DSM stands ready to help innovative device designers improve performance in a variety of existing and emerging application areas, and growing demand has prompted the company to expand its production of Dyneema Purity® fiber to its Greenville, NC, facility. Designed to best-in-class quality and manufacturing specifications and guided by customer input, the facility supports a world-class medical manufacturing capability and is set to begin releasing product in the first quarter of 2012. Like all of DSM’s facilities, the Greenville plant is clearly differentiated from those of other materials players in the market by its focus on providing products of the highest quality that comply with ISO13485:2003 quality standards. Material Master Files of DSM products have been submitted to both the FDA and notified bodies in Europe.
While the materials you start with are critically important, of course, the ultimate market acceptance of a finished implantable device utilizing novel biomaterials rests on myriad factors, including how the material is processed.
A Best-in-Class Material Requires a Unique Processor
As a company that applies sophisticated processing techniques to the fabrics selected by MDCs for their new device projects, Biomedical Structures knows well how dramatically the commercialization prospects can be compromised when MDCs align themselves with those materials fabricators that don’t have the quality systems in place to support what will ultimately become the device history file for that product.
Biomedical Structures meets all the top-tier quality standards, including clean-room facilities, adherence to cGMP protocols, operation and validation to ISO 13485, high-level documentation, and other requirements necessary for a product’s regulatory submission and approval. Yet the contract manufacturer also has a key differentiator.
Unlike other processors that specialize either in R&D or manufacturing, Biomedical Structures offers a comprehensive suite of processing services to MDCs that support everything from the MDC’s design development and proof-of-concept stages all the way to full production. This approach represents a more complex and challenging business model, but Biomedical Structures believes, given the growing complexity of the quality and commercialization landscapes, that MDCs are better served this way.
Biomedical Structures’ unique position in the industry also underscores its commitment to the quality practices that ultimately support the needs of its end customers. By participating in all phases across the device development spectrum – from product conception to prototype development to manufacturing – Biomedical Structures helps customers eliminate the quality pitfalls that can occur when an MDC transitions from the R&D stage to product manufacturing. If one company supports an MDC through the product design and FDA approval processes and then the MDC enlists another company to manufacture the product, the MDC must bring the manufacturer through the entire learning curve of the design and establish all the appropriate quality controls to ensure the production of a quality end product. Because of the complexity of the process, critical elements can be overlooked during the transition, ultimately causing delays to the product release timeline or worse: quality issues that occur postrelease.
Creating Value through Quality
DSM, in fact, believes that quality management is not just an exercise in meeting regulatory checklists, but more importantly a core business responsibility that permeates the entire value chain. Manufacturers must gauge their customers’ requirements and plan their quality management approaches accordingly. For DSM, that entails understanding what the MDC wants and knowing how to translate that through the materials it supplies and the critical processes it employs. For DSM, quality management is not just about compliance – although that’s critically important – but also add value for MDCs.
Biomedical Structures is similarly focused on designing the quality approaches that provide long-term value for clients. For all the players in the medical device development cycle, the landscape is significantly more challenging than it’s ever been. But the need for innovative new devices that perform better and bring more cost efficiency into the healthcare delivery system is also at a peak point. Companies like DSM and Biomedical Structures, with their focus on quality and on supporting MDCs through this highly complex process, are doing their part to fuel the cycle of medical innovation and make way for the groundbreaking products and treatments to address unmet clinical needs and, ultimately, improve patient outcomes.
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