4 steps to create a medical device

Jul 9, 2019 | Product Development, Quality + Regulatory, Risk Management

Having watched other videos in this series, you’ll appreciate that developing a medical device is a complex business, with many opportunities to experience pain. We’re here to help you avoid as many of those painful moments as we can.

If you had a straightforward route to get you from here to there, what would you do, armed with that?

In this bite-sized video, we’re taking a look at four phases every medical device goes through.

Effort and costs rise significantly as you progress, whilst the risks of failure are mitigated – you go from high risk and uncertainty in the early phases through to a defined risk profile.


The first stage is Define – finding out about an unmet need, that you’re going to work on resolving. As a result, you know you’re creating something that has a real-world value, a benefit to patients.

All this so you can “Begin with the end in mind”, with a clear picture of where you’re headed, a sense of when you’ll know you’re done.

You’ll carve some device concepts, checking you’re free to operate in that space you’re constructing, finding out what potential market there may be for your idea.


And then we move on to Develop – refining your idea into a fully fledged medical device that you know is capable of addressing the users’ needs, safely, and can be made.


Once you’ve got a device you’re happy with, your focus moves on to Industrialise it – Your product evolves from the lab to the production line, using qualified processes and validated methods. You’ll end up with all the documents you need to tell the story of your device, how you’ll manufacture, test and release it. It’s the story that regulators will need you tell them.


And finally, after all the hard work to create a product, you need to get approval before you can start selling it. This Launch phase includes preparing for (and then doing) routine manufacture. And it doesn’t stop there, as you’ll need to take care of post market surveillance and clinical follow-up requirements.


And here’s where it loops back, to develop the next generation of your medical device, or address issues that arise from complaints, and, more seriously, adverse event reports.

As you watched this video, you’ll have started to think about how your project should be making the best of each of these phases. You may now want to get some guidance on how to go about it more effectively.

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