Sensible Approach to Biocompatibility

I have quite a bit of experience with medical device product development. Most of my experience, though, came from a large, private, well-funded, well-established medical device company with a plethora of resources to support every aspect of product development.

My current data point is in process and with a start-up medical device company. Every decision made and dollar spent needs to support absolute needs. Too bad medical device product development has lots of gray and is not as simple as black and white.

One sometimes gray topic is biocompatibility. The start-up device intended use is fuzzy and does not fit with ISO 10993 biocompatibility test matrix. We have speculated about possible fits. The trouble is the potential testing is quite lengthy and very, very expensive. And some of the test descriptions just don’t make sense.

We have received some great advice from a biocompatibility expert. He suggested risk assessment would be ideal for our device application. I think this seems very practical.

Biocompatibility practicality is also the subject of this article from MD&DI. Chemical characterization is another possible approach to address biocompatibility. Bottom line: make sure testing is value added and necessary.