There are two kinds of problem solving in the medical device world: 1 – Solving for improvements in effectiveness and efficiency 2 – Solving for corrective action/preventive action (CAPA) compliance The transition from #1 to #2 seems to perplex organizations entering the medical device arena for the first time. CAPA is too often seen as a burden, stealing valuable time from scientists and engineers who would rather focus on what they know best – designing and making new products. Ironically, […]

» Read more

This is the last post in a 4-part blog series on medical device root cause analysis. If you want to start at the beginning, read our first post on the basics. We’ve also combined all four posts into one easy-to-read PDF, plus added some extras. Download it here. One of the cute annoyances of 4-year-olds is their persistent inquisitive nature. Why can’t I have another piece of cake? Why do a I need to take a nap now? Why can’t […]

» Read more

This is the third post in a 4-part blog series on medical device root cause analysis. In our first post we covered the basics, followed by a discussion on how to do problem scoping. We’ve also combined all four posts into one easy-to-read PDF, plus added some extras. Download it here. Now that you have convinced management that they should dedicate resources to solving a specific problem, it’s time to get started on solving it. Woohoo, let’s go! Not so […]

» Read more

This is the second post in a 4-part blog series on medical device root cause analysis. In our first post we covered the basics and in subsequent posts we will talk about formulating a plan, and root cause verification. We’ve combined all four posts into one easy-to-read PDF, plus added some extras. Download it here. “If I had an hour to solve a problem I’d spend 55 minutes thinking about the problem and 5 minutes thinking about the solution.” Pretty […]

» Read more