Today’s Regulatory Crawl
The U.S. medical device market, already the largest in the world, continues to grow at an accelerated rate, which is easy to deduce just by the numbers: In 2015, 86 novel devices were authorized by the FDA, compared to 132 authorized in 2020[i]. This innovation explosion, coupled with a strain on resources caused by the COVID-19 pandemic, has led to a noticeable slowdown in the regulatory pathway for medical devices.
Given the step-by-step process governing device development and approval, these delays often cause a trickle-down effect — from a delay in IRB review to a delay in site startup, ultimately leading to a delay in getting devices and treatments to patients. While regulations and processes have not always kept pace with the evolution of technology, the changes necessary to reconcile the two require longer-term solutions at an institutional level beyond the reach of device sponsors and manufacturers. So, while there is no quick fix for the related issues, there are methods for mitigating these slowdowns to market.
STEP 1: Be Prepared
While the rising number of medical device startups is exciting the industry, these smaller organizations often face larger problems due to their size. Without the resources in both manpower and knowledge that larger companies enjoy, the initial steps can easily become more burdensome. Keeping everything on track begins with organizations aligning their anticipated timelines and budgets with those documented by previous projects within the same category, minimizing the chances of exceeding either time or budgetary constraints.
Further along the pipeline, simply being intimately familiar with FDA regulations can make a huge difference by ensuring organizations do not hit self-inflicted delays caused by incorrect filings, missing IDE numbers, and the like. These first steps, including utilizing the proper online flowcharts to determine the best options for a device, can guide sponsors successfully onto the path to approval.
STEP 2: Collaborate With the FDA
While this idea can be intimidating, involving the FDA in the process is one of the best ways to keep timelines in check. Aside from the numerous resources available on the FDA website (many of which fit within Step 1), there are opportunities for sponsors and manufacturers to get valuable pre-submission feedback directly from the regulatory body responsible for approval.
While simple questions can be addressed by FDA staff, there are also options like the Pre-Sub (Q-Sub) program, which provides regulatory guidance on testing requirements, selecting the right pathway, and determining the formal risk designation. While this voluntary pre-submission program does add time to the front end of the process, the potential benefits often outweigh that drawback. The written feedback (with the option of face-to-face meetings) gives sponsors the information necessary to avoid timeline-slowing errors later in the process.
STEP 3: Collaborate With Your IRB
As a collaborative partner in the process, sponsors should also look to their IRB for support and assistance in navigating the complex and often confusing web of regulations and guidelines regarding medical devices. Experienced IRBs, like Sterling, are eager to assist sponsors in keeping the process moving. In some cases when an organization is truly unfamiliar with requirements, these discussions may happen prior to the previous steps, as IRBs can refer clients to the proper resources for both general FDA medical device guidelines and pre-submission services. By taking advantage of the often robust regulatory consultation services IRBs provide, sponsors can ensure they are taking the right steps in the right order.
A Faster Future
The general slowdown in the medical device regulatory pathway has not gone unnoticed. The FDA continues to staff up in hopes of more effectively meeting the needs of sponsors and manufacturers, and outside organizations are increasingly producing educational content meant to ease confusion and empower innovation. While these are positive steps, it is still incumbent on organizations to utilize all the resources at their disposal to keep timelines on track. Sometimes the best first step is simply getting direction on where to start from an authority, like the team at Sterling IRB.
i In 2020, FDA Authorized 132 Novel Medical Devices. MedTech Intelligence. Published 2021 Feb. 17.