High Confidence Medical Device Software and Systems (HCMDSS) Workshop

Insup LeeDepartment of Computer and Information

ScienceUniversity of Pennsylvania

June 2-3, 2005Philadelpia, PA

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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 participantso 49 from academiao 16 from medical sectors (care-givers, reseachers)o 12 from industryo 12 from government

40 position papers Sponsors: NSF, NCO, Penn Engineering Supporting government agencies: FDA, ARO, NIST, NSA

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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.

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HCMDSS Workshop Planning Meeting

Nov 16-17, 2004 in Arlington, Virginia 59 participants Goal of the workshop planning meeting

o 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.

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The Eight Topic Areas

Enabling Technologies for Future Medical Deviceso Implantable regulatory devices, networked biosensors, telesurgery, robotic surgery

Foundations for Integration of Medical Device Systems/Modelso Component-based foundations for accelerated design and verifiable system integrationo System of systems (including models, medical devices, care-givers, patients)

Distributed Control & Sensing of Networked Medical Device Systemso Robust, verifiable, fault-tolerant control of uncertain, multi-modal systems

Patient Modeling & Simulationo Large scale, high fidelity organ and patient models for design and testing

Embedded, Real-Time, Networked System Infrastructures for MDSSo Architecture, platform, middleware, resource management, QoS (Quality of Service), PnP

(Plug-and-Play) of MDSS High Confidence Medical Device Software Development & Assurance

o Care-giver requirements solicitation and capture, design and implementation V&V (Verification and Validation)

o Heterogeneity in environment, architecture, platform in medical devices Medical Practice-driven Models and Requirements

o User-centered design, risk understanding, and use/misuse modeling in medical practice Certification of MDSS

o Quantifiable incremental certification of MDSS, role of design tools COTS, non-determinisitic and self-adaptive medical device systems

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HCMDSS workshop

Motivationo 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.

Goalso Identify research challenges and emerging issueso Produce a comprehensive report on research

needs and roadmap at the national level across multiple agencies

o Create a community

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Overall Program

Government panel 2 keynote talks 3 invited talk sessions

o Medical perspectiveso IT perspectiveso Manufacture perspectives

3 Breakout sessions (six working groups) Summary presentation (tomorrow) Banquet (tonight)

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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 prepareo summary presentation (during the last session of the workshop)o summary report (1st draft due several weeks after the workshop)

Three Breakout Sessionso Session 1: discuss position statements, problems, current state, needso Session 2: discuss and refine R&D challenges and roadmapo 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.

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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)

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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).

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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

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Deliverables of the workshop

Immediately after the workshop, the HCMDSS web-site will have:o Video clipso 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

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HCMDSS Banquet - sponsored by

Cadence RestaurantKimmel Center for the Performing Arts

Home of the Philadelphia Orchestra

6:30 pm today

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Helpers

Registration & local informationo Jennifer Finley:

Presentations and Working Groupso Madhukar Anand (WG 4), presentation laptopo Arvind Easwaran (WG 5), presentation slideso Insik Shin (WG 1), presentation slideso Dave Arney (WG 3), video projectoro Aaron Evans (WG 6), video projectoro Sebastian Fischmeister (WG 2)o Jesung Kim (WG 1), video projector

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Today’s morning schedule

Government Session, Sally Howe, NCO Keynote talk, Shankar Sastry, UC Berkeley Break Invited Session 1: Medical Perspectives