AAMI Recap – Battle of the Titans
The Corner Office
Wayne Moore
7/24/2024
Heralded for months as the upcoming battle of the titans, the remanufacturing versus servicing panel discussion at AAMI featuring yours truly, Binseng Wang, and Larry Hertzler, many wondered if it would live up to the hype. Well, most felt that it did but maybe not in the way that many expected (or perhaps hoped for).
Binseng and I did not get into a physical altercation and Larry was most gracious in how he moderated the debate. Attendance for this discussion was at standing-room-only capacity highlighting the impact of the requirements found in the FDA Guidance document on Remanufacturing of Medical Devices. I think most attendees were surprised to find that Binseng and I had more in agreement than disagreement.
One of the larger “takeaways” was our agreement that the issue of who should be servicing medical equipment would be better left to the actual stakeholders — in this case OEMs and Third Party Servicers — rather than wait for the FDA to provide definitive guidance. There are currently multiple examples where OEMs and Third-Party Servicers work together under an agreement detailing work product, quality management, information-sharing, and communication. These should be held up to industry as the model for collaboration.
I really enjoyed the panel discussion and hope that it too will serve as a model for how to reach agreements — even when the issues might be difficult or complex. The FDA had announced it was going to have a Zoom seminar on July 27th to discuss and answer questions on the new Remanufacturing and Servicing Guidance, but unfortunately, they cancelled that virtual meeting on June 23rd without announcing when they might reschedule such a critical feedback loop for ensuring a pathway for ongoing collaborative work between OEMs and Third-Party Servicers.
If you have not read the FDA Guidance document on remanufacturing yet, the link is below.
Until next month,
Wayne