1. Regulatory Compliance
Our product lifecycle strictly adhered to EU medical device regulations (MDR). We utilized international standards specifically tailored to facilitate regulatory processes. For software development, our guiding standard was IEC 62304.
IEC 62304 framework
2.1. User-Centric Approach
Our direct involvement with the healthcare sector was pivotal for authentic user insights. This enabled us to capture genuine user perspectives in their natural setting of medical professionals. We further leveraged video calls for efficient and cost-effective data gathering.
2.2. Holistic Understanding
To grasp the challenges our end-users encountered, we extensively mapped their work environment and processes. Gaining insights into healthcare professionals' workflows helped our understanding of decision-making patterns and attention dynamics in clinical settings.
3.1. User Experience Design
Maintaining consistent end-user engagement ensured that primary challenges remained at the forefront of our considerations. We collaboratively refined design specifications and introduced new features through an iterative process, always in consultation with relevant stakeholders.
3.2. Prototyping & Testing
After establishing our design strategy and key flows, we developed interactive prototypes and subjected them to rigorous testing phases.
Powerful Medical used project-based development to ensure a more agile environment - 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