The document provides an overview of a keynote presentation about architecting medical devices for outcomes-focused healthcare in a Big Data world. It discusses how healthcare is shifting from treating infectious diseases to managing chronic conditions, and how this change and the rise of Big Data are impacting medical device design. Specifically, it outlines how devices need to integrate data to provide diagnostic and predictive analytics, involve care teams, and enable automated diagnostics to support value-based payments.
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Architecting Medical Devices for an Outcomes-Focused Big Data World
1. Architecting, designing and building medical
devices in an outcomes-focused Big Data world
Day 4 Keynote
By Shahid N. Shah
www.HealthcareITGuy.com
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
3
4. NETSPECTIVE
What’s Big Data all about?
“Normal Data” is about getting things done
www.netspective.com
“Big Data” is about answering big questions
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5. NETSPECTIVE
What you’ll learn in this keynote
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 (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
• “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.
www.netspective.com
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6. NETSPECTIVE
Bacteria used to kill us the most…
Per 100k population, Historical Statistics of the United States, Millennial Edition
www.netspective.com
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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
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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
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9. NETSPECTIVE
Patient populations need different devices
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
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10. NETSPECTIVE
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
PPACA
ACO
PCMH
“Affordable Care
Act”
“Accountable
Care Org”
“Medical
Home”
Switch from FFS
to value based
payments
www.netspective.com
mHealth
MU
“Meaningful Use”
PCPCC
“Patient Centered
Care”
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11. NETSPECTIVE
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
www.netspective.com
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12. NETSPECTIVE
Customers are struggling with Accountable Tech
Everything your device does to help answer important questions below means more sales and better margins
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
www.netspective.com
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13. NETSPECTIVE
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
www.netspective.com
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14. NETSPECTIVE
The tech trends that must influence your device design efforts
Commodity
components can be
put together cheaply
to create new
solutions using PCs,
tablets, phones, and
software.
www.netspective.com
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
How much of what’s
special in your device
has or will become a
commodity?
Consumerization
Commoditization
Ignore these and you’ll be disrupted out of existence
Can your device fit
into agile clinical
workflows?
Workflows will
change faster in an
outcomes-focused
world than in a fee
for service world.
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15. NETSPECTIVE
The data trends that must influence your device design efforts
Customers are
seeking to build a
programmable world
where devices can
coordinate and
cooperate their data
collection efforts.
www.netspective.com
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
connect into the
existing IT
ecosystem?
Connected EHRs
Device Interoperability
Ignore these and you’ll be disrupted out of existence
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.
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16. NETSPECTIVE
Smart buyers are evolving hardware purchase decisions
Consumerization of Devices
Language in new RFIs, RFPs, etc. indicate preference to purchase
devices with more virtualization.
Thick Devices
Thin Devices
Virtual
Devices
Sensors Only
with Built-in
Wireless
Sensors on
mobile
phones,
platforms
www.netspective.com
17
17. NETSPECTIVE
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.
Software for
algorithms
www.netspective.com
Software for
functionality
Software for
connectivity
Software
only
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18. NETSPECTIVE
Smart buyers require device connectivity
Consumerization of IT
Few people buy these when other choices exist
Stand-alone
and
monolithic
www.netspective.com
Connectivity
within own
organization
Multi-vendor
connectivity
System of
Systems
(SoS)
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19. NETSPECTIVE
Smart buyers require advanced integration
Changes in Practice Models
These won’t be bought if other
choices exist
Single-purpose
devices
standalone
Multi-purpose
standalone
Multi-purpose
with
documentation
connectivity
Multi-purpose
with cooperating
connectivity
Multi-purpose with
analytical
connectivity
www.netspective.com
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21. NETSPECTIVE
Data changes the questions we ask
Simple visual facts
www.netspective.com
Complex visual facts
Complex computable
facts
22
22. 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
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23. NETSPECTIVE
Data is getting more sophisticated
Social Interactions
Biosensors
Admin
Phenotypics
Since 1970,
pennies per
patient
Since 1980s,
pennies per
patient
• Business focused data
• Retrospective
• Built on fee for service models
• Inward looking and not focused
on clinical benefits
www.netspective.com
• Must be continuously collected
• Mostly Retrospective
• Useful for population health
• Part digital, mostly analog
• Family History is hard
Genomics
Since 2000s,
started at $100k
per patient, <$1k
soon
• Can be collected infrequently
• Personalized
• Prospective
• Potentially predictive
• Digital
• Family history is easy
Proteomics
Emerging
• Must be continuously collected
• Difficult today, easier tomorrow
• Super-personalized
• Prospective
• Predictive
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24. NETSPECTIVE
Unstructured phenotypic patient data sources
Patient
Source
Self reported by
patient
Health
Professional
Labs &
Diagnostics
Medical Devices
Biomarkers /
Genetics
Observations by
HCP
Computed from
specimens
Computed realtime from
patient
Computed from
specimens
Uncommon
Uncommon
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
www.netspective.com
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25. NETSPECTIVE
Structured phenotypic patient data sources
Patient
Source
Self reported by
patient
Health
Professional
Observations by
HCP
Labs &
Diagnostics
Specimens
Medical Devices
Real-time from
patient
Biomarkers /
Genetics
Specimens
Errors
High
Medium
Low
Low
Low
Time
Slow
Slow
Medium
Fast
Slow
Reliability
Low
Medium
High
High
High
Kilobytes
Kilobytes
Kilobytes
Megabytes
Gigabytes
Gigabytes
Gigabytes
Uncommon
Uncommon
Discrete size
Streaming size
Availability
www.netspective.com
Uncommon
Common
Somewhat
Common
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26. 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
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27. NETSPECTIVE
Smart buyers looking for poly-connectivity
REST
DDS
Option 1 (no cellular access or hospital IT integration required)
Device
Wireless
Bluetooth,
WiFi, Zibee, etc.
Wired
Hospital
Network
Corporate
Gateway
Could be a Home
Network, too
HL7
MPEG-21
External
Cloud
Hospital
Systems
X.12
Option 2 (cellular access and no hospital IT integration required)
Device
DDS
REST
MPEG-21
Wireless, Cellular
www.netspective.com
External
Cloud
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28. 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
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29. NETSPECTIVE
Key regulatory questions
Will the FDA accept
networked safetycritical 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
www.netspective.com
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30. NETSPECTIVE
Regulatory Strategy
“The Device”
510(k) PMA,
Class 3, Class 2,
etc.
510(k)
Class 2
Class 1
“Data Bridges”
MDDS
Unregulated
EHR or others
www.netspective.com
“Everything else”
Customer registry
Patient registry
Patient profile
Study Management
Billing
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31. NETSPECTIVE
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
www.netspective.com
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32. NETSPECTIVE
Key marketing & product management questions
Can your sales
team sell it?
Yes, if they’re
incentivized and
trained
www.netspective.com
Can customer
manage the
technology?
They need a good
IT and test
environment to
ensure reliability
Does customer
have the existing
infrastructure?
Can you deliver
after you build it?
Can your
solutions team
customize it?
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
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
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36. 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
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