Clinical Trials Series 6/6: Best Practices on Interacting with FDA

Allison Komiyama is a regulatory consultant focused on FDA submissions for the medical device industry. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of device companies. Her company (AcKnowledge Regulatory Strategies, LLC) was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle. Much of her recent work has been focused on digital therapeutics, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about Regulatory Submissions as a faculty member at UCSD extension. She was an FDA reviewer for a brief stint from 2010-2011 and received her Regulatory Affairs Certification (US) in 2014.

Tala Harake started her medical device career at UC Irvine as an undergraduate researcher in an animal cardiac research laboratory. After completing her undergraduate studies in Biology and Mathematics, Tala went on to earn a graduate degree in Biochemistry. She then began her career at Masimo, where she headed their clinical research department. In this role, Tala supported regulatory submissions, marketing, and engineering. During her time at Masimo, Tala rapidly scaled up their clinical lab to accommodate her newly designed clinical studies. This directly enabled development and expansion of the company’s vast product line from proof of concept to validation. During her tenure, she established multiple chemistry laboratories that supported in vitro research efforts and allowed for the validation of product DFU procedures in compliance with new FDA requirements. In 2020, Tala departed Masimo to start her consulting company Vigilant Clinical Trials Consulting, LLC. Since starting VCTC, her clients have included medical device start-ups, university research centers and medical societies. Throughout her career, Tala has been driven by a passion for medical devices and an underlying desire to help get these incredible devices to market and into the hands of healthcare workers.