Strategic Insights Delivered

Technical consulting expertise to help organizations and clients with their scientific, engineering, and business needs.

Kevin Ong, Ph.D., P.E., is a nationally recognized expert in medical device performance and real‐world evidence generation. With Bachelor of Science and Doctorate degrees in Mechanical Engineering from Cornell University and almost three decades of experience, he has led complex research, regulatory, and clinical‑evidence programs supporting medical device manufacturers, healthcare organizations, and investors. Dr. Ong is a licensed Professional Engineer and has earned numerous prestigious awards for scientific contributions, including multiple honors from the American Association of Hip and Knee Surgeons, the North American Spine Society, and international medical societies.

He has evaluated a wide range of medical products, from implants and surgical instruments to hospital and medical equipment. These include orthopaedic implants, spinal disc replacements, spine fusion rods and screws, fracture fixation hardware, bone anchors, inferior vena cava filters, tissue reconstruction/tissue repair mesh products, catheters, endoscopes, ventilators, fluid circulating devices, pain pumps, patient lifts, and hospital beds.

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Advisory Services

How He Helps Clients

Kevin’s consulting services are designed to accelerate decision‑making, strengthen regulatory and clinical strategies, and reduce development and market‑access risk. His expertise supports:

  • Regulatory submissions and risk‑benefit analysis

  • Health‑economic modeling, payer‑evidence strategy, and reimbursement support

  • Clinical‑study design and real‑world evidence programs

  • Failure analysis, retrieval analysis, and device/biomaterials evaluation

  • Technology assessment for investors, M&A, and due‑diligence teams

He has also provided technical services for legal clients in product liability and intellectual property disputes.

By combining deep technical expertise with pragmatic, data‑driven insights, he helps organizations bring safer, more effective medical technologies to market and optimize their clinical and economic impact.

His technical consulting services include:

  • forensics/failure analysis

  • product design and development

  • mechanical and preclinical test design

  • risk analysis

  • biomaterials selection

  • technology assessment

  • regulatory support

  • epidemiology

  • clinical research

  • health economics and outcomes research (HEOR)

  • medical writing

  • study design

  • product commercialization

  • intellectual property evaluation

Committed to Measurable Impact

Kevin has written one book on orthopaedic biomaterials, ten book chapters on various subject matters related to medical devices, and has authored approx. 150 peer‑reviewed papers and over 300 scientific presentations.

  • spanning device complication rates, patient outcomes, biomaterials science, and system‑level healthcare impacts. His work has informed clinical guidelines, payer policy, and industry strategy.

  • recognizing excellence in clinical outcomes research, biomaterials analysis, and economic modeling.

  • including leveraging claims analyses, cost‑effectiveness modeling, and national utilization projections across orthopaedic, spine, and cardiovascular technologies.

  • including with internal (marketing, regulatory, R&D, clinical and medical, etc.) and external (clinicians, hospitals, medical societies, etc.) teams.

  • at premier scientific and clinical conferences across orthopaedics, spine surgery, rheumatology, and health‑economics, demonstrating broad cross‑disciplinary impact.

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