Biocompatible Rapid-Prototypes

If you are developing a patient-contacting medical device, biocompatibility is likely something you’ll need to address. In the past 10 years, biocompatibility requirements, testing, and standards have evolved. The harmonized standard is the ISO 10993 series.

Anyway, talking about biocompatibility standards and testing is not the reason for this post. I just read about stereolithography resins that reportedly meet parts of ISO 10993. From Medtechinsider:

Stereolithography (SL) resins WaterShed XC 11122 and ProtoGen 18420 from DSM Somos reportedly are the only SL resins to meet ISO 10993 standards for use in medical device applications. The clear, water-resistant Watershed XC 11122 and white, ABS-like ProtoGen 18420 resins are certified to ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitisation) and ISO 10993-10 (irritation).

Why is this big news? If you are an early-stage medical device company developing a product that incorporates plastic parts, chances are you’re looking into injection molding and/or machining. And chances are you are already planning on getting some stereolithography or other rapid-prototype parts. Imagine if you could use these rapid-prototypes in their end use environment, possibly even for some pre-clinical and clinical testing without cutting any tooling? Rapid-prototypes are not cheap. But neither is cutting a tool for a part whose design has not been validated by end-users.