Medical Device Link.

INDUSTRY INTELLIGENCE: Tough Decisions

Touted as a new tool in the fight to prevent breast cancer, the Breastlight from PWB Health Ltd (Dumbarton, Scotland) makes it easier to perform self-examinations at home by literally shining a light on breast tissue to illuminate internal changes. It was exhibited for the first time in the United States at the recent MD&M event in Anaheim, CA, by Sabic Innovative Plastics (Bergen op Zoom, Netherlands). Thomas F. O’Brien, Industry Manager – Healthcare, at the company’s world headquarters in Pittsfield, MA, took the opportunity to describe Sabic Innovative Plastics' contribution to this award-winning product.

“PWB and its design and development partner Wideblue, also based in Dumbarton, got in touch with us early in the process,” says O’Brien. The application requirements for the material were substantial—a high-flow resin was needed for the thin-walled housing and a crystal-clear polymer was specified for the lens, both of which had to be impact resistant—but the early involvement allowed Sabic Innovative Plastics to prepare a thorough customer-needs map. “We were able to focus on finding the most suitable materials and adding value to the project by providing technical and design services,” notes O’Brien. “Too often, companies call in suppliers after many of the important design decisions have been made,” he adds. “Under those conditions, we may be trying to force-fit a material into an existing design, which doesn’t always work as well.”

Impact resistance was a primary concern for the manufacturer of the Breastlight. “The device is typically used in bathrooms, which tend to have tile floors, so that is an important property in case the device is dropped,” explains O’Brien. Since this is a home-care product, aesthetic qualities were also high on the list. A bright white colour was specified, but at the same time this light-colored resin needed to minimize light seepage from the high-power red LED bulbs that illuminate the breast tissue. Finally, to keep the device as lightweight as possible, the walls had to be relatively thin, which required a high-flow resin. For the Breastlight lens, the company specified a crystal-clear material that could withstand ultrasonic welding. A Cycoloy PC/ABS resin was used to mould the housing while a Lexan PC resin was chosen for the lens.

Both materials feature excellent impact resistance and are assessed to ISO 10993 for biocompatibility, explains O’Brien. Moreover, opacifiers can be integrated into the Cycoloy resin without affecting its mechanical properties. (The resin was specially formulated to block red light.) Sabic Innovative Plastics colour-matched the white shade requested by the customer at its ColorXpress facility in Bergen op Zoom.

Commercially available in Europe and Canada, the Breastlight is currently under review by FDA for the US market. Wideblue won the Innovation and Design Excellence Award (iDEA) 2008 for its work on the product.

www.sabic-ip.com