Global regulatory is becoming a very strategic problem for medical device companies. The landscape has become more complex as each agency has matured in their requirements. These continuously evolve and the change to them and change to products must be considered continuously to determine if re-filing is required.

This makes the difference between being able to sell hips, catheters and MRI machines in China, EU, Brazil, Argentina, etc. A PLM centric approach can enable companies to accelerate registration in those regions. This equates to massive revenue opportunities.

This is enabled by having a single copy of the submission data that is accessible in collaborative environment and can be quickly and reliably reused between regions.

Additionally managing this change process poorly can result in fines.  A core strength of PLM is managing change and all associated processes (such as supply chains used across a product assembly).  Therefore using this information while simultaneously tracking continuously evolving country requirements (including “Grandfather” rules) it is possible to determine with much greater simplicity and accuracy what on-market products are affected.  Similarly when introducing a new product or making a product change it is easier to understand what country requirements exist.

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.