AAMI Exchange (formerly AAMI Annual Conference & Expo) takes place this year from June 7-10 in Cleveland, Ohio. HealthCare Business News caught up with Association president Robert Jensen in advance of the big event for our annual update.

HCB News: In last year’s interview, you talked about how you wanted to bring in new people as more senior members retire from committees and working groups. How do you feel that’s going? Do you have a baseline for measuring that success?
Robert Jensen: I wish we could say we discovered an easy solution, but that’s not the case. Succession planning remains an ongoing challenge, one that many organizations are grappling with. We’re working to bring younger members into the association by making student membership free. We’ve also ramped up our efforts to reach out to younger professionals by growing our social media platforms in recognition that how people communicate, connect, and exchange information is changing. That’s also why we’re doing more podcasts. We have to keep up with the times and reach out to professionals in ways that they are going to value and respond to. In addition, we’ve greatly improved our technology so that more people can successfully engage with committees remotely. I’m optimistic that’s going to appeal to professionals who want to get involved, as well as to companies that would like to build their succession plans, but are facing time and cost restrictions. We are beginning to draw younger professionals into committees, but are continuing to push for more.

HCB News: The ACA continues to be a point of debate and discussion. Does AAMI have an official position on the ACA or the efforts to repeal and replace?
RJ: AAMI does not take positions on specific pieces of legislation.

HCB News: Last year, you talked about AAMI’s three-year strategy approved in November 2017, and well underway by the time of our interview. You outlined community, infrastructure and knowledge. Can you provide an update on those goals?
RJ: I’m happy to say we’re advancing on all fronts. In terms of community, our membership continues to grow. We’re doing more direct outreach to our members, collaborating with new stakeholders, and expanding our global footprint. We’re seeing more engagement across the board. With infrastructure, our biggest news is that we have moved into a new headquarters. We’re still in the same general area in Arlington, Virginia, but our new facility is much more high-tech, offering both staff and visitors a better experience. I’m especially proud of our AAMI Center for Excellence, which now hosts the many industry events and education programs we offer. In March, we held a very successful Sterilization Standards Week, drawing a record crowd, with hundreds of in-person and virtual attendees. We believe other organizations will want to use this space as well. When it comes to our knowledge goal, we’re taking multiple steps to better-serve our members and other stakeholders. We’re close to unveiling a new website; one with a fresh, clean look and streamlined navigation. We are determined to make it as easy as possible for visitors to find the information they need. We’re updating our education programs to make sure our training is in line with the latest FDA thinking and global regulations. We’re taking steps so that our standards program is more nimble, able to keep up with the fast-moving changes in healthcare technology. And we’re taking a fresh look at our publications and other communication channels to make sure we are delivering the content our members want and in the formats they find most beneficial. I could not be prouder of the teams working on these goals.

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.

HCB News: Have any new devices been approved in the past 12 months that grabbed your interest?
RJ: I really don’t point to specific company products, but I will say that, in general, I’m very impressed by two things. The first is those technologies that are helping clinicians garner knowledge — and make decisions — from all the data that’s being collected in healthcare. We’re amassing more data than ever before, but we have a way to go before that data is valuable and actionable for many healthcare facilities. Second, I’m seeing more and more understanding around the use of secure operating systems (OSs) in medical devices. These OSs could immensely help reduce the risk of patient harm or cyberattacks on the clinical organizations that attempt to come through a device. I believe this would be a huge step forward for device security and user facilities.

HCB News: How is AAMI helping to drive outcome-based care?
RJ: Outcome-based healthcare is about reducing variation in how diseases and conditions are treated. Standards in healthcare technology are also about reducing variability and bringing more certainty to how medical devices are developed and come to market. In that sense, I think AAMI has long supported outcome-based care. Outcome-based care is also about being more proactive, so the more we can do to help the healthcare ecosystem turn that ever-growing mountain of Big Data into knowledge, the more we support outcome-based care.

HCB News: What do you feel is the biggest challenge facing healthcare today and what is AAMI’s part in addressing it?
RJ: Without a doubt, the biggest horizontal challenge, if I can call it that, is the pace of change itself, which impacts everything else. Healthcare technology is evolving faster and faster, and AAMI’s role is to be nimble enough so that we can provide our members, no matter where they work, with the guidance and resources they need to succeed and grow.