While Monday, December 10, the first day of the U.S. FDA’s public workshop, focused on differentiating between medical device servicing and remanufacturing, Tuesday, December 11, the second—and final—day of the meeting was all about collaboration—namely how OEMs and servicers can come together in what the FDA has dubbed a “collaborative community.” (Watch webcasts from day one and day two of the workshop here.)
To open Tuesday’s session, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), laid out the agency’s four goals for the day: to gauge whether there are “areas or issues that OEMs and [servicers] both believe are important for [facilitating] high-quality servicing and may warrant additional actions to maintain that objective;” to determine if both parties are interested in identifying and implementing those actions together; and, if so, to determine who will participate in the collaboration and who should serve as its convener; and, finally, to establish a time frame for executing the goals.
After all, Shuren told members of the workshop, the real goal is bringing the industry together in a way that benefits public safety. “Should there be interest by OEMs, ISOs, and others in the device ecosystem in addressing shared objectives and solving shared problems on an ongoing basis, parties may wish to establish a collaborative community, which is one of the CDRH’s strategic priorities over the next three years.”
Under this approach, private and public sector stakeholders meet together on an ongoing basis in what Shuren calls an “environment of trust and mutual respect.” The FDA will certainly participate in the community, Shuren acknowledged, but the agency won’t lead it. “If that’s where the community wants to go, we would engage with OEMs and ISOs in that collaborative community and ultimately go in the direction that the community wishes to go,” he added.
Where the industry wants to go largely remains to be seen, although two attendees of the workshop say that everyone played nice during the final day of the meeting, which included panel discussions. Speaking to 24×7 Magazine exclusively, Brad Sailsbury, a service manager for Broken Arrow, Okla.-based ISO Integrity Biomedical Services, says he is personally optimistic about the possibility of collaboration between OEMs and servicers.
“I thought day two was a step in the right direction in establishing a dialogue toward collaboration between the different communities in our field on cybersecurity, training, parts availability, and quality management systems,” Sailsbury says.
Binseng Wang, a member of 24×7 Magazine’s editorial board and panelist representing the American College of Clinical Engineering (ACCE) at the workshop, says that only time will tell, however. “Everyone promised to collaborate, [so] we’ll see.” Another meeting is scheduled for the first quarter of 2019 to determine how the collaboration will be structured, Wang told 24×7 Magazine—and the outcome of that meeting remains to be seen.
Even so, the ACCE has officially agreed to participate in a collaborative community since “promoting safe and effective application of science and technology to healthcare” is the association’s overarching mission, Wang says. “Coming out of this workshop, ACCE is cautiously optimistic that collaborations among all stakeholders will further this mission,” he adds.
What do you think, though? Is collaboration realistic or simply a pipe dream? Please share below in the comments section.