Navigating FDA clinical trials in Neurotech with Tim Marjenin

Greg and Matias interview Tim Marjenin, a regulatory consultant at MCRA with 16 years of experience at the FDA, to discuss the regulatory landscape for neurotechnology devices.Tim provides insights into the FDA approval process for neurotech devices, drawing from his extensive experience on the FDA's Neurostimulation-Neurology Devices Team. The episode explores the evolving field of neurotechnology and its regulatory challenges.In this episode, we discuss:Different regulatory pathways for neurological devices (510(k), De Novo, PMA)FDA's approach to novel neurotechnologies like brain-computer interfaces (BCIs)Considerations for invasive vs. non-invasive neurotech devicesThe importance of cybersecurity in neurotechnologyCommon mistakes companies make in the regulatory process and how to avoid themThe potential future of neurotechnology, including human augmentation and telepathyCreated by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank and Krotoa by Makropulos