Suppliers to medical device manufacturers don't face the same stringent government regulations that their customers must adhere to, but those who have quality systems in place have an advantage over competitors who don't.
Michael Plishka, an engineering specialist for Baxter Healthcare's Device Center of Excellence in Round Lake, Ill., talked about the pressures on device manufacturers and the requirements they in turn have of their suppliers during a presentation at the International Silicone Conference. The event was held April 8-9 in Chicago in conjunction with the International Rubber Molding Conference.
Plishka said device manufacturers are under increasing pressure to develop devices that are ``safe, clinically effective, more cost-effective and launched in record time.'' Regulations from the U.S. and other governments place the ultimate responsibility for the safety and efficacy of the devices on the manufacturers, and as a result those companies are required to have quality systems which allow them to be proactive in getting a product to market and reactive to quality problems as they occur, he said.
The quality systems also assure that the raw materials-including silicone and rubber-used in the device will perform as needed in the intended environments, Plishka said. While suppliers are not required by regulations to have quality systems in place, the materials' importance makes it preferable and practical in the eyes of the medical device manufacturers, he said.
Suppliers should be concerned primarily with two aspects of a quality system: traceability and process control, Plishka said. In other words, there should be procedures in place to guide material inspections and manufacturing-process control-and proof that the processes were followed correctly-traceability-he said.
If there are problems with a manufacturing process or a product, the medical device manufacturer should be able to come back to the supplier and see the conditions under which a specific lot of raw material was produced, Plishka said. Suppliers should be able to ``say what they do and do what they say,'' he said.
Quality systems must be transparent as well, Plishka said, because it's likely a device manufacturer will audit a material supplier's systems before starting production.
In addition to quality systems, suppliers can offer other services to a customer to make them more competitive. An important service is providing biocompatibility data, Plishka said.
Because many medical products will be placed into-or will be in contact with-the human body, any materials used must pass tests for biocompatibility, he said. While choosing the level and type of testing is the device manufacturer's responsibility, in the early stages of product design the materials are evaluated not only on mechanical properties but their ability to pass biocompatibility and toxicity tests, he said.
Suppliers are at a competitive disadvantage if they cannot provide biocompatibility data for their materials, Plishka said. Manufacturers prefer testing according to the guidelines of IS0 10993-a set of standards for evaluating the biocompatibility of a medical device-or the corresponding Food and Drug Administration guidance document, he said.
Costs for that testing, however, can be quite expensive, Plishka warned. An alternate method to get a relatively quick basic understanding of a material's biocompatibility is to test it through U.S. Pharmacopeia Class VI standards, he said. This method tests extractables as well as the body's reaction to the implanted material.
The Class VI testing is not the most thorough, Plishka said, but a material that passes it is more likely to pass the more rigorous tests and also more likely than a material that has not been tested to be used in a medical device design.
Medical device manufacturers are aware of the financial impact of a material suppliers' becoming compliant, and expect to be charged more if a given supplier has a good quality system, tests its materials and documents and shares the results, Plishka said. As quality systems become more common and the field is leveled, suppliers must find other ways to add value and ``make them stand out from the crowd,'' he said.
Becoming a ``working partner'' with a medical device manufacturer is the best way to do this, Plishka said. ``If a supplier only sees itself as a supplier, its responsibility to the customer ends when the raw material is supplied,'' he said. ``However, if a supplier sees itself as a vital link in the chain of quality health care, the relationship with the MDM will grow naturally and in a mutually beneficial way.''