Global Medical Device Podcast Powered By Greenlight.guru

How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when researching clinical evidence? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Keith and Kevin Kallmes of Nested Knowledge. Following in the footsteps of their father who was a medical device inventor, the two brothers designed and developed a balloon catheter that was acquired by a major strategic. Some of the highlights of this episode include:Keith and Kevin focus on clinical, regulatory, and publication consulting in the data management/data analysis services industry.Like other entrepreneurs, Keith and Kevin understand the importance of central clinical outcomes data in every stage of the medical device development process for a product rooted in an unmet clinical need.Engineers tend to focus on the immediate task at hand. Entrepreneurs have to consider why startups succeed or