Oct 20, 2009

DSM Somos Brings Speed, Efficiency to Medical Device Prototyping

First Stereolithography Resins to Meet ISO 10993-5 and ISO 10993-10 Medical Standards.

Elgin,IL: DSM Somos announced today that two of their best selling materials, WaterShed®XC 11122 and ProtoGen™ 18420, have become the only currently available SL resins to meet ISO 10933 standards for use in medical device applications. The announcement came after Watershed® XC 11122, a clear, water-resistant SL resin and ProtoGenTM 18420, a white, ABS-like General purpose resin, received ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and ISO 10993-10 Irritation certifications.

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