About

“Ask your engineers how much time they spend just trying to find the information they need to do their job,” Mark recommends to any medical device executive. “As companies grow beyond a few people, they develop information silos and start duplicating business processes. 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.”

Mark’s vision is for the Consiliso architecture and information configuration to become the industry standard. This will make the communication of complex technical information between manufacturers, subcontractors and regulators more efficient and less error-prone, as well as speeding the mergers and acquisition integration process.

In addition to authoring two books, developing a complete Consiliso-ready configuration on Oracle’s Agile PLM system and keeping all that information current with changes in regulations, guidance and best practices, Mark has been a key player in a project with big future impact on the industry.

The Medical Device Innovation Consortium (MDIC) and the US Food and Drug Administration (FDA) have teamed up with the Capability Maturity Model Institute (CMMI) to create the Medical Device Maturity Model (MDMM) program. As part of the core team developing the assessment used by CMMI to determine a device manufacturer’s maturity level, Innovize (where Mark is currently the Vice President of Quality) was the first company in the world to undergo an assessment. After piloting this concept at Innovize, with the FDA observing, the company will be one of the first to open its doors to an official MDMM assessment. The FDA has committed to reducing inspections and approval times for companies that continually participate in the program.

If you want to learn more about how Consiliso is the best way to architect your processes and achieve a higher maturity rating, Mark is available as an event or company speaker, and as a consultant.