In recent years, the FDA and MHRA (EU) have approved or drafted new guidance documentation regarding usability (FDA 2016; MHRA 2016)—leading to a dramatic increase in the need for contextual inquiry, formative and summative studies. Our challenge is that although the healthcare community agrees that usability can enhance patient safety (Armijo et al 2009), there has been little interaction with the healthcare providers to communicate the value proposition.
The combination of HIPAA concerns, the Sunshine Act and other recent legislation have limited the hospitals and corporations ability to provide access for observation and recording in surgical and hospital facilities.
Tor Alden, IDSA, moderates this panel of industry leaders—Diana Gunnarson, Medtronic senior principal human factors engineer and MaryBeth Privitera, PhD, F/IDSA—who will discuss challenges and ideas on what improvements could be implemented to aid in providing open access for design research in a shared community environment.
Specific topics of discussion include: The challenges and importance of observational studies in medical device development. We’ll explore questions that address the increased demands asked of the medical staff; certification and awareness programs; opportunities to create a clear pathway for collaboration and safety in conducting user research.