Using QFD for Medical Device Development

by | May 24, 2021 | FDA, Medical Devices, Quality, Quality Systems, Regulatory

Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was initially developed in Japan in the 1960s but was popularized in the US by the automotive industry in the 1980s1. QFD is a tool often leveraged by Total Quality Management (TQM), which is a quality principle that customers define quality and subsequently should be prioritized at all stages of the product, both pre-and post-production.

Since the number one priority of QFD is to satisfy the customer, you must begin with understanding what the customer needs. This, of course, will ring familiar to anyone who has been involved with the design and development of a medical device. Per 21 CFR § 820.30 (Design Controls), every design input should begin with addressing the needs of the user and the patient. There should traceability to the user needs throughout all stages of the medical device design and development process. In essence, your design history file should be totally focused on fulfilling the user needs of your identified target population, thus being able to fulfill its intended use safely and effectively.

In addition to ensuring that customer requirements are incorporated into the design, QFD also aims to translate customer needs into other cross-functional company actions. Manufacturing, supply chain, even sales are all functional areas that a properly deployed QFD tool can cohesively tie back to the voice of the customer. For a medical device manufacturer, this means a more cohesive quality system, from supplier controls to risk management, to process & production controls. Of course, these processes are all part of the Quality System Regulation; however, utilizing QFD can be another tool in the toolkit to ensure a leaner, customer-focused operation.

Several popular Quality methodologies can be leveraged in the medical device industry. QFD is just one of many popular tools, that although not required, may be helpful to medical device firms who are looking for ways to optimize their current system. EMMA International can help you optimize your QMS and processes to ensure operational excellence and compliance. Call us at 248-987-4497 or email info@emmainternational.com to get in touch with our quality experts today!


1ASQ (n.d.) What is Quality Function Deployment (QFD)? Retrieved on 05/23/2021 from: https://asq.org/quality-resources/qfd-quality-function-deployment#:~:text=QFD%20is%20a%20focused%20methodology,States%20in%20the%20early%201980s.

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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De Novo Classification

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