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5 Patterns That Make or Break Medical Device Commercialization
Commercialization can mean different things depending on where you are in the journey. Ultimately, medical device commercialization is about taking something proven to work and turning it into a product that meets user needs, can be manufactured at scale, and makes business sense. 1. Build a Reliable Benchtop Prototype Before You Outsource If you’re still…
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HUMAN-CENTERED DESIGN CONTROLS
There are Design Controls, and then there are Human-Centered Design Controls. Both fulfill the baseline regulatory and risk management requirements necessary to prove a device is safe and effective. The difference? A human-centred approach elevates standard ‘user needs’ beyond basic compliance, ensuring the final product truly resonates with and optimizes the experience for the people…
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Medical Device Prototyping Explained: Stages, Techniques, and Challenges
What Is Medical Device Prototyping and How Is It Different From Non-Medical Devices? Medical device prototyping is the process of turning a scientific idea into a tangible product and progressively refining it through iterative development. While the process is similar to that used for non-medical devices, medical device prototyping has an additional emphasis demonstrating not…
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How to Conduct Effective Medical Device Design Reviews
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,…
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Project Management In The Medical Device Industry
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…
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Design for Manufacturing (DFM): Principles, Processes, and Best Practices
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,…
