Design Controls in the MedTech Industry

Product design is an outgrowth of a very similar discipline called industrial design. According to the Industrial Designers Society of America, “Industrial design is the professional practice of designing products used by millions of people around the world every day. Industrial designers not only focus on the appearance of a product, but also on how it functions, is manufactured and ultimately the value and experience it provides for users.”

Product design and development in life sciences companies are a critical part of the overall product life cycle. Beginning at research and gradually prototyping and actual product development and subsequently fulfilling user needs; product design is crucial for patients or healthcare givers because it governs the safety and usability of the medical device, ensuring trouble free operation. A poorly designed device not only endangers patient lives, they can also mean a complete loss of business for the manufacturer. Moreover, it will never achieve the necessary regulatory approval or market authorization within a predetermined period due to lack of supporting justification that the product is safe. And by chance if it does, it will still fail to safely perform its intended use resulting in mistakes and errors.

In this paper, we focus on the requirement of design controls during the product development stages, from research to commercialization. It’s always advantageous for manufacturers to embrace the best technologies at the design phase to support verification and validation activities, eliminate the cost of rework, make the design transfer process smooth and ensure hassle-free commercialization.