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Vaccines – a shining example of innovation & change

Posted: 17 June 2021

We explore the principles that are central to the improvement projects Chartwell leads with its clients

author-JY

It goes without saying that the last 18 months have been some of most disruptive in a lifetime; the impact of COVID has fundamentally changed all aspects of modern life. Despite the disruption, a number of events have shone through as reminders of humanity’s philanthropy, intelligence and perseverance.


The development of a COVID vaccine is undoubtably one of these. Considering that the average time taken to manufacture a vaccine is 10-15 years, and that the previous record (for the mumps vaccine) was 4 years, the fact that not one, but seven vaccines have been produced in a single year is astonishing.

So what can we learn from possibly the finest example ever seen of rapid product development in a heavily regulated industry? What can those involved in the manufacturing industry take from this story to benefit our businesses, customers, and ourselves?

Let’s first look at the steps involved to develop a vaccine:

  1. Pre-clinical analysis
  2. Phased testing
  3. Regulatory review and approval
  4. Manufacturing scale up and distribution

Pre-clinical analysis refers to the developmental research required to construct a vaccine which will safely train the body to trigger an effective response to the virus. Due to the prevalence of other coronaviruses such as SARS and MERS in 2002 and 2012 respectively, scientists were well-placed to develop a vaccine specifically for the COVID-19 strain of coronavirus.

After the fundamental development of the vaccine, three phases of clinical trials were needed to empirically verify its suitability for use. Phase 1 told us that it was safe, Phase 2 told us the correct dose, and Phase 3 demonstrated the effectiveness. These trials spanned multiple countries and involved tens of thousands of people. In the AstraZeneca Phase 3 trial in the US alone for example there were over 32,000 participants.

One of the critical factors for reducing the timeline here was the parallelisation of Phases 1 and 2. Dr Douoguih, Head of Clinical Development at Janssen Vaccines (the driving force behind the Johnson & Johnson vaccine) said parallelisation “is what really enables us to move that timeline up so substantially, from a year or more to just months”.

After the phased trials finished, the data was submitted to regulatory bodies such as the European Commission and the FDA in the US. Given the urgency, many vaccine manufacturers submitted data on a rolling basis, yet again increasing the speed of processing.

Once trialled and approved, there was the significant task of manufacturing hundreds of millions of doses under the watchful eyes of the world. Some of the larger players in the race such as Johnson & Johnson and Pfizer had sufficient manufacturing capacity to handle the production themselves; others, like Moderna and CanSino were backed by the American and Chinese governments respectively.
vaccine-graph-01
The above development pathway shows clear parallels with the principles of SMED, a method developed by Toyota in the 1950s designed to reduce the changeover times of dye press machines (hence the name: Single Minute Exchange of Die). This method - to fastidiously and sequentially study each step of a cycle, has since been applied in continuous improvement initiatives in countless other examples of repetitive cycles.

Chartwell has amended and simplified the original SMED method, making it even more powerful and easier to apply by repeatedly asking four questions for every step in a process:

The four questions of SMED:

  1. Do we have to do it?
  2. Can we do it outside of the cycle?
  3. Can we do it in parallel?
  4. Can we do it faster?

SMED is particularly evident in the case of the phased testing and regulatory approval. Each of the Phased Trials for the major vaccines were run in parallel (question 3 of SMED), as was the purchasing of the manufacturing infrastructure. The speed of trial organisation across geopolitical boundaries (question 4) was another way the timelines were compressed.

This is our first learning: even something as complex and daunting as the introduction of a vaccine can still benefit from a theoretically simple improvement tool. Look around you now, how many repetitive cycles in your business or life would benefit from an improvement approach using the same structured manner? It is valuable to remember that even the simplest of methods, when executed correctly, can lead to the largest impacts.

There was of course more to the rapid development of the vaccine timeline than just the use of SMED. Several other factors combined to have a dramatic impact on rate of progress:

• Meticulous planning and execution
• Willingness to take on risk of failure by running stages in parallel
• Cooperation across geopolitical divides
• Financial and political support from governments and private organisations


What common thread underpins all of the above?

Let’s consider the burning platform: a situation where the cost of not making a change, however uncertain of the result, would surely lead to ruin. The necessity to stymie the spread of COVID provided this burning platform. It gave those involved a laser sharp focus and urgency to pull together and advance with unparalleled speed.

Clearly, we cannot rely on a global pandemic to bring about the urgency for organisational change. Instead, we should use the experience to remember that the burning platform is much more than just a metaphor. When executed correctly, it is the best initiator of rapid change.

So now is the time to reflect on the journey your business is undertaking. What is your burning platform and how is the urgency for change being generated and communicated? Is it felt across the business or just by a few at the top? How is this drive for change being supported? Do you have the right people and tools in place to implement change?

The burning platform for the COVID vaccine was communicated and understood clearly, with KPIs presented daily by Chris Whitty, Dr Fauci and other leaders across the world. Is your business equal in its ability to communicate your burning platform in such a crystal-clear manner? Are operators, supervisors, and managers able to access live graphs of yield and productivity figures? Imagine if the topic of conversation in the canteen was a new productivity record or the triumphant reduction in the number of defects. That sort of collective awareness and ownership has an incredible power.

You can’t succeed with a burning platform alone. Blind urgency without the ability to guide this energy leads to panic and frustration. In his books Leading Change and The Heart of Change, John Kotter lays out a blueprint for promoting real and sustainable change in organisations. These principles underpin almost all successful change programmes, including the vaccination effort.

Kotter’s concept of a Guiding Team was seen as the companies, governments, and NPOs came together to champion vaccine development and share the risk. A clear picture and strategy of a desirable and feasible future state and the empowerment of broad-based actions are also evident in the vaccine response to the pandemic.

At Chartwell, these principles are central to the improvement projects we lead with our clients. The COVID pandemic has provided the world with an incredible reminder of how powerful these principles can be and what we can achieve if we work together. Harnessing even a fraction of that spirit gives us a powerful tool with which to drive change in the people and businesses around us.

 

Sources
https://www.bbc.co.uk/news/health-54027269 
https://www.bbc.co.uk/news/health-55041371 
https://www.biocentury.com/article/305091/end-of-the-beginning-for-COVID-19-vaccines 
https://www.criticaleye.com/archive.cfm?id=662 
https://resiliencealliance.com/change-management-classics-burning-platform/ 
https://www.kingfishercoaching.com/leading-change-kotter-part-2/ 
https://www.jnj.com/innovation/the-5-stages-of-COVID-19-vaccine-development-what-you-need-to-know-about-how-a-clinical-trial-works

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