IPM Insights

By Carl Manthe, Director and Medical Technology Industry Lead, Integrated Project Management Company, Inc. We all have limited time and resources, both in our personal…

Medical device and diagnostics companies found out the hard way that complying with the European Union In Vitro Diagnostic Regulation (IVDR) is more challenging than…

Some good news: In March, final product safety certification deadlines were extended until 2027 or 2028 depending on the device class for European Union Medical…

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…

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…

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…

In March 2023, the European Commission got approval to extend the European Union Medical Device Regulation (EU MDR) deadline, which is a relief for patients…

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…

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.…

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…