SIn the fight against breast cancer, women can perform self-examinations to note any changes in their breasts. Now, new life-sciences company PWB Health Ltd from Dumbarton, Scotland has introduced, here at MD&M West, the award-winning Breastlight, a home-use device that makes it easier to perform self-examinations by literally shining a light on breast tissue to illuminate internal changes. To optimize the performance and durability of the Breastlight, SABIC Innovative Plastics’ Lexan* and Cycoloy* healthcare resins are used in the housing and lens of the device. These medical-grade materials, combined with value-added technical and design services provided by SABIC Innovative Plastics, helped PWB Health bring the Breastlight to market quickly – giving women a powerful new tool as part of their regular breast awareness routine.
Wideblue, PWB Health's design and development partner won the Innovation and Design Excellence Award (IDEA) 2008 for their work on Breastlight. The Breastlight is being exhibited here for the first time in the United States at SABIC Innovative Plastics’ booth #2209 at MD&M West. This device is an example of how SABIC Innovative Plastics, a pioneer in the development of advanced material solutions, works side by side with its customers as long-term partners to help them deliver business success.
Robin Sayer, Wideblue's product design leader, noted that as a new life-science start-up, PWB Health needed more than just the right materials. “We were looking for world-class suppliers with strong expertise in the medical device field who were willing to spend extra time to help us with technical and regulatory issues. SABIC Innovative Plastics and our production partner, Carclo Technical Plastics, provided a wide range of assistance, including design suggestions, background on biocompatibility and healthcare regulations, and services such as express color matching with quick material delivery. The resin was specially formulated to block red light and SABIC Innovative Plastics was able to provide a healthcare grade of polycarbonate/acrylonitrile-butadiene-styrene (PC/ABS), which was biocompatibility assessed. As a result, SABIC Innovative Plastics played a key role in making the Breastlight a success.”
Creating a Durable, Attractive Consumer Healthcare Device
To create the Breastlight, 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, the company wanted a tough, impact-resistant resin. A bright white color was specified, but at the same time this light colored 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.
Breastlight has been approved for sale in Europe and Canada and is currently under review by the Food & Drug Administration (FDA) for sale in the United States.
A World-Class Portfolio of Medical Resin Grade Materials
From its large portfolio of medical resin grades, Cycoloy* PC/ABS resin was selected for the housing components of the Breastlight. Cycoloy* resin, which is assessed to ISO10993 standard for biocompatibility, offers excellent impact resistance for durability and a high flow for thin-wall molding. It also offers the ability to incorporate special opacifiers without deteriorating mechanical properties. SABIC Innovative Plastics color-matched the desired white shade at its ColorXpress* facility in Bergen op Zoom, The Netherlands.
For the lens, Lexan* polycarbonate resin provides optical clarity, impact resistance and the ability to be ultrasonically welded to the housing. This grade is also assessed to ISO10993 standard for biocompatibility.
“The medical device market is a key focus for SABIC Innovative Plastics,” said Rob de Jong, product market leader, Europe, SABIC Innovative Plastics. “We have developed a large number of high-performance plastics that comply with FDA regulations and European Food Contact legislation and offer important performance and aesthetic properties for home-use and personal well-being devices, as well as traditional in-patient products. In addition to our growing healthcare portfolio, we also provide global technical resources that can help start-ups such as PWB Health Ltd and other firms bring important new devices to market more quickly.”
SABIC Innovative Plastics has implemented a “healthcare product” policy as a service to its customers. Products that are part of this policy have been assessed for biocompatibility, are covered by a FDA Drug Master File, and are subject to formula lock and a stringent management of change process.
For additional information on SABIC Innovative Plastics’ healthcare grade resins, please go to www.sabic-ip.com.
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