Stephan Nieuwoudt, PhD | Director of R&D
Dr. Nieuwoudt is the Director of Research and Development at Neuronoff, Inc.
Building on more than 12 years of preclinical and clinical academic work coupled with hands-on industry R&D experience, Stephan leads novel development projects; from the initial concept and design phase, to proving functionality in preclinical and benchtop setups, and then optimizing the design for scalable manufacturing quality management system integration. His leadership has been instrumental to Neuronoff, achieving the stage of design freeze within tight timelines and readiness for clinical and regulatory submissions.
Working hand-in-hand with QA and manufacturing, Stephan is leading the strategic planning and implementation of our R&D pipeline towards design transfer to manufacturing. In parallel, he fulfills the role of preclinical surgeon for acute and chronic studies from the exploratory phase up to GLP level study execution. He relies on more than a decade of hands-on rapid prototyping experience for medical devices, including tooling needed to build singles and small batches for research evaluation. He furthermore functions as scientific liaison to a vast number of academic and clinical research partners, driving the data acquisition from early concept all the way to publication.
Prior to his work at Neuronoff, Stephan managed clinical research trials and preclinical studies in diabetes, endocrinology, exercise physiology, and nutrition at the Cleveland Clinic and Case Western Reserve University.
Stephan holds a PhD in Physiology and Biophysics from Case Western Reserve University and a BSE in Biomedical Engineering with a focus on Tissue Engineering from the same university. Concurrently to his academic development at Case Western Reserve, Stephan designed and executed preclinical and clinical work at the Cleveland Clinic from 2008 to 2018. Following his PhD, he conducted a Postdoctoral Fellowship and founded a medical research device design and prototyping company just prior to joining Neuronoff, Inc.