Monthly Archives: August 2025
The dos and don’ts of preparing for FDA submissions in the medical device industry
Preparing for FDA submissions isn’t new to us. As project management consultants for the medical device industry, prepping for these(among other project management activities) is what we do well. Currently, one of our clients is in the middle of an FDA submission, responding to a round of questions. The lessons from this, and from many other submission prep efforts, are very top of mind right now, so I thought I’d share them with you. The dos of preparing for FDA submissions in the medical device industry 1. Understand your Project…
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People You Should Know: Dr. John Piatkowski
This episode is a part of our new “People You Should Know” series, where we spotlight industry professionals shaping the future of life sciences, healthcare, and physicians’ compensation. In today’s episode, we talk about what it takes to lead transformation without losing your people in the process. Meet Dr. John Piatkowski a physician executive who has led from just about every seat: pediatrician, medical group leader, hospital CEO, Deputy Chief Clinical Officer at Medica, and now a promising consultant. He’s helped lead value-based care for over 750,000 members, overseeing $3.5…
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