hcmdss breakout session requirements specifications for certifiable design peter lee, george pappas,...
TRANSCRIPT
HCMDSS Breakout Session
Requirements Specifications for Certifiable Design
Peter Lee, George Pappas, Peter Coronado, Robert Galloway, Purush Iyer, Robert Kircher, Eric Linner, Jane W. S. Liu, Tom Petelenz, Jesse
H. Poore, Majed G. Tomeh
Our charge
Think about the current and needed future practice in specification of medical devices and systems
What we talked about
1. Current standards and practices
2. What is needed / desirable
3. Opportunities
4. Other questions
5. Workshop recommendations
“We are like the barber-surgeons of earlier ages, who prided themselves on the sharpness of their knives and the speed with which they dispatched their duty -- either shaving a beard or amputating a limb. Imagine the dismay with which they greeted some ivory-towered academic who told them that the practice of surgery should be based on a long and detailed study of human anatomy, on familiarity with surgical procedures pioneered by great doctors of the past, and that it should be carried out only in a strictly controlled bug-free environment, far removed from the hair and dust of the normal barber's shop.” – Sir Tony Hoare
Current practice
Based primarily on “shall” statements
completeness?
missing behavior in normal vs failure modes
missing “shall not” statements
“User-centered” approach deemed important but deficient today
specification should include user scenarios (and verify against them)
Current practice, cont’d
Some key issues: extrinsic vs intrinsic properties need to iterate specification
development over the design process
important for fault analysis to include extrinsic properties
interoperability is essential certification of requirements vs
certification of device
What is needed / desirable
More formal specifications? abstracts away from data presentation to users useful for testing and verification should be used whenever possible formalize FDA guidance documents?
Composable specifications? implies ability to specify the environment interconnection constraints component interfaces are essential but take effort science opportunities? (eg, ISO 1070)
Opportunities
Reduce cost of certification only 40% of cost is due to development and test –
can we reduce the rest (which includes overhead, FDA, etc)
what would be sufficient evidence for certification?
Cope with diversity of human subjects high-fidelity simulations?
More intelligent, adaptive devices what would be enabled? adjust to new parameters and environments? cope with failure
Other questions
Do we allow devices that cannot be tested for all conditions?
Models are missing for device development who will develop those models? esp. patient models
Component-oriented systems? e.g., sensors, algorithms, control subsystems, etc. certification/verification of interactions of
components?
Networking, communication, data sharing are overriding concerns in the near term
Security, privacy, HIPAA?
Workshop recommendations
People to consider:
OT&E and DoD certification criteria Ernest Seglie, Chief Scientist
NAS study representative
FAA, avionics system experts
Praxis, other formal developments
Patient modeling Steve Jacobsen (biomechanics)