Helping Medical Device Innovation
While advances in the scientific process, imaging, and other factors have played a major role in the advancement of medicine, medical devices have been one of the primary linchpins driving advances that extend and improve peoples’ lives. Ensuring these devices are safe and effective, however, is a critical task: Poor regulation can lead to a market marred by ineffective and, even worse, dangerous products. In the United States, the FDA is at the forefront of this task.
Ensuring medical devices are safe and effective is the FDA’s mandate.
The FDA’s role, however, is not static, and challenges spawned by the rapid rate of innovation have led to changes in how devices, both new and existing, are tested to ensure they meet high standards. Over the years, devices have become more complex as new types of technology become key drivers in medical device development. In particular, the rise of digital components, ranging from simple sensors to complex artificial intelligence, have forced new types of testing. Furthermore, ensuring devices can come to the market in a reasonable time frame lets patients gain access to effective new treatments in a timely manner while also providing incentives for companies to invest in innovation.
The Medical Device Development Tools Program
When creating new medical devices, developers typically rely on “voluntary consensus standards.” These standards, officially recognized by the FDA, often take years to develop as new types of products enter the market. For medical device developers, they provide a clear roadmap to gaining approval, and these standards generally ensure devices are both safe and effective. However, they also pose a challenge to those creating new types of devices, as the years it takes for these standards to coalesce mean that device developers have the bare the burden of proving their products should enter the market without a clear development path. As a result, device developers often take on a significant financial risk, which can stifle innovation, and people who could benefit from such devices must wait.
To provide clarity to device manufacturers and help form voluntary consensus standards, the FDA administers the Medical Device Development Tools (MDDT) program. These tools, which include questionnaires, rubrics, and analytical software, among more traditional medical testing tools, are officially recognized by the FDA as providing useful, scientifically-plausible results. Each of these tools fits a specific use case, and they cover a wide range of aspects of medical devices people often don’t consider. As devices more frequently communicate over the open internet, for example, cybersecurity concerns become acute, and device developers might struggle to determine how to provide robust protection against attacks. Tools in the MDDT program can offer helpful guidance, giving developers a means of implementing necessary privacy and malware protection.
It’s worth noting that the FDA doesn’t consider the MDDT to be a replacement of voluntary consensus standards. Instead, it serves as a complement, helping to fill in gaps where voluntary consensus standards lack clarity.
The Catalog of Regulatory Science Tools
Due to the rapid pace of innovation and growing complexity, device developers often encounter situations where neither voluntary consensus standards nor the MDDT can be used. In such scenarios, device developers bear the burden of having to create their own ad-hoc testing methods to meet FDA standards, a process that can sometimes be even more daunting than creating a safe and effective product to begin with. When relying on ad-hoc testing, developers must be able to demonstrate that their testing, along with the device itself, is based on a sound scientific foundation. Ad-hoc testing places a significant burden on the FDA as well, as it takes a significant amount of work to determine if a testing method meets the standards of both statues and regulations.
The Catalog of Regulatory Science Tools (CRST) aims to let device developers replace ad-hoc testing with methodologies that have the support, and understanding, of the FDA. These tools provide benefits for device developers of all sizes, but they are particularly beneficial for smaller companies that lack the capacity to design their own testing methodologies. More established developers benefit from knowing that they are at less risk of a devices failing to gain approval due to inadequate testing procedures, and the FDA’s burden is reduced as regulators can rely on known tools instead of having to evaluate ad-hoc methodologies.
Tools in the CRST can also provide guidance. They typically come with instructions for how they should be used. Furthermore, references to peer-reviewed sources help device developers understand the rationale for their use and data demonstrating effectiveness. As a tool in the CRST becomes more established and is better understood, it might eventually become an MDDT if it proves to be useful.
The FDA Advances Medical Device Industry: The Photoacoustic Imaging Example
One example the FDA provides to demonstrate its engagement and support of the medical device industry is photoacoustic imaging (PAI). This new technology combines two well-known technologies, laser and ultrasound, to allow for the noninvasive mapping of blood vessels and blood oxygen saturation. The novelty of PAI, however, means that established testing standards have not yet been developed, making it difficult for device developers to bring products to the market.
Although the FDA is primarily considered a regulatory agency, they also develop innovations that can help spur development in the medical field. An interdisciplinary team at the FDA sought to create useful testing tools for PAI and created tools called “phantoms,” designed to replicate human tissue in a manner that allows device developers to test their products without having to rely on human or animal subjects, an expensive and complex process. The FDA has also taken steps to ensure phantoms are available on the market, allowing device developers to access them.
The FDA is often thought of as a reactive entity that primarily decides whether to approve products or not. However, the FDA also aims to provide the tools needed for helpful devices to reach the market and serve patients while reducing risk for those who develop them. Thanks to the MDDT, the CRST, and other initiatives, the FDA doesn’t just prevent unsafe and ineffective products from reaching the market; they also aid in innovation and help patients and medical providers access potentially life-changing devices.