HCMDSS Workshop PANEL 1: Design for Future Medical Devices November 16, 2004

1. HCMDSS WorkshopPANEL 1: Design for Future Medical DevicesNovember 16, 2004 Presentation by: Robert Kircher, Jr. Dose Safety Company P.O. Box 22865 Seattle, WA 98122 bob@kontact.com 206-856-1995

2. About Dose Safety Company • Formed in 2003. Early phase. • Developing IDC (Insulin Dosing Controller) software for closed loop control of blood sugar for insulin-dependent 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

3. 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

4. Meeting the Challenge • Executable, PVS formal design specification and provable correct implementation of the IDC system which meets Safety and Efficacy Requirements (in work.) • Need: PVS libraries for infusion pumps, glucose sensors, infusion sets, etc. • Need: Formal Methods compliance with FDA regulation. • Need: High fidelity human subject simulation model. PANEL 1: Design for Future Medical Devices Dose Safety Co., Seattle, WA

5. Meeting the Challenge - details • Need: PVS libraries for infusion pumps, glucose sensors, infusion sets, etc. • 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

6. 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.