Lack Of Planning On Your Part

Should not constitute an emergency on my part.

I’m guessing you have heard this saying a time or two as well.

But based on the actions of a couple of our clients, I’m guessing this saying has little meaning. Let me share a brief example.

A medical device company has several products on the market in the U.S. and many other parts of the world. They are actively pursuing getting their products cleared all across the world. The company relies on distributors in the specific countries to take care of getting products registered. The company has no in-house regulatory or quality resources and has relied on us to serve in this capacity as a very part-time basis.

And when I say very part-time basis, I mean that we help with regulatory issues somewhat after the fact. Let me explain. Company works with in-country resource to register products, unbeknownst to us. In-country resource has an issue with information provided or needs additional documentation and needs a response within a couple days. Company contacts us in a rush with the emergency to help address deficiencies.

This scenario has happened half a dozen times. Each time, we have communicated the need for the company to be more transparent with us, to let us know what products and where they plan to register. However, there is NO regulatory strategy. There is NO business strategy. The company might argue differently. To paraphrase what the company would say is their strategy: To get products registered in every country in the world and sell, sell, sell.

I can ramble on and on. Let me get to the point.

Lack of planning on your part should not constitute an emergency on my part. Develop a vision and strategy to support it. You should have a plan based on the strategy and communicate this plan to your team and resources. When actions are required, keep your team and resources informed, tweak the plan, and course adjust.

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