AAMI News September 2017

'It's OK to Disagree' and Other Lessons from Developing Standards

Every year, a wide variety of professionals with an interest in healthcare technology devote themselves to developing and revising the guidelines that establish the foundation for the safety and effectiveness of medical devices and equipment. What do these individuals get out of participating in the standards development process? AAMI News decided to find out.

Stephen GrimesI’ve learned and gained varied perspectives from very experienced, knowledgeable members of the healthcare technology management, manufacturing, and regulatory community. This broader exposure helped me learn the benefits of listening and developing truly consensus-based standards.”

Stephen L. Grimes, managing partner and principal consultant at Strategic Healthcare Technology Associates, LLC in Swampscott, MA

Neela SaikrishnanIt gives me the opportunity to participate in an activity that is meaningful and has far-reaching impact—to think of the fact that the standards that I help develop will drive future innovation is a very compelling reason for my involvement.”

Neela Saikrishnan, principal engineer at Abbott in St. Paul, MN

Richard SchuleNetworking with industry leaders, scientists, and engineers has been invaluable to my professional development and personal growth. It truly is a small world.”

Richard Schule, director of clinical education at Steris in Mentor, OH

Eamonn HoxeyI cannot overstate the amount of personal development that I have gained from involvement in standards work. This comes from experience in understanding different points of view, interpersonal skills in influencing and negotiating, leadership in convening meetings and chairing committees, awareness of international practices and differences in cultural norms and behaviors, skills in writing and communicating, project management in delivering programs on deadline—the list goes on and on.”

Eamonn Hoxey, director of E V Hoxey Ltd in Cirencester, England

Charlie FinleyI benefitted personally in expansion of my knowledge in many technical areas ... in which I had limited or no prior experience. This includes the standards world itself—especially how practical compromise is achieved in balancing safety, clinical, scientific, engineering, and business issues for a consensus, voluntary standard. I have benefited greatly from the personal, collegial friendships developed with industry, clinical, and regulatory partners.”

Charlie Finley, fellow at Advanced Bionics in Valencia, CA

Lena CordieBeing involved with standards has reinforced for me that it is OK to disagree—and still be able to laugh (and have a drink) together. It has helped me recognize my strengths and my weaknesses, but not to dwell on them. And it has made me genuinely proud to be involved with the work we do.”

Lena Cordie, principal consultant at Qualitas Professional Services in Minneapolis, MN

Chris OwensI get a great sense of satisfaction in knowing that the work we do will improve the state of the art for the industry and ultimately provide a service to the public by having fair requirements for the technology they use. Their lives depend on it, and I take that seriously.”

Chris Owens, engineering manager at Medtronic in Miami, FL

Mark SwansonWorking on standards development has had a direct impact on my personal work. It’s allowed me to ask questions and gain knowledge that I was not exposed to anyplace else. The other people who work on the development of standards are truly leaders in the field.”

Mark Swanson, executive director of intelligence and technical excellence at R&Q in Minneapolis, MN

Anita SawyerFor me, making sure that all medical devices are evaluated by the best methods possible to assure biological safety is a passion. ... A few of my closest friends are my ISO/AAMI colleagues; I have learned so much from them.”

Anita Sawyer, biocompatibility and standards manager at BD in Research Triangle Park, NC

Ravi NarayananFirst and foremost, the inner satisfaction of contributing to human life and the wellness thereof. Second, it offers an opportunity to work along with my peers in the medical device field and learn from them.”

Ravi Narayanan, global product manager at Nordson Medical in Loveland, CO

Participating in Standards Development

There are several ways to get involved in the AAMI Standards Program: proposing a new work item, joining a technical committee, submitting comments on public review drafts, or attending open meetings of AAMI committees and working groups.

To learn more, visit www.aami.org/standards or email standards@aami.org.