As a cardiologist, I’ve seen firsthand the life-saving promise that breakthrough medical devices can offer. When a patient has a major heart attack because a coronary artery shuts off, placing a stent can help save the patient’s life by opening the blockage. First approved by the Food and Drug Administration (FDA) in 1993, stents were a breakthrough for innumerable heart attack patients.

“Breakthrough”, as it happens, is a key descriptor when it comes to drugs and medical devices. Disquietingly, legislation now being considered by the Senate - and pushed hard by device manufacturers - as one of several medical innovation bills dilutes this designation. If the “Advancing Breakthrough Devices for Patients Act of 2016” becomes law, patients will be less likely to benefit from true breakthroughs because the bill poses merely a flimsy hurdle to merit calling devices “breakthroughs,” and it significantly undermines FDA approval standards.


This bill loosely defines breakthroughs as devices that offer “significant advantages over existing approved or cleared alternatives” or are in “the best interest of patients.” These vague requirements lack any meaningful benchmarks, and they will be left open to interpretation on a case-by-case basis. An FDA breakthrough pathway already exists for drugs, and the FDA grants over one-third of requests for breakthrough designations – suggesting an easy threshold. And with devices, less than half of the highest risk devices are even tested against existing alternatives. If a device is not compared to alternatives, how can we know that it offers enough meaningful advantages to be called a breakthrough?

Once a device is designated as a breakthrough, the legislation erodes that device’s standards by endorsing clinical trials to be “as efficient and flexible as practicable, when scientifically appropriate.” Efficient is not defined, but efficient trials generally mean those completed quickly with the least investment. This also means the trials are smaller and less likely to include a diverse array of patients—mainly women and racial and ethnic minorities, groups who are already significantly underrepresented in clinical trials because it often takes more effort to enroll them. Although more women die of cardiovascular disease than men, women comprise just 1/3 of patients in high-risk cardiovascular device studies. The FDA’s Commissioner, Dr. Robert Califf, has called 2016 “The Year of Diversity in Clinical Trials.” Contrary to this proclamation, if this bill becomes law, breakthrough devices could be approved on “efficient” trials that tend to exclude women and racial minorities - hampering our understanding of how devices help (or don’t help) the diversity of patients who will receive them.

Efficient trials, as endorsed in the bill, are also likely to be shorter. Unfortunately, device studies are already too short. For example, despite going through the FDA’s most rigorous pathway, the permanently implanted Essure device for female sterilization was approved largely on one-year data in women. In the months and years after approval, hundreds of women began having unintended pregnancies – exactly what the device is meant to prevent. Because of the pregnancies and other complications, in March the FDA ordered a new, longer study of the device. Notice that it took 14 years after initial FDA approval of Essure. 

Setting the legislation’s weaknesses aside, the term breakthrough is deceptively alluring to both patients and physicians. A recent study showed that 92% of patients preferred a drug labeled as a breakthrough over the same drug not labeled as such but described as meeting the breakthrough criteria. In another study, over half of board-certified physicians incorrectly believed that strong evidence is needed to earn the breakthrough designation. Further, over three-fourths of physicians thought a breakthrough designation meant a drug was more effective than currently available treatments – even though this need not be the case.

To be sure, patients must have timely access to new devices that help them live better and longer lives. All devices require FDA approval, but clinical trials and the approval process can be lengthy and costly. Device company representatives have testified in Congress and funded reports claiming that the FDA is too slow and, thus, the current bill authorizing efficient trials has emerged.

Cutting corners isn’t the answer. Rather than speeding device approval by permitting softer evidence of efficacy and risk, Congress should provide more funding so that the FDA’s staff can engage with companies to create meaningful studies that inform our understanding of how devices work in patients. 

At this exciting time in medical innovation, safety and efficacy must remain paramount. True breakthroughs will emerge only by holding firm to trustworthy evidence.


Sanket S. Dhruva, MD, is a cardiologist at Yale University.