Case Studies
Breaking up is hard to do. We’re not talking about broken hearts but company divestitures. When a company carves out part of its business, the…
Articles
Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…
Articles – Video
The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products…
Articles
This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021. According…
Articles
Overseeing the development of a new medical device is a challenging undertaking. There are many moving parts involved in the process and risks and pitfalls…
Case Studies
The R&D team of a global medical device company was experiencing project slippage, diluted resources, prioritization problems, and too many projects within its current portfolio.…
Case Studies
Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…
Case Studies
Project Background A global manufacturer received an FDA mandate on one of its medical devices to repair, retire, or replace all units (more than 200,000)…