Since this country’s founding, the United States
Unfortunately, a few members of Congress are proposing to slow that progress by launching a broadside against intellectual property protections. And they’re trying to use the COVID-19 pandemic to justify their actions.
At issue are the rules governing who can repair advanced medical equipment. Right now, the companies that develop and make things like MRI machines and ventilators are often the only firms that can service them.
That makes some degree of sense. Manufacturers have invested time and money researching how to build advanced medical devices. To protect that investment, they’ve secured patents for many of the constituent parts and systems underpinning their products.
Third-party repair companies want in on this line of work. They argue that they should be allowed to fix advanced medical equipment—and that the companies that make that equipment should have to help them do so.
Throughout the pandemic, third-party servicers have claimed that manufacturers have restricted access to manuals, parts, and other materials needed to repair or maintain advanced medical equipment.
They’ve found a few sympathetic ears in Congress, most notably Sen. Ron Wyden, D-Ore., and Rep. Yvette Clarke, D-N.Y. The two are lead sponsors on legislation that would essentially force manufacturers to hand over their intellectual property to third-party servicers.
That would have significant implications for the end-users of advanced medical equipment—patients.
For starters, it would allow third-party servicers to fabricate replacement parts with no consistent standards for safety or quality. The servicer could just 3D print a reverse-engineered replacement part—or cobble together something with parts from the hardware store—with no oversight.
The original manufacturers of advanced medical equipment, by contrast, must submit to the Food and Drug Administration’s approval process before they can bring their products to market. Third-party servicers would face no similar obligation as they attempt to ape original manufacturers’ intellectual property.
Permitting third parties to repair advanced medical equipment would also frustrate manufacturers’ efforts to monitor their products throughout their lifecycle. When something goes wrong with a device, manufacturers typically notify other customers so they can check for similar issues. Allowing independent servicers to utilize unregulated replacement parts will render this critical monitoring process futile.
And what if one of those third-party replacement parts fails? Who bears responsibility for making things right?
Then there are the cybersecurity risks associated with opening up advanced medical equipment to third-party repairmen. Fixing a cutting-edge device these days may take a software patch rather than a screwdriver. Third parties may not have the expertise needed to implement those software fixes.
As my PRI colleague Dr. Henry Miller has pointed out, third-party servicers are not bound to FDA regulations that require manufacturers to “ensure that device software updates, patches, and more comprehensive repair jobs are done correctly.” Today’s advanced devices frequently connect with one another and to broader computer networks. One device left compromised by a third-party servicer could undermine the security of an entire hospital network.
Finally, loosening intellectual property protections undermines the incentive for manufacturers to invest in improving their products. If an innovator firm knows that its research handiwork could be appropriated by a third-party servicer—or modified in ways that it can’t control or doesn’t approve of—it will devote less time and money to creating better replacement parts, incremental software fixes, and the like.
The result will be stagnation in the market—and fewer advances that improve patients’ lives.
Medical progress depends on strong protections for intellectual property. The Founding Fathers thought that precept important enough to include it in the Constitution. More than two centuries later, Congress mustn’t forget that.