1. Compliance
The whole product cycle was tied to the EU medical device regulations (MDR). International standards have been designed for the purpose of assistance with the regulatory processes. As our guiding framework for the software development, we’ve used IEC 62304.
IEC 62304 framework
2. Research
2.1. User
Direct exposure to the healthcare industry covered a crucial part of the research. The common setup allowed the most natural stream of the user’s perspectives. Alongside, many video calls were conducted, allowing a much faster and more cost-efficient process.
2.2. Full Picture
In order to fully understand the problem end-users face, we mapped out the full picture and flow of the environment where the problem was fitted in. Seeing the workflow of a healthcare professional had a huge impact on understanding how the decision-making and human attention in such a setup work.
3. Design
3.1. Experience Design
It was important to keep the end-user in the loop, to assure the main pain points were kept in the priority all the way to the highest decision-makers. Through an iterative process, we’ve validated and narrated the design & specification of new implementations alongside the responsible stakeholders.
3.2. Prototyping & Testing
Once the strategy & main flows were done, new wireframes were put into interactive prototypes and run through cycles of testing. As a medical device, we had to prevent any possible flaws upfront.
4. Development
To ensure a more agile environment, PM used project-based development - new features & implementations were split into separate projects. Each project was planned and led by CPO, who managed the backlog of milestones needed to take features from the requirement to release, on budget, and on schedule.
Flow of a single project