D3 - Liz Bacon: Extraordinary Design Considerations for Medical Devices

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(hard to summarize)
emphasis on regulatory landscape
communication is vital
documentation is king
research must be specified in writing for regulatory compliance -- so lean processes and guerilla work is less practical
luckily, there are professionals dedicated to risk management
product requirements *must* be maintained throughout process to match current designs because that's what's reviewed by regulators. requirements must be testable and traceable.
since regulations underspecify components of "design phase," you need to fill in your own methods that still conform with the regs
(also, use the phrase contextual inquiry when you do initial research, since that's the phrase that's in the standards!)
need to think about maintenance of prototypes in design documentation processes
usability testing - classic, moderated form and need to define clear objectives from research so that you know what you're being judged against
so user research is a very good investment
-- long shelflife for personas because of power of roles in medical domain, since people live by checklists and standards
and strength to defining design patterns so that you can leverage institutionalization (this also includes style guides)
design to avoid problems, rather than mitigate them - make errors impossible.
so systems and QA people are your friends, since there's so much to do -- and because regulatory agencies prefer designers don't do their own usability tests
challenges
- few design agencies have regulatory know-how, but it's not hard to get
- need to recognize that you need more documentation, and support it for longer times
- get involved in standards-making
- but please get involved! this is a field in which bad design can kill people.

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