David A.B. Smith Email & Phone Number

As a member of the J&J Medtech Knee Arthroplasty R&D Team, I am a technical leader in the development of novel implant designs to create more natural biomechanics for optimal TKA outcomes. Developing state of the art materials and manufacturing techniques to improve implant life and outcomes and decrease complications. Leveraging robotic technologies (VELYS) to decrease variance in TKA component alignment for improved outcomes and OR times while reducing complications. • Product Development of TKA implants and instruments.• Metallurgical and materials engineer Subject Matter Expert for DePuy-Synthes Knees.• Led the collaboration between Knee Product Development and J&J Materials for novel implant development.• Lead engineer collaborating on vendor selection and manufacturing. Negotiated processes to increase through-put and reduce COGs. Collaborated with vendors on advanced technologies for manufacturing novel products.• Implemented DFM into knee products working with vendors to reduce COGs.• Integrated manufacturing expertise for products early in design phase to achieve the required performance and COGs.• Leadership role for Knee R&D on Regulatory Strategy for US and EU.• Developed verification test plans, predicate strategies and presented to FDA in Q-sub meetings.• Lead Knee Engineer for Medical Device Regulations (MDR) updates for CE Mark – updated instruments and implants from MDD to MDR. Product lines represent over $300M+ (2023) in annual EU sales. • Ran cadaver labs for implant testing and collaborated with KOL surgeons. Included VELYS Robotic Assisted Surgery (RAS).• Represented DePuy-Synthes at surgical meetings to discuss products and VELYS RAS with surgeons.• Main contact for university collaborations for simulations of implant design utilizing statistical shape and intensity models (SSIM). • In the leadership role, ran a monthly educational literature seminar. The program became very popular and other departments began attending.

Braecori Analysis and Engineering, LLC is a Biomedical Engineer and an Orthopedic and Spine Surgeon with fifty years' combined experience providing engineering consulting services to the medical device industry. Some of our Services:• CAD - Solidworks (19 years experience).• CAM - Computer Aided Manufacturing (CNC programming).• Thorough understanding of spinal and orthopaedic surgical procedures,• Orthopedic / spinal implant design and testing,• Biomechanical testing of orthopedic implants / spinal instrumentation,• Research & Development / Product Development (QSR CFR820 / Design Controls), • Development of manufacturing processes within GMP framework,• Project management,• Engineering and research management,• FDA Testing/ IRBs/ Clinical Trials for evaluating medical devices and surgical procedures,• Technical writing,• 3D printing (metals, plastics), Investment casting, powder metallurgy, biomaterials,• Metallurgical failure analysis,• Materials characterization (mechanical testing, SEM, TEM, standard testing scenarios, ASTM methods, USP, etc…),• Computer (MS Windows, Office; SolidWorks; LabView; Visual Mill; INSTRON Bluehill; MTS Testware / TestStar, QuickBasic). • Macrophotography for engineering.• Metallurgical / Mechanical Engineering.

Nashville, Tn, Us

Designing and developing a new line of spinal spacers and accompanying surgical instruments. Responsible for all QSR (CFR 820) documentation and validations to support the surgical instruments. CAD/CAM (Solidworks) and mechanical engineering for tooling, CNC programming, and processes for manufacturing. Headed design, development, technology transfer, manufacturing and other engineering aspects of the production of spinal spacers and other CNC-machined bone allografts. Developing novel processes through the full product development cycle (Research and Development, Product Development, Process and Product Validation and Technology Transfer). Osteobiologics - Developed new manufacturing techniques to increase yields on osteobiologics product line from 54% to 98%. Interfacing with spine and neurosurgeons as well as OEM customers on the development of new CNC-machined allografts. Interacting heavily with spine surgeons and neurosurgeons at surgical meetings and in the hospital / O.R. environment. Intellectual Property Development – Numerous proprietary technologies and two patent applications.

Nashville, Tn, Us

Baltimore, Maryland, Us

Managed research and teaching activities of the Spine Surgery Fellowship Research Group run by Thomas G. Lowe, M.D., Anthony P. Dwyer, M.D. and Michael F. O’Brien, M.D. at the Woodridge Orthopedic and Spine Center / University of Colorado Health Sciences Center. (UCHSC). Supervised a team of 14 engineers, clinical research associates and support staff. • Collaborated heavily with major industry partners (Medtronic Sofamor Danek and Depuy-Acromed) on evaluating implant systems both surgically and in the laboratory. • Designed and implemented clinical and basic science research protocols pertaining to the clinical and surgical issues of spinal biomechanics. • Combined in work two previously poorly interacting separate surgical groups. • Attained over $300,000 for the Spine Surgery Fellowship through UCHSC for research on spinal deformity, pathology and trauma. • Engineered and developed laboratory equipment for implant mechanical testing.• Designed and managed several clinical trials at my site including an FDA Investigational Device Exemption (IDE) trial for a Class III Medical Device (surgical trial for PMA) for Depuy-Acromed.• Built an international reputation for the UCHSC / Woodridge Spine Surgery Fellowship as a strong research force in spinal biomechanics and bioengineering.• Built an active business and scientific relationship between the UCHSC Spine Fellowship and the Colorado State University Department of Mechanical Engineering / Biomedical Engineering Division.• Initiated research projects that resulted in numerous scientific presentations and coauthored seventeen publications in peer-reviewed journals and three book chapters.

Bachelor Of Science, Metallurgical And Materials Engineering

Master'S Of Science, Metallurgical & Materials Engineering / Biomedical Engineering