High Confidence Medical Device Software and Systems (HCMDSS) Workshop

1. High Confidence Medical Device Software and Systems (HCMDSS) Workshop Insup Lee Department of Computer and Information Science University of Pennsylvania June 2-3, 2005 Philadelpia, PA

2. Welcome • The Federal Government sponsor agencies and the university organizers are grateful that you forfeited participation in other activities on your busy schedules to be here • We thank you and hope that this meeting proves to be well worth your time and effort. • 89 participants • 49 from academia • 16 from medical sectors (care-givers, reseachers) • 12 from industry • 12 from government • 40 position papers • Sponsors: NSF, NCO, Penn Engineering • Supporting government agencies: FDA, ARO, NIST, NSA HCMDSS workshop

3. The Problem Statement • The Federal government recognizes that the rapidly increasing software complexity of medical devices makes the development of high integrity medical device software and systems a crucial issue in public health. • Software for future medical devices cannot be developed using existing design and productivity technologies. • The increasingly heterogeneous nature of medical device design requires the need to identify emerging technical and scientific issues in medical devices and to identify obstacles to the development and certification of medical device software and systems. HCMDSS workshop

4. HCMDSS Workshop Planning Meeting • Nov 16-17, 2004 in Arlington, Virginia • 59 participants • Goal of the workshop planning meeting • Identify crucial medical device software and systems issues that will help shape a research needs agenda for a larger national-level HCMDSS Workshop slated for Spring 2005. • The eight topics are considered critical in the development and production of future HCMDSS that are safe, secure, and reliable. HCMDSS workshop

5. The Eight Topic Areas • Enabling Technologies for Future Medical Devices • Implantable regulatory devices, networked biosensors, telesurgery, robotic surgery • Foundations for Integration of Medical Device Systems/Models • Component-based foundations for accelerated design and verifiable system integration • System of systems (including models, medical devices, care-givers, patients) • Distributed Control & Sensing of Networked Medical Device Systems • Robust, verifiable, fault-tolerant control of uncertain, multi-modal systems • Patient Modeling & Simulation • Large scale, high fidelity organ and patient models for design and testing • Embedded, Real-Time, Networked System Infrastructures for MDSS • Architecture, platform, middleware, resource management, QoS (Quality of Service), PnP (Plug-and-Play) of MDSS • High Confidence Medical Device Software Development & Assurance • Care-giver requirements solicitation and capture, design and implementation V&V (Verification and Validation) • Heterogeneity in environment, architecture, platform in medical devices • Medical Practice-driven Models and Requirements • User-centered design, risk understanding, and use/misuse modeling in medical practice • Certification of MDSS • Quantifiable incremental certification of MDSS, role of design tools • COTS, non-determinisitic and self-adaptive medical device systems HCMDSS workshop

6. HCMDSS workshop • Motivation • Improve the design, certification, and operation (by both health care professionals and consumers) of medical device software and systems that will result in better and more cost-effective medical care. • Goals • Identify research challenges and emerging issues • Produce a comprehensive report on research needs and roadmap at the national level across multiple agencies • Create a community HCMDSS workshop

7. Overall Program • Government panel • 2 keynote talks • 3 invited talk sessions • Medical perspectives • IT perspectives • Manufacture perspectives • 3 Breakout sessions (six working groups) • Summary presentation (tomorrow) • Banquet (tonight) HCMDSS workshop

8. 3 Breakout Sessions • Each participant is assigned to one of the six breakout group, and they were asked to prepare for the four questions in the next slide. • Each working group is to prepare • summary presentation (during the last session of the workshop) • summary report (1st draft due several weeks after the workshop) • Three Breakout Sessions • Session 1: discuss position statements, problems, current state, needs • Session 2: discuss and refine R&D challenges and roadmap • Session 3: prepare summary presentation slides and outline/plan for written report • There is a helper per breakout group who will help the leader to capture discussion highlights and prepare summary slides, etc. • There will be a court/tape recorder who will document discussions of each breakout session. HCMDSS workshop

9. Six Working Groups • Foundations for Integration of Medical Device Systems/Models (leader: Rance Cleaveland) • Distributed Control & Sensing of Networked Medical Device Systems (leader: Bruce Krogh) • Patient Modeling & Simulation (leader: Havey Rubin) • Embedded, Real-Time, Networked System Infrastructures for MDSS (leader: Lui Sha) • High-Confidence Medical Device Software Development & Assurance and Medical Practice-driven Models (leader: Peter Lee) • Certification of MDSS and Requirements (leader: John Hatcliff) HCMDSS workshop

10. 4 Questions to participants • List the top three lessons learned/technology in this area of X • List the top three needs that have not been met in the area of X • List the top three research topics/challenges (with timelines) being/should be pursued in your domain of expertise related to X. • List the top three challenges (with timelines) in the area of X (including outside your domain of expertise). HCMDSS workshop

11. WG summary presentation and written report • Problem statement • Summary of state of the art • R&D challenges • Prioritized list of IT research needs • Roadmap for the next 5 and 10 years HCMDSS workshop

12. Deliverables of the workshop • Immediately after the workshop, the HCMDSS web-site will have: • Video clips • Copy of the presentation slides • 1st draft WG summaries: Aug 1, 2005 • Final draft WG summaries: Sept 30, 2005 • 1st Draft executive summary: Oct 15, 2005 • Final report: Dec 15, 2005 HCMDSS workshop

13. HCMDSS Banquet - sponsored by 6:30 pm today Cadence Restaurant Kimmel Center for the Performing Arts Home of the Philadelphia Orchestra HCMDSS workshop

14. Helpers • Registration & local information • Jennifer Finley: • Presentations and Working Groups • Madhukar Anand (WG 4), presentation laptop • Arvind Easwaran (WG 5), presentation slides • Insik Shin (WG 1), presentation slides • Dave Arney (WG 3), video projector • Aaron Evans (WG 6), video projector • Sebastian Fischmeister (WG 2) • Jesung Kim (WG 1), video projector HCMDSS workshop

15. Today’s morning schedule • Government Session, Sally Howe, NCO • Keynote talk, Shankar Sastry, UC Berkeley • Break • Invited Session 1: Medical Perspectives HCMDSS workshop