Formative study: Trialling UX for a point-of-care antibiotic susceptibility diagnostic device
Last year, Steve Green and I had the privilege of collaborating with We are Human, a ClariMed Company who are Human Factors & User Research Specialists, at their facility in Atlanta, GA. Together, we conducted a Formative Study for Innotive Diagnostics' point-of-care medical device.
Over the course of four action-packed days, we set up and led simulated walk-throughs with nine fantastic healthcare professionals (HCPs) from a variety of clinical backgrounds. The study involved three test workflows to explore different product interactions. The goal? To gather valuable feedback and pre-validate the device concept by focusing on its usability, user experience, and user interface.
Behind the scenes in the observation room, we simulated all device interactions to replicate a seamless clinical experience. Since the device interface was still in development, we used a creative setup with a keyboard and buttons to mimic the product's functionality—a true "puppet master" moment!
The insights we gained have already influenced the next steps of the Alpha development.
Why we conduct formative studies?
A formative study is conducted to observe and evaluate how target users interact with a device during the early phases of a project. The primary objectives are to assess the effectiveness of use-related risk mitigation strategies and identify previously unknown errors.
As the product development progresses, the cost of implementing changes increases significantly. Therefore, formative studies are essential for exploring and identifying the strengths and weaknesses of early design decisions. It is common to conduct multiple formative studies throughout the development process to implement necessary adjustments and ensure the device meets user needs before it reaches the market.
As product developers, we have a responsibility to anticipate and prevent foreseeable misuse of our devices. This is achieved through comprehensive formative and summative evaluations conducted prior to market release.
At OPD, we adhere to critical standards, including IEC 62366-1 and ISO 14971. When submitting a medical device to the FDA, it is essential to provide evidence of the insights and learnings gained from formative evaluations. This information constitutes a vital component of the Human Factors and Usability Engineering (HF/UE) submission report.
The role of this formative study
Since the device had a 1 hour run time, we needed to assess the market response from HCPs. It was important to assess this market response to ensure the product would be practically and commercially successful. The product’s goal is to provide HCPs diagnostic results in under an hour. The learnings from the Formative Study have highlighted the incredible importance of the device being developed and the value it will add to the field.
Human Factors at OPD
At OPD, Human Factors (HF) play a crucial role in our product development process. By applying HF principles, we minimise the risk of user errors and promote the safe operation of the devices we design. Integrating human factors analysis throughout every stage is vital in medical device development, safeguarding against serious injuries or even fatalities associated with product use.
To learn more about Human Factors at OPD, check out our capabilities or get in touch.
