By Leslie Kossoff
There’s probably no better industry than pharma/life sciences to most clearly differentiate how Lean is misinterpreted and how it can be successfully executed and made immediately profitable. The biggest single misunderstanding about Lean is that it is not the tools and techniques you use to implement it. Lean is, by origins and definition, a strategic tool. Its purpose is to exquisitely align and coordinate every aspect of the organization so that it is always working as a holistic, cooperative entity. It should never be in silos and always with every action, function, project, and division be directly reflective of and measurably contributing to the organization’s strategic goals. That makes Lean (or, actually, quality) the responsibility of the organization’s leadership. And, from the executive team down, the more that focus is in place, the more profitable the results.
Strategy Versus Compliance
Now you’re going to say that quality is a compliance issue. And, it is, which is a good thing because that’s where you can get the biggest bang for your Lean, Six Sigma, or whatever you want to call it “buck.” It’s a strategic decision to ensure you are certification-compliant for whichever set of alphabetical requirements you need. Execution can (and should) be achieved using the tools and techniques of Lean, but that’s operational. It also applies as much to your back office paperwork processing as it does to your R&D and manufacturing functions.
If you’re implementing quality, you’re making a strategic business decision for market positioning and access as well as for profitability and innovation. It’s not the certification. It’s the reason for and selection of the certifications that makes it quality — which makes it strategic.
Making Lean Profitable — Lean Start-Up And Clinical Trials
There are a number of ways, both within your implementation structure and the specific arenas in which you implement various tools, that make quality profitable. The easiest example is in your clinical trials. In the technology space, venture firms and angel funds are demanding that potential portfolio companies use a Lean start-up system. You want to do the same with your clinical trials.
Clinical trials can be treated like start-up companies because they are (and have to be) complete unto themselves. The compliance issues will remain, but within those, you can streamline, learn from, and codify your trials so they are consistently more efficient, effective, and less expensive.
The best and fastest way to accomplish that goal is to use the zero-staging technique. If you’re not familiar with it, think of it as planning on steroids. It is a holistic, start-to-finish, completely front ended analytical process that defines the overall system and specific processes, critical indicators, decision points, and measures and, most importantly, identifies exactly where problems will arise and how to solve them before you ever go live. It’s time-consuming, but the more you invest in this front end process, the more you’ll create success.
After you’ve impressed yourselves with your clinical trial zero-staging pilot, go back and assess how Lean, implemented strategically, will net you the results you wanted. The more strategic your initiative, the greater and longer-term the benefits will be. The initiative will be more profitable, too.
Leslie Kossoff is a renowned writer, speaker, serial entrepreneur, and confidential advisor to executives and entrepreneurs worldwide. A former executive in the aerospace/defense and pharmaceutical industries, she is the award-winning author of Executive Thinking and the forthcoming From Lean Start-Up to Six Sigma Turnaround, as well as over a hundred articles in journals including the Financial Times and Investors Business Daily. She also authors the Obtuse Angles Blog — a new resource for executive and entrepreneurial development. For more information go to thekossoffgroup.com.