Additive manufacturing is the hottest thing to hit the medical device industry since the first pacemaker was implanted in a patient 60 years ago. The technology has transformed the way that engineers design numerous products. Now, it’s starting to move beyond prototyping into production.

Designing a new medical device is a bit more complicated than designing a toaster or an automotive cooling system. Besides the issues common to any product—feasibility, usability, and design for manufacture and assembly—there are also issues of biocompatibility, sterilization and FDA regulations to deal with.

Light is critical for our health and well-being. In the morning, bright light helps us wake up and feel alert and energized. At night, dimmer light cues us to go to sleep. Equally important, the right type of light enables hospitals to provide surgery and other essential medical services 24/7.

Medical device engineers have many considerations when designing an assembly. Safety and effectiveness are top priorities, of course, followed closely by cost.

WASHINGTON—A new FDA report notes that medical device recalls have almost doubled in the past 10 years. The most common reason for recalls in that period was device and software design failure.

Each year, the U.S. Food and Drug Administration logs some 100,000 reports of adverse events related to medical devices. More than a third of those are due to human error.

More than 90 percent of electronic medical devices initially fail to comply with standards.