While walking around a recent industry conference, I’m often asked about the title on my badge: Consiliso Evangelist.
“What’s that mean?” they ask.
Replying “we’re sharing a proven architecture for improving all your business processes, not just your Quality System” usually results in glazed eyes. We’re the boring part of the medical device industry. The ones who nag to get people trained properly, to document things correctly. The ones who come around and conduct pre-audits before the notified body, FDA or customers come through. Worse, we’re the ones constantly changing how people do their jobs in response to regulatory requirements. When we haven’t learned about Consiliso yet, we’re often the ones that make you go through a complicated process to find the information you need in order to analyze a problem and propose changes to solve it.
So now I reply, “What about your job makes you want to bang your head on your desk? Because we probably have the solution for that.”
We’re a little irreverent around here, obviously. We’re trying to disrupt a status quo that robs every company of the thing it most needs: the time and attention of employees to getting critical work accomplished. We require people to question much of what they believe about how you must perform work in order to be compliant. Hundreds of ways to meet the regulations exist. But nobody has every created a detailed “how to” for the best, most efficient methods, developed after three decades in the medical device industry. Until now.
For example, as companies grow, they hire experts to design specific processes: people who know how to conduct Clinical trials properly, assemble and maintain regulatory submissions, run the R&D group, oversee manufacturing and customer service, handle complaints, etc. What you are left with, over time, is a hodgepodge of information stored in different locations, and different methods (and cultures) for getting similar work done. We’ve seen companies with multiple purchasing SOPs depending on whether you’re buying something for manufacturing, for the general business, or for clinical trial materials. Um, hello? Purchasing is purchasing. The same thing happens for all the different kinds of changes that must be documented, approved, and implemented. Change is change. Complaints, CAPAs, and Issue Tracking are all the same process as well, because problems are problems. If you look at everything from a systems architecture perspective, the only differences are metadata (fields on a form that differ according to the type of purchase, change or problem, to finish the example above). You might have a slightly different workflow (steps needed to properly complete the work) and different approvers based on the type. But the process is, when done correctly, easy for the people doing the work and doesn’t require them to jump through unnecessary steps, or spend time tracking down the information they need.
Whether or not you are using a software tool to support this effort (and there are several that can do it well) or you are paper-based doesn’t matter. With the detailed, how-to information in Consiliso (an exhaustive textbook covering all the systems and processes for every type of medical device maker) you don’t even have to start from scratch; the best-practice architecture is all there for you to pick up and implement. Become a Blueprint Subscription Service subscriber, and you not only get the online (most up-to-date) textbook, but free documents (Policies, Process, Procedures, Forms, Templates) to drastically speed your Consiliso implementation. We also maintain a database of all the Laws, Regulations, Guidance and Standards (LRGS) so you don’t need to spend a lot of time tracking down which requirements apply to your devices and the geographies in which you sell.
If you are interested in an overview of Consiliso, how it works, and what medical device companies need to do to keep their employees’ foreheads bruise-free, check out the quick read: Medical Device Company in a Box. If you happen to be at MDM West in February, head over to our booth at our sister company, Innovize, or come to Mark’s talk, for a free copy. Otherwise, it’s available on Amazon.
As a Consiliso Evangelist, I’m interested in hearing your answer to “What about your job makes you want to bang your head on your desk?” We’ll tackle some of those specific issues in future musings. Feel free to vent (professionally, of course) in the comments.
