BIOMATERIALS
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By determining material properties that are critical to an application and separating them from those that are nice to have, manufacturers can reduce design time.
(Photo courtesy NUSIL TECHNOLOGY) |
Choose a Vertically Integrated Supplier
Vertically integrated companies control the supply chain from initial precursor substances to final materials production. Suppliers with this capability can offer traceability, accountability, quality, consistency and safety.
Device manufacturers typically incur long and costly product development and regulatory processes, notes Michael Callahan, President, Invibio Biomaterial Solutions (West Conshohocken, Pennsylvania, USA). “Costly requalification can be avoided by selecting a biomaterials supplier with a history of stable and consistent manufacturing and long-term material supply and support.”
Consider the Source
It is important to know the medical uses of the supplier’s materials and match them to your needs, says Robert S. Ward, President and CEO, DSM PTG (Berkeley, California, USA). “For instance, does the supplier approve medical uses of his materials for in vitro or ex vivo use, for subchronic or chronic in vivo use?” explains Ward.
A track record of biocompatibility and regulatory approvals is critical to device manufacturers, surgeons and patients. Using a proven and widely accepted biomaterial and supplier can minimise risk and reduce costs.
Get the Vendor Involved Early in the Process
“It is always wise to get your materials supplier involved at the early design stages of the product,” says Curtis P. Smith, PhD, Principal and Director of R & D, New England Urethane Inc. (North Haven, Connecticut, USA). “The supplier can offer counsel on better processing procedures and alternatives, along with processing nuances, so you end up with a better end product.”
“Also, revisit the process with some frequency to determine if unconsidered or nonessential properties are of some significance,” suggests Steve Bruner from NuSil Technology (Carpinteria, California, USA). “You want to determine if the supplier can adjust to smooth lot-to-lot transitions.”
Draw Your Property Lines
Bruner notes that it is tempting to specify the best overall properties of materials in the design process, but designers will find that typically this is not possible and, if it is possible, definitely not cost-effective. Many property requirements entail trade-offs. “Deciding which properties are critical, and separating them from those that are nice to have, is essential for reduced design time and optimal in-process and in-device performance. In addition, do not forget uncured properties.
“It is also important to understand how a biomaterial varies in physical properties from lot-to-lot,” Bruner adds.
Maintain a Paper Trail
When dealing with polymeric biomaterials, it is critical for device designers to seek out suppliers who can provide comprehensive technical data and support, especially regarding regulatory matters. Documentation should be extensive, providing all critical and pertinent information on the materials’ manufacturing details and comprehensive testing data.
Insist on an nondisclosure agreement
Although it may seem obvious that a nondisclosure agreement (NDA) should be a priority, it is amazing how many companies neglect this issue, says Smith. “Insist on an NDA, especially for new applications.”
