Nobody tells you how to do it, they said. How to integrate all the various processes (R&D, design assurance, regulatory, quality assurance, product release, complaints management, supplier management, distribution, etc.) required to bring a medical device to market, and keep it there profitably. Nobody says what the best practice actually is for implementing compliance to all the regulations, for structuring the documentation, for handling all the problems that inevitably arise. Auditors tell you what you are doing wrong, but leave you to your own devices (pun intended) to dig your way out of the hole.
No one source for best practices specific to our industry existed, before Consiliso: The Blueprint for Integrating Business Processes in Medical Device Companies was written. After over 30 years of leadership experience in the medical device industry, Mark Rutkiewicz has distilled all his “how to” knowledge down to this 472 page manual, available now in Consiliso’s store for $200 off retail price. If you prefer, you may also purchase it directly from Amazon at additional cost. Most other books in this space present and expand upon one or two concepts (like how to improve your CAPAs, or audits, or submissions) but Consiliso covers literally every activity your business performs, whether you make bandages, implantable devices, accessories, capital systems, combo products or any other kind of device. Take a look at the Table of Contents for the book here (scroll down to see the full book description).
This is it: the “medical device company in a box” that we told you about in our short introduction book, The Case for Consiliso. Mark is well-known for fixing dysfunctional Quality Systems, and for moving beyond FDA or ISO compliance-oriented functions to ensuring the whole business does not duplicate processes, work, or information.
If you are a start-up, here’s how you set up your business correctly from the beginning, avoiding the mistakes and pitfalls of your competitors and achieving world-class business systems in record time. If you are looking to be acquired, the ease with which you can demonstrate that you’ve covered all the requirements of all the myriad laws, regulations, guidance and standards out there makes you far more valuable.
If you are a small or mid-sized company, Consiliso: The Blueprint gives you the detailed information you need on best practices for structuring your business in a way that drastically improves quality, efficiency, and productivity. Since this is the first-ever publication of a rational way to structure how you do your work, how your information and data is structured to allow for correct and quick analysis, you won’t start down the path where employees spend a great deal of time trying to find the information they need. You’ll be ahead of your larger competitors as you start down the road of continuous improvement in partnership with the FDA (see our blog post on this topic).
Even if you are in a mutli-national, multi-site corporation (perhaps especially if you lead in that environment) the concepts, tools and best practice advice in Consiliso: The Blueprint offer ways to retain or revive novel product development, drastically streamline risk management activities (from complaints to environmental health & safety to financial regulatory issues), simplify supplier and subcontract activities, and (most importantly) ensure that critical information doesn’t go missing or is inaccessible across departments or functional groups that need it.
Don’t forget, after you chew on the meaty morsels of invaluable information in this textbook, that the author is available to help you understand where to start with a little one-on-one help. Contact us for more information on our consulting services to get started with an initial assessment and road map for where best to expend your time and resources on implementing Consiliso principles in your organization.
