UX For Medical Device Development

UX For Medical

Device Development

Overview

I joined Oticon Medical as the first UX designer in the team (a team with close to 16 software developers), this required me to not only deliver on design work fast but also to plan, conduct, and document our usability practices. In Oticon Medical we worked with cochlear implants which are Class III medical devices, this meant there were many well-designed and documented processes around product development, however, there was a missing link between the feature development and the usability testing activities so it was my role to design a process which closed this gap.

Role

UX Designer

UX Research

UX Strategy

UX Ops

Usability

Time

2020 - 2021

Ongoing project

Defining the goal

I realized there was a challenge when I was the only designer for four feature development teams. So I needed a way to multiply myself and have a positive influence on the deliverables of each of the teams. My idea was setting up a process that I could present to the teams and that if they followed they could be responsible for the usability activities of their features. This way it would free some of my time to work on the design of the features.

Research

As part of my research, I familiarised myself with the usability engineering process already defined by our system engineers. The highlights and what I intended to bring forward to my teams were:


Usability engineering is the application of knowledge about human behavior, abilities, limitations and other characteristics (anthropometry, biomechanics…) to the design of medical devices and tasks. Usability engineering aims at establishing safe and effective use in the intended use environment, and ultimately facilitate use and achieve user satisfaction.


and:


The usability engineering process encompasses activities like planning, analysis and specification, design and implementation, verification and validation, risk analysis and control. The usability engineering process therefore has close relationships to other processes such as the product development process or the risk management process.

Usability Process

Feature Development Process

Formative Evaluation

The main pillar of my new usability process was the Formative Evaluation and this was the definition I presented to the teams:


Formative evaluation allows to identify and address design flows more easily and less expensively than if discovered later in the design process. Formative evaluation can be conducted at one or more stages during the user interface development process and can be tailored to focus on specific parts of the user interface, including accessories. Formative evaluation typically is an iterative process (ex: 1st iteration may focus on evaluating different user interface concepts, 2nd iteration may focus on evaluating a prototype that combines strengths of the different concepts previously evaluated, and 3rd iteration may focus on refining the user interface design on the implemented user interface).

Adding the process in the right place

As mentioned above as part of my research I studied the current product development and usability processes, and so decided that the best place for the new design process was in Phase 2 of the Product Development Process, which was called the Design Input Phase, and defined as followed:


The objective for the Design Input phase is to specify requirements and to identify feasible solutions and concepts to meet these requirements.

Deliverables

There are two main deliverables of the new process, the Formative Evaluation Plan and the Formative Evaluation Report. One to be done before and to outline all the activities to be done to properly evaluate a new feature. One is to be done after and contains the participants, findings, and conclusions from the evaluations.


Each Feature team must be responsible for delivering these documents and my role will be as support.

Conclusion

After presenting the new process, it was adopted by the different feature teams, it was slow at the beginning the teams required quite a bit of support, but as they learned more and more about the usability process and how to plan, conduct, and report the Formative Evaluation, it provided a huge advantage to our team as my time as designer was freed to do so much more designing.

Soon: Application Redesign