How much does a complete biocompatibility test package cost?

[Alberto Ragusa]

I have recently joined this forum and hope to be in compliance with the forum guidelines. I am a medical device manufacturer and I would like to have from you if possible an idea of how much a complete set of biocompatibility tests could cost. For chemical characterization for example, the price will fluctuate a lot according to the type of device, my request concerns, in particular, the LAL test.

However, in my opinion, it would be very useful to have feedback from those who have already met the requirements of 10993. It could help me a lot to decide my strategy for the future.

Of course, the cost will depend a lot on the categorization of the product based on duration and type of contact, the device with which I have to deal is let's say the worst in terms of endpoint having a long term contact with tissues and even blood.

If anyone would like to share their experience based on cost or other info it would be very helpful for me.

 

[planB]

Alberto,

I assume you mean "complete" in the sense of experimentally investigating every endpoint proposed in ISO 10993-1:2018, Table A.1. As you correctly note the number of endpoints depends on the nature of exposure (duration) of the device and thus, also overall test cost may greatly vary. Other factors that may have an impact on cost are test considerations for specific markets (USA and Japan being one of the most prominent).

Bottom line: without knowing more specifics about your device, even a rough cost forecast is impossible. Most straightforward is to contact two dedicated test houses for quotes and compare. Cost of LAL tests may vary depending on the employed method (e.g. qualitative vs. quantitative), but are one of the cheapest (and fastest) tests in this context.

Be aware, that "just" testing the biological endpoints of table A.1 is not state-of-the-art anymore. You have to properly characterize your device in terms of chemical and physical properties upfront within a risk management process. This approach has the advantage that you can fine-tune your subsequent test strategy and experimentally address only those risks that cannot be mitigated by existing data. Thereby, you could significantly reduce time and cost while increasing compliance to the 3R (replace - reduce - refine) principles stipulated throughout ISO 10993-1.

Hope this helps,