Health tech giants like Apple Inc. and Samsung Electronics Co. with an eye towards the future of smart medical devices are making inroads with federal officials exploring ways to regulate computer coding.
While volunteers in the Food and Drug Administration’s pre-certification pilot program won’t necessarily see their products hit the market faster, the experience could give them the inside track as the agency develops new approval methods for software-based medical devices.
Initial pilot participants said advancing digital health innovation is motivation enough, especially since the market for “smart” medical devices is large and expected to grow.
“This program aims to evaluate companies, not products,” Howard Look, president and CEO of Tidepool, a non-profit diabetes data hub that participated in the pilot, said. “Provided companies can meet certain excellence appraisals, that would provide a more streamlined path to getting that company’s products reviewed. Those excellence appraisals are what the pilot participants are working with the FDA to develop.”
The software these companies are developing could be used in treating, diagnosing, or informing a doctor about a patient’s condition without being attached to or controlled by a regulated hardware device. So, the code that classifies a patient’s heart activity as normal, for example, should be subject to the same FDA review as low-to-moderate risk medical devices like some hearing aids, the agency said.
The pilot, which was launched in 2017, initially had nine digital health-care power players who helped round out the first version of the Pre-Cert program—Apple Inc., Samsung Electronics Co., Tidepool Inc., FitBit Inc., Roche Diagnostics, Johnson & Johnson, Pear Therapeutics, Phosphorus, and Alphabet Inc.'s Verily Life Sciences.
Now, the FDA wants to add more volunteers to the program, which is intended to develop a speedy review process for the growing wave of smart medical devices.
“The goal of adding test cases is to find the additional appropriate test cases that will allow the FDA to continue to test our proposed pathway during the Test Plan,” Stephanie Caccomo, an FDA spokeswoman, told Bloomberg Law.
Participation Paying Dividends
Companies such as FitBit are already using the pre-certification pilot to help develop their own tools.
“One way to advance that goal is through strong, collaborative partnership with regulatory agencies such as the FDA, which is working to develop a new framework for digital platforms and new medical devices,” a FitBit spokesperson said.
FitBit plans to collect more clinical data to test and develop tools to detect atrial fibrillation and sleep apnea, so it will work with the FDA to choose an approval route best suited for those products.
Working with the FDA is an important step in cross-industry collaboration—especially when coming up with safety and efficacy standards for modern software-based medical devices, according to Richard Stewart, head of regulatory affairs at Verily Life Sciences.
The pre-certification process is another way for the FDA to adapt to new technologies and will help the industry innovate, according to Lesley Maloney, the head of U.S. regulatory policy for Roche Diagnostics.
“Development of tailored, risk-based software regulatory frameworks will allow software innovation to keep pace with technology,” Maloney said. “We’ve seen FDA take similar steps in looking for new approaches to speed innovative medical products to the public related to next-generation sequencing (NGS) and direct-to-consumer tests.”
Not All Investments Pay Off
Other businesses looking to sign on to the pilot need to plan head for sudden changes to the program or its abrupt end, according to Suzan Onel, a partner with Kleinfeld Kaplan & Becker LLP who primarily focuses FDA and medical device law.
“The program could die, the program may not help the specific volunteering company, or it might not even be helpful for another five to 10 years,” Onel said. “Those are all uncertainties.”
The pre-certification program could also change as the FDA evaluates the results, which means participating companies may not see real benefits from it, Bradley Merrill Thompson, a member of Epstein Becker Green, said.
“In the future if the program is ultimately adopted, the final version is quite likely to be different from the piloted version,” Thompson said. “So, determinations that FDA makes during the pilot program may well not even carry over to the permanent program.”
Volunteers, time, and effort, however, are necessary for this pilot and future programs for smart medical devices to work, Stephanie Domas, the vice president of research at cybersecurity consulting firm, MedSec LLC, said.
“If medical device makers want the process to be usable and work the best for everyone in the industry, they have to be test guinea pigs and put the work and resources in,” she said.