Driving Innovation Through Changes to FDA Medical Device Regulations

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…

The product development timeline for a new pharmaceutical is fragile. If one link in the chain breaks, it delays everything else, including clinical trials, regulatory…

There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing…

The potential gains from digital pathology are endless. The ability to capture, curate, analyze, and rapidly share information about the effects of newly developed molecules…

Companies often begin achieving some business benefits of a merger or acquisition as soon as the two entities become one. And forward-looking organizations are eager…

Successful mergers and acquisitions integrations depend on strong leadership and a consistent message of a compelling shared vision and strategy. Presumably, a sound strategy drove…