FDA Regulatory Leadership For Medtech/IT Convergence
Life Science Partner recruits 2 transformational leaders to the FDA
Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process. In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug Kelly, MD, MBA as Deputy Director for Science to the FDA’s CDRH Office. Since the creation of his role in August 2020, Dr. Kelly has already made a significant impact on improving FDA/innovator communication and accelerating patient access to high-quality, safe, and effective medical devices. Dr. Kelly has been instrumental in partnering with top leaders from industry and academia to expedite the regulatory clearance process to assure consumer confidence and advance innovative technologies.
“Through his serial entrepreneurship experience, Dr. Kelly understands the regulatory pathway obstacles that innovators face.”Tom Callaway, MD, Founder of Life Science Partner.
In May 2022, Dr. Kelly spoke as the key note speaker at the AdvanSE Conference in Atlanta, GA where he presented CDRH’s role in the COVID-19 response, the future of the Medical Device User Fee Act and its introduction to TPLC TAP (Total Product Life Cycle Advisory Program); a new team of experts focused on providing strategic advice actively coordinated with FDA review teams and across the MedTech ecosystem.
Doug Kelly, MD, and Tom Callaway, MD, at AdvanSE 2022
Most recently, Life Science Partner recruited David McMullen, MD, to serve as Director, Office of Neurological and Physical Medicine Devices (OHT5) for the CDRH where Dr. McMullen is the technical authority and principal advisor for ninety individuals responsible for the total product life cycle (TPLC) review of neurological, neurointerventional and neurodiagnostics devices, as well as responsible for a separate group focused on neuromodulation and physical medicine devices.
“Co-leading The BRAIN Initiative at NIH, McMullen has demonstrated the leadership to oversee various multi-faceted programs simultaneously and evaluating cutting-edge technologies such as computer-brain interfaces.”Tom Callaway, MD, Founder of Life Science Partner.
McMullen’s team will oversee premarket evaluations, compliance and quality parameters, and surveillance programs for all neurological products and devices and be engaged in the decision-making process on device submissions, classifications, petitions, 501(k)s, PMAs, IDEs and all supplements and amendments to submissions.
Life Science Partner is pleased to have recruited Dr. Kelly and Dr. McMullen as transformative leaders contributing to the FDA CDRH ’s mission to accelerate the adoption of innovative technologies to improve the healthcare of patients.
About Life Science Partner
Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.