Into 2019: Digital Leads US Policy Innovations, But Public Medtech Scrutiny Grows

Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact. 

Artificial intelligence (AI) technology moved squarely into the clinic in 2018 with multiple US Food and Drug Administration approvals and clearances throughout the year. In addition, the agency approved its first high-profile consumer mobile apps in 2018, with the Apple Watch ECG apps and another company's contraceptive app.

On top of these product-by-product advances, the FDA moved toward a launch of an experimental "pre-certification" approach to digital health oversight, and issued additional guidances and policies impacting the development of clinical-grade health software. (Also see "FDA Readies Digital Health Pre-Cert Program For Lift Off" - Medtech Insight, 26 Apr, 2018.)

This is all to say that digital tech was central to FDA commissioner Scott Gottlieb's overall pro-innovation focus. But it did not end with digital. The agency launched several 510(k) pilot programs to try to further streamline that path by which a majority of new and updated devices reach the US market, and it continued to progress policies to address advanced diagnostics, including next-generation sequencing and direct-to-consumer (DTC) genetic testing.

Meanwhile, the Breakthrough Device Program, originally envisioned to apply to a handful of devices per year, has exploded, with almost 100 investigation devices chosen to participate in the accelerated development pathway since 2015, and most industry feedback so far is positive. (Also see "Jeff Shuren Talks Breakthrough Bonanza, TPLC And Innovating Safety" - Medtech Insight, 26 Sep, 2018.)

Impending Progress With Medicare

But industry clearly does not love everything coming out of FDA. There have been some questions whether the agency is over-stepping its authority in some areas, including the digital health pre-cert program, and whether it is providing favorable treatment to big tech companies, like Apple, compared to traditional device firms. (Also see "FDA's Speedy Apple Watch De Novos Raise Questions For Industry" - Medtech Insight, 24 Sep, 2018.)

For most of 2018, the sense was that the agency continued to become a more welcoming place to go to get innovative products to market. That has been a trend for the past few years. Meanwhile, FDA's sister agency, the Centers for Medicare and Medicaid Services (CMS), has been the source of greater sector anxieties. Companies might be enjoying quicker FDA market approvals, but they often face an unclear path to the coverage and payment necessary to support market adoption. Nadim Yared, CEO of CVRx and outgoing chair of AdvaMed, calls this period the "valley of death" for industry.

But in US reimbursement policy in 2018, there were positive signs for industry, if not clear-cut advancements. White House and CMS officials made it clear in multiple public statements throughout the year that the administration is prioritizing the reimbursement process for innovative devices and diagnostics.
(Also see "'The Sky's The Limit' When It Comes To Device Reimbursement Reforms, White House Official Says" - Medtech Insight, 20 Sep, 2018.) 

That promise was formalized somewhat when CMS put a break-through device reimbursement pathway on its latest regulatory agenda, with a proposal expected to emerge by March 2019. The plan, supported by US industry, would establish automatic, but temporary, Medicare coverage for devices designated by FDA as "breakthrough," while manufacturers collect real-world data for the new technology. It would also establish a similar approach that can be tapped by device manufacturers, even if their device has not formally been designated as a breakthrough.

Scrutiny Escalates

This is all a positive for the device ecosystem, but companies should not get too comfortable. Several serious safety issues that have cropped up with particular devices in recent years are driving an increasingly vocal community of patient and consumer advocates. They are demanding stricter safety oversight of devices, including more pre-market data requirements.

Those passions were captured earlier in the year in a documentary, The Bleeding Edge, which was picked up by Netflix and has attracted public attention. (Also see "Top Medtech Lobbyist Doubts Legislative Repercussions Of New Netflix Documentary" - Medtech Insight, 28 Aug, 2018.)

Later in the year, the International Consortium of Investigative journalists (ICIJ) launched the Implant Files, an investigation of the industry that paints a picture of unsafe products and unchecked companies putting profits over safety. (Also see "The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While 'Wrath'-Behrendt Fumes" - Medtech Insight, 26 Nov, 2018.)

The ongoing series has a global focus, and puts an unflattering spotlight on the EU regulatory system in particular. But US FDA is feeling pressure as well. In the weeks before the investigation was made public (but when FDA was being asked for input by ICIJ reports), the agency released multiple announcements highlighting its focus on device safety and catching problems early. These appear to represent a tone switch away from a more prominent focus in public announcements on streamlining the path of new innovations to market.

On Nov. 26, the day after the Implant Files came out, FDA released a series of pre-planned proposals to reform the 510(k) pathway, by which most products and product updates reach the US market. (Also see "Opinion: The Great Implant Scandal Or 7.7 Billion Reasons To Celebrate Medical Devices? " - Medtech Insight, 10 Dec, 2018.) Primarily, the agency says it plans to encourage less use of older predicate devices (the previously-marketed devices that a device-maker references to prove substantial equivalence to gain their own 510(k) clearance). It makes a point in the announcement to stress that 510(k) submissions have become longer and have been subjected to more scrutiny in recent years.

It will be interesting to discover precisely where the agency's balance between encouraging innovation and ensuring safety comes to rest in terms of policy development in 2019.