Our Team

Bryan Pinder joined Biologics Consulting in May 2024 with over 17 years of experience between the U.S. Food and Drug Administration (FDA) and industry.  Bryan began his career in 2006 as biomedical engineer and lead reviewer of orthopedic devices at FDA within the Office of Device Evaluation (ODE).  Bryan organized and led multi-disciplinary teams in the review and assessment of 510(k)s, PMAs, HDEs, IDEs, and pre-submissions for various orthopedic device types, including those for trauma/fracture fixation, soft tissue fixation, and joint arthroplasty. During these reviews, Bryan worked with industry counterparts to clarify non-clinical and clinical requirements to help ensure least-burdensome approaches to the market. He also helped develop guidance documents for FDA staff and industry on regulatory SOPs and review practices.

Bryan left FDA in 2015 and started working for Hillrom (now Baxter International) as a senior risk manager.  In this role, Bryan was able to apply the principles of proving device safety and efficacy that he learned at FDA to a broad device portfolio at Hillrom that included software as medical devices (SaMDs), ophthalmic cameras, picture archiving and communication systems, and monitoring systems.  Bryan developed risk management files for these devices and presented risk profiles to executive management prior to gate and market releases.  Bryan transitioned to a regulatory position at Hillrom where he was responsible for establishing regulatory pathways and requirements for new product development, in addition to providing regulatory change control assessments for sustaining projects.  Many of Bryan’s projects involved either SaMDs or software in medical devices (SiMDs) where the proper use of user interfaces (UIs) was required for safe device use.  Bryan gained experience in the evaluation of these UIs using human factors analyses.

In 2019, Bryan returned to the world of orthopedics, supporting US and EU registrations as a contractor in the trauma division of a large orthopedics company.  Bryan worked on and received clearance/approval for 510(k)s, PMA supplements for manufacturing and labeling changes, and HDE supplements and amendments.  He provided regulatory change assessments for sustaining projects and authored internal documentation (i.e. letters-to-file) for changes not requiring submissions.  Bryan worked with both local and national IRBs to support HDE compliance.  On the EU side, Bryan performed updates to Technical Documentation to support EU MDR compliance.

Education
BS and MS in bioengineering from Syracuse University

Regulatory Affairs Certification – Medical Devices (RAC-Devices) credential from the Regulatory Affairs Professional Society (RAPS).