“A particularly sad consequence of operational mediocrity is its impact on innovation.”

What happened to “Operational Excellence”? It is a beautiful phrase and a worthy goal. But as biopharmas and CROs start to dismantle or de-fund their Operational Excellence departments, we should ask what is happening. Do we no longer desire excellence? Do we think we have achieved it?

Operational Excellence arrived as a melodious piece of jargon because of disillusionment with what came before it: TQM first, then Process Improvement, then various branded methodologies (hungry-eight-omega, you know who you are). The “excellence” efforts have suffered similar fates to the earlier incarnations – underfunding, insincere management commitments, skepticism, fatigue and fundamental misunderstandings about what process improvement can and should be. Changing the branding does not change the results because of these key flaws, and they all contribute to a negative feedback loop. Missed expectations leads to skepticism, poor techniques lead to change fatigue, underfunding prevents sustained effort, and insincere commitments makes re-prioritizing all too easy.

Improving clinical development’s methods is still very much needed. The fundamental inefficiency of biopharma clinical development is driven by many external factors, true, but we don’t do well with the hand we are dealt. And we’ve seen that simply outsourcing the problem (by far the most common solution today) has only created variable-cost inefficiency instead of fixed.

The irrelevance of outsourcing to improving efficiency is another column in itself. Sponsors like CROs to use methods they recognize, no matter how suboptimal, and CROs know they will be paid regardless, so the system has no meaningful incentives to efficiency besides competing billing rate charts. For all the many failings of biopharma outsourcing procurement departments, their failure to make an impact on overall industry methods may be the most damning.

Process improvement is ripe for action in all aspects of clinical development: protocol design, subject enrollment, data management, study team conduct, trial operations oversight, safety surveillance, use of information technology, investigative site communication and performance, monitoring and more. Your company probably has had multiple initiatives in most of these areas already, but meaningful results are rare and usually fleeting. We live in operational mediocrity instead of operational excellence. Nonetheless, we can no more give up on process change because it fails often than we can give up on early stage drug research because it fails often. Improving processes is still worthwhile; indeed it is an unavoidable imperative.

A particularly sad consequence of operational mediocrity is its impact on innovation. If we look at the current appealing innovations in clinical development – things like risk-based monitoring, fully electronic Trial Master Files, exploiting mHealth technologies, next-generation EDC, professionalized CRO oversight, and so on – each involve significant workflow and responsibility changes that must be as innovative as the technology used. The industry’s long experience with trying to exploit EDC and eCOA technologies has taught us this: underlying every innovation is a change in the way we work. Otherwise there is no innovation. And to make that change, organizations and internal thought leaders must understand and respect the nitty-gritty process changes which need to be defined, agreed to, tested and trained.

How do we steer back towards something approximating excellence? I have seen considerable success in what I call a “pragmatic” approach ­– one that takes on change step by step. It is grounded on several key essential items:

• Committed and visible executive management
• Traceability to key enterprise goals
• Breaking the task into manageable, iterative pieces which, once achieved, serve as positive examples which break the skepticism cycle
• Which must be followed immediately by additional improvement pieces to maintain momentum and convince staff it is “real this time.”

One way of thinking of this is that is akin to “evidence-based” medicine. As used here, it is an evidence-based method. EBM is a useful distinction from JBM (jargon-based methods), which is used instead all too frequently. It can be generalized that jargon is the refuge of those with little else to offer.

The building blocks of pragmatic process improvement will certainly sound familiar (identifying key business drivers, interviewing stakeholders, designing processes in workshop settings, documenting and implementing the changes and monitoring first use). This is like saying that basketball is dribbling down the court and putting the ball in that hoop up there. The hard part is overcoming all the typical obstacles that can so easily undermine improvement projects, some of which we have alluded to.

Let’s take the ubiquitous “workshop” as an example. Everybody in pharma has been to many workshops. What are the characteristics of those you remember as being productive? The workshop needs to have a crystal-clear purpose achievable in the time allotted. It needs a domain-knowledgeable facilitator. It requires some organizing mechanical technique to make the discussion and results tangible. Most important is the selection of the participants: 18 people chosen for their political affiliation does not a workshop make. That is better a definition of a circus. Instead a small group of stakeholders who can truly devote the necessary time to the task will be essential. It all sounds familiar, but the subtlety of applying pragmatism to each step is the heart of the matter.

Underlying the success of pragmatic process improvement is the correct governance – who is in charge, who funds, who decides, who staffs, who is accountable? The answer is always a little different from company to company. Should the people who do the work being improved be responsible for improving it? (Seems logical and essential to me.) Can process improvement cost less by creating a central dedicated department (which risks separating domain knowledge from the process knowledge)? Should it be outsourced like everything else? Should it be lumped in with the IT, HR or training departments? Every company will try it differently, but tying performance accountability to the management of the process in question is the most powerful solution.

Change fatigue, change skepticism, wasteful projects and unmet expectations are all real challenges to improving the way we work. They all can be overcome by a pragmatic approach to process improvement that is properly governed, with visible management commitment, taken in manageable steps that demonstrate success, and grounding those improvements permanently in our work environment. This steers us back toward excellence, which is the only direction worth traveling.