Risk & Reward: Taking The Guesswork Out Of Compliance & Safety For Medical Devices The world-famous and often quoted maxim: ‘the one constant is change’ certainly holds true for the medical devices sector. That doesn’t stop at the fast pace of innovation, but starts at the minefield of compliance and regulation that is rightly imposed […]

Helping Medical Device Businesses To Balance Fast Development & Meet  Regulatory Frameworks When does product development become a matter of life and death? There are high stakes riding on the development of medical devices and manufacturers. Everyone from startups to global players often only get a limited opportunity to jump from prototype to a wider […]

Agile Medical Device Development: Do or Don’t? Content aspects In this article we highlight two important differences between traditional organizations and agile organizations. These two content-oriented aspects demonstrate that working agile requires a different view and therefore a different approach to the same problem. These aspects are: “Continuish integration” Solution Intent This article is the […]

Agile Medical Device Development: Do or Don’t? Process aspects In this article we highlight two important differences between traditional organizations and agile organizations. These two process-oriented aspects demonstrate that working agile requires a different view and therefore a different approach to the same problem. These aspects are: Flow Cadence and Synchronization This article is the […]

Agile Medical Device Development: Do or Don’t? Organizational aspects In this article we are highlighting two important differences between traditional organizations and agile organizations. These two aspects demonstrate that agile requires a different view and therefore a different approach to the same problem. These aspects are: Resource allocation Organizational structure This article is the first […]

Agile Medical Device Development: Do or Don’t? Today, software development is predominantly applying Agile practices. Scaling agile from a couple of teams to hundreds or even thousands of people, developing software in different locations world-wide is today’s challenge. Medical devices however do not only consist of software. Hardware is also an important element to develop […]