A Quality-first Approach to Product Design & Development in the MedTech Sector

Intel’s Andy Grove famously said, “Only the paranoid survive.” Of course, he said this in the context of how the world’s leading chip maker, Intel, had to reinvent itself in the face of competition from Japanese chip makers who were able to manufacture hi-tech chips at lower costs and with better quality. Yet the statement holds true in almost any scenario.

In sectors like medical device manufacturing, it is absolutely critical to design and manufacture products that are safe, effective and of high-quality.

The Food & Drug Administration (FDA) in the US, the European Competent Authority in Europe, Health Canada in Canada and other similar agencies across the globe require medical device companies to comply with stringent rules and regulations. Not only do these regulations govern the end-product but also the product design & development process, called Design Controls.

The development of medical device products is complex, can take years of development and millions of dollars as investment. Teams are under pressure because a seemingly small problem with one mechanical component, or a mistake in one line of software coding, can lead to catastrophic product system failure.

In this paper, we highlight the challenges faced by engineering and quality leaders when it comes to compliant design controls and product risk management.

In this whitepaper, we cover these topics:

• Design Controls – A key element of the product development lifecycle
• Common pitfalls and errors that creep into the design controls process
• Why a solution like ComplianceQuest Design Controls can be a gamechanger
• Automating RTM and product risk management
• Step-by-step RTM management process
• And more