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Where to start?

Knowing where to start when trying to turn a cutting-edge, lab-based test into a market-disrupting, clinical, certified, diagnostic product is not easy.

Our advice is to start with the user; your target customer. Who are they? Where do they work? What is their work environment like? What tasks do they typically do? What don’t they do? Your list should be extensive.

Without sharing any specific details, we are going to use a project on which we previously worked as a framework to demonstrate the importance of user workflows in your product development pathway. All project details have been fully anonymised.

Always challenge your assumptions

In the aforementioned project, it was assumed that many of the current manual steps would not be suitable for clinical labs. We assumed that certain steps would need to be automated. However, we know better than to leap into expensive product development, based on only our assumptions. So, we spoke to target users, observed their labs and their processes and we were surprised. Whether they be highly skilled surgeons or vulnerable patients, your users will always surprise you. Some of your assumptions will be wrong and the only way to find out ‘how and why’ is to conduct user studies (primary research). We aim to start these as early as possible and carry them out regularly throughout a product development process in order to produce the best product, as efficiently as possible.

There are many different types of user studies, utilising different formats and techniques. We tailor these accordingly to suit the stage and scale of the project, the questions we are trying to answer, the risk level of the product, the type of user, the use environment and any other defined criteria.

In this case, we took an ‘interview and observation’ approach, known as a Day In The Life (DITL) analysis, to gain a deep understanding of the context of use. This includes information on the user and use environment.

For the sake of anonymity, the diagram below is entirely fictional and does not represent the project referred to. Although much of the detail and complexity has been removed to ensure this is generic, it is a useful demonstration of the level of consideration required throughout the process.

Map out your workflow

We also mapped out every step of their current, lab-based workflow, by seeing it in action. Having an outside observer for this can be surprisingly helpful, as they may spot important details within tasks that are overlooked by those who are mundanely carrying them out on a daily basis. This may include tasks that are standard practice in a lab but involve intricacies that will need to be considered when trying to convert those tasks into an automated device or a process for an entirely different setting.

For the development of a medical device or diagnostic, it can be beneficial to map out the user workflow in relation to the clinical pathway, with special attention to where the test, device and other aspects intersect with that clinical pathway, and with each other.

This initial round of user workflow development brought a lot of useful questions to the surface. It identified a key time point in the clinical pathway and highlighted the limitations that affect the lab test pathway with regard to timings and logistics. Because our clients were thinking ahead and considering this early in their product development process, this discovery occurred at a time when the lab test protocol could still be tailored as needed. They pivoted their development with the agility only a start-up can and within a few months had redesigned their novel lab test platform into a format that will be compatible with the practical constraints of their target application. This could have been far more costly, time-consuming and difficult had it been discovered later.

Usability engineering, as with all engineering, is an iterative process and the user workflow took many forms before it resembled something that was feasible, in terms of the lab test process, clinical pathway, user interaction and logistics. This will evolve as the product development continues and our collective understanding deepens.

As with the previous diagram, the following image is a stripped-back example of a basic workflow and does not relate to any eg projects however it shows how such a diagram can bring out the interdependencies between the different pathways and enable you to identify ways of integrating your product/test into existing pathways and lower the barrier to adoption.

Create a simplified version

After a few iterations, we converted the larger detailed user workflow into a simplified, easy-to-read graphic. This graphic was used by our clients to help secure further funding. It can be a useful tool to explain an otherwise complex process in a simple and digestible way to potential investors, whilst also demonstrating the depth of your thinking. It shows you have truly considered how your product will fit into your target market.

Oh, and this piece of work was achieved without breaking the bank!

For more information on getting your product to market or to discuss incorporating usability engineering into your product development, please get in touch with us:

Via email on, by giving us a call on +44 01223 813184, or by clicking here.