Meet Our Team

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Principal Consultant  

MedTech Clinical & Regulatory Strategy 

Vinay Bhal is a strategic medtech leader with over 15 years’ experience in designing clinical trials, managing global clinical operations team, CROs/Vendors, evaluating and disseminating clinical evidence to support market access and adoption of structural heart devices, thrombosis & antiplatelet therapy, orthopedic & sports medicine devices. Vinay held leadership roles at Edwards Lifesciences, Smith+Nephew, and Zimmer Biomet executing clinical and regulatory strategies for over 100 products. He has led successful PMA, 510(k) and CE submissions, creation of PMCF plans & CERs, study progress reports, engaged with KOLs for study designs, real world data capture, investigator-initiated studies, podium presentations, white papers, and manuscripts. Vinay earned MS and PhD in Biomedical engineering from University of Memphis conducting hemodynamic studies in microcirculation.

Principal Consultant  

MedTech Clinical & Regulatory Strategy 

Stephan Mangin is a seasoned medtech leader with over 26 years of experience developing global clinical evidence for medical devices, biologics, and sports medicine including EU MDR approvals for over 300 product indications . He has led clinical and regulatory strategies at global companies including Smith+Nephew, Zimmer Biologics, Johnson & Johnson, and Boston Scientific. His broad expertise spans drug delivery systems, antibacterial coatings, cartilage repair, electrosurgical technologies, biologics, vascular devices, and sports medicine solutions. Stephan holds advanced degrees in Biomaterials (MIT) and Biomedical Engineering (École Centrale de Lyon). A multilingual leader, Stephan brings deep clinical, regulatory, and scientific expertise to advancing patient care.

Statistical Strategy Advisor

Clinical Trials & Outcomes Analysis 

Karan P. Singh is Professor and Chair of Epidemiology and Biostatistics in the new School of Medicine at the University of Texas at Tyler Health Science Center. With over 35 years of experience, he has contributed to numerous Industry-sponsored and NIH-funded projects, serving as PI, Co-PI, Biostatistician, and Core Director. Dr. Singh has provided expertise in statistical methodology, clinical trial design, and NIH/FDA compliant data analysis. He has served on the NCI Gynecologic Cancer Steering Committee and Cervical Task Force, multiple Data Safety Monitoring Boards, and scientific review panels. His research interests include longitudinal data analysis, proteomics, biomarker cut-offs, and health services research methodology.

Clinical Advisor

Orthopedic Surgery

Medical Affairs & Strategy

James Wood, MD is business-savvy orthopedic surgeon, Fellow of American Academy of Orthopaedic Surgeons (AAOS) and senior medical affairs leader with more than four decades of experience advancing innovation in orthopedics, trauma, and sports medicine. Former Senior Director at DePuy Synthes and Smith+Nephew, leading clinical strategy, product development, lifecycle management, and global regulatory initiatives. Recognized as a subject matter expert in fellowship training, KOL development, and clinical trial oversight. Deep experience across medical education, governmental affairs, post-market surveillance, and health equity advocacy. A fellowship-trained surgeon with extensive leadership in hospital, academic, and industry settings, he combines clinical insight with business acumen to improve patient outcomes and drive strategic product value. 

Clinical Advisor

Cardiothoracic Surgery

Medical & Clinical Affairs 

Sai Prasad, MD  is an award-winning cardiovascular medical executive with over 30 years of experience in cardiothoracic surgery and interventional cardiology, and 10 years of structural heart industry leadership in Medical & Clinical Affairs at Edwards Lifesciences. Successfully delivered clinical strategies for early to post-market studies, supporting 20+ global regulatory clearances and market access. Spearheaded the development and launch of seven Class III cardiovascular products, with over 24 peer-reviewed publications. Educated 6,000+ professionals, recognized for excellence in trial design, clinical safety, KOL engagement, medical information management, and regulatory alignment, influencing FDA and EU notified bodies. Dr. Prasad is a trusted partner in evidence planning, clinical evaluation, risk management, and commercialization