Lean Principles: A Life Sciences Overview

Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees.

And while some companies solve problems with more resources, more staff, and more funding, the answer for others is less. First used in the auto industry, “lean principles” are helping firms in a variety of verticals, including life science.

Used by respected companies like Nike, Intel, John Deere, and Toyota, lean principles help businesses eliminate waste, reduce the number of faulty products, and ensure they’re focusing only on products consumers want and need.

A History of Lean Principles

In the 1930s, Kiichiro Toyoda and others from Toyota Motors visited the US to observe Henry Ford’s production line. Their goal was to determine its strength and shortcomings. On one hand, Ford was a progenitor of lean principles because his assembly line drastically reduced the time it took to make a car. By having one person specialize in each task, Ford generated tremendous productivity in the labor force.

On the other hand, Ford’s factories only produced one type of car, a black Model T—a shortcoming that wasn’t lost on Kiichiro Toyoda on their visit. Their process was effective in building cars, but it disregarded the desires of customers. After World War II, Toyota took Ford’s assembly concept and made it more flexible in order to provide the customization (such as other colors) the public wanted.

Today, companies of all industries mass-produce and customize goods based on the ground-breaking concepts Ford and Toyota engineered. It’s only been in recent years, however, that the biotech sector has taken notice of lean principles.

Understanding the Lean Concept: the House Analogy

A house analogy illustrates lean principles simply.

The Roof

In its essence, lean principles manifest the belief that a company’s ultimate goal should be to serve society, customers, and employees. Lean experts call this overarching concept the “Value-Driven Purpose.” If a house’s main purpose is to protect residents, it’s the roof that fulfills this primary purpose.

The Pillars

To serve its purpose, however, a roof needs to be held in place by other structures. Business operations professionals like to envision a roof as needing pillars to support it. In business, the pillars are the company’s processes and capabilities. These components are what allows a company’s purpose to remain in place.

The Foundation

Supporting the house is a foundation consisting of a company’s unique approach and culture.

Patagonia’s value-driven purpose is to bring sturdy, sustainable clothing to the market. Its pillars are its unique sourcing and manufacturing processes and capabilities. Its foundation is its dedication to environmental renewal and the outdoor lifestyle.

Implementing Lean Principles: Key Questions to Ask

To apply lean principles in your life sciences firm, you must first ask the following helpful questions. Designed to provoke productive discussion, they can be used at any level from clinical operations to lean medical writing procedures.

What is your value-driven purpose? What problem are we trying to solve?

Organization leaders must think big. Is your company trying to eradicate a specific disease or condition? Or, instead, are you trying to enhance the quality of life for patients who are currently suffering?

Yes, your answer could be your company’s existing mission statement. Still, it’s critical to find a  concrete way to act upon that mission. These questions will help.

What processes are required?

Once you have your value-driven purpose established, ask yourself, what’s standing in the way? Would you like to deliver more life-extending treatments faster? Do you wish to save money by cutting less promising products in the pipeline and reallocating those funds to products with the most potential?

Without a change in current practices, it’s hard to expect real progress. The answer to this question builds the process pillar in the lean model and supports your value-driven purpose or “roof.”

What capabilities are required?

For example, on the medical writing side, more and more companies are finding that centralized information repositories save time both in CSR creation and the FDA review process. These writing libraries eliminate duplication by allowing multiple documents to link them.

In addition to lean medical writing practices, companies can enhance their capabilities through strategic resourcing and subject matter expertise based management consulting. One skilled outside consultant can often take the place of multiple internal team members.

What management system can I define?

Management and employees enact all processes and capabilities. By involving them in lean improvement meetings, executives gain access to a treasure trove of potential areas to be streamlined. Leaders need the soft or people skills necessary to lead teams through this process.

When implementing lean principles, team members select metrics to monitor progress. Other practices can be as simple as allowing projects to fail more quickly, so time and budgets can be devoted to others.

What is our organization’s mindset or culture?

Culture draws not only top talent but like-minded consumers as well. Leadership and staff must agree on company culture. If there’s a gap in perception of culture, work on closing it. No significant improvements are possible without a positive culture that encourages collaboration.  If a life sciences organization wants its clinical operations team to work together, its culture must promote teamwork and not reward division.

Bring Lean Principles to Your Organization

Although many companies have already used the lessons of lean to improve, still others have not. Rest assured, it’s never too late to get started! To learn more about how your life sciences corporation can benefit from lean principles, contact Treximo today.