Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices. Some of the highlights of the show include: Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both. A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices. A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process. Best Practices: Open communication between internal and external customers and the product development team as well as cross-functional involvement to define good requirements early in the process. Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals. Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements. Mantra: Invest time and money in useability/engineering models to get it right the first time to prove indications and meet proper requirements.