Is "Pragmatism" a wolf in sheep′s clothing?

"We have to be "Pragmatic" in our approach."

One of the things you get unique insights on if you have ever worked as a consultant, is shared cultural trends within ones field. I have found "Pragmatism" to be one such persistent trend.

I have, during my consulting years, heard the above statement uttered a few times from people working within top management of medical device companies. I have even found it to be the guiding principle in the culture of some companies.

I think the idea of "Pragmatism" is appealing for many people within the device world because it appears to lead to fewer expenses in delivering a product to the market.

"We should not need to pay for a test based on that standard, since the standard is not a legal requirement and, by the way, our product is the most state-of-the-art product out there, as is!"

Statements like these can sound appealing to people responsible for management level decision making and if an expert engineer is making that case, it can be hard to argue against.

But does that kind of "Pragmatism" work?

It is important to realize that in many ways that kind of "Pragmatism" stands on the opposite spectrum of Quality:

"Pragmatism" <-> Quality

For "Pragmatism" to really work, I would argue that it should be able to drive Value better then Quality.

In the following I will give three unique ways in which I believe this kind of "Pragmatism" does not drive value and three ways in which Quality does.

1. "Pragmatism" can put patients and your device Market Access at risk!

Imagine if your company has a multitude of devices already on the market and you are now made responsible for a new device being developed. The success and generated income from that device could potentially be a "blockbuster" level success for the company!

You are asked to give your support and to make a decision to allow changes to your Quality Management System to make it easier to develop the new device, and you are told that the way the "older" devices have been made is too slow and should be "not necessary" based on the above example statement.

Hopefully you are told by your Quality responsible that you cannot make such change decisions without review and approval and hopefully the Quality and Regulatory functions stop you before you put your entire ISO 13485 certificate at risk, which would make it so that you could loose the sales of all your devices!

In your eagerness you were about to risk the Market Access of all your devices, potentially bringing the entire company to a halt!

There is real potential for that outcome, and ignoring experts and supporting that route may actually lead to short term Value, until it is known what happened and real regulatory consequences catch up to you. And this negative impact is not even exploring the risks that may be be introduced to patients!

2. A culture of "Pragmatism" drives away talent!

When you have entered an organisation enough times as an outsider, you develop an intuition, like a spider sense, that can alert you to the state of the organisation. When alarms do go off, you naturally begin to assess the culture of the organisation in more detail.

I have noted that organizations that lead with this kind of "Pragmatism" tend to have high employee turnover within their quality and regulatory functions. The organisation can begin to spiral out of control as talented and experienced profiles do not want to stay and, paradoxically, the problems that the "Pragmatic" approach is accumulating cannot be solved unless talented and experienced profiles are working on them!

This awareness trickles down to all areas of the organisation and even outside, in the rumor mill, and can lead to the organisation having to pay higher and higher salaries for less experienced and less talented profiles.

Hiring less experienced profiles and promoting them as "super-talents" is not a meaningful solution to the overall issue.

Where you have a culture of Quality and Compliance, on the other hand, there is no such thing as being an outsider. Clear processes and appropriate openness to all systems makes it easy to work and utilize your competencies. This is the culture that attracts and retains experienced profiles which helps establish the organisations brand among professionals.

The state of the culture can be said to be a direct reflection of the managements leadership qualities.

3. "Pragmatism" is misunderstood.

Believe it or not, I actually like "Pragmatism"!

In what I have highlighted in the above text, the Pragmatic approach is actually a cover for something else, namely an approach that promotes departmental influence and monetary gain in isolation.

In my belief, "Real Pragmatism" is about judging a situation based on objective truths and based on practical effects and outcomes, rather than abstract principles or theory alone.

With that approach concepts and beliefs should be evaluated by how well they work in real-world situations, and the belief should be that ideas are tools for real action.

Pragmatism values adaptability and changing beliefs or approaches based on what works best in practice, as opposed to rigid adherence to dogma or tradition.

Well, how does "Real Pragmatism" differ from what I have described as "Pragmatism" above, you might ask?

Just as an example, lets have a look at standards development.

When standards are being developed, some of the worlds best experts share their experience and know-how to put down requirements that will work best in practice. They understand the principles and ideas behind regulatory texts and translate them into meaningful actionable text. In my experience working with ISO in the development of ISO/TS 82304-2 for health and wellness apps, I have witnessed first hand how that work is focused on creating requirements that will work in real-world situations.

These standards may or may not be harmonized or may or may not be a legal document, but it will always represent the state-of-the-art and the most Pragmatic approach available to any manufacturer.

This is why "Real Pragmatism IS Quality:

"Real Pragmatism" = Quality

And why Quality ultimately drives Value.

Final thoughts.

I hope this edition of "The Circle Insider" was meaningful and insightful to you. I am celebrating my Decade of Devices and during this time I have seen work being done on many different types of devices, yet the same concepts and ideas are often repeated.

We tend to have long meetings revolving around the same concepts, but often cannot dive deeper into what the long term effects of certain approaches may be.

If you think this is a useful article for promoting Quality and Compliance for how we plan to create Value within our field, do share it and help more followers become Circle Insiders.

Thank you for your time.