Osiris Med Dev Information

Founded in 2018 by Mike Bravo, our goal is to blend our preclinical/R&D backgrounds (surgical/interventional procedural support, engineering team interactions, science and design of studies) with our multifunctional team experiences (regulatory, clinical, biostats, etc.) to help clients drive their progress in a very efficient and forward thinking manner. Product Development/R&D Support: Evaluation/vetting of devices from pre-prototype (physiologic theory) thru GLP Data generation strategies for fund raising or go/no-go Multifunctional/multidisciplinary developmental strategy formation and execution (R&D, regulatory, clinical, quality perspectives) Study design Surgical and Interventional Support (animal, human cadaveric, and bench models): >15,000hrs of procedural experience (study implants, iterative/benchtop feedback, usability studies) Interventional (coronary, neuro, peripheral) Cardiovascular Ablative therapies Vascular access Neuromodulation Hemostasis Wound healing Hernia repair Dorsal root ganglion (DRG) harvests Commercialization: Developing and executing informational, training, and publication-driven lab studies/sessions for: • Engineers • End Users • Principal Investigators (PIs) • KOLs • Sales & Marketing Teams Overall Support: Program leadership/management CRO selection & navigation Regulatory Interaction: Guidance document interpretation Pre-sub strategy and presentation Submission strategy and construction Deficiency/response strategy and presentation SEND dataset management Data Review: Interpretation Gap analysis