Despite rapid advancement in life science and technology, much is still unknown about disease biology and variation in individual human responses to the pathogens and therapeutic interventions.  Our ability to understand the mechanisms and create effective solutions is still limited relative to the wide, complex problems.  Research and development as well as the manufacturing of vaccines, medicines, and diagnostic tests take much more time and resources than most people realize.  One of the reasons is that these products must meet very high standards of safety and quality, and therefore, require very rigorous development and testing.  Another reason is that the biological processes take time, e.g. time for patients to respond to the treatments, time for cells to grow in production, etc.

While we have limited ability to accelerate the natural processes in biology or control their outcomes, there are significant opportunities to reduce unnecessary failures, defects, delays, and waste in general that we can control.  As a scientist and quality professional, I have worked in R&D, manufacturing, quality, and business improvement in life sciences for over two decades.  No one wants to generate failures, defects, delays, or any type of waste.  Nevertheless, waste occurs and impedes the development and delivery of life science products, impacting the life and well-being of people.  

Waste stifles the innovative potential of life science and technology.  Waste must be reduced.

The first step to reducing waste is to see it. 

Lean practitioners are familiar with the traditional 7 or 8 types of waste that are common in all organizations across different industries.  However, many types of waste, especially in R&D, are not as visible as defects in manufacturing.  They are hidden in plain sight because they appear to produce desired results.  Even negative results are often explained away as expected biological or natural variation.  It is only when we look closely and compare them to the alternatives, do we realize they are full of waste.

Here are a few examples.

1. Design and perform experiments that only marginally improve our existing knowledge or decisions.   Even if successful, the outcome merely confirms what we already knew — we could have made the same decision without it.  The cost benefit analysis should clearly define the incremental knowledge sought before committing time and resources.  

2. Fast-track product development without a thorough characterization of the design space or without proper process and method validation, resulting in high costs, rework, and poor quality downstream in development and/or manufacturing. Quality by Design (QbD) would have been much more effective over the long term.

3. Conduct poorly designed experiments that unknowingly include high variation (noise), leading to failure to detect the change or difference (signal).  Poorly executed experiments can also create noise and lead to similar failures.  

4. Include an unnecessarily large number of runs or replicates when a properly designed experiment can get the same results at a fraction of the time and cost.  Statistically designed experiments can also reduce the likelihood of inconclusive results due to lack of power (i.e. too few replicates). 

5. Use manual procedures to perform tasks when technology is available to automate the job with much less time, cost, and errors.  It is not uncommon to see highly educated, expensive resources perform routine, manual tasks in the laboratories and on the computer.  A few lines of code can turn hours of manual data analysis into instant results.

6. Acquire and/or build complicated solutions when a simple and robust solution exists.  Ambitious scientists/engineers tend to chase cutting-edge solutions without investigating simpler, cheaper, readily available solutions.  Dedicated equipment and sophisticated algorithms cost much more time and resources but may not perform significantly better.

The above are only some examples of hidden waste at the operational level.  Bigger waste can happen at a strategic level (e.g. developing the wrong product and solving the wrong problem) and at an organizational level (e.g. misaligned objectives and broken processes); they must be addressed by the senior executives of the organization.  But everyone can improve productivity by learning to see the waste in what we do every day.

I hope the COVID-19 pandemic heightens the awareness of the value of life sciences and the need for higher productivity.  I am proud to work in this industry, but also feel strongly our duty to continually reduce waste – the opportunity cost is simply too high.

Life science products save not only lives but also our livelihood. 

Many people are familiar with the seven types of waste originally identified by Taiichi Ohno.

• Defects or rework
• Waiting
• Overproduction
• Overprocessing
• Inventories
• Motion
• Transport

These types of waste are common not only in physical production but also in services and transactional environments.  With some experience, one cannot stop but see waste everywhere they work.  For example, mistakes happen and require rework (defects).  Documents go through multiple reviewers before approval (overprocessing).  Searching a number of locations before the information is found (motion). 

In my observation, this simple concept and basic awareness of waste is a very effective first step toward building a Lean organization.  Who wants to waste their time doing things not valued?

As an organization becomes more mature in Lean thinking, it will discover more types of waste that are less visible and potentially more detrimental.   For example, James P. Womack and Daniel T. Jones, in their book Lean Thinking, included “the design of goods and services which do not meet user’s needs” as an additional type of waste. 

Personally, I think the worst type of waste is underutilized human potential.  Many would agree.  It is also the most difficult type to reduce.  I see it manifest in three common forms.

1. Employees spend a large proportion of their time on non-value added activities.  These include attending unproductive meetings, writing lengthy reports that few people read, or preparing elaborate presentations for management when a summary suffices.  
2. Employees are not able to use their knowledge and skills they are hired for.  To quote a senior executive, “The company hires the best people and then ties their hands when they come to work.”  Often motivated employees eager to solve a problem only are told “that’s not your job.”
3. Employees are not growing to be more productive or effective.  They are stuck doing the same job using the same skills for years.  Many are not aware of the growth opportunities until late in their careers.  Some technical training, coaching, or exposure to leadership concepts, continuous improvement methodologies, or computer skills goes a long way to improve their performance.     

As more people move from traditionally manual work to knowledge work, the demand for new knowledge and skills only accelerates.  If we do not effectively address the waste of underutilized human potential, the loss will be immeasurable for both individuals and organizations.

Just to understand the problem is an enormous challenge.  But I believe there are steps that employees and managers can take to make a significant difference.

For example, for employees

• Take ownership of our career and professional development; no one else has the responsibility.
• Continue to develop ourselves professionally, in technical, business, and leadership skills. This can be achieved through education (e.g. taking classes) and experience (e.g. taking on a challenging project).
• Seek mentorship and feedback from others within our own organization and outside.

For managers,

• Encourage our employees to do the above and support them with our words and actions.
• Be aware of the impact of our actions and decisions on our employees.  Are we the root cause of their non-value added activities?
• Have a growth mindset in our employees.  Continue to provide them challenging opportunities.  Support, mentor, and coach them along the way. 

What is the worst type of waste you see?  How do you reduce it?

Who doesn’t? But how?

For over a decade, I have used many management methodologies for business improvement, e.g. Lean, Six Sigma, Enterprise Process Management, Change Management, etc. One of the biggest lessons I learned is that no matter what methodologies we use, ultimately, sustainable improvement is built on one foundation: understand, develop, and enable people.

Anytime when the people component is lacking in a change initiative or operating model, it will inevitably fail.

It is not a new concept, and no one seems to disagree with the premise. Yet few put enough emphasis on people in everyday practice. The people and culture piece often gets the least amount of attention on a Balanced Scorecard — if it is used at all. Businesses need to achieve financial goals, satisfy customers, and improve capabilities. No doubt. Guess who make these happen: it’s their people.

Many organizations start to pay attention to people only after they begin a change initiative or when there is an attrition problem. Even then the task is often delegated to Human Resources or other specialists, and the resources disappear as soon as the initiative officially ends or when the symptom is gone.

But change is constant. The need to develop and enable people never ends, and it is the professional responsibility of the managers.

Nowadays, every organization tries to be agile and embrace change, including digital transformation. But are their people willing, prepared, and ready? The outcome is predictable: those who succeed have nurtured the right culture and people from the start.

People familiar with the Lean concepts know the seven types of waste and the benefits of relentless elimination of such waste. Lean practitioners are trained to see them in everyday activities and act on them. There is the eighth type – unused human potential, which is the biggest but least visible or recognized waste. Reducing or eliminating this type of waste is not the responsibility of a process improvement or HR specialist but management. Unfortunately, many managers (if not the majority of) do not proactively develop and enable their people. They are only trained or expected to handle performance issues when things go wrong.

Not realizing people’s creative and productive potential is a huge missed opportunity for both the organization and employees. But it doesn’t have to be.

I encourage every manager to ask one question:
What have I done today to develop my people or improve the environment to enable them to accomplish more? How about in the last week, in the last month?

I want to leave you with one of my favorite quotes from Peter Drucker.

Entrepreneurs innovate. Innovation is the specific instruments of entrepreneurship. It is the act that endows resources with a new capacity to create wealth. Innovation, indeed, creates resources. There is no such thing as a “resource” until man finds a use for something in nature and thus endows it with economic value. Until then, every plant is a weed and every mineral just another rock.