In a perfect world, the shared top priority for everyone in the medical industry would be better patient outcomes. My colleagues and peers will say that’s what brought them to medicine or biomedical engineering, and I believe them.

As a business owner, I also know my competitive advantage comes from offering a level of knowledge and service no one else can. If I want my business to succeed, I have to safeguard my expertise and use it in support of my professional growth. I have a team of lawyers who craft nondisclosure agreements and protect my intellectual property.

This is the paradox of running a business related to human health.

So I understand why the recent town hall at the Additive Manufacturing Users Group was a cautious, often halting conversation. Meredith Price Vanderbilt, director of Consulting for Empirical Technologies and one of the moderators, struggled to elicit responses from the 40 or so people in the room, all of whom were either subject matter experts or hoping to learn from experts.

“The additive manufacturing environment is changing so quickly, there are no standards with which they can keep up,” she said. “I wanted to have an open dialog. But nondisclosure contracts interfered with my ability to facilitate communication.”

Brian McLaughlin, president of ARCH-Additive, Portland, was the second moderator. He echoed Vanderbilt’s concerns.

“Many company representatives in public forums have said, ‘We’re gonna share data,’ but when it comes to it, they don’t do it,” he said. “The implant database with the FDA is one way to do it, but that’s just a fraction of what gets recorded.”

By soliciting honest feedback and best practices, these two moderators were essentially asking participants for the secrets to their success. But most of the attendees felt bound by company policy or legal guidance to stay silent. A recent law school graduate herself, Vanderbilt understands the catch-22 of what she was asking. But she fears the progress of the industry is at stake here.

“It’s adding layers to an already complex problem,” she said. “The people making decisions [about data sharing] are siloed in a corporate structure. They don’t have a broader view of how all the different parts of the process affect the final product and patient outcomes. The lawyers review contracts within the four corners of the pages for protectionist language without a greater understanding of the societal and long-term business benefits of information sharing.”

At the AMUG roundtable, one participant floated the idea of an anonymous chat where members could share best practices and questions. But especially now with rampant disinformation filling all corners of the internet, how could anyone trust the lives of patients to the words of an anonymous stranger? Imagine trying to tell your boss that CatGirl76 on an anonymous chat forum told you this was a good solution.

The information gap doesn’t exist solely in the business space. Because of the rapid growth of additive manufacturing, it’s also a challenge for regulatory bodies to keep up with the pace of change.

“Meredith has a list of questions from FDA that she’s had to answer [about additive manufacturing],” McLaughlin said. “There’s some consistency with some of those questions, which means there’s a lack of education or broad knowledge the FDA can go look at. The [original equipment manufacturers of additive manufacturing platforms] are not doing a good enough job of educating the marketplace. There are tremendous knowledge gaps all over the place. How do you fill those gaps if no one will talk to each other?”

Vanderbilt worries that we’ve reached a point where our focus on protecting our businesses is inadvertently damaging that lofty goal of best patient outcomes.

“All of these contracts and requirements build walls that no longer make sense for our industry,” she said. “These contracts are impeding safer products, newer products, and better products from getting on the market.”

The FDA medical device database is a good start,” McLaughlin said. But based on feedback from surgeons, he hears anecdotally that there’s really no good way for surgeons to report their data.

“And given the fact that many surgeons are now working in surgical centers rather than larger healthcare systems, their focus tends to be performing more surgeries and developing their business further,” McLaughlin said.

“The large majority of surgery centers are owned by surgeons, and that market is growing—there is part of the problem,” he went on. “They’re not incentivized to gather data and feed it into the system. There’s no mechanism that helps the surgery center or makes it easier to do that…Most hospitals are not privately funded and the vast majority are huge networks. You have a level of administrative and operational incentives to share data across that network.”

Both Vanderbilt and McLaughlin agree there’s no simple answer or clear way forward.

“We’ve reached the point where our attempts to protect ourselves have started to limit us,” Vanderbilt said. “We have to look at it holistically instead of as parts of a process. It’s outside of everybody’s norm. It’s limiting progress for everybody.”

“I don’t know the answer,” McLaughlin said. “You have a common goal of common good for the patient—that’s the perfect world, that that’s the vision. In a perfect world, it’s the right technology for the right indication for the right patient and it’s not a business decision, it’s about what’s best for the patient. The question remains how do we get there, particularly when the OEMs are highly competitive against one another for product placement?”

We know it can be done; COVID-19 proved that. When the vaccine manufacturers agreed to share data—to not prosecute for patent infringement for the sake of global health—we caught a glimpse of what can happen when we set aside our fear of competition for the sake of life-saving technology.

I remain hopeful that we’ll find some middle ground between healthy profits and healthy patients. Like Vanderbilt and McLaughlin, I don’t know where that is yet, but I’ll continue to work toward that goal. If you have ideas on how to build better lines of communication and transparency to benefit patients, please email me at dlissy@empiricaltech.com.