When building your Quality Management System (QMS) for your Medical Device Company, use this simple guide to develop the foundational three-legged-stool.  Realize that building an ideal QMS takes more than a good quality manual.  We must consider people, processes, and tools as critical components of a system that comes together in harmony.

I had the opportunity to return to a client which I worked with over three years ago.  My first contact with this multi-billion dollar Medical Device Company was to develop a PLM strategy for the R&D organization, mainly focused on the early design experiments.  At the time, they were already leaders in their market but still used paper lab notebooks for their initial engineering design and experiments.  Over the course of the project, I found that they understood the need for change but many felt that they were being forced to update a process that had worked well for them and had made them industry leaders.  After working with them for nine weeks, the strategy finalized and delivered to them which lead to a three year series of project that I was not involved with, but others in Integware worked on the implementation.

PLM is not a new concept. It has expanded well beyond the industries where it started.  A question that we at Integware continue to hear from most companies, and in particular the visionaries within companies new to product lifecycle management, is “how do I show the business value of product lifecycle management?”

I’ve had the opportunity to manage a large number of projects over the years from very large to very small and I have often found that the main challenges related to successful enterprise solution delivery are usually not technical.  Yes technical obstacles will exist, will need to be overcome and engineering tradeoffs made.  But in my experience the major roadblocks to enterprise implementations stem from improper governance, issues related to management of change (by that I mean organizational acceptance and understanding of value) and strategic investment shifts.

I have been calling directly into the Life Sciences (LS) space for about a year and a half.  I will not call myself an expert, but given that I have been in the business world for over 30 years, I feel I have crossed over into the category of a “gray hair” and therefore I can have some relevant observations.  My below observations are in some ways provided as an outsider looking into the LS industry.

This posting describes an approach to PLM implementations when an OOTB approach is not feasible and following this process leads to the characteristics a first rate PLM implementation.  The engagement should be run in an agile manner with frequent deliverables that can be signed-off.  The deliverables start as light-weight easily refined components of a Paper Prototype (PP) and evolve with feedback to a Demo Prototype (DP) and finally to a Conference Room Pilot Prototype (CRP) that shows the total solution.  Each prototype is signed off by the business users.  The purpose of the prototype refinement is to gradually transition the user from a paper-based world into an understanding of a PLM-based solution.

Now that spring is here and summer is on the horizon and if you are like me you want to look your best for summer. What does that mean? Usually a diet of some sort, but what do you look for when starting a diet and how am I going to apply that to PLM?

Product Definition Knowledge Management (PDKM) is a solution architecture approach that guides the use of PLM in supporting the full lifecycle of a product.  The purpose is to have all the relevant product information in one place, connected to meet business needs, and safe.  In other words, PDKM is a single source of the truth.  The PDKM solution covers the product definition scientific and engineering information from the earliest research through all the improvements made to the product and its manufacturing process until the end-of-life.

During a recent business trip, I was sitting in an airport café with some colleagues while discussing how to build and manage BOMs.  We got some strange looks.  Then I mentioned something about exploding the BOM.  More strange looks.  Nervous glances.  Finally, we decided it was best to avoid using the B word in airports.  But since you probably know a thing or two about BOMs and PLM (otherwise, uh,  why are you reading this?), I'll assume you know what I'm talking about and I can use my normal Nerd-speak of PLM acronyms.  (My nickname around the office is "Big Nerd", because I'm six foot four and I think BOMs are interesting).