From the Expert: Working with the FDA
As director of regulatory and quality assurance for medical device startup Francis Medical in Minneapolis, Joel Phillips worked closely with the U.S. Food and Drug Administration for years. The company is developing a novel technology that uses water vapor to treat prostate cancer. Known as Vanquish, the device hasn’t gained full approval from the FDA yet, but it took a major step forward in early August, when regulators gave it “breakthrough device designation.” That means the FDA will work with the company to help fast-track development and approval. Phillips offers a few tips on getting through the regulatory approval process.
1. Safety first. The FDA has a mandate to protect public health. Establish a good safety profile for the device and communicate this to the FDA. Remove safety from the list of FDA concerns as soon as possible.
2. Focus on effectiveness. Understand and clearly communicate to the FDA how the technology will help patients/users. Share the technology with the agency, ask questions, and listen to FDA feedback. Share the intended use of the device and the target patient population.
3. Data wins the day. Establish solid clinical evidence and clear clinical benefit. Make sure the FDA understands how patients will feel, function, survive, and, ideally, thrive when your device is on the market.
4. Remember: Human beings staff the FDA. Know where your device fits into the agency’s organization. The FDA works on mandated, set timelines—not yours.
