The FDA’s new Action Plan focuses on safely reducing regulations — which creates opportunities for patients, medical providers, and marketers in the process.
In a new Action Plan released on April 17, 2018, FDA Commissioner Scott Gottlieb affirmed the organization’s commitment to balancing safety and innovation. The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health outlines how the agency intends to encourage technological advancement while simultaneously improving safety, detecting security risks earlier, and keeping doctors and patients better informed.
As the Action Plan states, “Innovation and safety are not polar opposites but rather two sides of the same coin.” Gottlieb’s efforts to improve patient care and reduce regulations will likely have a widespread impact on the medical device industry, especially when it comes to bringing cutting-edge technology to the market sooner rather than later.
Protecting Patients, Promoting Public Health
The FDA’s Center for Devices and Radiological Health (CDRH), led by Dr. Jeffrey Shuren, has developed a plan that focuses on five key areas:
- Establish a robust medical device patient safety net in the U.S.;
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations;
- Spur innovation towards safer medical devices;
- Advance medical device cybersecurity; and
- Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.
In a recent press release, Gottlieb highlighted particular areas this plan will address. He explained, “Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings.”
To encourage innovation towards safer technology, the FDA issued a new draft guidance that presents a more modern pathway to expedite the process of demonstrating safety and efficiency for moderate risk devices.
The FDA is also committed to ensuring that these new technologies maintain high safety standards once they have reached the market. The agency is working to establish the National Evaluation System for Health Technology (NEST) to gather and evaluate data on medical devices. In particular, Gottlieb emphasized the importance of improving the quality of Real World Evidence (RWE) generation for technologies that impact women’s health.
In the press release, Gottlieb addressed the additional topic of cybersecurity, which has become a highly-discussed issue in the medical community. He stated that the FDA is working to “further minimize medical device security vulnerabilities and exploits.” Strategies include providing software information to patients that could help them better manage their devices.
Support For New Technology
The Medical Device Safety Action Plan is yet another example of the FDA’s intention to pave the way for new technology without compromising safety. These developments have impacted areas like machine learning diagnostic tools, wearables, and digital health technology, among others.
Under Gottlieb’s leadership, the FDA has increased cooperation with medical providers and developers to streamline the approval process for new technology. With benefits for both medical device companies and the patients who use their products, these reduced regulations indicate the FDA’s commitment to innovation and progress.
For medical marketers, the industry-wide trend toward patient centricity presents new opportunities to put consumers in the driver’s seat of their own care. With the proliferation of increasingly sophisticated wearable devices, informed patients can participate with physicians in the decisions that will determine how their conditions are monitored, what data is collected, and what treatments are planned.
While wearables — no matter how advanced — will never replace trained professionals, medical marketers can do their part to educate patients on the devices that are positioned to reshape the healthcare market going forward.