Visible to the public High-Confidence Medical Devices, Software, and Systems (HCMDSS) Workshop Planning Meeting

November 16-17, 2004 | Arlington, Virginia

Conference Archives: November 2004 Planning Meeting | June 2005 Workshop

The rapidly increasing software complexity of medical devices makes the development of high integrity software a crucial issue. Several Federal agencies are interested in identifying the research needs required to 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.

The November 2004 planning meeting assembled a select group of leaders and visionaries in the medical device industry, research laboratories, academia, and government who helped identify short-term and long-term technological challenges faced by medical device manufacturers and regulators.

Information gathered from this planning meeting is being used to establish the full scope and agenda for a larger national-level research workshop slated for June 2005. The objective of the workshop will be to identify and discuss potential approaches that can help answer the challenges.


0730 - 0830 Continental Breakfast | Registration
0830 - 0850 Welcome, Introduction, Schedule, Facilities
Insup Lee (University of Pennsylvania)
0850 - 0910 Remarks by U.S. Government High Confidence Software and Systems (HCSS) Coordinating Group (CG) Representatives
0910 - 0930 Purpose and Goals
0930 - 1030 PANEL 1: Design for Future Medical Devices
Moderator: George Pappas, University of Pennsylvania


  • Robert Galloway, Vanderbilt University
  • Robert Kircher, Dose Safety Company
  • Brian Litt, University of Pennsylvania
  • Tom Petelenz, SARCOS
  • Russell Taylor, Johns Hopkins University
1030 - 1045 Break
1045 - 1145 PANEL 2: Software and Systems Engineering for Medical Devices
Moderator: Insup Lee, University of Pennsylvania


  • John Anton, Kestrel Institute
  • Rance Cleaveland, Reactive Systems, Inc.
  • Peter Coronado, Varian Medical Systems
  • Mark Jones, Oregon Health & Science University (OGI)
  • Michael A. Parsons, Computerized Medical Systems
1145 - 1200 Break
1200 - 1300 PANEL 3: Future Usage Environments and Systems Integration
Moderator: Douglas Schmidt, Vanderbilt University


  • David Forslund, Cognition Group
  • Jane W. S. Liu, IIS, Academia Sinica, Taiwan
  • Raj Rajkumar, Carnegie Mellon University
  • Victoria L. Rich, Hospital of the University of Pennsylvania
  • Douglas Rosendale, Veterans Affairs Office of Information and Surgery
  • John R. Zaleski, Siemens Medical Solutions Health Services
1300 - 1400 Lunch
1400 - 1530

Breakout session 1

Group I: Current/Future Medical Devices
Group II: Medical Software Engineering
Group III: Medical Care and Support Systems
Group IV: Quantum Leap Technologies

1530 - 1545 Break
1545 - 1715

Breakout session 2

Group I: Requirements Specifications for Certifiable Design
Group II: Development
Group III: Certification
Group IV: Fielding, Operation, and Maintenance

1715 - 1730 Wrap-up Session / Review of the next day's schedule
0730 - 0830 Continental Breakfast
0830 - 1000 Reports from Breakout Sessions
1000 - 1100 Open Discussion
1100 - 1115 Coffee Break
1115 - 1145 Discussion of summary report topics as a basis for a call for white papers for the June 2005 Workshop (Topics derived from breakout reports and panel summaries)
1145 - 1200 Wrap-up (Overview of Expectations for the June 2005 Workshop)
1215 Planning Meeting Adjourned
1230 - 1500 Program Committee Meeting (Closed)

Event Details
Arlington, Virginia