The device is a product of collaboration. Wideblue was PWB Health‚’s design and development partner. Carclo Technical Plastics provided design suggestions, background on biocompatibility and healthcare regulations, and services such as color matching. The resin was specially formulated to block red light and SABIC was able to provide a healthcare grade of Cycoloy polycarbonate/acrylonitrile-butadiene-styrene (PC/ABS), which was biocompatibility assessed.

PWB Health had a number of application requirements, beginning with the device‚’s housing. Because the product is typically used in the bathroom where it might drop onto a hard tile floor, engineers wanted a tough, impact-resistant resin. A bright white color was specified, but at the same time the resin needed to minimize light seepage from high-power red LED bulbs. For ease of use, PWB Health wanted relatively thin walls (2 mm) to make the housing lightweight, which required a high-flow resin. Also, the material had to be a medical grade. For the Breastlight lens, the company wanted a crystal-clear material with excellent impact resistance and the ability to be ultrasonically welded.

Cycoloy PC/ABS resin was selected for the housing components. Cycoloy meets ISO10993 standard for biocompatibility and offers excellent impact resistance and a high flow for thin-wall molding. It can incorporate special opacifiers without deteriorating mechanical properties. SABIC color-matched the desired white shade at its ColorXpress facility in The Netherlands.

For the lens, Lexan polycarbonate resin was selected for its optical clarity, impact resistance and the ability to be ultrasonically welded to the housing. This grade is meets ISO10993 for biocompatibility. 

Breastlight has been approved for sale in Europe and Canada and is currently under review by the Food & Drug Administration for sale in the United States.