Getting a Medical Device to Market: A Step-by-Step Guide

At first turning a concept into a marketable medical device feels daunting. Your great idea solves a critical concern in the health care field, however, the concept itself comprises the first step among many to getting your innovative product safely to market. The next critical steps turns that medical device into a physical product. So what do you do first?

Step 1. Prototype & Design of the Medial Device

In short, prototyping takes innovative ideas or concepts and manufactures a physical model that you can touch and feel.  In addition, with the right design team you create a physical product that demonstrates the viability of the idea.

Step 2. Functionality of the Device

After developing the prototype, now you’ll determine if it’s usable. That’s where collaboration with a design engineer comes in. Design engineers not only help you figure out if your prototype works, they determine if there’s a more effective and efficient way to achieve your product goals. In addition, the right design and manufacturing engineer identifies alternate designs that translate into a more robust, reproducible and cost effective manufacturing process that maximizes revenue and creates a marketable medical device.

Step 3. Protocols for Manufacturing

As you move through the stages of design and development into manufacturing, you’ll need protocols, and lots of them. Namely, these formal test plans, or protocols, ensure your manufactured product remains true to its required functional design. In addition, they provide the evidence you require to get your product approved in a regulated marketplace like medical devices and pharmaceuticals. In short, protocols comprise the fundamental building blocks for verification and validation activities. They also specify the standards, testing tools, targets, materials, and the step-by-step instructions for making and testing your product.  

Step 4. The Manufacturing Process

Finally, you need a process to manufacture your device en masse for market. Successfully. Thousands of ways exist to manufacture just about anything, but the right process ensures your prototype can be made over and over again, in a safe and repeatable way, without a cost that prices you out of the market.


To summarize, the complex manufacturing pathway involves a multitude of steps that ends with seeing your idea come to market fruition, a marketable medical device. However, your goal of getting your innovative and possibly life-saving product to market becomes possible with the able assistance of an experienced design and manufacturing engineer.

Need help with that? MAE Group is here to help with all your Product Design needs. Contact us today.

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