Combined, our technical consulting team leverages over a century of successful product commercialization experience to support our client’s rapid navigation through the challenging development, clinical trial, regulatory submission, and post market evaluation stages in this dynamic and competitive global medical device market.

Whether using Fathom Engineering as a complete turnkey product development partner, or as a supplement to your existing team, we support your complex 510(k) and PMA development activities including:

  • design optimization for
    • safety
    • efficacy
    • manufacturability
    • differentiability
    • cost
  • failure analysis
  • project management
  • material selection
  • specification and protocol creation
  • verification and validation activities
  • supplier qualification
  • manufacturing scale-up
  • quality systems design

Our network of affiliate testing laboratories can be utilized to test iterative designs for functionality, or frozen designs for demonstration of acceptable performance, biocompatibility, and safety in support of your regulatory submission and/or litigation.

Fathom's engineers have consulted for most of the major medical device companies in the United States including:

  • Medtronic, Inc.
  • Zimmer, Inc.
  • Oral-B (Procter & Gamble)
  • Cordis Corporation
  • ICU Medical, Inc.
  • Cook Medical
  • Covidien
  • Abbott Laboratories
  • W. L. Gore & Associates, Inc.
  • Alcon
  • Stryker
  • Boston Scientific
  • Terumo
  • Ormco
  • Dentsply International, Inc.
  • 3M
  • Edwards Lifesciences Corporation
  • St. Jude Medical, Inc.
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