Contact Information

  • Additional States: New Jersey
  • Phone: (248) 971-5427
  • Cell: (201) 927-5091
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Specialties & Experience

General Specialties: Medical Devices and Products Liability

Specialty Focus: medical device, implant,bone graft,orthopedic, vascular grafts, collagen, biomaterials, hydrogels,FMEA,FDA, CE Mark, Design Control, ISO13485: CAPA, biocompatibility testing, spine, spine fusion, chemical analysis, chemical characterization, sterilization, ethylene oxide, wear debris, 510k

Education: PhD, Washington State University & Tulane University; BS, University of Wyoming

Years in Practice: 28

Number of Times Deposed/Testified in Last 4 Yrs: 2

Additional Information

Medical device expert with PhD in Chemistry and 28 years experience. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial for product liability and patent cases. Authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Have worked in all areas of product development from conception, design, design validation, design transfer, production and commercialization. Responsibilities included preclinical safety, chemical analysis, residual testing, biocompatibility ISO 10993, static/ fatigue biomechanical testing. Invented and commercialized an FDA, 510k cleared product. Invented and launched minimally invasive spine products sold in Europe under CE Mark. Wrote Clinical Evaluation Reports and biological safety for EU MDR 2017/745. Recertified production facility to ISO 13485:2016. Familiar with histological findings and histology processing methodology. In PhD training, performed organic and organometallic synthesis, chemical characterization and kinetics. Have extensive prior experience with HPLC, GC, GC-MS, UV, IR, and chromatography for purification of biomolecules, gel electrophoresis, western blotting, thin layer chromatography and chemical kinetics. Developed collagen based products for bone reconstruction, bone grafting and vascular graft coating. Developed sales training methods and gave presentations to investors, physicians and sales personnel. Developed protocols for clinical trials. Raised 25 million in venture capital.