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Breakout Sessions
Questions. The following questions that are relevant to the assigned
breakout group discussion:
- Where are we now, and where should we be in 5, 10, and 20 years?
- Why can software for future medical devices not be developed using existing
design and productivity technologies?
- What are emerging technical and scientific issues in medical devices?
- What are key obstacles to the development and certification of medical
device software and systems?
- What are the major obstacles in innovative design and accelerated
certification? How can information and software technology help?
Deliverables should provide content for each Breakout session report.
"For each breakout session, the facilitators are expected to produce
summary slides in powerpoint and 2 page discussion report. They should
contain the information:"
- Identify and articulate the list of challenges and opportunities
- Identify and list existing solutions
- Identify and prioritize the list of (short term and long term) research and
development needs
- Define logistics to meet unmet research & development needs
- Develop research & development roadmap
- Recommendations for the full workshop (areas, people, organization)
Breakout Session assingments:
Breakout Session 1
Group I: Current/Future Medical Devices
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Description: Design for Future Medical Devices:
We ask this breakout to address trends and the convergence of information technology and medical device technology. A key area of discussion concerns what we may need to do in order to achieve highly reliable IT-intensive devices that are feasible to both develop and to certify. What new types of devices are appearing or are needed in the OR, the ICU, medical transport systems? For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: What are the high integrity design challenges for future medical devices? What enabling technologies are on the horizon? What is the vision of future medical device automation? Are the challenges for assuring high confidence software & systems changing? Is device technology becoming more software and information technology intensive? How will information technology, such as wireless networking or universal on-line patient records systems, change the routine design of medical devices? Can we characterize the type of software that is needed? What are the functions that are migrating to SW? Is distribution a trend? Are real-time functions involved? How about security? How are medical device requirements different from (e.g.) future, highly-automated and networked automotive or avionics systems? What reports and data document these trends and challenges?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
Peter Lee
George Pappas
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| Participants: |
Lutz Andersohn
Mike Blomquist
Ron Hensel
Edmond W. Israelski
Purush Iyer
Peter Kazanzides
Tom Petelenz
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Group II: Medical Software and System Engineering
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Discussion: We ask this breakout to address current and needed best practice in software engineering for medical devices and systems. This would consider changes in the software and systems to be deployed, and the increasing challenges of IT certification. For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: What is the industry perspective on best practice in safety, security, and quality assurance? How will increasing use of IT change this? What is the medical community's (user's) perspective on these matters? What is the state of current SSE practice: What kind of tools and methods are currently being used by SSE's, what do SSE's need to develop HCSS medical devices, how to produce software and systems faster, better, cheaper? Software components from comparable processes and with reliability equivalent to silicon chip sets?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
Rance Cleaveland
John Hatcliff
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| Participants: |
Amit Bose
Peter Coronado
Ronald Gerner
Karl Hammermeister
Mark Jones
Robert Kircher
Eric Linner
Jesse H. Poore
Sohan Ranjan
Vy Tran
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Group III: Medical Care and Support Systems
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Discussion: Future Usage Environments and Systems Integration:
We ask this breakout to address the current and changing variety of environments in which the new medical device technology would be deployed, and the certification challenges that accompany them. For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: In what sort of environments might future medical devices be found? For example, hospitals, telemedicine, remote surgery, home care, networked, biomedical (interfacing with the human nervous system or body organs), cellular design. Who would the users be, and what skill levels can be expected? What are the implications for certification?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
John Anton
Douglas Schmidt
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| Participants: |
Felix Alfonso
Anindya Banerjee
Scott L. Bartow
Andrew Casertano
Vincent Crum
David Forslund
Michael A. Parsons
Stacy Prowell
Douglas Rosendale
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Group IV: Quantum Leap Technologies
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Discussion: We ask this breakout to look forward and predict possible future states of medical technologies 10-15-20 years out. What breakthroughs are needed to enable this vision, particularly in IT? What are the certification challenges? For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: Will micro- and nano-scale technologies be in use? Which emerging IT technologies will be relevant (e.g. RFID)? What are the control challenges for broad use of emerging medical treatment technologies (laser/lidar, magneto-stereotaxis, microrobotics, other). How mobile can currently-situated diagnostic devices (MRI, Ultrasound, ...) be made and what are implications for patient records? How will cost of medical care delivery be affected? What are the implications for certification?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
Raj Rajkumar
Harvey Rubin
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| Participants: |
Kevin Cleary
Robert Galloway
Brian Litt
Jane W. S. Liu
Daniel Maloney
Victoria L. Rich
Russell Taylor
Majed G. Tomeh
John R. Zaleski
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Breakout Session 2
Group I: Requirements Specifications for Certifiable Design
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Discussion: We ask this breakout to think about current and needed future practice in specification of medical devices and systems. Getting the right requirements and specifications is never easy: they must be complete without prematurely constraining design, interoperable, etc. They should be certifiable in some sense, even at this stage, and should lead to easily and usefully certifiable devices and systems. For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: Enumerate the current standards and best practices. How effective are they? What is the effect on innovation? How do issues such as universal patient records and increasing automation affect this? What about component-oriented systems? What about the skill levels of users?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
Peter Lee
George Pappas
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| Participants: |
Peter Coronado
Robert Galloway
Purush Iyer
Robert Kircher
Eric Linner
Jane W. S. Liu
Tom Petelenz
Jesse H. Poore
Majed G. Tomeh
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Group II: Development
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Discussion: We ask this breakout to discuss current practice and improvements in available technologies and approaches needed for high-confidence system and software development. What are the challenges in developing highly reliable software for medical devices and systems, yet achieving reasonable time-to-market and profitability? For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: How might end products of development steps need to include information for certification or V&V that can enable this? How solid is the current technology base upon which medical devices and systems are built (e.g., real-time operating systems and networking technologies)? What are the security issues? Are reusable IT technologies (e.g., middleware, frameworks) in use? Is system code generated from mathematical control design frameworks such as MatLab and Simulink? How do critical decision support and highly-automated systems become trusted?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
Rance Cleaveland
John Hatcliff
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| Participants: |
Lutz Andersohn
Mike Blomquist
Kevin Cleary
David Forslund
Edmond W. Israelski
Mark Jones
Peter Kazanzides
Sohan Ranjan
John R. Zaleski
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Group III: Certification
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Discussion: We ask this breakout to consider best current and possible future practice in device and system certification. Other domains (e.g., aviation) are considering whether certification should move from a process standard to a greater orientation towards product and design evidence. What is the perspective of this community regarding needs in V&V and certification? For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: What are the current practices for assurance and certification? How are they carried out? Are they effective with respect to product safety and security? For example, how is V&V done now? Is design evidence used? What is the effect of V&V and certification practice on product liability? What are the "contractual" assurance needs of a component-oriented market? How will certification practice need to change to accommodate IT and software-centric device and system integration? How would these adapt for IT- and software-intensive systems?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
John Anton
Douglas Schmidt
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| Participants: |
John Anton
Anindya Banerjee
Amit Bose
Vincent Crum
Ronald Gerner
Brian Litt
Daniel Maloney
Michael A. Parsons
Russell Taylor
Vy Tran
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Group IV: Fielding, Operation, and Maintenance
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Discussion: We ask this breakout to discuss current and future scenarios for fielding, operation, and maintenance. What changes are occurring and what changes are needed? What assurance needs exist for high-confidence deployment, operation, and upgrade of medical systems in these settings? For the spring meeting, what questions should we be asking, and who should be participating in the discussion?
For example: How can system administration be managed for high-confidence systems? Will medical technologies increasingly be used in mobile and home-care settings? Will ad hoc integration of these be needed? What are the skill levels required (and available) for operation? The wonder product has been designed, built, and certified. What are the challenges in training users (e.g., nurses)? Will pushing the "Lamp Test" button harm the patient? The "Self Test" button? How do I know? Who configures the systems and set defaults? Who should? Why? Where are the policies decided? How can the system admins avoid settings that have vulnerabilities? Does widget ver. 3 work if you still use ver. 2 widgets? Is the latest version of NurseStation certified to support all the old devices? What if the next version is just a patch or software download?
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The attendees are expected to participate in
the breakout sessions as follows:
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| Facilitators: |
Raj Rajkumar
Harvey Rubin
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| Participants: |
Felix Alfonso
Scott L. Bartow
Andrew Casertano
Karl Hammermeister
Ron Hensel
Stacy Prowell
Victoria L. Rich
Douglas Rosendale
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