The FDA Wants to Bring Manufacturing ‘Home’

No sooner did I finish writing my last Editor’s Letter regarding the challenges of a changing medtech supply chain than the FDA weighed in on the very topic via an op-ed piece on CNBC’s site (where I caught it anyway). The opinion piece titled “The coronavirus pandemic underscores the need to bring drug manufacturing back to U.S.” was authored by U.S. Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn and Deputy Commissioner Dr. Anand Shah. While the title only mentions drugs, the comments make reference to medical devices alongside pharma.

The agency commissioners comment how the need to modernize the critical medical supply chain is long overdue and offer insights on just how many of these necessary products are manufactured overseas. They explain the pandemic served to put a bright spotlight on the problem.

They go on to recognize the financial incentives companies have for outsourcing to locations like China and India. Meanwhile, the manufacturing technologies and processes being used for the fabrication of drugs and medical devices are often 50 years old. “In other words, we’re often using 20th century technology to manufacture 21st century cures,” they explained.

Hahn and Shah mention the millions that have been invested into the initiative to “Bring MedTech Manufacturing Home.” Unfortunately, in my jaded opinion, the effort seems to have had about as much impact on the problem as “thoughts and prayers” does in the social media response to a tragedy. Words are nice, but action (and, in this case, financial incentives) are truly what’s needed.

Fortunately, perhaps recognizing the initiative isn’t quite enough, Hahn and Shah lay out three points to further the effort. First, they are interested in gaining access to “better data to untangle the knots of our supply chains.” They also mention the possibility of the creation of a quality rating system. I’m not sure who would run such a system, but it would need to be an independent entity that is above reproach. I’m not sure the FDA wants to add more to its plate, but it would need to be run by an organization similar to the agency.

Second, incentives for manufacturers to “return home.” This is a double-edged sword, however, as I mentioned in my Letter in the last issue. The U.S. simply cannot support the return of essential medical device manufacturing. If this was to occur, the labor shortage being experienced currently would look like “the good old days” compared to the disaster that would be. But, there’s certainly room to move the needle more toward domestic manufacturing than what’s currently happening. And that would go a long way to helping alleviate future challenges like those we saw with this pandemic.

The commissioners did make an interesting mention though that sounds like something similar to what I’ve brought up in the past. That is, they said “hospitals have banded together to manufacture their own generic drugs.” I’ve discussed the idea of additive manufacturing being leveraged within a healthcare setting to produce medical devices, whether patient specific implant or an instrument that’s needed for an emergency. Whether or not this idea is feasible, there’s still a debate regarding that.

The third point made in the op-ed is focused on the need for investment in advanced manufacturing technologies. This item would actually go to helping with the concerns I expressed on point number two. Advanced manufacturing technologies, including automation and robotics, can help to make domestic manufacturing more efficient, reducing the need for manual labor, and decreasing the overall costs. This would bring U.S. manufacturers to a more competitive level with overseas vendors, especially when you add the logistics costs to the international manufacturing expenses.

The FDA isn’t the only one addressing this topic. On October 20, MPO will kick off its virtual event—the MPO Symposium. This event will take place over the course of four weeks, touching on themes brought about due to the pandemic as well as those that are more evergreen and critical for medical device manufacturers. Alongside a session on the reshoring of manufacturing, seven other virtual webinar-style broadcasts will cover topics over the time period (the event will also be available on-demand for at least six months). COVID-related sessions will include an examination of what is required to establish a resilient supply chain, lessons learned from the race to get COVID diagnostics to market, and how to successfully engage in remote audits. The more universal industry issues addressed will encompass academic-industry partnerships for technology commercialization, a look at where we stand on regulatory changes, bridging the generation gap in the work place, and an examination of the future of device sterilization.

Whether you have interest in “attending” a single event or want to take in all eight, get over to www.mposymposium.com to register so you don’t forget later. 

Sean Fenske, Editor-in-Chief
[email protected]