Hi Josh,
These are excellent questions. In addition to Biomedical Technologies, NSF has also creased a Pharmaceutical Technologies topic area.
1. Given the broadening of the topic areas of interest for NSF, there will begin to be more overlap with NIH. The best way to find out if a small clinical study would be appropriate for these new topics areas would be to reach out to the program officers: Henry Ahn (hahn@nsf.gov) for BT and Alastair Monk (amonk@nsf.gov) for PT. We highly recommend talking to program officers well in advance of submission to ensure your proposal aligns with the agency’s goals, as they can change.
2. NSF SBIR proposals are structured by Technical Objectives (similar to Specific Aims with NIH). Again, talk with the program officer about your project’s goals. Typically, NSF proposal include engineering objectives, but it is also paramount for the technology to be novel and innovative. Combining basic engineering to push your innovative technology toward commercialization is one option (ie. using traditional methods to create a novel device).
Please let me know if you have additional questions!