Urgency: Promise or Problem for FDA-Regulated Companies

Jack Garvey |

A couple of months ago I was engaged in a brief, friendly dialogue with one of my close friends – a college buddy – about a current business imperative:   urgency. My friend is a Senior Partner with a large, very well-known business consulting firm, and has responsibility for major projects within large pharmaceutical companies.

As part of our regular communications, my friend forwarded me the following “book review” that he thought would be of interest:

Latest book from John Kotter: “Urgency”

Essentially talks about how people/organizations need to develop “true urgency” as a core competency.  With the rate of change at an ever escalating pace, the traditional episodic approach to change (aka projects) will not be sufficient to sustain competitive advantage.  He describes three modes of operation:

1. not urgent — protecting the status quo 2. false urgency — frenetic activity… but not aligned, goal is to stay “busy” vs winning 3. true urgency — objective is to WIN – NOW, by doing something important everyday

My reaction to this review was somewhat less enthusiastic than I’m sure he was hoping for.  It initially struck me as “consultant speak” and self-serving – something that I feel is all too common in consulting circles.    After thinking about it further, I think that much of the challenge facing FDA-regulated companies, and business in general, is that individuals within these companies don’t challenge conventional wisdom nearly enough, and simply “lap up” the concepts presented to them. On this topic – the topic of “urgency” – I don’t think that we aren’t moving fast enough in the business world – in fact, I think we are often doing without thinking – we respond often without seeking to understand deeper issues just because we have to get a response developed, NOW! In this context, I offered the following back to my friend:

Being the contrarian that I am, I would suggest that “Urgency” has a big price — ask Toyota or BP.  The more things change, the more they stay the same — fundamentals are key today — and failure to focus on fundamentals (culture, the long view, structural profitability, maximum asset contribution, portfolio stability and strategy, etc.) is where companies are having difficulty. It would seem that viewing business challenges as running faster on the hamster wheel is a convenient distraction to actually achieving anything that builds long-term value.

My $0.02

Since that was a sound-bite, I’ll expand upon the principles I was trying to convey there. I am a strong believer in robust strategy development; open, honest communication and feedback; and comprehensive program planning and execution. Call me old-fashioned, but I’m a strong believer in fundamentals, and this is an area that I don’t think industry, and especially FDA-regulated industry focuses on enough.

I had three high-school football coaches that taught me life lessons I still embrace today (Thank you Coach Gilbo, Coach Cotter and Coach Guyette!), and one of the most important was the power of fundamentals. They used to tell me that in football, every play was meant to score a touchdown – if each person executed their blocks perfectly – the play would score. Simple. Fundamentals.

My friend responded back;

love the spar

Fact is the world has changed… no arguing the globalization and pace of continuous change we all deal with today  — due to advances in technology, the flattening of the globe, the information access afforded by the internet… etc.

Point is urgency (action towards competing the important activities — aka those that give you advantage) must be transformed from project specific and baked into the fabric of the enterprise (CULTURE)

Too many mistake “busy” for progress.

Now, I’m not exactly sure what he meant by this, but I’m guessing he bills more by the hour than me! Call me crazy, but I’m more in line with the ”Haste Makes Waste” camp than John Kotter’s (or my friend’s!) camp.

So, what do you think? Are we not moving fast enough? Or are we moving too fast? Any comments are welcome!

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For information on how to urgently address FDA compliance deficiencies and build sustainable compliance solutions within pharmaceutical, medical device and other FDA-regulated companies, please contact Compliance Architects® at info@compliancearchitects.com or at 888-734-9778.

2 thoughts on “Urgency: Promise or Problem for FDA-Regulated Companies

  1. There is three fold issue here:

    1. Hiring practices: Company failed to screen applicants, and hired an employee who did not see seriousness of him ignoring the failing data.

    2. GMP training was not effective. This is often seen in many companies because upper management does not take it seriously or does take time to pay serious attention to gmp training.

    3. Data checker was not trained or was not allowed enough time to check data all the way to SOURCE DATA.

    That is why I always emphasize the fact that GMP is not regulations but A CULTURE FOR A SUCCESSFUL PHARMA COMPANY.

    RAMESH

  2. Allow me to simplify this, if a rocket is built to go fast, then there is problem if it does not go fast enough. But if you build a plane and try to make it go at a rocket speed then certainly it will not work.

    If companies has STRONG FUNDAMENTALS AND CULTURE, to mary with speed then FAST is good.

    Ramesh

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