▎WuXi AppTec Content Team Editor
In the first half of this year, 11 types of devices that have been granted “Breakthrough Medical Device Designation” issued by the US FDA were approved for marketing, bringing the total number of listed medical devices to 54. Less than five years ago, that number was just 2.
If we draw a graph, we can see that the number of “breakthrough medical devices” approved by the FDA has skyrocketed in recent years. What is the trend behind the nearly 30-fold increase?
Image source: Reference 
Let’s go back to 2016 first. Under the influence of the 21st Century Cures Act, the “Breakthrough Medical Device Program” came into being, aiming to simulate “breakthrough therapy designation” in drug development. The principle is to strike the right balance — one end of the scale is the FDA’s stringent requirements for safety and efficacy, and the other is the long road to review of innovative treatments and medical devices.
Image source: 123RF
As envisaged, the FDA expects these breakthrough devices to be more effective. In addition, they must meet at least one condition: they are extremely innovative, irreplaceable, offer further improvements over existing treatments, or best meet the needs of patients.
Once this designation is obtained, developers can get faster feedback from FDA reviewers. Sometimes, they can also discuss with reviewers how to design faster and more flexible clinical trials for the benefit of patients. In addition, the program ensures that certified devices receive priority review.
Some regulatory experts point out that some truly innovative medical devices do not have an established regulatory pathway to follow. Programs such as Breakthrough Medical Device Designation” allow FDA to communicate with industry and promote the development of innovative treatments.
One such example is an artificial intelligence tool developed by Paige Corporation to diagnose prostate cancer. In 2019, the tool was labelled “breakthrough”. In September 2021, it officially obtained the market authorization to be listed for the benefit of patients. Although the process still took a few years, Paige’s vice president of oversight noted that without this designation, the expected time could be 2-3 times longer.
Image source: 123RF
Early on, this project didn’t get a lot of corporate attention. As of September 2018, the FDA had received only 100 applications. Encouraged by a series of policies in recent years, this number has soared. In 2019, as many as 250 applications were submitted; in 2020, the number is closer to 400. The increase in these numbers also shows that more innovative medical devices are pouring into the track, which is expected to benefit patients.
But it’s still a relatively young field after all. Well-known industry media STAT recently released an in-depth report analyzing these medical devices. While the number of applications has increased significantly, the overall quality has declined, the report noted. In 2018, about 70% of the applications received breakthrough designation. In 2020, that number has plummeted to 40%.
In addition, some researchers have pointed out that it is still open to question whether these breakthrough-designated devices actually improve clinical outcomes for patients. From the perspective of the “Breakthrough Medical Device Designation” project, many devices are still in the early stages of development when they receive the title, and the evidence obtained is relatively limited. To this end, some researchers point out that both physicians and patients need to recognize the limitations of the designation.
Overall, the FDA is incorporating more and more devices into the program, and the pace of new breakthrough designation authorizations is unlikely to slow in the future. At a time when emerging technologies such as artificial intelligence are gradually maturing, it is believed that more innovative devices will come out. In this trend of the times, we hope that more breakthrough devices can prove their potential in clinical practice and benefit patients as soon as possible.
WuXi AppTec provides integrated, end-to-end new drug R&D and production services for the global biopharmaceutical industry, covering chemical drug R&D and production, biological research, preclinical testing and clinical trials R&D, cell and gene therapy R&D, testing and production. If you have relevant business needs, please click the picture below to fill in the specific information.