Effectively exploring opportunities for new medical device development can be a complex process that often requires a multidisciplinary approach. Senior Design Engineer & Business Development Manager, Will, shares some steps you can take to get started.

As a design consultancy, we receive and work on a wide variety of new product and medical device development project briefs. However, we often notice that clients haven’t fully explored a new opportunity which means that project briefs aren’t always well informed. So, here are some tips for exploring and validating new medical device ideas before significant investment is made:

1. Identify an unmet clinical need:

The first step is to identify a problem or challenge in the medical field that has yet to be solved. You can start by talking to healthcare providers, patients, and industry experts to understand what the current challenges and gaps are. It may be possible to identify an unmet need from observation and by immersing yourself in the environment or problem and questioning why things are done in the way that they are. It’s also possible to use existing data such as available literature, patient feedback or clinical workflows – there is often existing key insight that is currently being overlooked or not fully appreciated. 

2. Conduct a market analysis:

Once you have identified an unmet need, you should research the market to truly define the problem statement, understand the boundary conditions and determine whether there is a demand for a new medical device that could address the identified need. You should conduct market research to identify the potential size of the market, existing competitors, and regulatory requirements. You should also begin to understand the regulatory pathway for your device, it’s potential classification and how certain claims may affect it’s regulatory and development strategy.

There is a lot of guidance material through ISO standards to help identify device classification, or you could research competitor devices to see what claims are made. Alternatively, you could seek assistance from external organisations such as Universities or Consultancies.

3. Define the claims and design input requirements:

Once you have validated the need, potential demand, and you understand the regulatory requirements, you should define the potential claims and design input requirements. This includes developing an intended use statement (how is the device supposed to be used and what is the medical application), understand the technical requirements (what does the device do and how might it do it), understand the design features (how might the device be formed, and what bits do what), and the functional limitations of the medical device (what doesn’t the device do). It is advised that you create a hypothesis of how your device might be used by the patient, how you could improve ease of use, and how this might affect your design input requirements. This could be a simple list of intended use claims, a storyboard  or a process flow diagram. Remember that the intended use claims are mapped to the final device validation, so will be tested under actual or simulated use conditions. When conducting an opportunity exploration process, these claims might depend on the concepts designed. 

 4. Develop a prototype:

After defining the requirements and claims, you can start developing prototypes. This can involve working with key stakeholders, such as end users, engineers, healthcare professionals and other specialists to develop a series of working models that can be tested and refined. It is advised to start with the core technology and layer development value as you iterate your device. Try to separate functional elements into discrete work packages flip between when encountering a specific challenge. It can be strategically advantageous to develop an array of prototypes that seperately focus on proving the efficacy, safety or usability of various aspects, prior to full integration into a single device prototype. 

 

Developing a new medical device requires extensive work and collaboration among a variety of specialists. However, if you have identified an unmet need and developed a product that can address it, the potential impact on patient care can be significant. Following the steps above will help encourage you to ask the difficult questions early on and help ground the idea in reality. Developing a proof of principle prototype is advantageous but not essential, however, it can be used as a tool to build confidence in other key stakeholders that your idea is feasible.

If you’re looking to identify potential opportunities or looking to validate an opportunity proposal, please reach out to us at Haughton Design – we’ll be happy to collaborate and implement our New Opportunity Exploration and other design engineering services to refine your idea and accelerate your medical device development.

William Morris - Senior Design Development Engineer & Business Development Manager at Haughton Design Will Morris 21 April 2023

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Get in Touch with Will Morris

Senior Design Development Engineer & Business Development Manager

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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