Bringing a new medical device to market is a complicated, highly regulated process, one that requires documentation at every turn.
Kristin Mortenson doesn't believe there's been a simple solution for most medical device companies to keep track of it all, until now.
Mortenson is co-founder of
Acera Innovation, maker of a software-as-a-service application built specifically to help medical device companies manage workflow and collaboration around product development, regulatory compliance, and quality management.
"Our goal to lower their time, risk, and cost to bring their product to market," says Mortenson.
Most medical device companies are like the ones Mortenson has worked with the past 20 years: fewer than 100 employees and too small to be able to afford large enterprise software customized to their needs.
As a consultant, she looked for software that would help clients stay organized but couldn't find any good solutions. As a result, regulatory compliance became a time-consuming headache for many firms.
About a year and a half ago she met with a couple of software entrepreneurs, Myke Miller and Steve Swartz, and they formed Acera Innovation. The company signed up its first paying user about a year ago. It's in a "limited-release" mode right now with about a dozen customers, mostly in the Twin Cities.
Because it's a cloud-based service, companies don't need any specialized staff or hardware to run the program, just a computer with Internet access. This frees up companies to concentrate on the task at hand:
"Placing the energy and the time and the creativity on the device."
Acera Innovation is currently raising money and also preparing to release an updated version of the software in the fall.
Source: Kristin Mortenson, Acera Innovation
Writer:
Dan Haugen