EXECUTIVE PAGES
Biomedical Textiles Quality Matters Creating Value with Biomedical Textiles Leads to Innovative Quality Practices By Carola Hansen, Business Manager for Dyneema Purity® fiber of DSM, and Kevin Johnson, Director of Quality Assurance and Regulatory Affairs, Biomedical Structures LLC Over the last few years, much of the innovation in the medical device industry has been fueled by advancements in fiber and other textile technologies specifically designed for use inside the human body. These medical textile breakthroughs have supported a broad array of implantable devices ranging from vascular grafts and surgical mesh to heart valve components and orthopaedic sutures to fabric scaffolds designed to aid in tissue engineering. The fabrics these applications are built upon help deliver more life-like products with the potential to perform better, last longer, and increase comfort in the body - all of which can potentially significantly improve outcomes for patients.
To fully capitalize on new materials for device applications, it’s critical for textile developers and yarn manufacturers to make quality their No. 1 priority.
Medical-grade Materials —The Fabric of the Future These advantages, along with the growing concerns around more traditional implantable materials such as metal, are causing medical device companies (MDCs) to consider textiles for more device projects than ever before. But as demand for medical textiles grows, so too does the concern about the quality of these materials and the controls implemented by the companies that process them. Many traditional materials developers and textile manufacturers, seeing a promising business opportunity, are attempting to expand into medical textile development and processing, often without the necessary medical focus or expertise. While MDCs’ interest in and reliance on these innovative new materials has increased exponentially over the last decade, they nevertheless have only scratched the surface of their potential in device applications. To fully capitalize on them, however, it’s critical for textile developers and yarn manufacturers to make quality their No. 1 priority so that evolution is not hindered or slowed by concerns about these promising materials’ performance. MDCs attempting to manage the unprecedented regulatory and economic challenges of the current environment, and simultaneously trying to meet growing surgeon and patient expectations, have to carefully balance investment in new technologies with intensive risk mitigation. Manufacturing partners that fail to meet the highest quality standards won’t just compromise their own business prospects, but also will hamper the development of one the most exciting industries within the med-tech sector. As partners to the world’s most innovative MDCs, DSM and Biomedical Structures LLC are acutely aware of the challenges associated with med-tech development and are intently focused on the development and promotion of the quality practices for materials that not only support the successful commercialization of groundbreaking textile-based medical devices, but also raise the bar for the entire medical textile industry. That top-tier quality management is so top of mind for MDCs today is hardly surprising. With aging populations increasing product demand, economic volatility tightening margins, and political reforms heightening regulatory oversight, MDCs are under increasing pressure to bring innovative, better-performing products to market quickly and successfully. NCM-JULY 2013 20