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As part of the diverse client and product mix in our company, there are several medical technology products under development. In discussions with clients, the question occasionally comes up as to whether we have obtained ISO 13485 certification status. ISO 13485 outlines requirements for quality management systems for the design and manufacture of medical devices. The implication is that a product development (PD) professional services company needs this certification in order to design and deliver a production-ready product design. But in reality, a product development services firm does not need to have its own certification. The client—the party responsible for the end product—needs to obtain certification. To this end, there are key skills and characteristics on which companies need to focus in a product development partner.
The issue all boils down to three essential facts:
1.) The client needs to own the quality system.
When it comes to certification, the client who owns the product needs to have its own quality management system, regardless of any downstream partners. When it comes to product liability and ultimate product certification, the FDA will be looking into the records of the company that sells, distributes, and supports the product. While there are generally common requirements for each class of medical device, there can also be variability from company to company in the specifics of how they structure their quality management system (QMS). There are tools that help facilitate here, but the most critical thing is the company’s QMS—not a QMS in place at a PD partner.
2.) The product development partner needs to learn the client’s quality system.
Engineers and designers are smart people. None of us were born with innate knowledge of a particular QMS. Any technical professional with a good head on their shoulders can learn the tools and techniques of a company’s QMS. In a variety of industries employing ISO 9000 systems, or in Department of Defense projects involving MilSpecs, engineers and designers often come to the industry with no knowledge of the specifications because this can be learned in days or a few weeks. That is the nature of such specifications. ISO 13485 systems, as well as the numerous other applicable regulations and standards, are no different.
The PD partner can easily learn the nuances of the client's QMS and, similarly, readily learn to capture and load the required artifacts into the client’s database. In so doing, the evidence and design data will then reside where it belongs—in the client’s system and not an external system, even if such an alternative is a valid system. It is the client’s system that must reign supreme. Ultimately, all design artifacts have to be approved by the authorized individuals representing the company marketing the device.
3.) The partner needs design and engineering excellence.
While any good designer or engineer can learn to work within a client’s QMS environment, the inverse is patently not true. Having intimate knowledge of a QMS does not make someone a good engineer or designer. Becoming an expert in using a QMS is a short-term and simple process. Building PD expertise takes years of formal education, product development experience, creativity, and talent (some of which cannot even be taught).
In a top PD services firm, the focus is on creativity and competence. An excellent PD team must possess the medical device development experience to be fully cognizant of the need to assess and manage risk throughout the development process, while also strictly adhering to the QMS of record.
There are medical product clients engaged with PD firms who did not have a QMS when they arrived. (This is often, but not always, the case with startup firms.) When PD teams encounter this situation, it’s important to educate clients on the need for them to own a QMS within their company and then, if needed, to engage them with folks from the PD team or external resources who can help them create their own QMS. A quality product development service firm can then work within the rules and tools of the client’s QMS.
It’s important for a PD firm to come to the table with what the clients need—a top-notch team of designers and engineers who are experts in their technical fields. These engineers have the expertise to understand the subtleties of use case/user experience and to develop creative, practical, and reliable solutions to highly complex problems. They analyze solutions and discern the ones that satisfy the requirements and then execute on the design. The QMS is table stakes. A qualified PD team easily attains the knowledge necessary to manage within any client’s system.
Mitch Maiman is the President and Cofounder of Intelligent Product Solutions (IPS). He honed his deep knowledge of product design on the strength of a 30-year career with companies that manufacture commercially successful products for the consumer, industrial, and DoD markets. Prior to launching IPS, Mitch was VP of Engineering at Symbol Technologies. He can be reached at email@example.com.
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