Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider […]
Brazil ANVISA launches notification pathway for low-risk medical devices and IVDs
By Stewart Eisenhart, Emergo Group Brazil’s medical device regulator ANVISA has issued a new regulation for a “notification” market pathway providing streamlined market access for low-risk devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]
7 women in medtech you should know
Women hold more executive leadership roles in the medtech industry today than they did 20 years ago, but there’s still a long way to go. There is still a women’s leadership gap in the U.S., though. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S. […]
RIP MTD Micro Molding founder Dennis Tully
Dennis Tully, owner of MTD Micro Molding, passed away on Feb. 28 at the age of 58. Tully, who bought MTD Micro Molding from his father in 2008, was a family man who was involved in contract manufacturing since he was in high school. “The desire to help the family business was pretty intriguing and […]
These 2 medical devices have sparked controversy
Sandra Maddock, president, IMARC Research The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death. It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of […]
Safeguarding against no-shows and late participation in medical device usability testing
By Rachel Aronchick, Emergo Group It’s 1:25PM, and you’ve just jotted down “P6” – the 1:30PM participant’s unique identifier – at the top of your moderator’s checklist in preparation for your next test session. Five minutes go by, and it’s time for the scheduled session – surely they’ll walk in the door any second now. […]
Brazil to implement ANVISA Class I medical device notification pathway
By Stewart Eisenhart, Emergo Group Brazil’s medical device regulator ANVISA is nearing implementation of a new “notification” market pathway for low-risk devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The history of clinical research
John Lehmann, director of business development, IMARC The history of clinical research is both fascinating and troubling. It’s a series of trial and error, followed by regulations that put patient safety ahead of profits. In fact, it’s the reason IMARC Research exists—and why we’re proud to be a partner in compliance for so many medical […]
Can AI take medical device manufacturing to the next level?
Artificial intelligence could improve medical device manufacturing efficiency and reduce risk, but it’s still a work in progress. Artificial intelligence is driving the world and our habits. Some of the world’s most well-known companies are using AI: Apple in Siri, Tesla in self-driving cars, Amazon in Alexa and even Netflix. Now medical device companies including […]
Medtech outsourcer innovations you need to know
The medical device industry is seeing all kinds of innovations, but people often overlook the myriad medtech outsourcer technologies making innovation possible. From tiny sensors, magnets and cameras to materials and adhesives that get the job done, contract manufacturers and other suppliers are supporting the medical device industry in myriad ways. They’re enabling everything from […]
When human factor specialists become the patient
By Allison Strochlic, Emergo Group I just had a baby – my second daughter. This means that, like over 98% of my fellow American moms-to-be, I checked into a local hospital to have nurses and doctors oversee what I hoped would be the smooth delivery of my baby. This entitled me to the firsthand experience […]