Medical Device Development Concept and Feasibility Part 2

Medical Device Development: Concept and Feasibility, Part 2

In MRO, Regulatory by Darci Diage and Therese Everson

During the feasibility phase for a medical device, the company further explores the product concept and often examines several design configurations to determine if it is feasible for the company to design, develop, manufacture and commercialize the product idea.

Testing is typically performed on prototypes to determine if the design is sufficiently robust to meet performance requirements (aka design freeze) and if it is of tolerable risk to end users.

When assessing risk, it is not only the regulated risk management process that is required (ISO 14971), but also an assessment of business risk. The assessment of what should be tested should take into account: whether the product is a new technology to the industry or your organization, if the processes required to manufacture the product are new to your organization, whether new suppliers of materials are needed and if new materials are required. These unknowns should be vetted and risks should be identified and mitigated before finalizing the product design and launching into verification and validation testing.

A question you may have is, “How many samples should be tested during concept and feasibility?” The answer is, enough to make you feel comfortable but not excessive to minimize the cost of testing. Sample sizes may be 3, 5, 10, 15 or 30 depending on the newness of the product and the history of use in the past.

Regardless of the sample size, feasibility testing is best performed on a product that is as close to finished as possible. Sterilized products which are representative of the finished device are ideal. If attainable, fully assembled products are best, but subassemblies may be acceptable if no downstream assembly or manufacturing processes modify the subassembly.

Another key aspect of feasibility is the importance of maintaining traceability. Although it is still early stage development and testing, parts and designs need distinguishing identifiers (e.g. lot numbers, serial numbers) and revision control. What’s the purpose of testing if you don’t know what was tested? Test failures and successes alike are valuable data, but without traceability to the design configuration that was tested, you might as well not be testing at all.

Finally, planning is important during feasibility. The plan can be dynamic and fluid; not set in stone. Planning the framework, project scope, desired outcomes and responsibility will ensure efficient and productive feasibility outcomes. Small efforts upfront to lay out a plan will result in larger payoffs down the road and ultimately lead to smooth, seamless, stress free verification and validation testing.

Concept and feasibility stages while not required, are very important steps during design and development. Information gathered and testing completed during concept and feasibility minimize product risk during product development and prevent unexpected test failures during design verification and validation testing. Taking time early in design and development to explore the concept and ensure that it is feasible can save costly delays due to product redesign and retesting.

Please look for the next post in this series, Medical Device Development: Design Validation and Preclinical, Part 1.

You can view Part 1 of Medical Device Development: Concept and Feasibility here.

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Authors:

Darci Diage, a Principal Medical Research Manager at NAMSA, holds a Masters of Biomedical Laboratory Science from San Francisco State University and a Bachelors of Science in Molecular Biology from Sonoma State University. Her primary expertise is in the areas of medical device quality and regulatory compliance with over 16 years of experience in the medical device industry focusing on manufacturing, design control, risk management and concept to commercial product development activities. Ms. Diage holds an ASQ Lead Auditor Certification and is currently a member of the American Society for Quality (ASQ).

Therese Everson, a Senior Principal Medical Research Manager at NAMSA, holds a Masters of Business Administration with an emphasis in Operations Management from the University of Minnesota and a Bachelor of Arts in Biology and Chemistry for the St. Thomas University. Her primary expertise is in the areas of medical device quality, regulatory compliance and clinical quality assurance, with over 28 years of experience in medical research and in the medical device industry. Ms. Everson holds the following ASQ Certifications: Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), and Certified Manager of Quality and Organization Excellence (CMQ/OE). She is currently a senior member of the American Society for Quality (ASQ).