Med Device Online: Biocompatibility Testing Tips to Speed Your Medical Device to Market

August 31, 2023

Mention biocompatibility testing to a medical device developer, and you may evoke expressions of fear and terror. In truth, biocompatibility testing can be complex, time-consuming, and expensive. When you’re singularly focused on getting your device on the market, getting biocompatibility testing right can determine whether your device — and often, your company — will succeed or fail.

The good news is that there are proven ways to mitigate those factors and maintain your critical path to market. Boulder iQ’s Jim Kasic has outlined a few key ways to keep time, cost and stress in check in his latest article in Med Device Online.

  • How to use ISO Standard 10993
  • How Chemical Abstract Services Registry Number can speed your testing
  • How the risk analysis serves as a guide for development of your biocompatibility test plan
  • How and why to do lowest-cost tests first


These, and other tips, can save a developer tens or hundreds of thousands of dollars in out-of-pocket costs. Moreover, they can mean millions of dollars in revenue by speeding your product to market.