What makes the development of a complex medical device different? Some people assume it’s the same as developing any medical device, but that’s a risky assumption. Russell Singleton and I have seen many development projects go awry for capital equipment and other complex medical devices. We are excited to be featured in the MPO Magazine. In our series of articles, we have outlined why complex medical devices demand a different development approach.
We will examine what is different about developing complex medical devices, how project risks are multiplied, and why different methods are required to maximize the chance of successful development. This discussion focuses on new product development (NPD) of complex medical devices and especially how to avoid traps that teams may fall into. By “new,” we are distinctly separating the kind of incremental or “me too” development in nature and focusing on products that involve new applications, technology, or science. By “complex,” we generally mean development projects that require a large team of individuals from diverse specialties working together to achieve an outcome. The issues we discuss may crop up with simpler medical devices or non-medical products, but they are particularly challenging for complex medical devices.
You can read the first article of the series here: https://www.mpo-mag.com/issues/2024-05-01/view_columns/what-makes-complex-medical-devices-different/
Additional joint articles I have done with Russ on successful product development
PART 1: The Secret to Product Development is to Not Start Development
PART 2: Nail your Strategy and Technology Before Development
PART 3: Forming the Right Product Development Team
PART 4: Micro Projects and Other Practices
PART 5: A Tale of Two Companies
PART 6: Post-Mortem Pre-Celebration
Stay tuned for more on more articles in MPO Magazine.