This post originally appeared on MedScrum.com. Visit for industry news and tips. 

The 2014 Regulatory Convergence put on by the Regulatory Affairs Professionals Society (RAPS), an annual five-day gathering of regulatory professionals from around the globe, wrapped up last week in Austin, Texas. The speakers were stellar and their presentations chalked-full of great insights that all regulatory professionals should embrace.

I focus here on one of them: the concept of “simplexity.”

Simplexity is more than just another buzz word

You’re not alone if you work for an organization that's sincerely devoted to continual improvement of product and process. Yet despite the numerous improvement projects that have been implemented over the years, you now find yourself in a situation where it takes you nearly four hours to submit an adverse event report to FDA.

What once resembled continual improvement now resembles continual regression.

But first, simplexity… Really?

I'll admit it. I wasn’t crazy about the term when I first heard it spoken by David Bosshart, CEO of the Switzerland-based think tank Gottlieb Duttweiler Institute (GDI) during his keynote address. I tend to get a little suspicious of calls for the induction of new words into the English language (what, couldn’t find a suitable candidate amongst the roughly one million words that already exist?). But this one, like "cyberspace" and "selfies," is probably here to stay. That’s because the theory of simplexity supplies a very useful framework for negotiating the increasingly complex nature of our personal and working lives that doesn't involve hiding from or ignoring it.

So what does simplexity mean?

Simplexity describes the process whereby nature strives towards simple ends by complex means. Take, for example, an ordinary houseplant. Seems simple enough. It absorbs nourishment through its roots and the sun's energy through its leaves. It can also stretch towards the light. Yet the inner workings of houseplants are more complex than many large-scale manufacturing facilities. That’s simplexity. Simple on the outside. Complex within.

Another way to put it is this: simplexity is about finding the simplest way to interface with a complex system. In this regard, simplexity is at work in the push towards a Theory of Everything in the world of physics. The theory, as the name implies, attempts to explain as simply and elegantly as possible everything about how our universe works, from the quantum level to the intergalactic. The theory, in other words, is an attempt at getting at that simple interface.

But I should point out we're a long way from seeing the theory actualized. That’s because the theory of special relativity – which describes the workings of our universe at the macro-level – and quantum theory – which takes on the micro-level – have not yet been reconciled. They do a pretty good job of predicting how the universe behaves at their respective scales, but not so much at explaining the behavior of the universe at the opposite scale.

There just isn't room for two theories of everything, or, to put it another way, two incompatible approaches to interfacing with the same tangle of complexity (if you’ve ever been through a merger you know what I mean).

Still, there is growing consensus among physicists that a single, simple theory is somewhere out there waiting to be discovered (similar in simplicity and elegance to E=mc²). There must be, because if nature indeed favors simplexity, by perceiving the complexities of the universe from just the right angle and distance, we'd expect it to appear, well, simple. The universe, like our houseplant, is apart of nature. The challenge lies in bringing that elusive “right angle” into view. Nature’s partnership with simplexity has been in the making for millions if not billions of years, after all. Ours, relatively speaking, is just beginning.

It's time we embraced simplexity

Despite the challenge, we have to embrace simplexity if we want to rid our systems of their unwieldy characteristics. We can’t just wish complexity away. It's here to stay and we have to deal with it.

We can achieve this by first recognizing – and applying the lessons learned from observing – the unique interplay of simplicity and complexity that defines so much of the world we live in.

Simplexity, in other words, is the lens through which we need to be rethinking our somewhat dated conception of technological progress (plane trumps car!), restructuring our political, social and economic systems, and, at a more personal level, approaching the work we as regulatory professionals do everyday to avoid a state of continual regression. We've got to start thinking like usability engineers.

Global harmonization of national regulations is a tangible benefit of simplexity

Think about the current state of global regulatory affairs, for example. For the longest time, each regulatory authority, which typically represented a single country, would develop its own rules and regulations and take responsibility for their enforcement. Over the course of a few decades, we’ve seen countries begin to partner with one another to form international bodies like the WHO, EU, GHTF, and, more recently, ASEAN, as the global economy continues to undergo a period of radical transformation with the emergence of multiple new markets. If growing administrative burdens could be shrunk, global leadership recognized, industry could get their health products to market more quickly to the benefit of more people.

But, again, the push towards simplexity is incredibly challenging, and not just from an administrative perspective. Simplexity often requires the disruption of old boundaries, hierarchies and loyalties. The biggest obstacle may be intergovernmental mistrust, as Murray Lumpkin, deputy director of regulatory affairs and lead for global regulatory systems initiatives at the Bill and Melinda Gates Foundation, pointed out in the closing plenary at the 2014 Regulatory Convergence. Many issues with the EU, for example, come down to a lack of confidence in an EU member's counterpart to do its part to achieve a particular end that affects the union. In order to eventually get to that single interface to navigate global regulations, trust, that commodity that is so hard to generate yet so easy to lose, needs to be built up between global regulatory players. This is no easy task.

So, clearly, we're not there yet, as far as this example of simplexity-in-action goes. As is always the case, the old boundaries are resisting there own destruction. Growing pains come with the discomfort of change, after all --but so does growth itself, as Martha Brumfield, president ant CEO of Critical path Institute, who also sat on the closing plenary panel, reminded us. So I have faith we'll get there eventually. In the meantime, there are so many other ways simplexity can be put to use within the regulatory profession. I'll address some examples in my next post. Stay tuned.