Everything Medical Device Startups Need to Know about New Medtech Legislation

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With continuous innovation occurring in the medical field, it is imperative for federal regulations to keep pace. Today, most new and follow-on devices experience a lengthy regulatory process, especially when compared with their drug counterparts. But the federal government is trying to address this and other concerns through new proposed legislation. Here is what we know thus far.

How it started

The US House of Representatives passed its “21st Century Cures Act” in July 2015, in what many believe to be an exciting display bipartisan support. One of the biggest facets of the bill was its addressing of the National Institutes of Health (NIH) budget. According to David Richardson of Modern Medicine Network:

“The 21st Century Cures Act would establish in the U.S. Treasury an NIH and Cures Innovation Fund endowed with $1.86 billion in mandatory funds per year for FY2016 through FY2020 to be disbursed across the following initiatives: biomedical research, cures development, an accelerating advancement program, high-risk high-payoff research, and special funding support for early career researchers. The fund offers encouragement to researchers seeking assurance that lack of money will not represent a prominent roadblock to advancement of their lines of inquiry.”

In addition, the bill “modernizes and streamlines” the approval process for bio- and life-science innovations, opening the door for medical device startups to present alternatives to clinical trials as part of its premarket submission and ultimately speed up the commercialization of their products.

Where it is today

Although the NIH funding could mean significant resources to entrepreneurs and researchers, it also became a major sticking point as the bill was taken up in the US Senate earlier this year. This was primarily due to federal budgeting concerns and sourcing of the additional funds for the NIH. Instead of moving forward directly with the House version of the bill, a Senate committee began marking up its own version of companion legislation - specifically 5 different bills - and garnered bipartisan approval in early March.

One of these was the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, which attempts to eliminate regulation of “low-risk” health-related software and other digital applications. Another important bill approved by the committee was the Advancing Breakthrough Devices for Patients Act, which aims to accelerate the FDA approval of new medical devices. Bill co-sponsor Senator Orinn Hatch (R-UT) applauded the legislation:

“This measure ensures that FDA can help Americans benefit from the latest life-saving research and innovative devices developed by the medical community,” he said. “By providing a clear path by which innovators can get breakthrough devices to patients in as timely a manner as possible, we’re giving more patients a fighting chance to improve their lives.”

What it means for medtech

It’s hard to understate the importance of this new legislation. In fact, Senator Lamar Alexander (R-TN) believes it will be the “most important bill signed into law this year” if indeed it passes. It could mean a simplified path for innovators looking to get their devices to market. Potentially life-saving drugs and other technologies that typically languish in the research and discovery phase for months and even years could reach patients and make an impact much sooner. But not everybody is excited about the new bills.

Numerous organizations have spoken out against the proposed legislation, citing health and safety concerns over exempt health IT applications and quicker regulatory approvals. Our take is that this certainly is a real issue that will have to be addressed by these bills and their enforcement; but overall they represent a significant leap forward for the biotechnology and medical device community. If they can reduce the bureaucratic inefficiencies and allow patients to gain access to products that could improve their lives, then bring it on!

At the end of the day though, we’ll have to watch and see how it all plays out on Capitol Hill. Additional hearings on related bills are expected to commence in early April.

Greg BullockComment