Medical device manufacturers are faced with a myriad of design decisions during product development. Several key decisions affecting market readiness must be addressed between bench-top prototypes and initiation of clinical trials. Among the most important are cloud connectivity considerations surrounding firmware, hardware, and use cases. The earlier cloud connectivity factors are identified, considered, and integrated into the design process, the more successful the resulting commercial roll-out in terms of cost, certification, and market acceptance. • Key design factors medical device manufacturers should consider • Advantages of considering connectivity early in the design process • Practical use-case examples highlight more cost-effective clinical trials, wider market acceptance, and reduction in operational costs This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

1. Design Considerations to Maximize Medical
Device Cloud Connectivity
1
Chris DuPont
CEO, Co-founder
Keith Drake, Ph.D.
Vice Pres. of Business Development

2. “Greenlight Guru Software is the handrail for Medical
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Chris
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4. What is a connected medical device?
4
Medical Device
 Wearable or implantable electro-mechanical “gadget” that:
 senses physiological patient data, and/or
 applies a therapy (e.g., neurostimulator)
 Data input and/or output
 Includes “near patient” patient equipment (e.g., CPAP machine)
Connected
 Uses networks to transfer, manage, store, and analyze health data

5. What is medical device data?
5
1. User physiological data (device Output)
 Vital signs: measurement of body function such as body temperature, blood pressure, heart rate,
brain activity, etc.
2. User therapeutic data (device Input)
 Information specifying device-applied therapies (e.g., neurostimulator signal parameters)
3. User demographic information (device Output)
 User information not directly measured by a medical device’s sensors
 Examples: height, weight, age, and exercise and sleep activity
4. Device status data (device Output)
 Parameters indicating the status and health of the device itself
 Examples include battery level and other device-specific information
 There is no “check engine light” for a medical device!

6. Keep focus on the real goal: Market Acceptance
6
MarketAcceptance
Market Clearance
Core
Functionality
• Usability
• Cloud connectivity
• Regulatory
• Quality
• Working device verification
• Clinical trial validation

7. Key factors for Market Acceptance
7
Quality
ConnectivityRegulatory
Factors are not
independent
They overlap and
complement

8. POLL: What is your current connectivity focus?
8
 Connectivity is already implemented
 Connectivity in design/development
 Definitely planning on connectivity—no action yet
 Not sure if we need connectivity or not
 We don’t need no stinkin’ connectivity!

9. Three key design questions device companies
should ask
9
1. Should my device connect at all?
2. What platform design options should I address?
3. What market opportunities should I consider?

10. 1. Should my device connect at all?
10
 Yes – there are risks in connecting your device
 Privacy (PHI)
 Cybersecurity
 Far greater risk in not connecting
 Example: neurostimulator fails and disease
state returns
 Connectivity risks can be mitigated
 Result: huge opportunities from connecting
your device

11. 2. What platform decisions should I address?
11
Components
• Device (on patient)
• Smart phone app
• Base/charging station
• S/W as a Medical Device
(SAMD)
Communication
• Bluetooth
• Wi-Fi
• ZigBee
• Cellular
• MICS
Software
• Where will data analysis
reside? (device, base
station, cloud)
• Operating system(s) on
device and base station?
• Smart phone app
(Android, iOS, others)
Complex spectrum of inter-dependent factors

12. 3. What market opportunities should I consider?
12
 Not directly a “design” factor
 Brainstorm (early and often) how connectivity will increase market
acceptance among patients, clinicians, and payors …

13. Use Case 1 – Reimbursement
13
 Reimbursement often requires demonstration of device use
 Much easier to show with connectivity

14. Use Case 2 – Compliance
14
 Clinical trials protocols require documented use of device
 Much easier to show with connectivity

15. Use Case 3 – Device Diagnostics
15
 Ability to monitor and diagnose the health of the device
 Much easier to implement with connectivity

16. Galen Cloud
Incentive Program
16
Does the Galen Cloud™ meet
your needs?
 Fully-operational
environment
 No cost for two months
 Qualification requirements
 Program eligibility period
ends 8/31/2020
 Incentive@GalenData.com

17. 17
Monthly presentation of topics of interest to medical device manufacturers
and affiliated organizations
Medical
Device 2020
Outlook
AI & Data
Analytics
5G Impact
Privacy &
Security
COVID-19
Use Cases
Galen Data
Medical Device Connectivity Innovation Webinar Series

18. Your next steps …
18
1. Think about how your device aligns with cloud connectivity
 Technical/design issues – platform considerations
 Market acceptance: competitive advantages and business opportunities
 Include Quality and Regulatory
2. Include cloud connectivity in your design, development and business
planning processes
3. Let us know if Galen Data can help!
Chris DuPont
CEO, Co-founder
Chris.DuPont@GalenData.com
346.310.0399
www.GalenData.com
Keith Drake, Ph.D.
Vice Pres. of Business Development
Keith.Drake@GalenData.com
346.310.0399
www.GalenData.com

19. Questions?
19