Reaching out.

2010 was a year where significant changes were made to the guidelines and standards that the FDA expects medical products to be developed under, especially in the areas that govern the validation of user interface design. In many ways this is very exciting since the new rules are trying to codify what is essentially "good design process". The concern I would like to raise is that these rules are being developed without input from an organized group specifically representing designers.

Our role as the creators of the physical and digital interfaces for these devices gives us a unique perspective on how to communicate safe use of medical devices to the end user. If we fail to embrace the impact that our work has on the safe and effective use of medical products and do not engage with regulatory or standard producing organizations, we limit ourselves. Good design has always followed a robust process so the compatibility exists between our work and the new guidelines created by the FDA.

IDSA’s medical device development professional section presents an excellent vehicle to reach out to the FDA or groups like AAMI and ISO/IEC. We have a number of IDSA members that belong to AAMI and even a few that have authored or reviewed standards. It seems like a natural extension of our professional section to begin a dialog with AAMI's leadership, seeking to become more involved in the development of the design standards and the design process standards that direct our activities.

So what do you think? Share your thoughts or alternative ideas below.