Design Methodology

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Research & Understanding​

When designing a new product, my approach is to begin with user-centred research. It is imperative to understand who the product is for and what their pain points are — whether they are a patient, a carer, or a clinician. When planning, it is key to know existing technologies and methods in the area, specific requirements from stakeholders, and the overall landscape of the market area. In the field of medical devices, I have used a biopsychosocial model, when appropriate, to understand all aspects that require improvement in a user’s life.

 

Ideation & Concept Development​

Using research input, my concept development process starts and is quick and iterative. My goal with a team is to encourage out-of-the-box thinking and generate as many concepts as possible in a sprint — the more the better. These many concepts are refined to around 5 to 10 designs where sketch models are made (if they can be made at pace) and proof of concept achieved. I typically present concepts on a spectrum of spanning from conservative concepts to more radical ideas. Conservative approaches might make slight gains in usability but quick and low cost to implement. More radical concepts might apply an unproven technology in the space or a groundbreaking design. A key step in concept selection is qualitative user feedback and a cross-functional review team where concepts can be ranked through the applicable metrics (e.g. usability, project cost, manufacturing, regulatory path, etc.)

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Refinement & Concept Freeze​

Whether with one concept or multiple, the next step is refinement. This is where detailed prototypes are generated and product requirements are developed. These requirements include user, regulatory, test, and marketing requirements and form the design inputs for the device. Feasibility testing is completed on low volume prototypes, and where possible, supported with qualitative data gathered from patients and stakeholders. The final refined concept should then be reviewed by stakeholders before it is frozen and the design is brought forward to the next development phases.