Design reviews are a mandatory part of medical device development and are often mistakenly treated as a compliance checkbox. When done properly, however, they can become a meaningful competitive advantage. This article explains why medical device design reviews matter and how to conduct them effectively—from what a design review is and who should be involved,…
Project management (PM) is crucial in medical device development because the stakes are uniquely high. You’re not just managing scope and timeline, but also navigating strict regulatory standards, user safety, technical complexity, and market viability. In this article, we break down what makes MedTech project management different from other industries, what a medical device PM…
What Is Design For Manufacturing (DFM)? Design for Manufacturing (DFM) is the practice of refining product designs so they can be produced reliably and cost-effectively at scale using standard manufacturing methods. For instance, a prototype that works on a 3D printer may not be feasible for mass production with injection moulding. DFM bridges that gap,…
For companies looking to bring moderate-risk medical devices to market, navigating the FDA’s 510(k) premarket notification process is essential and often complex. This guide breaks down the fundamentals of a 510(k): what it is, how the process works, and the practices that can make or break your submission, but most importantly, it emphasizes the need…