In short, the term means “The unity of processes.” Mark Rutkiewicz, inventor of the term, had an epiphany during his morning run. The word builds off William Whewell’s term “consilience” or a “coming together of knowledge” from traditionally separate disciplines in order to achieve new breakthroughs. Mark needed a term to describe how his architecture for medical device business processes results in integration and process re-use—a coming together of the traditionally different, silo-structured aspects within your company.

The best way to quickly understand the nature and power of Consiliso is to obtain the quick read:  Medical Device Company in a Box: The Case For Consiliso. Written for company executives and leadership, this short book provides numerous examples to help you understand Consiliso’s basic concepts. Now available on Amazon in paperback and ebook!

Consiliso is NOT  a theoretical program—it’s a BLUEPRINT! Not to say that all the programs out there don’t have a place in improving your company. But Consiliso isn’t some kind of exercise that you do to simply improve compliance and efficiency around a specific function. It’s the detailed architecture for how your business works: how different functions interrelate, and how critical information must be categorized, labeled, and stored in order to facilitate quick retrieval by anyone who needs it to do their job. Mark developed this blueprint over 30 years in leadership positions as a Quality professional in various kinds of medical device companies. As an analogy—figuring out how to improve the design of a room in a building in order to make work more efficient is like performing a Lean or Scrum activity. Consiliso is the underlying blueprint for the entire building—walls, mechanical systems, wiring, safety features, aesthetic elements—was created. Pre-order the textbook Consiliso: The Blueprint for Integrating Business Processes in Medical Device Companies.

It varies, but is scaled based on a variety of factors. How complex and large of an organization do you have? What types of devices do you manufacture and/or service? How differently is each aspect of your business was architected?  Cost also depends on your leadership’s commitment to changing fundamental aspects of how your employees currently work (typically, in information silos and within processes that are not re-used and often duplicated in various parts of the company). The technology tools that support Consiliso are not prohibitively expensive (as long as you are not wedded to a computer system that does not allow for flexible configuration or cannot be made compliant; otherwise you will have a data migration project). You can order the complete Consiliso textbook and take on the effort with little to no help from us, or utilize our consulting services to speed your implementation. Contact us and we will perform a quick assessment of your company‘s size, the complexity required due to the types of products you manufacture or services you provide, and the geographies within which you sell.

Beyond efficiency and non-compliance savings, you are adopting an industry standard and improving the maturity level of your company. Obviously, having defined, integrated processes improves efficiency and reduces the chances of receiving an audit or inspection finding. Your people know the framework around what must be done, but are empowered to act as needed within those boundaries (and have an instant mechanism for reporting and tracking problems as they arise). Beyond efficiency and compliance, the Consiliso architecture standardizes terminology and information hierarchies in a way that makes it far easier to share information with contract manufacturers, suppliers, and customers.  How easy is it for your company to consolidate the information needed to report on progress to your Key Performance Indicators (KPIs)? Can you drill down into detailed information in order to understand why you are missing your goals or targets? Consiliso (with the right information tools behind it) can facilitate instantaneous retrieval of that information.

It’s no secret that acquisitions are a goal of most start-ups and how large corporations expand their product portfolios. With Consiliso, the process for discovery and integration is vastly simplified.

In conjunction with the Medical Device Innovation Consortium (MDIC) and the Capability Maturity Model Institute (CMMI), you can participate in assessments to determine your company’s maturity level and, if you commit to a continuous improvement process, the FDA will change your inspection schedule. Your maturity rating will also be a large selling point with your customers, and something you should look for in your suppliers. Guess who was a key player in developing the assessment for the Medical Device Industry? Yes, the inventor of Consiliso, Mark Rutkiewicz. Consiliso is specifically designed to provide your company with the framework for achieving a high maturity rating.