Francheska’s brow furrowed as she looked at this quarter’s operational metrics.  Her lips pursed with annoyance, “Every month I’m getting requests for more headcount, more support, and more funding.  Things are tight, but even when I work miracles to bring extra support, nothing is moving any faster.  I’m frustrated with our performance.”  You’re not alone, Francheska.

Slow and getting slower

According to the CSDD, for an entire new set of 377 drugs and biologics approved by the FDA between 2008 and 2018, the clinical phase took an average of 83.1 months from 2008-2013, but that timeframe grew to 89.8 months for 2014-2018.  Given the massive shocks to the life science industry since 2020, I would estimate that timeline has grown since 2018.

In other words, we are all feeling the pinch.  But why?  Is this pain mostly self-inflicted?  For Rob Goodwin, vice president of operations at Pfizer’s center of excellence for product development, part of the reason for this is an entrenched preference for avoiding risk.  “From an internal perspective,” he says, “the industry hasn’t really changed in about 40 years. There is a complacency around the current drug development process, because it works.”  Or does it?  There are clear signs that the model is deteriorating.  However, let’s take a step back and understand how our own bureaucratic clinical processes add to the problem.

How we got here

In the olden times, we needed to make sure people had a “standardized way of doing things” so that we could stay compliant with regulations, so we started with a simple set of processes.  Over time, as clinical research became more complex and more regulated, we added more rules to our internal processes.  As findings and CAPAs pile up across trials, we create more new rules to serve those new needs.  These processes, over time, became more refined and more specific, as to not leave room for interpretation or errors.  As the rules became more specific and more numerous, the system became more complicated and more bureaucratic.  How did we react?  “Here’s another document that explains the other documents…”  *sigh*

Why this matters:  Innovation, complexity, and productivity

In a highly bureaucratic system, decisions become “compliance-based” rather than “risk-based.”  People’s mindset becomes, “If I follow the process, I wont get in trouble.”  This makes perfect sense, because when the trial investigator shows up, the first scramble is to figure out who’s fault it is.  If people can step back from responsibility and say, “Its not my fault, I followed the process”, they can keep their noses clean.  This adds a level of risk aversion to an already compliance-driven risk-averse industry.  With that risk aversion comes a desire to ‘follow the rules and do exactly what Im told.’  Rule followers don’t innovate.

Ultimately, complex and bureaucratic rules lead to simplistic and silo’d thinking.  Process owners become babysitters of complexity, and often add more complexity and specificity in a misguided attempt to reduce complexity.

According to BCG, “Complexity kills productivity growth by slowing innovation and the deployment of new products and services.  And it cuts margins by injecting inefficiency and cost into operations.”  If your role is responsible for operational excellence, you want to limit complexity as much as possible.

Now what?

Here’s how to think about it in a different way:  Rules exist to enhance compliance, but rules are rarely tied to an explicit ‘intent’.  In other words, complicated processes focus on the what and the how, but not the why.  This is a wonderful opportunity for us to re-frame how we think of processes.  It starts with intent.

Tie the rule/process to its intent (the why).  Help people understand the intent of the rule, and what it needs to comply with, and they will have a better time making judgements and decisions in the moment.  Bear in mind, the intent is not meant to replace SOPs and work instructions, rather to augment them.

The processes that slow productivity, kill innovation, and lead to silo’d thinking did not appear overnight.  They are the result of a disorderly evolution over a series of decades.  Starting with intent allows people to make sound judgement calls looking at both the letter of the SOP as well as the spirit (intent) of the SOP.

Until next time…

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