Designing a new medical devices can be daunting, there are numerous factors to consider such as regulatory requirements, external market competition and device team capability, let alone the core fundamentals of device efficacy and safety!

Design Development Engineer, Will, has identified some of the factors to remember when designing a medical device to help you launch and accelerate your medical device development project(s).

Begin with a good idea

Work on an idea that has true real-world practical benefit. Try to focus on unmet user needs or unmet market demands. The medical device design & development process is costly and time consuming so having an attractive and novel idea will not only improve the probability of project success but will also improve the probability of success throughout development as your team and investors will naturally buy into the cause. It’s also best practice to keep the design simple, try not to include extra features if they don’t benefit the intended use of the device.

Test the idea

Think about all the potential stakeholders or people who will interact with your device. Think about how they may perceive your idea, map different personas to those people and run a simple study, refining your use statements, and presentation every time. Reach out to real people, don’t hold back through the fear of someone stealing your idea (however ensure that you have adequate NDA’s set up if discussing confidential IP). Most importantly, always keep your user in mind. Human factors is arguably the most important aspect of designing a medical device. Test the idea throughout to make sure that it’s suitable for those intended use it, whether they be medical professionals or patients.

Read everything

Ensure that you have collated, read and understood the relevant standards that your medical device will need to conform to. ISO standards can be great tools as they set out the requirements of a particular device, and sometimes include guidance material to help steer you in the ’right’ direction. Understand the ins and outs of your target markets legislation; be it UKCA, CE, MDR or CFR and keep a record of the design and development history of the device.

Check if it’s been done before

Research the market to see if your idea has been developed before, is being manufactured by a competitor, or if it’s been patented or protected in any manner. Conduct a patent search, and also a patentability review to see if you could potentially protect your idea.

Refine your IUS

Draft a highly precise Intended Use Statement and ensure that any claims are easily verifiable through testing. Any non-relevant claims will have to be verified through testing, so ensure that you could draft a test protocol around that claim prior to locking it in.

Keep it Simple

Try not to make your development program overly complex. Strip out the non-essential features. All projects go through a series of divergence and convergence in complexity, don’t forget to do the convergence bit! Think about your novelty and efficiently execute that in medical device form. Make consideration for your stakeholders’ considerations, but that doesn’t necessarily mean that you have to include them. The more you include, the more you’ll have to do which implies the more that could go wrong. Map out your project plan so that everyone knows exactly what they’re doing, and time is allocated correctly in order to reach certain design milestones.

Ask for Help

You don’t have to do everything yourself. Build a team of highly skilled and knowledgeable people or partners to help you achieve your vision and ensure that you have buy in from all partners from the get-go. Ensure that your curated team is as passionate about your idea as you are.

Although these tips relate to medical device development, they also stand for general new product development too. Here at Haughton Design, we help clients develop new products and medical devices effectively and efficiently. Please get in touch to discuss how we can help with your new product or medical device development project.

Will Morris 13 July 2022

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Get in Touch with Will Morris

Design Development Engineer

Will graduated from the University of Wolverhampton with a degree in Product Design. Prior to Haughton Design, Will worked for Renishaw, where he led the industrial design for the current and next generation metal Additive Manufacturing machines. Will has a strong interest in Design for Sustainability, and the Circular Economy, looking to reduce companies’ environmental impact and often teaches about design engineering at local STEM events. Outside of work, Will enjoys Formula 1, rugby and travelling with friends.

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