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. 6/2/05 HCMDSS workshop 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 o49 from academia o16 from medical sectors (care-givers, reseachers) o12 from industry o12 from government  40 position papers  Sponsors: NSF, NCO, Penn Engineering  Supporting government agencies: FDA, ARO, NIST, NSA

3. 6/2/05 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.

4. 6/2/05 HCMDSS workshop 4 HCMDSS Workshop Planning Meeting  Nov 16-17, 2004 in Arlington, Virginia  59 participants  Goal of the workshop planning meeting oIdentify 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.

5. 6/2/05 HCMDSS workshop 5 The Eight Topic Areas  Enabling Technologies for Future Medical Devices oImplantable regulatory devices, networked biosensors, telesurgery, robotic surgery  Foundations for Integration of Medical Device Systems/Models oComponent-based foundations for accelerated design and verifiable system integration oSystem of systems (including models, medical devices, care-givers, patients)  Distributed Control & Sensing of Networked Medical Device Systems oRobust, verifiable, fault-tolerant control of uncertain, multi-modal systems  Patient Modeling & Simulation oLarge scale, high fidelity organ and patient models for design and testing  Embedded, Real-Time, Networked System Infrastructures for MDSS oArchitecture, platform, middleware, resource management, QoS (Quality of Service), PnP (Plug-and-Play) of MDSS  High Confidence Medical Device Software Development & Assurance oCare-giver requirements solicitation and capture, design and implementation V&V (Verification and Validation) oHeterogeneity in environment, architecture, platform in medical devices  Medical Practice-driven Models and Requirements oUser-centered design, risk understanding, and use/misuse modeling in medical practice  Certification of MDSS oQuantifiable incremental certification of MDSS, role of design tools  COTS, non-determinisitic and self-adaptive medical device systems

6. 6/2/05 HCMDSS workshop 6  Motivation oImprove 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 oIdentify research challenges and emerging issues oProduce a comprehensive report on research needs and roadmap at the national level across multiple agencies oCreate a community

7. 6/2/05 HCMDSS workshop 7 Overall Program  Government panel  2 keynote talks  3 invited talk sessions oMedical perspectives oIT perspectives oManufacture perspectives  3 Breakout sessions (six working groups)  Summary presentation (tomorrow)  Banquet (tonight)

8. 6/2/05 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 osummary presentation (during the last session of the workshop) osummary report (1 st draft due several weeks after the workshop)  Three Breakout Sessions oSession 1: discuss position statements, problems, current state, needs oSession 2: discuss and refine R&D challenges and roadmap oSession 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.

9. 6/2/05 HCMDSS workshop 9 Six Working Groups 1.Foundations for Integration of Medical Device Systems/Models (leader: Rance Cleaveland) 2.Distributed Control & Sensing of Networked Medical Device Systems (leader: Bruce Krogh) 3.Patient Modeling & Simulation (leader: Havey Rubin) 4.Embedded, Real-Time, Networked System Infrastructures for MDSS (leader: Lui Sha) 5.High-Confidence Medical Device Software Development & Assurance and Medical Practice-driven Models (leader: Peter Lee) 6.Certification of MDSS and Requirements (leader: John Hatcliff)

10. 6/2/05 HCMDSS workshop 10 4 Questions to participants 1.List the top three lessons learned/technology in this area of X 2.List the top three needs that have not been met in the area of X 3.List the top three research topics/challenges (with timelines) being/should be pursued in your domain of expertise related to X. 4.List the top three challenges (with timelines) in the area of X (including outside your domain of expertise).

11. 6/2/05 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

12. 6/2/05 HCMDSS workshop 12 Deliverables of the workshop  Immediately after the workshop, the HCMDSS web- site will have: oVideo clips oCopy of the presentation slides  1 st draft WG summaries: Aug 1, 2005  Final draft WG summaries: Sept 30, 2005  1 st Draft executive summary: Oct 15, 2005  Final report: Dec 15, 2005

13. 6/2/05 HCMDSS workshop 13 HCMDSS Banquet - sponsored by Cadence Restaurant Kimmel Center for the Performing Arts Home of the Philadelphia Orchestra 6:30 pm today

14. 6/2/05 HCMDSS workshop 14 Helpers  Registration & local information oJennifer Finley:  Presentations and Working Groups oMadhukar Anand (WG 4), presentation laptop oArvind Easwaran (WG 5), presentation slides oInsik Shin (WG 1), presentation slides oDave Arney (WG 3), video projector oAaron Evans (WG 6), video projector oSebastian Fischmeister (WG 2) oJesung Kim (WG 1), video projector

15. 6/2/05 HCMDSS workshop 15 Today’s morning schedule  Government Session, Sally Howe, NCO  Keynote talk, Shankar Sastry, UC Berkeley  Break  Invited Session 1: Medical Perspectives