AAMI News January 2019

In Midst of Change, AAMI CEO, Chair Share Vision for Future

Rob Jensen
Rob Jensen
Eamonn Hoxey
Eamonn Hoxey

2018 was a year of change for AAMI. It marked the first year of a new strategic plan and was topped off by a move to a state-of-the-art office space intended to bring fresh opportunities for members and the entire health technology community. So what does 2019 hold for the association? AAMI President and CEO Rob Jensen and AAMI Board Chair Eamonn Hoxey, an international quality and regulatory compliance consultant, reflect on the year that was and anticipate what lies ahead.

Q: Which AAMI accomplishments in 2018 are you most proud of?

Jensen: It is truly difficult to specify a small number of accomplishments because there were many parallel paths of strategic execution in fiscal year (FY) 2018, but let me list several. First, AAMI has made great progress in building a much more global constituency. Our Innovation, Standards, and Education departments have built relationships outside the U.S., creating demand for AAMI products and services, and are developing international events and innovation program pilots we expect to field in FY19.

The new Healthcare Technology Management (HTM) Department conducted wide-ranging interviews with HTM experts across the U.S. to get an up-to-date view of the frontlines of the field and hear from senior management personnel. This produced insights we used to plan the execution of FY19 strategies in the HTM field. Finally, our Operations Department succeeded in significantly enhancing AAMI’s infrastructure. Our AAMI Center for Excellence (ACE), improved staff work spaces, and modernized information and audio-visual (AV) technologies will help us better support our stakeholders. I think the whole team is looking forward to building on these successes in FY19.

Hoxey: It is difficult to single out one thing because all the pieces matter. Looking at the big picture, AAMI is successful when it engages and convenes all stakeholders to address an issue. The work across the organization in reaching out to those stakeholders, getting their active participation, increasing active membership in AAMI, and building relationships with organizations with shared goals is high on my list.

Q: What was the biggest surprise in 2018 in terms of the challenges facing the health technology community?

Hoxey: It shouldn’t be a surprise, but the pace of change continues to increase. The rate at which information flows just gets faster and faster.

Jensen: In this position I’m guessing most would assert I’m not supposed to get surprised, but there were a couple of things that I’d mention. First, we are increasingly seeing industry interested in and needing earlier guidance about topics related to product development and future standards. Standards have traditionally taken a relatively long time to develop, perhaps two to four years. Product development cycles and new product releases are moving much more quickly now than they ever have, and medical device manufacturers want to make sure that initial guidance, even if it is basic, is published so they will have a high likelihood of intersecting with a future standard. We’re responding to this by developing several approaches to provide this service and piloting them to ensure they meet the needs of the industry.

The other increasingly important trend I see is more personalized medicine based on an individual’s health state. Although it remains unclear what the impact of this approach might be for medical devices, we are keeping a close eye on growth in this space to see if we can provide early insights to the health technology community.

Q: What do you foresee as the biggest challenge facing the health technology community in 2019? What role will AAMI play in addressing it?

Jensen: The speed of change. I think everything is moving much more quickly than it used to and with much more sophistication—design, development, supply chain advances, nanotechnologies, artificial intelligence, robotics, and the list goes on. In such a competitive global economy, health technology businesses will be managing a rapidly changing set of environmental challenges. They have done this for years, but the speed continues to increase.

For those in HTM, I believe the digitization of the clinical health environment will challenge some of the traditional ideas around the separation of IT and devices. When devices are connected to a network, it creates a host of challenges, not the least of which is cybersecurity, and I think organizations will need to find the best ways to cope.

With regard to speed, I believe AAMI has to get out in front of as many of the health technology industry’s challenges as possible and help inform our stakeholders’ decision-making so they can create the future that the industry and healthcare environment truly need. New approaches to advance guidance on coming standards, better channels for education delivery, and possibly new practical tools for coping with cybersecurity in facilities could all be part of AAMI’s role.

Hoxey: I agree with Rob; the biggest challenge will continue to be the rate of change—separating what is important and sound from the vast mass of information that is circulating and finding ways to implement improvements effectively. AAMI will help address this challenge by being a recognized, authoritative, and unbiased source of actionable knowledge.

Q: What will be AAMI’s main areas of focus in 2019?

Jensen: Our main areas of focus are defined by our FY18–20 Strategic Plan as set forth by the Board of Directors. In FY19, we will have targeted efforts across all three goals: community, infrastructure, and knowledge. In support of the community-related goal, we intend to reach an even broader set of stakeholders through revised marketing strategies and improved communication channels. Our progress with global stakeholders will be tested with multiple pilots intended to deliver products and services outside the U.S. We will also be including feedback from our HTM stakeholders and integrating their contemporary needs into longer-term strategies.

In addition, we hope to move to near completion of our infrastructure goal this FY. We have moved into our new facility, and the IT upgrades are continuing while common processes and procedures are being developed within and between departments. We’ll be measuring the success of our integrated facility/AV capabilities with users to ensure we achieve best-in-class operational effectiveness and usability.

Finally, in pursuit of our knowledge goal, we will begin to transition successful innovation pilots to operating departments, as well as lay the technical baseline for a knowledge management system. We believe this will help liberate our data for the custom use of our members.

Q: AAMI just moved into a new state-of-the-art facility. What opportunities will this bring for the association and its members in 2019 and beyond?

Jensen: With our education offerings and standards development activities, we have found in the past that our ability to control the quality of the forum and the support (i.e., AV, Wi-Fi, catering) was an important variable in delivering the best possible environment and experience to our stakeholders. Our new facility was designed to allow us to ensure that each of these areas, which were typically uncertain and irregular in hotels, will be of high quality and contribute to the functional activities in a meaningful way. This also will allow us to provide much better virtual meeting capabilities, giving stakeholders—especially those outside the U.S.—the opportunity to curtail travel expenses while still participating in real time. Let me add that we will actively be seeking feedback on the facility and our operation of it. We are truly seeking to understand the experience of facility users, so if there are adjustments—small or large—that would promote improvement, we would love to know about them.

Q: What is your New Year’s resolution for AAMI?

Hoxey: To grow as a listening and learning organization.

Jensen: That AAMI will relentlessly pursue strategic execution to support our mission.