Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

The world of medical devices is rapidly changing. In place of disconnected, simple medical devices, a new world of complex software both on and off the now-connected device is providing a larger ...

Anyone who has worked inside a MedTech organization knows that bringing a new device to market is not a single sprint. It is a marathon made up of dozens of short, fast, sometimes messy races — market ...

Back in 2022, I wrote about the triple threat of additive, agility and automation—three forces that were already reshaping manufacturing and product development. Fast forward to 2025, and these trends ...

Agile product management is becoming an increasingly important approach to developing products that have transformative potential and meet market needs. However, while many business leaders recognize ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...