Recent news coverage of the medical technology industry has irresponsibly hyped up claims that medical devices are under-regulated and as a result pose an overwhelming danger to patients. This is false — and the reality is, misleading stories like these are what really put patients at risk.
These incomplete and misleading stories obscure the overwhelmingly positive impact medical innovation has on billions of patients worldwide and seed unwarranted and dangerous doubt, stoking irresponsible fear in patients.
Across the globe, medtech researchers are pioneering new devices and technologies for one reason alone — to improve the lives of patients. And that is the real story of the medical technology that saves and improves millions of lives every day.
It’s hard to find a better story to illustrate the life-changing power of these innovations than the story of Herb Thau. Medical technology saved Thau’s life — twice. In 2001, he survived a heart attack because surgeons conducted open-heart surgery to implant a porcine mitral valve in his heart.
Fast forward to age 84, Thau experienced severe shortness of breath and fatigue as that valve reached the natural end of its useful life. However, a second open-heart surgery to replace it could have led to serious infection or blood clotting. There was a one-in-six chance the operation could kill him.
Fortunately, a new minimally invasive medtech procedure had recently been approved by the Food and Drug Administration. Thau’s surgeons replaced the valve using a catheter, allowing him to return home from the hospital in less than 24 hours.
Thau’s story is not unique. Millions of patients have seen more birthdays, returned to work and enjoyed more time with loved ones because they had access to the latest medical technology.
The medtech industry and the FDA are committed to a regulatory system that balances the need for rapid innovation with the highest patient safety standards, so lifesaving innovations are there when it matters for patients like Thau.
Medical technology is constantly evolving so that patients such as Thau have better outcomes, but innovative devices and procedures are only helpful if physicians and patients can use them.
Medical technologies have rapid innovation cycles; companies replace a typical medical device with an improved version every 18-24 months. For Thau and patients like him, this rapid improvement — and a regulatory system that promotes safety while ensuring timely patient access — may mean the difference between life and death.
The individual benefits of medical technology to patients like Thau are clear — fewer days in the hospital, more time with family, and longer, healthier lives. However, the rapid innovation of medical technology companies also has had a significant impact on overall health in the United States.
Medical innovation has added five years to U.S. life expectancy and reduced disability rates by 25 percent. With major health crises looming — like rapidly growing opioid addiction and an aging population grappling with chronic disease — medical technology has an important role to play, but only if devices can make it to market safely and quickly so that physicians and patients can use them.
Before medical technology can save a life like Thau’s, it must go through extensive clinical and non-clinical studies involving bench testing, animal studies, biocompatibility and usability studies, etc. And safety assurances don’t stop when a device hits the market. Medical technology companies work closely with the FDA to ensure devices are manufactured consistently to meet predetermined safety specifications. Companies are also required to track and report device-related issues, such as serious injuries and deaths, and establish procedures for recalling or correcting devices that pose a risk to public health.
The medical technology industry has always been ahead of the curve in medical innovation. The industry continues to lead the way for the patients like Thau whose lives depend on it. The medtech industry and the FDA must continue to work together to implement the highest standards in patient safety without delaying the patient outcomes Americans deserve.
Scott Whitaker is the CEO of AdvaMed.
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