Simulating Injection Back Pressure in Design Verification Testing

Overview of EdgeOne Medical's Services and Track Record

Learn about Scott and discover the critical role EdgeOne Medical plays as a Contract Device Development Organization in the drug delivery ecosystem

Hear from the founder on how EdgeOne Medical delivers crucial services for leading and supporting device development programs and organizations.

An overview into the current state and future of connectivity in drug delivery and pharma

When incorporating digital and connected health technologies into device/combination product development, several critical factors must be carefully considered. First, identify the key stakeholders’ motivations and needs, then select the technology that aligns with those needs and finally define the product specifications and design requirements. This discussion will cover the essential elements that require thoughtful strategy planning and integration to supplement your product development plan.

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.