IPM Insights

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…

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…

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…

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…

Project Background A biotech company formed an alliance with a large medical device manufacturer to develop and commercialize three device and reagent combination products. Cost…

Project Background A large medical company had salvaged a medical device system from a failing company and planned to commercialize this product for new medical…