David McGurl Joins MCRA as a Director

David McGurl, former FDA Premarket Senior Lead Reviewer, will be joining Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), as a Director.

According to the March 1, 2016 news release, “Prior to joining MCRA, McGurl served as a FDA Premarket Senior Lead Reviewer of medical devices in one of the Orthopedic Joints Branches (Joint Fixation Devices Branch Two) in the Office of Device Evaluation. McGurl brings to the firm extensive regulatory experience from his seven years at the FDA in various roles, including his roles as Acting Branch Chief for the Joint Fixation Devices Branch One and Acting Branch Chief for the Orthopedic Joint Devices Branch. Further, he served as lead reviewer on many complex total joint and trauma technologies. McGurl’s leadership and experience included leading a staff of professionals engaged in the scientific review of Investigational Device Exemptions (IDE), Premarket Approvals (PMA) and 510(k) submissions. In his new role at MCRA, McGurl will be responsible for strategic regulatory planning, FDA regulatory submissions and client regulatory advisory services.”

McGurl said, “I am honored to join a talented, dynamic firm where I can leverage my FDA experience and biomedical engineering background to assist MCRA’s clients in planning and obtaining regulatory clearances and approvals for their medical device technologies.”

David Lown, General Manager of MCRA, added, “MCRA has been very successful in helping clients with their FDA interactions in a data-centric and orthopedic indication-specific manner. We are pleased to have Mr. McGurl join MCRA and assist our industry clients in continuing the advancement of technology innovation for surgeons and patients.”

Dave McGurl told OTW, “My first steps will be to get acclimated with the MCRA team and how they operate. Just like any great team I need to learn how they build success and then I hope to be able to build upon that and generate my own unique value that makes the team better.”

David Lown commented to OTW, “I think it is really important to understand that when MCRA is hired by sponsors and manufacturers we are an important conduit to bringing innovation to market. The surgeon and industry are instrumental in inventing and funding innovation and we believe MCRA’s experience to both strategize and execute on the myriad of factors (regulatory, clinical research, reimbursement, among others) to help prove the validity of the innovation really makes us an important part of the process. The more experienced our team becomes understanding the history of orthopedics in all anatomies as well as understanding what is important to all constituents the greater MCRA will be able to assist surgeons and patients in having more quality options for neuro musculoskeletal diseases.”