There are certain challenges that will typically be faced by all design teams during the new product development process – these hurdles are often magnified during medical device development. Design Manager, Mark, highlights some of the challenges to be aware of when designing & developing a medical device:

If a concept for a device is new to the client’s portfolio of products, the first challenge can often be identifying whether the device would be classed as a medical device, and if so, which class would it fall in to. In basic terms, the answer to this question is based on the potential risk it poses to the user. The FDA provides a list of existing device categories and their classifications for guidance, but it can be worthwhile getting expert advice at this stage to ensure the right processes are followed throughout the device development.

Complying with the correct government and industry regulations helps ensure that the device won’t get rejected by the client or recalled after launch. At Haughton Design, our design processes are certified to ISO:9001 and ISO:13485.

When designing a medical device, it’s important to bring in the right expertise to help plan the project as some aspects of the process can take longer and more effort than expected. By planning some stages to run concurrently with others, the overall timeframe of the project could be reduced. For example, producing purely aesthetic prototypes can enable formative human factors studies to take place whilst the detail is still being worked on.

One of the defining characteristics of most medical devices is the ability to carry out its function accurately and repeatedly, whether it’s delivering a measured quantity of a drug or diagnosing a disease from a measured quantity of pathogens detected in a sample. The device needs to be manufactured in a controlled way, but also designed with any critical tolerances in mind from the beginning. Critical areas should avoid large tolerance stacks, where perhaps multiple components fit together.

Material choice is sometimes overlooked in the development process which can lead to low quality parts, feature failures, changes in dimensional stability, stress cracking through chemical contact, or other unanticipated results such as squeaking components. These failures could cause easily avoidable harm, just by selecting the wrong material.

Haughton Design's medical device development team

Intellectual Property (IP) is highly protected in the medical device industry so ensuring that your design doesn’t fall foul of any existing patents from the offset could save a lot of time and money further down the line. Before we begin any new project here at Haughton Design, we typically carry out an Immersion stage where existing products and risk of IP infringement can be identified.

With the Covid-19 pandemic influencing supply chains of many industries, delays and price increases are increasingly common so it’s important to put contingency plans in place for any supply issues that could occur. If suitable, using generic materials and components can reduce the reliance on any one supplier and avoid needing to re-test or even re-design devices in the unfortunate event of delays or a dramatic increase in cost.

The team at Haughton Design uses a wealth of knowledge and experience to avoid these common problems and overcome challenges that clients face when developing a new product or medical device – get in touch to discuss how we can help you.

Mark Heynes 3 August 2022

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Get in Touch with Mark Heynes

Design Manager

Mark has worked in new product development for almost 15 years. Graduating in Product Design from Staffordshire University and designing for the medical, healthcare, building products and automotive sectors, Mark uses this experience to manage the design team, ensuring project resource is well planned and design outputs meet high standards. Outside of work, he spends time with his family and practicing karate. Currently a 4th Dan with over 30 years training, Mark has the same dedicated approach to karate and design.

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