The medical field is an evolving environment of more complex therapies and stricter regulations, and that translates into more opportunities for new materials to meet those demands.
Thomas Hutchinson, senior director of new products for pharmaceutical giant Pfizer Inc., discussed the expectations product companies have for their suppliers in the regulation and opportunity areas during a presentation at the ACS Rubber Division's first-ever TPE Conference, held May 11-12 in Akron.
The regulatory requirements for medical products-and thus the materials being used to make them-are driven by the classification of the product being evaluated, Hutchinson said. The classifications include pharmaceutical, medical device/diagnostic and biological.
These regulations were developed from the perspective of safety, efficacy and associated risk to public health, he said.
Within each class, the specific areas of interest to thermoplastic elastomer suppliers depends on how the material is used in the medical product-for example, as primary or secondary packaging or as a functional component, Hutchinson said. Typical areas examined are the material's physical performance/functionality, stability, toxicology and the presence of leachables or extractables.
The U.S. and European Union also have quality system requirements to be met. The U.S. has good clinical, laboratory and manufacturing practice standards, and specific federal regulations for drugs, biologics and medical devices, Hutchinson said.
The EU has its own rules and standards governing medicinal products as well.
Applicants for new product acceptance must have a thorough understanding of performance/functional characteristics of all materials in the application, including sealing, strength and the presence of particulates, Hutchinson said. They also must have a feel for the impact of various scenarios on the material's stability and the consequences of leachables and extractables, he said.
He said the applicant must have a complete history of all materials, components and process changes associated with clinical and commercial lots used, and demonstrate a state of control for the components, processes, testing and manufacturing methods, changes and post-approval activities.
Issues on a global scale for suppliers to consider include increasingly sensitive methods for detecting potential impurities in materials and rising levels of attention given to the identification and management of genotoxic impurities, Hutchinson said.
There are product development challenges out there as well, as the complexity of health care industry's products continues to increase, he said. In particular, the drug-delivery technology arena is expanding in areas such as implants, transdermal and pulmonary applications, extended infusion and subdermal pumps.
While the regulations and challenges are many in bringing a product to market, the opportunities are there for companies along the supply chain, Hutchinson said.
Pfizer has about 200 products in the development stages at a given time, and typically about 20 to 25 percent use elastomers, he said.