Challenges:

Over the years, the initial majority of Product Data Management (PDM), and later Product Lifecycle Management (PLM) systems grew out of existing CAD and engineering tools.  This meant that these data/change management tools were very technical and not very user friendly for general users.  These tool were and largely still are very good at managing their own data and not so good at managing other data, particularly complex CAD geometry., (much better at collaboration now than initially).  Through time several, more agnostic PLM tools came about that weren’t so tied to the CAD systems that created the geometry.  These systems were able to focus on change management, BOM structures, supply chain, quality, etc.   Not that the “”CAD PLM” systems did not also focus in these areas, it seems that they often wanted to keep the acorn close to the tree.  This allowed them to sell more of their products to existing customers and keep their intellectual property close to the vest.

INTEGRATION FOR A MEDICAL DEVICE

As with many companies this medical device client determined there was more value in using best-in-class for the CAD repository, (the CAD PLM – or some may revert to saying PDM), and utilize the more business oriented, less technical, “generic” PLM systems for the more pure PLM tasks.  This created 2 systems to manage the more technical engineering data, and the BOM, business data.  This is a very common scenario in many industries and organizations – then and now.

However health science, medical device, and pharma companies have an additional requirement to manage that is the FDA requirements.  For good reasons, the FDA mandates that any of these organizations that create product that is touched or are ingested by the human bodily must have a Design History File (DHF) to prove that they are designing what they state they are designing.  In addition they must have a Design Manufacturing Record (DMR) to show that what the organization is manufacturing is what they designed.  On top of all of this, the FDA, (CFR 21, part 11) mandates that all software utilized to create and support these products and processes must be validated to show they are performing “as advertised”, as desired, and as required.  This takes a great deal of additional effort in updating and testing the systems, particularly when there are more than one being utilized/combined to achieve these goals.

This segregation of technology and processes can cause:

  • A disconnect with engineering and the rest of the business
  • Less collaboration between disciplines
  • Hindered feedback mechanisms
  • Miscommunication
  • Additional validation because of multiple systems, processes, and disconnected data
  • Older methodologies of problem solving, PDF, XLS, FAX, etc.
  • Costly Time-to-Market (TTM) delays, manufacturing and quality issues

Solution:

Integrate the CAD and the PLM systems to:

  • Share more precise and up to date information across disciplines
  • Make the engineering data more available to others:
    • Design reviews
    • Quality
    • Labeling
    • Manufacturing
    • Packaging
    • Portfolio evaluation (different sizes, engines, etc.
    • Analysis
    • Legal

Value:

  • Greatly diminished the time it took for bringing product to market:
    • Reducing reviews and decision making time
    • Diminishing out of synch data
    • Improved ability to evaluate feasibility
    • Improved training and understanding
    • Improved, prompt feedback mechanisms
    • Enhanced multidiscipline collaboration – many different needs could be discussed and evaluated with the same data at the same meeting
    • Greatly diminished validation, testing, and use cases

For detail or more information on this or any of our case studies or content please contact us at info@professor-plm.com