Can we really take the risk out of medical devices?

Below is a response to an editorial board opinion piece published in the New York Times on Sunday, May 4 titled “80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.”

No doubt the loss of any life resulting from a botched surgery or medical treatment is a tragedy. I applaud the NYT for bringing this issue forward but some key points are missing and some misguided impressions that should be corrected. As a person living with paralysis from a spinal cord injury I sustained more than 20 years ago, I’ve had a front row-seat in the U.S. health system and the world of medical device development. And as a user (please don’t say “patient”) of an implanted neuroprosthetic system, I saw first-hand the benefits of allowing access to experimental new medical devices.

The process of bringing a technical discovery to clinical care is grueling. On average a new implanted medical device can take 10 to 12 years and about $1.3 billion to bring to market. Those dollars and durations vary depending on the nature of the medical device. Shame on the NYT for not pointing that out. Instead, your editorial lumped all medical devices into one big pot. There is a drastic difference between a Class I and a Class III medical device. Testing standards for devices surgically implanted into the body, and for minimally invasive and external applications are not the same.

The editorial also aptly pointed out that 35 percent of the FDA is funding by industry fees. No one is denying that. Let’s be clear on who sets these. It is our elected representatives on Capitol Hill — not the regulators — who establish the rules that the agency lives by. It is the lawmakers who cut budgets in a political environment that touts that regulation is the root of all evil. When, in this case, proper regulation saves lives.

Like it or not, we have a capitalist economy running our healthcare system. We misunderstand our system if we think that consumers (patients) are the main customer. The main customer of a manufacturer of implanted medical devices is not the end user and not even the clinician. It is the hospital systems and surgical centers. Have we forgotten the true mission of medical care?

The main responsibility of the FDA is to protect us by ensuring the “safety, efficacy and security of human and veterinary drugs, biological products and medical devices,” according to the stated mission. The notion of safety versus efficacy is a gray area. Understanding both really cannot occur until we move discoveries into humans. A person facing life with paralysis has a very different risk/benefit assessment compared to a person who has a mild skin rash. It even varies among the cohort living with similar conditions. In a recent survey of people living with SCI, nearly half said they would sacrifice safety over effectiveness while half would prefer the opposite. Many people are willing to undergo a treatment that is high risk. What is more important is informed consent.

The idea that the FDA is not responding is simply not true. The Center for Devices and Radiological Health is currently going through a complete reorganization to address these review and surveillance issues. The agency treads cautiously knowing that lives are at stake. Lives are at stake for clearing devices that may malfunction in the future but lives are also at stake if we do nothing. The FDA is now building programs around consumer (patient) input. The time is now to have the voice of the end-user heard.

We as a society need to stop sending mixed messages to the FDA. We want technical innovation now but we also want all the risk stripped out of it too. The best of both worlds does not exist. How many promising therapies are buried in the valley of death for not meeting the efficacious end points? Northstar neuroscience for a treatment for depression, Cyberkinetics for a brain computer interface, or Andara with a treatment for paralysis.

At some point we need to take responsibility for our own health. It is the job of those in the healthcare system (including payers and regulators) to help consumers make informed decisions about their own health and not to stand in the way. The choice may be to do nothing but the choice may be to take a risk.

People living with life-altering conditions are willing to take the extra risk. At the 2018 Society of Neuroscience meeting, there was a panel discussion with people using experimental neurotechnologies. The participants shared their experiences and decision-making processes in deciding to participate in a clinical trial. One panelist, an upper extremity amputee, expressed his frustration with burdensome regulation to an FDA representative who was in attendance. “We had this wonderful Luke Skywalker arm but I wasn’t allowed to put it on,” he said.

Let’s stop pointing figures and be part of the solution.