If you’re familiar with Innovize, you’ve probably heard of our VP of Quality, Mark Rutkiewicz, who quite literally wrote the book on Quality Systems.
His textbook, Consiliso, is a 470-page blueprint for integrating business processes in medical device companies.
“As companies grow beyond a few people, they develop information silos and start duplicating business processes,” said Mark. “Consiliso tells you exactly how to sort it all out. It is scalable from a start-up to a multinational, does not require expensive IT capital and time, and adds real value to your business.”
In 1995, Mark was working on a pacemaker as part of the product development team at Guidant (now Boston Scientific), when the original concepts for Consiliso were developed. He was learning about the new FDA design controls when a massive compliance issue arose due to an FDA consent decree. To help resolve the issue, Mark proposed his team implement standardized business system requirements and an online documentation tool. During the next three years, after incorporating Mark’s suggestions, the FDA did not have any findings at the site.
Mark took this concept of business process standardization and integration to St. Croix Medical (now Envoy Medical), Cardiac Science (now Zoll), and to AGA Medical (now Abbott). All three companies found that it improved their compliance, leaned out the processes, and simplified everyone’s work.
“Even people that weren’t in quality, like legal and marketing, wanted to use these tools,” said Mark.
After six years with AGA Medical, Mark left the company to do similar work at Monteris Medical. At his going away party, a co-worker said, “you should write really write this down!”
So he did.
He spent the next year drafting and refining a 30-page book outline of his methodology. At Monteris Medical, Mark implemented Consiliso concepts and tools in less than a year. Mark also added best practices associated with the installation of capital systems to the outline.
In 2013, Mark joined the team at Innovize and began writing his book.
“I learned even more at Innovize,” said Mark, “things I’d never done [before].”
After five years, and several iterations later, the Consiliso textbook was published in 2018.
Since, the Consiliso blueprint has been adopted by 10 companies.
The Medical Device Company in a Box, and an abbreviated 150-page executive version are available for purchase at www.consiliso.com.
