John Stroncek, Ph.D.

John is a regulatory and product development leader with over 15 years of experience building and assessing novel implantable devices and surgical systems from concept to clinical use and market entry. Dr. Stroncek’s work with DHC clients focuses on bridging the gap between innovative engineering and Agency expectations to help clients anticipate and mitigate regulatory hurdles. John’s expertise allows him to incorporate cross-functional insight—spanning R&D, Clinical, Quality, and Regulatory—to ensure the delivery of high-quality, safe, and effective products.

Prior to joining Dark Horse, John served as a Lead Reviewer at the FDA’s Office of Orthopedic Devices. During his tenure at the Agency, he was the primary reviewer and sponsor-facing point of contact for more than 100 regulatory submissions, including pre-submissions, 510(k)s, IDEs, and panel-track PMA supplements. His tenure at the FDA was defined by his ability to coordinate multidisciplinary teams of statisticians, clinicians, veterinarians, and engineers to drive clear regulatory decisions.

Before his time at the FDA, John was Associate Director of Product Development at AgNovos Healthcare, a medical device company developing first-in-kind treatments for osteoporosis. There, he led end-to-end development of a novel implantable spine device from early concept through pivotal clinical trials. His responsibilities included securing FDA Breakthrough Device Designation, IDE approval in the U.S., and clinical study approval in Europe.  John led multiple FDA pre-submissions, designed GLP animal studies, co-developed clinical protocols, and authored core design control and regulatory documentation, operating at the intersection of engineering, clinical, and regulatory teams in a lean environment.

Earlier in his career, John was a Staff Scientist within Smith & Nephew’s Advanced Healing Technologies Group. He served as the technical lead for the development of a family of 26 bioabsorbable implants for tendon and ligament reconstruction. John’s work spanned the full development lifecycle, from early-stage R&D—including finite element analysis and long-term in vitro degradation studies—to late-stage manufacturing process development, where he used Design of Experiments (DOE) to optimize injection molding variables and double implant performance. Additionally, he acted as the technical lead for early-stage combination product R&D, developing cellular assays to identify drug candidates for a PMA-track drug-device product.

John gained entrepreneurial experience as the Co-Founder of Cerene Biomedics, a startup focused on treat-to-target implantable devices for epilepsy. He holds a Ph.D. in Biomedical Engineering from Duke University, where his research focused on biomaterials and tissue engineering related to vascular grafts. He received his B.S. in Mechanical Engineering from the University of Maryland.

Constant C, Stroncek JD, Zeiter S, Arens D, Nehrbass D, Gehweiler D, Menzel U, Benneker LM, Hill RS, Albers CE. Venous Injection of a Triphasic Calcium-Based Implant in a Sheep Model of Pulmonary Embolism Demonstrates Minimal Acute Systemic Effects. European Spine Journal, 31: 2812-2821, 2022.

Howe JG, Hill RS, Stroncek JD, Shaul JL, Favell D, Cheng RR, Engelke K, Genant HK, Lee DC, Keaveny TM, Bouxsein ML, Huber B.  Treatment of Bone Loss in Proximal Femurs of Postmenopausal Osteoporotic Women with AGN1 Local Osteo-Enhancement Procedure (LOEP) Increases Hip Bone Mineral Density and Hip Strength: A Long-Term Prospective Cohort Study. Osteoporosis International, 31: 921-929, 2020.

Stroncek JD, Shaul JL, Favell D, Hill RS, Huber BM, Howe JG, Bouxsein ML.  In Vitro Injection of Osteoporotic Cadaveric Femurs with a Triphasic Calcium-Based Implant Confers Immediate Biomechanical Integrity. Journal of Orthopaedic Research, 37(4): 908-915, 2019.

Stroncek JD, Ren LC, Klitzman B, Reichert WM.  Patient-derived Endothelial Progenitor Cells Improve Vascular Graft Patency in a Rodent Model, Acta Biomaterialia, 8(1):201-208, 2012.

Stroncek JD, Haque N, Xue Y, Lawson JH, Reichert WM.  In vitro Functional Testing of Endothelial Progenitor Cells that Overexpress Thrombomodulin, Tissue Engineering Part A, 17 (15-16):2091-2100, 2011.

Stroncek JD, Grant BS, Brown MA, Povsic TJ, Truskey GA, Reichert WM.  Comparison of Endothelial Cell Phenotypic Markers of Late-Outgrowth Endothelial Progenitor Cells Isolated from Patients with Coronary Artery Disease and Healthy Volunteers, Tissue Engineering Part A, 15(11): 3473-3486, 2009.

Stroncek JD, Bell N, Reichert WM.  Instructional PowerPoint Presentations for Cutaneous Wound Healing and the Tissue Response to Sutures, Journal of Biomedical Materials Research Part A, 90(4):1230-1238, 2009.

Stroncek JD, and Reichert WM. Overview of Wound Healing in Different Tissue Types, Indwelling Neural Implants: Strategies for Contending with the in vivo Environment, CRC Press: Boca Raton, 2008.

FDA‍

Lead Scientific Reviewer

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AgNovos Healthcare

Associate Director Product Development

Senior Project Engineer

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Smith & Nephew

Staff Scientist

Scientist

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Cerene Biomedics

Co-Founder and Chief Technical Officer

Duke University

Ph.D., Biomedical EngineeringPh.D., Biomedical Engineering

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University of Maryland‍

B.S., Mechanical Engineering