When Marketing makes a promise,
but QARA says no.

When a promise reaches the market before the evidence exists, QARA becomes the problem. Or does it?

In the middle of a Teams meeting for a product change (come on—we never make product changes, only process changes), a Marketing director says:

So, we already have the marketing material for our product. Sturdier, resilient, sharp.

The Regulatory Affairs director immediately interrupts and says:

Where does this come from? I haven’t been told about new marketing claims.

Oh, did we have to tell you? We’ve already printed everything and have started distributing the material.

“Yes, you need to tell me,” said the director. “We need to review this in detail.”

Ten minutes later, I saw a meeting request—How to review marketing claims.

Two days later, the general manager was shouting, “I don’t care what RA says, you need to make it happen.”

Yeah, the FDA doesn’t work like that. He didn’t know that (maybe).

But Marketing made a promise and QARA said no. QARA became the problem.

Let’s unpack, shall we?

There comes a time when every marketer needs to bring a product to market. If you’re outside medical devices, that might be easier.

This product flies.

You can translate 192 languages with this app.

You don’t need to think anymore; AI will do it for you (thanks ChatGPT).

But then, you talk with product development, and they tell you:

Well, technically it doesn’t fly. It… planes, kind of. But yeah, it’ll hold in the air for a while.

I mean… yeah, it translates 192 languages. However, partially. I wouldn’t say “translate”; I’d say it works like a dictionary.

Oh, sure, it can think on its own and make decisions. But you need to feed it with data. Real-life data.

All of these are examples of claims. But what is a claim—not according to the FDA, but according to the dictionary?

Merriam-Webster defines “claim” as

“an assertion open to challenge”.

At this point, it really looks like Marketing never read it.

Sturdier.
Resilient.
Sharp.

If these concepts are claims, they should be open to challenge, right?

How much sturdier? Better than that, what does sturdier mean, and how do you measure it? Are we measuring it? What’s the current state? What will the new state be?

That’s what Marketing and R&D couldn’t answer.

We’re just doing a process change; why are you asking these questions? —said the R&D Manager.

That’s not the question. The question is why you decided it was correct to put this in the marketing material without recognizing that it was a claim.

Yeah, but the process change is intended to increase sharpness.

Ah, that, my friend, is a marketing claim, said the President.

What’s the missing piece here? What PDSL always says: Alignment.

Let’s state the facts:

01Marketing wanted a sturdier, resilient, and sharper product.

02R&D should have defined what all those concepts meant. What’s “good enough”?

03The product development system should have connected those expectations with the people responsible for turning them into engineering requirements.

04The resulting product should have provided the evidence Regulatory Affairs needed to support the marketing material.

I won’t tell you how the story ended, but I can tell you the following:

You can disagree with QARA.
You cannot negotiate with evidence.

QARA wasn’t the problem. The lack of alignment was.