March 12, 2020
Nicholas Benetatos, Ph.D., manager at Exponent, recently wrote an op-ed titled "FDA approach helps private sector," published in the Boston Business Journal. This piece addresses the fundamental balance between arduous medical device approvals and the ability to creative innovative devices for public use. Often times, it can take the can take the U.S. Food and Drug Administration multiple years to approve a device for use, potentially stifling innovation during the drawn out regulatory processes.
It is important to understand that the FDA is a key stakeholder in the marketplace, ultimately deciding what products can be sold, how, and to whom/for what purpose. The most successful companies are active, engaging and driving the discussion to address the FDA's concerns. The ability to proactively align with the FDA can assist companies in going to market and continue to develop innovative products and devices.
To read the full article, click here.