Transcript HCMDSS Workshop PANEL 1: Design for Future Medical Devices

HCMDSS Workshop
PANEL 1: Design for Future
Medical Devices
November 16, 2004
Presentation by:
Robert Kircher, Jr.
Dose Safety Company
P.O. Box 22865
Seattle, WA 98122
[email protected]
206-856-1995
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About Dose Safety Company
• Formed in 2003. Early phase.
• Developing IDC (Insulin Dosing Controller) software
for closed loop control of blood sugar for insulindependent diabetics.
• “Artificial pancreas” = IDC + insulin pump + sensor.
• Ongoing preliminary clinical trial. Started September
2003.
• Beginning to address regulatory process.
PANEL 1: Design for Future Medical Devices Dose Safety Co., Seattle, WA
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The Future Challenge
“Safe and effective for its intended use”
Insulin
pump
Insulin Dosing
Controller (IDC)
BGL
sensor
By insulin
pump mfgr.
By Dose
Safety
PANEL 1: Design for Future Medical Devices Dose Safety Co., Seattle, WA
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Meeting the Challenge
1) Executable, PVS formal design specification and provable
correct implementation of the IDC system which meets
Safety and Efficacy Requirements (in work.)
2) Need: PVS libraries for infusion pumps, glucose sensors,
infusion sets, etc.
3) Need: Formal Methods compliance with FDA regulation.
4) Need: High fidelity human subject simulation model.
PANEL 1: Design for Future Medical Devices Dose Safety Co., Seattle, WA
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Meeting the Challenge - details
2)
Need: PVS libraries for infusion pumps, glucose sensors, infusion sets, etc.

3)
4)
Customizable, building blocks required for the development and certification of
medical device combinations.
Need: Formal Methods approach in compliance with FDA regulation.

Tailor FM processes and artifacts as needed to comply with applicable regulation.
Support development of new FDA guidance as necessary to minimize cert. efforts.

Example: 21 CFR Part 820 Quality System Regulation, Subpart C Design Controls
( Google “21 CFR Part 820” )
Need: High fidelity human subject simulation model

Customizable model: gender, age, health, etc.

Run real-time life scenarios: eat meals, get exercise.

Use as ‘plant’ model for closed-loop system development and test.

Focus on areas that have most immediate benefit to public health and have the
highest chances of success.
PANEL 1: Design for Future Medical Devices Dose Safety Co., Seattle, WA
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Bio
Robert C. Kircher, Jr. is the co-founder and managing partner of
Dose Safety Company, for whom he developed software controller
prototype and safety for a diabetes clinical trial being conducted. He
worked twenty years for the Boeing Company supporting the
requirements specification and validation testing of Boeing
Commercial Airplane flight-critical systems, and accrued three US
patents for digital navigation systems. Bob has published papers in
peer-reviewed industry journals and has a B.A. in Mathematics from
U.C. Berkeley and a Masters of Software Engineering from Seattle
University.
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