EdgeOne Medical Inc.

About EdgeOne Medical Inc.

Since 2012, US-based EdgeOne Medical has been the only independent Contract Device Development firm with it's own device development & testing labs supporting top pharma/biotech/drug delivery platform companies (including 11 of the top 20 global pharma). Our mission is to get our client's combination product device component compliantly developed/tested per the FDA regulations and to avoid unnecessary device development delays in getting to commercialization.




Scott Ariagno & Jim Leamon will co-present "Simulating Back Pressure during Device Verification Testing" Feb. 1 @ 10:10am CET

  • US
  • 2022
    On CPHI since
Contact info
Meet us at

Pharmapack Europe 2025

Paris Expo, Porte de Versailles - Hall 7.2 | Paris, France
22 Jan 2025 - 23 Jan 2025

EdgeOne Medical Inc. Resources (2)

  • Webinar Pitfalls in Combination Product Verification Testing

    Design Verification (DV) testing is the critical point in a Combination Product development program when all activities converge to generate the performance data necessary to support a successful regulatory filing. Any failure or delay during the DV stage of program has the potential to directly impact submission filing dates and initiation of clinical trials or commercial launch. Based on EdgeOne Medical’s extensive experience with design verification testing, this technical talk will highlight some key pitfalls that we’ve had to help our clients navigate to achieve success with their testing programs: test method validations; sample sizes and setting design input requirements.
  • Webinar Simulating Injection Back Pressure in Design Verification Testing

    Ability to achieve successful injection of drug or biologic depends on many factors including but not limited to needle diameter, drug viscosity, spring force, lubrication, plunger geometry and material properties. One additional challenge to be considered during verification of the drug delivery system is effect of back pressure from the patient (tissue). This talk will highlight various options and/or considerations for back pressure during feasibility and design verification testing. Concepts are broadly applicable to pen/auto injectors, on body delivery systems, pre-filled syringes and other delivery systems.