For Entrepreneurs8/14/17

What you need to know about FDA’s game-changing Digital Health Innovation Action Plan

Written by Bill Evans

Managing Director

We noted in our midyear funding report that we’d be keeping a close eye on the FDA’s plan to set more definitive regulatory guidelines for digital health in the coming months. It turns out we didn’t have to wait too long—on July 27th, the FDA announced the Digital Health Innovation Action Plan, which includes the launch of the much-talked about Software Precertification Pilot Program (PreCert). In a webinar on August 1st, the agency introduced the action plan and discussed the new pilot program. Didn’t make it for the webinar? No worries—we hashed out the important details for you.

You have until September 1st, 2017 to volunteer to participate in the FDA’s precertification pilot—get in on the action here.

Breaking down the Digital Health Innovation Action Plan

In order to clarify and streamline the process of bringing digital health innovation to market, the FDA’s Digital Health Innovation Action Plan seeks to “develop a precertification program that could replace the need for a premarket submission in some cases and allow for decreased submission content and/or faster review of marketing applications for software products in other cases.”

There are three parts to the FDA action plan:

  • Issuing new guidance in accordance with the 21st Century Cures Act
  • Reimagining digital health product oversight (starting with their precertification pilot)
  • Growing the FDA’s digital health expertise (hiring!)

What’s wrong with the way it is?

Though the FDA has worked in recent years to clarify boundaries between low-risk software as a medical device and higher risk devices, today’s regulatory processes often presuppose the existence of a physical device with a tightly-defined intended use, which is established prior to device implementation. Traditional devices are tested through a series of clinical trials and both validated and verified to operate as intended. At the end of this process, the device needs to deliver the clinical results that were intended and planned before design and implementation of the device was initiated. Put simply, current processes often run counter to iterative, market-driven design and development practices.

This is the most waterfall of all development processes. Traditionally, within medical device manufacturers, this process is run in a sequential manner. It’s designed to enable tight control and heavy documentation at each step with the intention of eliminating risk of error or deviation from an agreed approval or study paradigm. Internal controls on this process often mean there’s no easy way for product development (or R&D) teams to iterate a product once the initial intended use and design are “signed off” by the regulatory and quality leaders.

Lions and tigers and bears: IEC 62304, ISO 13485, and ISO 14971?

At the core of the medical device software development process lies a set of widely-adopted standards that define the software development lifecycle process, the quality system processes, and risk management in the development of medical devices. The medical device and medical software companies we’ve spoken with in the past have voiced concerns about how to marry these standards with modern, agile software development practices that have the potential to speed innovation of new solutions and to accelerate the rate at which improvements in quality and reliability are developed for existing medical software.

During the August 1st call we posed the question to the moderators: Should companies currently using these standards to govern the development of their SaMD (Software as a Medical Device) look to participate in this pilot and work with the FDA? Or is the FDA primarily interested in companies who are already believed or known to fall outside these standards? The answer: Yes to both!

21st Century Cures: Healthcare policy we (already) agreed on

At the end of 2016, the 21st Century Cures Act passed with overwhelming majorities in both the House and Senate. Weighing in at over one thousand pages, it’s longer than the better-known Affordable Care Act. The Cures Act goes into greater depth than we’ll cover here.

Among other things, the Cures Act requires the FDA to implement a number of policy changes that affect digital health. By the end of 2017, the FDA will provide draft guidance with interpretations of how the Cures Act will be implemented, especially in regards to several digital health-focused areas:

  • Mobile medical applications
  • Medical device data systems, used for the electronic transfer, storage, display, or conversion of medical device data
  • Medical image storage devices, used to store or retrieve medical images electronically
  • Medical image communications devices, used to transfer medical image data electronically between medical devices
  • Low-risk general wellness products
  • Laboratory workflow

A journey, not a destination

When we looked back over recent digital health-oriented guidance from the FDA, it became clear that the Precert Program Pilot is but one part of a journey that the FDA embarked on more than four years ago to streamline the path toward regulation. Progressively maturing guidance provided on mobile medical apps, cybersecurity, and medical image and data transport and display all preceded this program.

We’re excited to see these developments from the agency—and entrepreneurs seem to share our sentiments. In our recent poll, 70% of startups indicated interest in obtaining precertification from the FDA. The FDA is quite open about its intention to learn from this pilot program—and to ultimately develop a learning regulatory model that is capable of adapting to emerging needs and changing technologies. Their focus is a strong indicator of the increasingly rapid maturation of technology-based healthcare innovation.

How can you get involved?

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