1. Breakout Sessions HCMDSS Workshop

2. Six Working Groups 1.Foundations for Integration of Medical Device Systems/Models 2.Distributed Control & Sensing of Networked Medical Device Systems 3.Patient Modeling & Simulation 4.Embedded, Real-Time, Networked System Infrastructures for MDSS 5.High-Confidence Medical Device Software Development & Assurance and Medical Practice-driven Models 6.Certification of MDSS and Requirements

3. Organization/Expectation Each participant will be assigned to one of the six breakout group, and they will be asked to prepare for the questions (in the next slide). There will be one leader per breakout group. The leader is responsible for –summary presentation (during the last session of the workshop) –summary report (1 st draft due several weeks after the workshop). There may be a facilitator (or co-leader) per breakout group who will help the leader with discussion, summary slide preparation, etc. There will be a (court) recorder who will document discussions of each breakout session.

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).

5. Outline of summary presentation/report for each working group 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

6. Roadmap Identify major areas –Break down major areas as appropriate Include timelines, milestones, and metrics Identify needs, gaps, trends, interdependencies, and technology challenges Identify performers and processes by which the roadmap will be implemented

7. WG 1: Foundations for Integration of Medical Device Systems/Models Leader: Rance Cleaveland Possible subtopics –Component-based foundations for accelerated design and verifiable system integration –System of systems (including models, medical devices, care-givers, patients) Warwick Room

8. WG 2: Distributed Control & Sensing of Networked Medical Device Systems Leader: Bruce Krogh Possible subtopics –Robust, verifiable, fault-tolerant control of uncertain, multi-modal systems –Closed loop systems Chancellor Room

9. WG 3: Patient Modeling & Simulation Leader: Harvey Rubin Possible subtopics –Large scale, high fidelity organ and patient models for design and testing Walnut Room

10. WG 4: Embedded, Real-Time, Networked System Infrastructures for MDSS Leader: Lui Sha Possible subtopics –Architecture, platform, middleware, resource management, QoS (Quality of Service), PnP (Plug-and-Play) of MDSS Spruce Room

11. WG 5: HCMD Software Development & Assurance and Medical Practice-driven Models Leader: Peter Lee Possible subtopics –Care-giver requirements solicitation and capture, design and implementation V&V (Verification and Validation) –Heterogeneity in environment, architecture, platform in medical devices –User-centered design and use/misuse modeling in medical practice Pine Room

12. WG 6: Certification of MDSS and Requirements Leader: John Hatcliff Possible subtopics –Quantifiable incremental certification of MDSS, role of design tools –COTS, non-determinisitic and self-adaptive medical device systems –Risk understanding Grand Ballroom