Innovation Meets Compliance
Your organization has made the decision that Product Lifecycle Management is the right strategic business tool to help you remain competitive and secure successful organizational longevity in an increasingly globalized marketplace. With the decision to implement PLM, you now come face to face with a myriad of PLM solutions that you can choose from. For a successful implementation of PLM in your organization it is essential to select the “right” PLM for your business needs and organizational culture. The PLM decision will impact the organization for years to come. Once a PLM solution is implemented, organizations will find it difficult to move to a new PLM platform that replaces the incumbent PLM platform.
Check out Dave Hadfields new promotional video describing the need, impact and benefits of conducting a proper PLM Strategy:
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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.
The PLM Innovation Americas 2012 is North America's only independent and technology agnostic PLM event. Bringing together 300 senior end-users, thought leaders and select PLM vendors, the conference aims to leverage the collective wealth of knowledge and experience to identify and encourage best practice. The combination of a world class speaker roster, cross-industry case studies, targeted Think-Tanks and pre-qualified networking opportunities make this North America's must attend PLM gathering.
In a previous post I talked about the importance of governance for a PLM implementation and mentioned that overcoming issues related to management of change (MOC) is an important consideration. In this post I’d like to drill into that topic a little deeper. To me MOC in the context of PLM is about people in an organization understanding the value of their PLM solution and accepting it as an improvement over the processes they were previously using. You can’t necessarily depend on “if we build it they will come” with such an important undertaking; human nature is to want to continue to do things the way they have been done in the past.
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