In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M. Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for. "Design controls are yes, required by law, but they also represent good business practices." - Matt Romey Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.” "The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant. Today’s highlights include: ● Matt explains how good quality design control is just part of good business practices. ● You will hear why the classic “waterfall diagram” may not be the best guideline for a project. ● Why when you find design inputs, they need to be testable. "Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey