Facts at a Glance

Company: Start-Up Company
Challenge: Perform a clinical trial without having to perform long-term testing
NAMSA Approach:

  • Biological Safety Evaluation Plan
  • Toxicological risk assessment

Results: The plan enabled the company to enter clinical trials without the delay of lengthy implant and chronic toxicity studies.

CHALLENGE

A startup company submitting an IDE consulted with us to obtain approval for clinical trials on a permanent implant device prior to performing any biocompatibility testing. It was critical for the firm to get into clinical trials to secure its next round of funding, and the timeline was not conducive to performing long-term biocompatibility testing.

NAMSA’S APPROACH

We prepared a comprehensive biological safety evaluation plan and biological risk assessment for the company’s materials, processes, and final device. This plan and report were submitted to the FDA with short-term biocompatibility testing.

OUTCOME

This approach enabled the company to enter clinical trials without the delay of lengthy implant and chronic toxicity studies. At the pre-IDE meeting, the FDA was very responsive and granted approval to move forward. Additionally, the FDA was receptive to a biological safety plan that required minimal testing and substantially less money. Most importantly, by using a comprehensive biological safety evaluation plan and risk assessment, the company was able to shave several months off its timeline for entering clinical trials and secured its next round of funding.