Regulatory device compliance
The neoGuard, a first-of-its-kind wearable device vital signs monitor, launched in 2021 in Kenya, Africa. Designed specifically for regions with unreliable electronics and limited resources, neoGuard monitors vital signs in newborns and can alert nurses and doctors of signs of…
What is risk-based thinking in the medical device industry? Why is it essential? Around 4,500 drugs and medical devices are pulled from shelves across the United States each year. This alarming statistic highlights the importance of controlling and mitigating risk…
It’s rare for a small Medical Device business services provider to take on the commercialization of their own medical device. And that sort of challenge is not at all what Janet Kwiatkowski (CEO of MAE Group) intended when she founded…
“Cancer is relentless, so we must be relentless too.” Relentless: oppressively constant; incessant. Cancer never relents as it spreads through the individual’s body, or the collective population. Dario Rodrigues knows this well. In fact, he’s relentless in his dogged pursuit…
Female CEO takes the reins to get glioblastoma oncology device to the world That single word whispered by a doctor, “glioblastoma” changes everything. Glioblastoma, a long and complicated word to describe the most common and most aggressive brain cancer. Every…
Learning from mistakes allows your company to successfully see your product to market. Learning from mistakes, yours and others, remains an essential component to successful completion of the commercialization process. Your end goal is to bring your lifesaving device to…
Growing your team to be the best and most effective seems challenging especially as an executive, manager, or team leader. However, by using the model of a growth mindset, a company and team becomes the most effective and integrated team…
We’ve all seen it on television: a careful, methodical turtle taking one cautious step at a time. Very. Slowly. Meanwhile, a rabbit nearby is rushing, then maybe napping, but always losing the race. We might cheer for the turtle or…