Fenwick’s Sixth Annual Digital Health Investor Summit started on an upbeat note with Rock Health’s Megan Zweig sharing the venture fund’s mid-year funding report. After the uncertainty brought by the 2016 presidential election and the political drama surrounding the future of the Affordable Care Act, it would not seem surprising to see investors take

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the Center for Devices & Radiological Health released an action plan about its Digital Health Program and posted a notice for comment for a Software Pre-Certification Pilot Program.

The pilot program is a first step in the FDA’s reimagined digital health product oversight approach. What makes it stand out from the FDA’s prior regulatory approach is its aim "to develop a new approach toward regulating this technology – by looking first at the software developer or digital health technology developer, not the product."

Under its firm- and developer-based approach, the CDRH could "pre-certify" eligible digital health developers who "demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review."

In his blog post, the FDA’s Scott Gottlieb announced that in August companies can submit a statement of interest that includes the qualities listed above and request participation in the pilot to FDAPre-CertPilot@fda.hhs.gov. The FDA’s Digital Health Team will evaluate submissions and select companies that reflect the broad range of software developers later in the month. “A critical component is that we will include small and large companies, traditional and non-traditional medtech companies, and products that range in risk,” Gottlieb said in his post. (Read more about how the CDRH is recruiting participants to the pilot program.)


Continue Reading

Last September, we noted that payers and providers were expected to become increasingly active digital health strategic investors given their challenges to improve margins and outcomes.

While there were only three investments by payer/providers in the second half of 2016, we saw a notable uptick in investment activity in the first quarter of 2017, when

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San Francisco has evolved from a J.P. Morgan private meeting for healthcare investors to a week

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation.

Until recently, some investors shied away from companies targeting the regulated space out of concern that the regulatory landscape created too much risk. However, thanks in part to new guidance from the FDA regarding the

Fenwick’s fifth annual Digital Health Investor Summit brought together investors who are active in the digital health space to discuss the evolving digital health sector and their investment outlook for the year ahead.

Here are my three key takeaways from this year’s Summit:

Playing in the Regulated Space

The consensus is it’s time to stop

At our Digital Health Summit earlier this year, Malay Gandhi, Managing Director at Rock Health, noted that once digital health venture investing accounts for 10% of all venture investment, we should start breaking out investment by industry subsectors.

That made us think it might be interesting to look at our monthly download of digital health