Major medical device development is a complex and lengthy process with lead times of 3 to 7 years. Not only is the development slow, but it is often of questionable quality as well. In 2024, the US FDA attributes 30% of recalls by all medical device manufacturers to...
A leading Finnish medical device company was experiencing long lead times in fixing defects in its MRI systems, sometimes reaching 40 weeks, resulting in long delivery timelines and unhappy customers. The Challenge The company’s development process wasn’t keeping up...
The Challenge The company’s development teams were spread across 2 European countries, with Germany as the primary location. Its development process wasn’t keeping up with the complexity of its hardware and software systems. Defect resolution times were twice...
Compliance doesn’t have to slow innovation—it can drive it. In the MedTech industry, regulatory requirements are non-negotiable. But in fast-paced Agile environments, they can feel like a barrier to progress. They don’t have to be. When compliance is systematically...
