As part of this “Silver Bullet” session, I’d like to suggest that you spend some time summarizing FDA Guidance for human factors/usability testing (early and often would be a fair summary). While there are challenges operating in a regulated environment, the guidance has been in place for 15 years or so and is fairly prescriptive.

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm094957.htm

This well-written material has also been helpful for me in setting scope/boundaries for formative HF testing — and assuring peers in QA or R&D of the need for generative research for a first of a kind interface/product… assuring them that later studies will establish a baseline and prepare for the evaluative test they need for release.