Scientific & Engineering Consulting Services for Medical Device Development
Company Overview & Expertise

 We offer scientific and engineering consulting services in the following areas.

  • New Clinical Opportunity Identification
  • Strategic Opportunity and Technology Assessment
  • Design & Development planning
  • Device-Tissue Interfacial Design Problems
  • Tissue biomechanics and biologic interactions (mechanobiology)
  • Mechanical Design and Materials Selection
  • Failure prevention strategies in devices and materials (polymers/ceramics/metals)
  • Advanced Biomaterials based device development & testing strategies
  • Sub Failure & Failure Mechanics of advanced polymeric materials and biological tissues
  • Pre-design controls phase concept feasibility assessment
  • Verification testing strategies
  • Developing justification documents for support of Design Inputs, Design Outputs, Design Verification Testing, Preclinical studies, and Clinical Trials.
  • Preclinical study design, management, and study interpretation
  • Supporting 510k, pre-IDE/IDE, and PMAs
  • Developing the scientific basis and mechanism of action messaging for new novel technologies
  • Training sales staff and clinicians/KOLs on mechanism-of-action of new products
  • Product/device/material failure investigations
  • Litigation support (analysis and testing, evidence review, event simulation)
  • Expert witness testimony for product liability and medical malpractice cases involving devices.


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