1. Breakout Session I Group 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