FDA Fosters Digital Health Innovation With New Software Precertification Pilot Program

Macadamian Technologies | December 8, 2017 | 5 Min Read

This past July, the FDA announced their Software Precertification Pilot Program aimed at digital health solution creators in order to increase product speed to market. Our Director of IoT discusses the implications of this new program.

This past July, the FDA announced their Software Precertification Pilot Program aimed at digital health solution creators in order to increase product speed to market. This would allow software companies developing innovative products that help the American people to fast-track the FDA’s current certification process. The agency is taking note of the opportunity that digital health technology has to help patients become more involved and engaged when it comes to their health, and to manage chronic conditions. With the launch of the Pre-Cert program, the FDA acknowledges that their current processes don’t stack up to the current pace of innovation in the market.

For example, when a need or design flaw is recognized, mobile applications can easily be updated to implement improvements. However, this is not the case with most medical devices, and the current certification process is prohibitive to key iterations and updates occurring in a timely fashion.

“Digital health technology has become a new health care revolution that empowers consumers to make better-informed decisions about their health. At the FDA, we recognize this revolution and are reimagining our oversight of digital health technology to help provide patients with timely access to high-quality, safe, and effective digital health products.” – FDA

“The goals of this program are to:

  • enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;
  • ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and
  • be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.”

In an interview for Healthcare Global, our Director of IoT – Timon LeDain – gives his thoughts on the Pre-Cert program:

How will the FDA’s recently announced Software Precertification Pilot Program for digital health software encourage innovation for companies like Macadamian?

Traditionally, the FDA has generally ignored any potential impacts from software, as the software presented limited patient risk. Traditionally, software solutions took a reading from an FDA approved medical device and displayed or graphed it within a desktop or mobile application. Even complex telehealth solutions were essentially a vehicle to deliver a vital sign measurement taken at home to a clinician at a distance.

With the advent of more complex solutions, like our My Diabetes Coach that leverages machine learning and artificial intelligence, the software and the “medical device” are merging. As a result, the FDA is taking notice. They do not want to stifle innovation in this space with undue regulatory oversight, so have implemented the pre-certification pilot program to balance risk management with the agile development process. Software has shown itself to be capable of looking at a medical image and providing a diagnosis that matches or exceeds what experts could achieve.

What will be the impact on business opportunities for medical tech developers?

This is a great initiative for software development companies looking to bring innovative connected healthcare solutions to market that would fall under the regulatory purview of the FDA. If you meet the requirements to be pre-certified by demonstrating that you are currently following best practices from a quality management, validation, and verification perspective, then you can benefit from this initiative. With less regulatory oversight, smaller and more nimble companies can compete in the same space as larger better-funded companies to deliver solutions that have a meaningful impact on patient care.

How do you see the end user benefitting?

New medical devices can take years to bring to market due to the regulatory requirements affecting their manufacture, marketing, and sale. This cost is transferred to the purchaser which increases the cost of these devices significantly. By reducing the regulatory burden for software-based solutions, new inventions can be brought to market much faster which can improve patient outcomes and drive down the cost of delivering healthcare.

What are your concerns?

On the whole, I think this is a great initiative and the pros outweigh the cons. It demonstrates that the FDA is aware of their impact on healthcare innovation and are looking at “out of the box” approaches to address this. Some might argue that the pendulum could swing too far towards the deregulated space with potential adverse health events as a result. I don’t see this outweighing the benefits though. There is already proof that unregulated products like the Apple Watch and Owlet Care’s baby monitoring solution have saved countless lives by providing consumers with information they previously never had access to, which they have acted upon to save their own lives or someone they care about.

Making Strides in the Right Direction

This initiative from the FDA shows that they are taking the digital health revolution seriously. By implementing the Pre-Cert program, the FDA is demonstrating they understand the impact that lengthy delays and regulatory bureaucracy can have on getting innovative products to market, and above all, can have on the health of Americans.

Nine companies, including Apple and Fitbit, have been selected from a pool of 100 applicants as pilot participants for the initial model of the program, and are meant to represent the current spectrum of digital health offerings. The FDA is encouraging engagement and feedback from all stakeholders in the program, including those who had applied.

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