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  • 1.  Medtech stories for Christmas

    Posted 20-Dec-2023 12:26
      |   view attached

    Dear experts,

    Attached is a Christmas story that may be appreciated by medical devices regulatory professionals. 

    If anybody has other stories, please share them here!



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Attachment(s)

    pdf
    20231219 Certification Carol.pdf   461 KB 1 version


  • 2.  RE: Medtech stories for Christmas

    Posted 04-Jan-2024 08:47

    Hello Ronald

    Thanks for sharing this story. I read it with great interest.

    I think we can all relate to it because, as QA/RA professionals in the medical industry, we have all lived through these kinds of experiences. We keep telling senior management about these issues, hoping they will prioritize them above other business needs. But we keep getting the same answer. And then, we are the ones who have to scramble at the last minute to get things done. 

    However, I think there is an important lesson here. Executive management is focused on both top line and bottom line growth. Depending on the type of the company in its lifecycle, topline growth and market share might be more important. Second, they are focused on quarterly performance while also trying to manage the long term business risks.

    I personally don't think they want to overlook or under-estimate regulatory risks. However, they may underestimate the effort required and/or overestimate the some of us burn out and leave!

    So, the moral of the story to me is that we as QA/RA professionals have to get better at communicating up. If we truly care about our business, we have to find a better way. There is always a tension among different priorities (R&D, Marketing, QA/RA, Manufacturing, Distribution etc.). Some of the functions do it better than others when it comes to getting the attention of Executive management. We have to learn how to play the game too!

    Best regards



    ------------------------------
    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
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    Original Message


  • 3.  RE: Medtech stories for Christmas

    Posted 04-Jan-2024 09:45

    Hi folks.

    Actually enjoyed the story because it is not just in MedTech but in almost every area of regulatory that we see similar issues.  I am in OTC and cosmetics and I can tell you we have had the same problems because of the same difficulty.

    I agree with Naveen - we need to do better communicating in a way that executive leadership can understand.  This is especially true regarding impact of the decisions being made (or in this case NOT being made) because management starts from a position generally of what is right for the business.  Depending on where in the lifecycle of corporations you are as a business sometimes this means what gets the most money into the business as working capital today or it is we are ready to be acquired tomorrow or it is we are Conglomerate MegaCorp and we at a business with 50 brands, 20 areas of expertise, 1000 products in market, etc.  The difference is not as great as some believe though - the ultimate issue for a company is when is the right time to do the work so that it is completed on time but not where it costs us other opportunities.  The example in this story is perfect - MDR required that you be in process of transition at a specific point.  The CEO knew just enough (possibly because he heard just enough) to be dangerous to his company's long term survival.  His misconception that the MDR didn't come into effect (and therefore his position that they had years and years to do something about it) led to a misstep that cost him his best employee.  Not going to tell you how often that happens - especially the "not being/feeling heard" issue!



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    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
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    Original Message


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