Breakout Session I

Group I

Design for Future Medical Devices

Participants

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

Topics discussed

• Design for user training/support

• Design engineering

• Design issues unique for medical devices

• Design topics not covered yesterday

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 ?

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,

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)

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

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