The new ISO certifications underscore the continued growth of DSM Somos as a leading provider of innovative additive fabrication materials for Life Sciences applications. 

“Passing ISO 10993 testing reflects DSM Somos’ commitment to meeting the medical devices industry's demanding quality standards related to biocompatibility,” says DSM Somos Marketing Manager Vince Adams.  “This ISO certification also demonstrates that use of Watershed® XC 11122 and ProtoGen^™ 18420 contributes to the ability of medical device developers to minimize product development risks and maximize their prototyping confidence."

Implications for the Medical Device Industry

In the 5,000+ companies throughout world that currently develop medical devices, success is all about speed—that is, the speed in which new and improved devices can be tried, tested, and introduced to the market.

Using traditional prototyping methods that most medical device companies are currently familiar with (such as micro-machining and vacuum casting), it can take several weeks or even months to create a new prototype. 

"Until now, medical device producers have been largely unfamiliar with stereolithography (SL) as a prototyping technology," says Adams, "which is not surprising, given that SL materials have, to this point, only been suitable for limited exposure to the human body and not qualified for biomedical applications.  When we explain to these companies that they can now use SL to develop a prototype in a few days vs. 1-2 months, and that it's going to be functional, not fragile, they're pretty excited." 

Watershed^® XC 11122 and ProtoGen™ 18420 can now be recommended for use in medical device applications that include:

• Medical Device Prototypes
• Anatomical Modeling
• Investment Casting patterns (to produce implantable hip and knee joint replacements)
• Hearing Aide Device Manufacturing
• Surgical and Dental Drill Guides

DSM Somos®, a world leader in the development of advanced stereolithography (SL) materials announced USP Class VI approval for their WaterShed® XC 11122 resin—a clear, water-resistant material already widely used in the medical device industry. The classification officially approves the resin for use in a wide range of biomedical or skin contact applications.

Developing advanced biocompatible SL resins for the medical industry is becoming increasingly important. According to Wohler’s Report 2008, the medical/dental industry is the third largest industry for additive manufacturing after consumer products/electronics and automotive, but growing at a faster rate than either. 

“Due to its functional properties and high dimensional stability, WaterShed XC has already been widely used in the medical industry for prototyping clear medical device housings and fluid flow analysis models,” says DSM Somos Product Manager Brian Bauman. “The new USP Class VI approval now opens up new applications, including prototypes to be used in clinical trials.”

Introduced by DSM Somos in 2007, WaterShed XC has quickly become the best-selling clear SL resin on the market, with its winning combination of clarity, durability and high dimensional stability.  By adding the biocompatibility component, medical design engineers now have a way to produce exceptional ABS-like prototypes that are USP Class VI approved.