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.