Dr. Sam Gilbert is a seasoned preclinical consultant with extensive expertise in advanced surgical techniques, regulatory strategy, and medical device development. With a strong foundation in veterinary medicine and mechanical engineering, Sam provides a unique perspective on navigating the preclinical research and medical device landscape. His experience includes open, minimally invasive, and robotic surgical procedures, as well as cadaver-based evaluations and regulatory documentation, all focused on advancing medical technologies through rigorous preclinical evaluation.

Sam has worked across cardiovascular, thoracic, orthopedic, gastrointestinal, urological, and respiratory domains, contributing to the design, testing, and optimization of innovative medical devices. He has also supported preclinical development programs and studies for numerous interventional products targeting cardiovascular, pulmonary, urologic, and neurovascular systems. His meticulous approach ensures every project aligns with stringent safety and efficacy requirements, supporting both regulatory and commercial success.

• Advanced Surgical Techniques: Expertise in open, minimally invasive (including laparoscopic), and robotic surgeries across cardiovascular, thoracic, orthopedic, gastrointestinal, urological, and respiratory systems. Proficient in sutured and stapled procedures, vessel sealing, arthroplasty, fracture plating, chronic wound management, and tissue healing techniques. Experienced in endovascular interventions, including coronary and peripheral stenting and valvuloplasty, as well as bronchoscopy, perineural injection, and nerve stimulation.
• Orthopedic and Neurological Surgery: Proficient in soft tissue, orthopedic, and neurological surgery with a focus on minimally invasive techniques, including robotic surgery. Specialized in orthopedic procedures such as arthroscopy, fracture and fusion, and total joint replacement. Skilled in cranial and spinal neurosurgery and duraplasty.
• Cadaver Experience: Extensive experience utilizing cadaveric models for training, protocol refinement, and medical device evaluation, ensuring realistic and actionable insights on product performance, usability, and the “surgeon experience”.
• Regulatory Strategy & Technical Documentation: Proven ability to develop successful regulatory submissions, including PMA and 510(k) filings, and align study designs with FDA guidance and international compliance standards. Skilled in summarizing and interpreting technical data for clinical, commercial, and scientific audiences.
• Medical Device Development: Comprehensive expertise in designing and testing medical devices, leveraging engineering principles to refine device performance and safety.
• Protocol Development & Study Oversight: Proficient in creating surgical study protocols tailored to specific device evaluations and managing studies to ensure robust and reproducible outcomes.

Preclinical research is a critical checkpoint in the product development pathway between concept and clinical use. Sam is dedicated to ensuring that medical technologies meet rigorous standards of safety and efficacy through meticulous planning and execution. By combining clinical, surgical, and research expertise, he strives to deliver high-quality, relevant, and reproducible results. Sam values collaboration and works closely with clients to identify innovative and efficient approaches to preclinical evidence generation, enabling regulatory and commercial success. His commitment to excellence ensures that every project aligns with the client’s goals and advances scientific innovation.

Experimental Design
Surgical
Data Collection
Report Generation
Training Services
Product Development

Fluoroscopy
CT and Cone-Beam CT
MRI
Microsurgical and Endoscopic Systems