7 Key Factors To Remember When Designing a Medical Device

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.

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.