Check out the recent article on the MDDI Device Talk Blog discussing the new challenges involved in demonstrating use and usability of medical devices as required by the FDA.
The recent white paper, co-authored by Dr. Mary Beth Privitera, M.Des, PhD, FIDSA and Tor Alden, MS, IDSA, of HS Design, discusses the close similarities of device testing and that of clinical trials. Collaboration between the clinical and development communities is more important more than ever to meet the clinical needs in Human Factors Engineering.