Process Improvement That’s Skin Deep

Process inefficiency and illogic is rampant throughout our industry – in every sponsor, CRO and investigative site. There are many relatively quick and effective ways to improve this situation, and they start with awareness.

Executive readers may protest that their company is well aware of the need for “process re-engineering” and that they have already spent millions to do so. Middle managers will groan at more talk about process improvement because they often have been the “victims” of their executives’ re-engineering projects. The frustration, and lack of impact, that results from these projects comes from the fact that too often, process re-engineering is only “skin deep”.

Does this scenario sound familiar? A corporation decides to re-engineer their company to develop “best-in-class practices”. It spends millions on high-level interviews and executive brainstorming which, predictably, produces high level goals like “triple our pipeline in three years,” or “reduce our costs 10% every year for ten years.” Multi-colored laminated diagrams elucidating the workings of interdepartmental teams are distributed company-wide and imprinted on coffee mugs. These goals become the objectives for middle managers to implement and on which their bonuses will be based. Meanwhile the executives congratulate themselves on having re-engineered the company – they have the wall posters to prove it. The rest is “just details.”

Details indeed. How is a department supposed to respond to a dictum stating “accelerating time to market is a key business strategy”? What is a manager to do with a re-engineering recommendation whose specificity is at a level of “regionalization of monitoring resources may be more productive”? The answer for clinical operations managers is having the skills and tools to apply management action and group process to improvement tactics – to either attack inefficiency or exploit a competitive advantage. The problem is, this is where the money runs out. Corporate leadership is ready to spend millions on the skin cream, but has not been helped to understand the cost of the surgery needed underneath. Even if executives recognize that more detailed work is needed, they find out their discretionary budget has now run dry. So they turn, in time-honored tradition, to middle managers and say: “implement our Seven Points of Light, and do it while you get your regular work done.”

Operations managers may have in fact been deeply involved in the re-engineering effort, at least in terms of time spent in interviews, team meetings and exercises. But often they do not see the results of their input translated into a useful operational plan. In this way, managers feel the process improvement was “done to them”, not for them. The more frequently this happens, the greater the skepticism about process improvement that spreads among all staff.

This irony is repeated every year across our industry. The more it happens the worse it gets. If left unresolved, the inefficiencies create more financial pressure, which in turn demands more effort from clinical operations groups, who then have even less time to correct the problem. Since clinical development is the longest, most costly period in bringing a new therapy to market, it deserves a more sophisticated, deeper approach to process improvement than it receives.

What should companies be doing instead? There is certainly strong value in aligning a vast corporate enterprise around a set of clearly defined business strategies, especially for the sprawling merged entities we have in our industry, or for the CROs who have grown far beyond managing by instinct. But once strategies are in place, those who suggest they are bringing value to the corporation through process improvement have to be willing to get their shoes muddy, and need to have the skills to lead the operations group through that mud.

Clinical operations managers need to anticipate this impact of skin-deep re-engineering and arm themselves with skills and resources to respond, while trying to influence the situation proactively. Here are some suggestions:

Routinely propose budget dollars and resources for process improvement in your annual plans and defend them aggressively

Raise the consciousness of the importance of tactics among your bosses and their bosses

Learn tactical improvement techniques, such as fact-based interviewing and process mapping

Watch out for re-organization plans based on politics instead of process: organization charts are the language of a corporate persona – they are too important to be determined by whose job needs to be protected or how to support a manager’s compensation through headcount

Protect yourself with (and learn from) metrics: measure how you work now so you can see how the imposed changes affect you, for good or ill

Don’t automate a bad process by trying to help it with technology without understanding the process problems first

We will write more about these and other techniques in future columns.

Clinical development is in crisis and superficial re-engineering is not a help. Beauty is only skin deep; process improvement need not be. It is in your hands to make your organization’s inner beauty shine through.