From the May 2019 issue of HealthCare Business News magazine
HCB News: Are there any items on AAMI members’ “wish list” new for this year?
RJ: Members want us to better leverage technology to make it easier to access benefits and participate in association activities. To that end, AAMI is developing new online tools that will help with the management of our standards committees. We’re going to make it easier for members and prospects to renew and join, respectively, online. And our online store will be overhauled to provide for a more seamless experience. Finally, as I previously mentioned, our website is getting an overhaul, with an accent on streamlined navigation and more personalized offerings.
HCB News: In early March, the FDA’s Scott Gottlieb announced he was resigning. Do you think that action will impact AAMI members?
RJ: The leadership of the FDA will always have an impact on AAMI members, especially those who work for medical device manufacturers. Having said that, AAMI has long enjoyed a close and productive relationship with the agency, one that benefits our members in terms of standards development, our training programs, and the conferences we organize. I’m confident that healthy relationship will continue, no matter who is at the helm of the FDA.
HCB News: Brexit discussions continue to carry on. Is that something that impacts your members and if so, is a Brexit or non-Brexit better for them?
RJ: Brexit is absolutely a matter of great interest for the medical device industry. As I consider your question, Britain is poised to vote on a Brexit deal, so there’s a lot that remains unknown about how things will play out. Uncertainty, in general, is tough for businesses; they appreciate predictability. In that sense, there is no question that Brexit has certainly been a challenge for organizations operating on the world stage, especially those who used Britain as their entry point into the European market. At this point, however, I don’t think it’s helpful for any business or organization, including AAMI, to spend time contemplating how else things might have unfolded with Brexit. Organizations have to deal with the realities of the environment they’re in. Navigating the Brexit waters will be tough, but the medical device industry is full of smart and strategic leaders. I believe the industry will continue to thrive.
HCB News: A number of associations are starting to delve heavily into VR and AI. Is this currently a big topic of discussion for AAMI? If so, can you detail some of the discussions?
RJ: I’m glad you asked this question because this topic is very much on our radar. AI is poised to alter the development of medical devices and infuse the health technology field with new tools for optimizing a range of device maintenance activities. One of our primary goals for our members is to share good information about these still-emerging technologies, identify opportunities and challenges, and point to some leading practices. There are no standards that cover the definition, development, deployment, and maintenance of AI in healthcare, and we need to change that. Earlier this year, AAMI and BSI published a set of recommendations for standardization activities related to the use of AI in healthcare, and we are going to engage in more activity on that front. Our recent International Conference on Medical Device Standards and Regulations, developed in collaboration with BSI and the FDA, covered AI. And we devoted both a recent podcast and cover story in our journal, BI&T, to AI. Finally, we’ve covering this topic at the AAMI Exchange in June. We’re certainly committed to raising awareness about the technologies that are transforming our landscape.
