Since the founding of this country, the United States
Unfortunately, a few members of Congress are proposing to slow this progress by launching an offensive against intellectual property protections. And they are trying to use the COVID-19 pandemic to justify their actions.
What is at issue are the rules governing who can repair advanced medical equipment. Today, companies that develop and manufacture devices like MRI scanners and ventilators are often the only companies that can service them.
It makes some sense. Manufacturers have invested time and money in researching how to build advanced medical devices. To protect this investment, they have obtained patents for many of the components and systems that underpin their products.
Third-party repair companies want to participate in this work. They argue that they should be allowed to repair advanced medical equipment and that the companies that manufacture such equipment should have to help them do it.
Throughout the pandemic, third-party service providers have claimed manufacturers have restricted access to manuals, parts and other materials needed to repair or maintain state-of-the-art medical equipment.
They found a few sympathetic ears in Congress including Senator Ron Wyden, D-Ore., And Rep. Yvette Clarke, DN.Y. Both are the main sponsors of legislation this would essentially require manufacturers to cede their intellectual property to third party service providers.
This would have important implications for the end users of advanced medical equipment, the patients.
For starters, this would allow third-party repairers to manufacture replacement parts without consistent standards of safety or quality. The repairman could just 3D print a reverse engineered spare part or DIY something with parts from the hardware store– unattended.
Original manufacturers of advanced medical equipment, on the other hand, must go through the Food and Drug Administration approval process before they can market their products. Third-party service providers would have no similar obligation when attempting to simulate the intellectual property of original manufacturers.
Allowing third parties to repair advanced medical equipment would also hamper manufacturers’ efforts to monitor their products throughout their lifecycle. When something goes wrong with a device, manufacturers usually let other customers know so they can look for similar issues. Allowing independent repairers to use unregulated spare parts will make this critical monitoring process futile.
What if one of these third-party spare parts breaks down? Who is responsible for doing things right?
Then there are the cybersecurity risks associated with opening up cutting-edge medical equipment to third-party repairers. These days, repairing an advanced device may require a software patch rather than a screwdriver. Third parties may not have the expertise to implement these hotfixes.
Like my colleague PRI Dr Henry Miller pointed out, third-party repairers are not subject to FDA regulations that require manufacturers to “ensure that software updates, patches, and more comprehensive repairs are performed properly.” Today’s advanced devices frequently connect to each other and to larger computer networks. A device left compromised by a third-party service provider could compromise the security of the entire hospital network.
Finally, the relaxation of intellectual property protections undermines the incentive for manufacturers to invest in improving their products. If an innovative company knows that its research work might be appropriated by a third-party service provider or modified in a way that it cannot control or does not approve of, it will spend less time and money on it. creating better spare parts, software fixes, etc.
The result will be market stagnation and less breakthroughs that improve the lives of patients.
Medical progress depends on strong intellectual property protections. The Founding Fathers believed that this precept was important enough to include it in the Constitution. More than two centuries later, Congress must not forget this.