The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

I clearly remember standing in the operating room (OR). I was there with our sales representative to observe a case as part of our normal Voice of Customer (VOC) process. I had seen well over 50 ...

Way back in 2001, MD+DI published an article detailing what the author considered to be The Seven Deadly Sins of Medical Device Development. The author reviewed dozens of device development programs ...

The Master of Engineering (M.Eng.) in Medical Device Development is a cutting-edge program that promises to accelerate the career development of aspiring engineers in all disciplines who wish to pivot ...

Anyone who has worked inside a MedTech organization knows that bringing a new device to market is not a single sprint. It is a marathon made up of dozens of short, fast, sometimes messy races — market ...

Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use. To create ...

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...