Current State of (Design) Mind

It is an exciting time to be a medical device design engineer. Development opportunities abound as medical device manufacturers (MDMs) seek to make smaller, more complex, and more functional devices. Industry 4.0, artificial intelligence, data analytics, and additive manufacturing are moving into the spotlight. Applications include digital healthcare, less-invasive procedures, interoperability, cloud computing, software as a service (SaaS), point of care, home healthcare, clinical studies, compliance, robotic surgery, and electronic medical records.

Design engineering is also being driven by the changing regulatory landscape. Medical device regulators in the U.S. and EU continue raising the bar to ensure device safety and effectiveness. With the new European Medical Device Regulation (MDR) now arriving in 2021, there will be greater consideration toward usability and risk mitigation throughout the design process.

“There is an increased focus on all facets of device design, especially usability engineering, driven by the European MDR that goes into effect in May 2021,” said Drew Calabrese, senior mechanical engineer at G