What we do

  • Comprehensive literature review and durability evaluation strategy

  • Cardiovascular biomechanics for device design, testing, and marketing messaging

  • Preclinical, cadaver, and clinical imaging studies to acquire boundary conditions

  • Boundary condition and reduced durability testing rationale for regulatory submissions

  • Execution of FEA and benchtop testing or working with your internal resources

  • Partnering during the entire submission process until approval (FDA, CE, PMDA, etc.)

  • Biomechanical rationale for reducing clinical trial constraints, e.g., widening criteria to improve recruitment

  • Expert services for FDA Panels, litigation, root cause, etc.

  • Clinical feedback from interventionalists (surgeons, radiologists, cardiologists)

  • Mock pre-sub review by experts and former FDA reviewers

  • Nitinol processing for optimizing fatigue performance

  • Door-to-door professor – Seasoned teacher to uplevel your team’s biomechanics knowledge