Medical Device Commercialization: Regulatory Basics

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Companies that are developing medical technologies pose incredible opportunities for high growth and significant economic impact (job creation, revenue generation, etc.); however, they also experience the need for significant capital as well as a lengthier time to commercialize their innovations. This is due, in large part, to FDA and other forms of regulation. Below is an overview of important regulatory principles:

Classify your Medical Device (I, II, or III)

According to the Food & Drug Administration’s medical device classification, devices fall into one of the three categories – Class I, II, or III – based on the “level of control necessary to assure the safety and effectiveness of the device” as well as any associated risk(s) posed to a patient through its use. In addition to the general controls to which all non-exempt devices are subject, Class II adds more stringent “special controls” (such as performance and labeling standards). Similarly, Class III technologies, which “support or sustain human life,” require additional Premarket Approval (PMA) above and beyond the general and special controls prior to their commercialization.

So how do you determine the classification of your device? Dr. Michael Drues, President of Vascular Sciences notes in Med Device Online that, although it is not an exact science, you must first identify its intended use – not what it is designed to do but instead how you dictate it will actually be deployed in the field. Something as simple as changing the labeling on your product can greatly impact its classification.

If you are developing a device that functions similarly to another device already existing on the U.S. market, then you can simply search for the existing device or specialty on the FDA website (Device Classification Panels). If your medical innovation is truly unique in the marketplace, Dr. Drues explains that it immediately is designated Class III within the FDA protocol, although the recently streamlined de novo classification pathway is also an option for these types of devices.

Identify the Appropriate Premarket Submission

Once classification is settled, the next step for most companies is to submit either A) a 510(k) premarket notification or B) a premarket approval (PMA). The FDA states that, for most Class I and Class II technologies intended for human use, a 510(k) premarket notification is required to establish that they meet the same safety and performance standards of “substantially equivalent” devices already in the marketplace; this means it shares the same intended use and similar technological properties as well as does not bring any new issues of safety into play.

Conversely, many Class III innovations must file the more-stringent Premarket Approval. As a result of these devices serving a unique purpose in the market and having no direct linkage to an existing product, the PMA establishes through validated scientific data that they meet certain safety and effectiveness benchmarks. Clinical trials can be part of the technical requirements of a premarket approval submission, and may therefore require an additional Investigational Device Exemption (IDE) prior to conducting the study. 

Cost and Timelines of Regulatory Approvals 

510(k) submissions, premarket approvals, and other regulatory filings cost money and take time…obviously. But how much and how long? The FDA provides a pretty good and updated breakdown of the different medical device user fees associated with each. Not surprisingly, Class III devices require the most financial investment primarily because of the cost for a PMA submission along with clinical trials and other product development needs. Numerous leaders in the med-tech space in Arizona cited these intensive financial capital needs as one of the primary barriers to the success of medical-based startups (Medical Metamorphosis: Doctors as Entrepreneurs, Sue Doerfler).

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Fees valid through September 30, 2015. Courtesy of the Food and Drug Administration

The time that it takes for a device to receive approval also varies, but recent research from the Emergo Group shows that 510(k) clearance from the FDA averages approximately 6 months. Interestingly enough, annual PMA approvals have increased overall since 2010, and the timeline for PMA review also decreased to just under 300 days according to 2012 FDA data. That stated, layer in the possible years of product development, research and clinical studies, regulatory approvals, and the path to medical device commercialization becomes a lengthy one.

Greg BullockComment