MCRA’s Team Accomplishes Fastest Spine PMA

Washington, DC-based MCRA, LLC (Musculoskeletal Clinical Regulatory Advisers), has accomplished many musculoskeletal clinical and regulatory firsts and, with the recently announced premarket approval (PMA) for Simplify Medical, Inc.’s disc, it adds only more impressive accomplishment to its portfolio. MCRA’s ability to navigate the regulatory and reimbursement gauntlet resulted in achieving the fastest U.S. FDA premarket approval for a spine device yet.

The beneficiary of MCRA’s expertise was Sunnyvale, California-based Simplify Medical, Inc. last month for its Simplify^® Disc.

OTW recently covered Simplify’s PMA, a rarity among spine devices, which typically follow the 510(k) clearance pathway, or even avoid regulatory scrutiny in some cases (such as structural allografts).

As a class III device, the FDA requires a PMA application showing evidence of safety and efficacy. Submitted in March 2020, the Simplify Disc became the spine device with the shortest time to approval—under six months. It should be noted that Simplify Medical did not celebrate this achievement alone; the Clinical  Research Organization (CRO) behind the submission, MCRA played a major role in the product’s successful approval.

MCRA is a CRO that specializes in bringing musculoskeletal products and treatments to market. The Washington, DC-based company fulfilled many of the necessary duties required for a successful PMA for Simplify Medical’s Simplify Disc. MCRA led Simplify Medical through the entire process, including design and management of the clinical trial. The company is continuing to assist Simplify Medical during the ongoing 2-level clinical trial, and subsequent PMA application.

MCRA Vice President of Spine Regulatory Affairs Justin Eggleton said in a recent press release from MCRA: “Simplify Medical’s PMA approval is anchored by a well-executed clinical study that required significant collaboration between MCRA and Simplify…FDA provided valuable feedback during the course of the IDE [investigational device exemption] study that was important to ensuring the PMA diligently presented all clinical data to demonstrate safety and effectiveness with a positive benefit-risk profile.”

More recently, MCRA announced the hiring of John Doucet, Ph.D. as part of the company’s intention to grow its Neurology and Breakthrough Device Designation pathway specializations. Doucet was previously the Policy Lead of the FDA’s Breakthrough Device Program, and has also served as the Lead Reviewer of Neurology and Physical Medicine Devices, among other leadership roles for the Agency.

Doucet was quoted in a recent press release from MCRA, “I am happy to join MCRA’s integrated team of deeply experienced experts. I look forward to this opportunity to provide value to MCRA’s medical device clients by creating tailored and efficient regulatory pathways to bring new technologies to market, and thus promote patients’ access to safe and effective products as quickly as possible.”

MCRA’s Senior Vice President of Clinical and Regulatory Affairs Glenn Stiegman spoke highly of Doucet and his hope to continue as a preeminent regulatory CRO as the regulatory process continues to evolve, “With the influx of breakthrough designations and their impact on companies and reimbursement, we understand John’s role being critical to continue assisting clients with their innovative products that will help thousands of patients.”

MCRA is a portfolio company of the Viscogliosi Brothers, LLC., a family investment firm that has been one of the most prolific and successful bankers, operators and advisors to spine and orthopedic medical device companies.