Originally published on Linked In

I grew up in a time when we never threw anything away. We repaired our TVs when they broke and took the vacuum cleaner to the shop to get it fixed. We even owned our cars for decades at a time. That's a different world from today when we change phones every year, replace dishwashers every few years, and find it more cost effective to buy a new TV instead of having it repaired. Frankly, even if we wanted to repair some of the appliances and devices in our homes, the newest shiny models entice us. The word obsolete takes on a whole new meaning in the consumer driven 21st century.

Which is why I was surprised when I heard that there's a big push in several states for legislation called Right to Repair. What is Right to Repair? Simply put, it means that when an equipment breaks down, the consumer of that equipment can have it serviced by someone other than the original manufacturer. That seems reasonable, right? Well, it's not as simple as it sounds. For non-complex equipment like mixers or stereos (does anyone even use stereos anymore?) you may be able to go to the shop down the street to have it fixed, but for complex electronic equipments like some computers and cell phones, you may be hard pressed to find anyone other than the manufacturer who has the parts and the expertise to be able repair it. There are apparently a whole host of reasons why this is the case, including the investment and innovation that goes into making the equipment in the first place.

Most if not all of complex equipments are patent protected making the specification for said equipment proprietary. In order for a third party to be able to access the parts and the means of repair it would require the original manufacturer to hand over proprietary information to that third party. It's hard to imagine anyone doing this for a car like Tesla for example, or an Apple Mac Book Pro. Hence we have the manufacturer's warrantee and authorized service providers. But the fight is apparently raging in 25 states today for the "right" of independent service organizations not associated with the original manufacturer to access proprietary information. And now with COVID, there's a push for expanding this effort to include medical devices.

Apparently during the pandemic and the ventilator shortage, healthcare providers found it difficult to repair ventilators and other hospital equipment for a variety of reasons. For example, healthcare providers were not able to access parts due to shortages, and manufacturer authorized service providers were not able to go on site due to COVID restrictions. So, on August 6th of last year, the Medical Device Repair Act was introduced in the Senate by Ron Wyden and in the House of Representatives by Yvette Clarke of New York, supposedly to remove barriers to repair of health related devices for COVID patients.

Office equipment repair is one thing, and even that seems dubious, but medical devices-- devices that affect life and death-- well that's something completely different. Let's take ventilators for example... ventilators help a patient breathe by assisting the lungs to inhale and exhale air. The SARS-CoV-2 virus (which causes the COVID-19 disease) attacks the respiratory system. When infected, a patient’s ability to breathe is compromised and in severe cases, the patient may require invasive respiratory support. This is provided by a ventilator through a tube that is inserted into the patient’s mouth or nose (and down the windpipe), or via a surgically-made hole in the neck. The principal function of a ventilator is to pump or blow oxygen-rich air into the lungs and assist in the removal of carbon dioxide from the lungs. This seems like a complicated process to me, especially given the function of modulating oxygen vs. carbon dioxide. Hence modern ventilators are highly complex and sophisticated pieces of equipment that require considerable expertise in research, design and manufacturing to make. It is this proprietary information that independent service organizations would like to access.

Now let's assume a third party did have access to the specs of the device and used the information to repair it. First and foremost there is the safety of the patient/consumer to consider. If a device is so complicated that it requires detailed specs to make it, it is highly likely that it was perfected through trial and error and may employ conditions that may not be reproducible by a third party. And on top of that, the device manufacturer is required to go through a rigorous regulatory review to prior to marketing, whereas the third party service providers do not. For such devices, in order to protect the safety of the consumer/patient, manufacturer licensed or authorized service providers would be needed. Is a manual really enough to ensure that the repair is done properly? How many of us have used an instruction manual to put together a simple piece of equipment only to be left with that one last screw or bolt? And now apply that same logic to the use of a manual to repair a complex device like a ventilator?? It doesn't take a rocket scientist to know that an unregulated third party service provider would jeopardize the safety of the patient.

But that's not all. What if that same device causes damage or death of a patient, or fails to function as indicated due to some error in the repair? The negative press around such an event would cause great harm to the reputation of the device manufacturer because the device would be associated with the manufacturer, not the service provider. In this age of social media outrage, a company's reputation would be tarnished before sufficient investigation is done to determine the culpable party. Investors and financial partners may abandon the company and it may take years before the company can recover. How many people would be hurt in the process? All the employees of the company, the service providers who rely on the company and the patients who depend on the products from the company would be affected.

But small device companies would be hurt the worst because many of these companies rely on investment from large device manufacturers and investors to construct their devices. Many novel devices are in the pipeline today spurred on by the financial backing of larger companies. If larger companies are unable to invest in future R&D because of damage done by third party providers, small device innovators will be left with little recourse. And then of course there's the issue of margins. Which investor would want to invest in a company that may be forced to give away its proprietary information?

It seems to me that the Medical Device Repair Act and Right to Repair movement, flies in the face of the importance policymakers to the survival of small businesses. And even more troubling is the legislation's disregard for real safety concerns by its attempt to further loosen any requirement for regulations on independent third parties. The COVID pandemic has brought our society's shortcomings into focus, but it doesn't follow that every one of these shortcomings needs a legislative solution. Trying to fix something by breaking something else doesn't seem like a good idea. There has to be a better way and I'm sure everyone can put there heads together to come up with it.