Scientific & Industry Insights

E&L testing, more formally known as extractables and leachables testing, has become a defining constraint in modern device development timelines. A device may be fully designed, materials selected, and verification underway; and yet encounter significant delays once extractables and leachables testing begins. For medical device developers, that shift is not theoretical. The U.S. Food and…

Bringing an innovative new medical device to market is no easy task. In the U.S., approximately 75% of medical device start-ups fail. One of the best ways to guarantee success is the rapid and mass adoption of a company’s newest device—and the best way to guarantee that is for the device to be easy to operate…

As R&D teams push the boundaries of innovation through the development of new materials, complex formulations, and first-of-their-kind medical devices, ensuring regulatory compliance becomes both more challenging and critical. A novel coating or unique material may offer groundbreaking benefits, but without a clear path to approval or a plan for scalable uses, even the most…

To be successful, Medical Technology (MedTech) companies must constantly evolve in order to meet patients’ needs. At the same time, external capital pressures are requiring companies to be more efficient with their money. This dynamic puts increased pressure on research and development (R&D) teams to find more efficient, cost-effective paths from development to market while…

Ensuring that new products get to market is a top priority for R&D teams, as delays can significantly impact ROI. But the actual cost of pre-clinical research delays comes from studies that must be repeated due to incorrect testing. iFyber President, Greg Mouchka, offers insights on how to avoid these expensive mistakes. Challenges in Pre-Clinical…