Driving Innovation Through Changes to FDA Medical Device Regulations

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…

“How can we submit sooner?” It’s long been the most common question a regulatory submissions team hears. Executive leaders have ambitious goals in mind for…

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…

It doesn’t matter how brilliant the researchers are or how many lives their potential new drug will save. Scientists can’t develop a new pharmaceutical on…

Even when a company is first to market with a groundbreaking medical device, product development doesn’t end. Medical staff, patients, and repair technicians—even payers—want it…

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…

Drug discovery, development, and commercialization is like a puzzle. The end may be easy to visualize, but there are many pieces that need to be…

A strength taken to the extreme can be a weakness. If a company provides a high-quality selection of products and adds new varieties and custom…