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What is PLM?





​​Product Lifecycle Management (PLM) is the governance, operational approach, infrastructure, tools, processes, and protocols used to bring a product from concept to customer. 


A PLM process ensures the product under development is aligned with corporate goals and ready for market, and that resources are being used efficiently.


The journey from product concept to patient is long and complicated.  A PLM process makes that journey predictable and efficient.  Think of it like a long backpacking trip: it takes careful planning and preparation to know what trails to follow, where to stop to reload supplies like food and water, etc.   Your PLM process is that planning.


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In the LUMINYST PLM WORKSHOP (part of the PLM Module) we work together to map out the framework for your PLM process. This will help ensure your products:

  • align with the company’s goals

  • meet the needs of the patient

  • get to market efficiently


It will allow us to

  • track project progress

  • ensure no critical steps or deliverables are missed

  • clarify everyone’s roles and responsibilities 

A PLM process adds visibility to everyone’s work so  the goals are clearer to everyone.

PLM- Frequently Asked Questions:


1. Aren’t we too small for this?  Isn’t this a big company idea?  Isn’t now too soon?

A PLM process can be fit-for-purpose for a small company, and small companies do not have the luxury of wasting time or runway.  Predictable deliverables and review cycles will ensure the important aspects of bringing a product to market are not forgotten and time and money are not wasted. All of this is crucially important to small companies.


2. Will this make product development take longer?

No. A PLM helps development stay on track, and improves the efficiency of the process. We aren’t adding more work or time to projects, we are making sure projects stay on track and have the resources they need to be done on time. Think of your work as cargo: the PLM is the train that carries your cargo to its destination through various stations.


3. How does this align with FDA guidelines?

The Luminyst PLM process is focused on the needs of science-based companies, including those in the regulatory environment.  The foundation of the PLM process for regulated companies is structured on FDA guidance, resulting on a organized and focused company prepared for FDA interactions. 


4. Will we have to create any new materials?

Luminyst has templates ready to go that can leverage existing work, making the stage gate reviews easy.


5. Who is going to drive this process?

The PMO organization typically owns the PLM process.

6.  Won’t this add more work for me?

No. A PLM does not add work; it highlights the critical work already being done.  It gives your work visibility to leadership and the entire company. If you’ve been wanting more resources,  a PLM can help showcase your cause. 

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