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Breakout Session I Group I

Join facilitators George Pappas & Peter Lee along with industry experts to delve into challenges and solutions in designing future medical devices. Topics include user training, engineering challenges, and unique design issues.

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Breakout Session I Group I

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Presentation Transcript

  1. Breakout Session IGroup I Design for Future Medical Devices

  2. Participants • George Pappas, facilitator • Peter Lee, facilitator • Lutz Andersohn • Mike Blomquist • Edmond Israelski • Purush Iyer • Peter Kazanzides • Lori Lazzara • Tom Petelenz

  3. Topics discussed • Design for user training/support • Design engineering • Design issues unique for medical devices • Design topics not covered yesterday

  4. Design for user training/support • Challenges • Decline in user training/skill • Fewer assumptions on user skill training • No standard hospital workflow • Increasing diversity of devices • Research Needs • User centric design standards • Emerging solutions : IEC 60601-1-6 • User interface standards (make it as easy as driving a car) • Simulators for surgeon training • Real-time assistance from (remote) technical/medical experts • “Black box” equivalent for fault analysis • When to customize ?

  5. Design Engineering Challenges • Complexity outruns assurance • System/environment interactions outrun assurance • Usability drains attention from software engineering • Poor patient models for design/testing • No common test suite • No support for device/component interoperability • Some standards for interoperability • DICOM, HL7, IEEE 1073,… • Middleware (CORBA, SOAP,

  6. Design Engineering • Research Needs • High fidelity patient models for design and analysis • High fidelity simulators for testing • Science of interfaces • Validate integrated systems with interoperable components without requiring combinatorial validation? • System architecture to support device integration? • Plug and play for re-certification • Interfaces should have behavioral/timing/fault constraints • Interface standards : Hard to develop (intensive)

  7. Unique Design Issues • Device Integration • Unlike autos/avionics, hospitals expect to use components individually and in new configurations. Therefore, interoperability is necessary • Models for Design • Poor models for design/analysis • Poor simulation for testing • Design should be more adaptive/robust • Software complexity not at same level

  8. Design topics not covered • Wireless issues • Interference, QoS, mobility • Selection of middleware/protocols • Security (vs. hackers, viruses, etc.) • Networking issues (availability) • Real time issues • Tele-medicine/tele-mentoring

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