Assessing Value, Step By Step

FDA Regulation Consulting

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I am working with a very interesting company (at Delta Consulting Alliance, we never release names of our clients) that wants and needs our services, but wants them “step by step”. You might be thinking, oh, they’re not the brightest crayons in the box, but this is not the case! I wish I was a bright and capable as they are. I am interested in what you think about this approach.

This client’s culture is, in my opinion, a high performance work environment culture. Individual productivity is extremely high, and in order to thrive in this environment, you have to be smart and capable.

Most clients want to know the overview or the whole picture for our services. For example, they may need to have a 510(k) Premarket Notification and consequently, they want to know what it will cost and how long it will take to go from “a napkin drawing to product clearance”. But, as I have said, this is not the case for the client I am discussing here.

But why is this? I was stumped for a little while, but then when I put myself in my client’s shoes, I think I began to understand. You see, if each process step makes sense, that is the value of the service in this step is greater than the cost, and the timing is appropriate for the associated Design and Development Plan, then the step should be purchased. If not, then the step should be modified so that it does provide more value than cost, or if it is not possible to modify the step, the client would be justified in seeking an alternative service provider. If each step is value added, then the sum of the steps should be value added. Does this make sense to you?

One of the first questions that came to mind for me is “what about synergy?”.  By understanding the whole picture, at least in my opinion, one is able to better combine activities to bring the greatest amount of value, with the least amount of effort. But is this really true? Does the plan or more specifically the planning process, drive a synergistic result? In my opinion it does, however, my perspective is being challenged by this client, and I am going to reevaluate my position on this matter, step by step.