
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   We’ve got most infections beat…
   …except the flu and pneumonia
   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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   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
   

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10. NETSPECTIVE
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    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
    

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

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12. 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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13. NETSPECTIVE
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    Wireless BAN Ecosystem
    Source: Qualcomm
    

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    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
    

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    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
    

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

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

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18. NETSPECTIVE
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    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
    

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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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20. 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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21. NETSPECTIVE
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    Needed: diagnostic quality mHealth
    

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22. NETSPECTIVE
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    Needed: predictive analytics
    

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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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    Needed: automated diagnostics
    

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

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26. 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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27. 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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