By Dave Hadfield, VP Customer Solutions with editorial support from Jon Nelson, VP Operations

I attended COFES 2014 this past week.   It was an excellent event bringing together some of the world’s best engineering minds.

Dedicated requirements management tools are available to manage product, user, system requirements for new product introduction projects.  These tools can be feature rich and very good, at least within the isolated context for which they were intended.  For example, with a dedicated requirement management tool it’s possible to define a hierarchical set of requirements starting with a product concept, through critical-to-quality user needs and down to detailed functional requirements.  Another key feature is tracking test cases and interfacing those with the tool, often it’s possible to automate the generation of traceability reports and validation protocols, whose accuracy is paramount.  

Many Product Lifecycle Management (PLM) Return on Investment (ROI) analyses are based on soft-savings such as efficiency gains and time-to-market improvements.  While these are incredibly impactful, possibly transformational, they are also hard to measure and can be less meaningful to some CFOs who are looking for harder savings opportunities.    

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.

PLM contrasts with two traditional approaches to managing the lifecycle of a product, which include:

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.