By Martin Lush, VP of Health Sciences, NSF International
One thing COVID-19 has given us is something previously in short supply: time to think and reflect. There’s an old saying: “pain + reflection = progress.” Pain is nature’s way of trying to teach us something. Everyone is experiencing pain right now; some more than others. As we navigate this uncertainty, two things are certain.
No. 1: We will get through this.
No. 2: The post COVID-19 environment (PCE) will be very different — but will it be better?
COVID-19 is more than a pandemic, it’s a painful warning, and how we react to it can be more than just a response; it can be an opportunity. Let’s capitalize on this opportunity to change as much as we can to ensure a better, safer world for our consumers and our industry. Let’s not waste this opportunity to rethink, redesign, and reprioritize everything we do in support of global public health.
In 2003, SARS infected 8,600 people; 860 died. While those numbers are terrible, SARS was a pandemic that didn’t happen. Its epicenters (Hong Kong, Toronto, Singapore) had robust public health systems able to implement mass quarantine protocols. Had SARS hit less developed centers, containment would have been far more unlikely, and the spread would have been catastrophic.
Over the last 20 years epidemiologists have identified plenty of new or resurgent pathogens. It’s a biological certainty that pathogens will relentlessly assault our increasingly packed and interconnected populations. While the individual disease that is COVID-19 might not have been foreseen, the potential for a deadly virus and ensuing pandemic was well known. To progress, we must listen more and act faster.
Rethink: What We Take For Granted
My dad always said the most important things in life are those we take for granted: food in the shops, family and friends around the table, and those responsible for making everything happen, from the delivery drivers and shop keepers to our doctors and nurses. Let’s make sure we never forget the vital importance of a fully resourced healthcare system. As communities, industries, and governments applaud our healthcare workers, let’s make sure this appreciation (and extra funding) lasts beyond COVID-19. Global healthcare in the PCE will need more funding, not less.
Rethink: What We’re Capable Of Accomplishing
Elite athletes and soldiers are taught the 40 percent rule: When you think you can give no more, you’re only operating at 40 percent of your capability, with 60 percent still in the tank. Want proof? Just look at what’s been achieved in the last few months. The U.K. built a 4,000-bed hospital — the nation’s largest — in just nine days. Companies adapted to manufacture medicines and medical devices with 30 percent fewer staff. During the tough times that lie ahead, remember the 40 percent rule. Don’t let our past capability be the standard for what we can accomplish in the future.
Rethink: The WHO And Global Institutions
Fighting an exponentially replicating virus requires a level of global cooperation that seems beyond our individual governments. Step forward the World Health Organization (WHO), a specialized agency of the United Nations with a broad mandate to act as a coordinating authority on international health issues like COVID-19, especially in regions with fewer resources to meet the fight. It’s been warning us about the threat of pandemics for years. Is the WHO’s reliance on voluntary and earmarked contributions enough when pandemics are considered high risk and high probability? Clearly not. The WHO must be given the resources needed to deliver on its mandate. Our institutions need to be better funded and prepared, listen better, and react faster. If not, there’s a risk that the blame game will dominate the PCE and that we won’t learn from our mistakes.
Redesign: Supply Chains And Globalization
COVID-19 has exposed the cold reality that our supply chains were built for efficiency and profit, not resilience. Assuming the world to be predictable, companies embraced things like lean inventory management and just-in-time delivery while making little or no provision for risk. Will COVID-19 force companies to build in redundancy? Will manufacturing return closer to home? Will industry start to question the wisdom of hyperglobalized, hand-to-mouth supply chains? Will artificial intelligence, predictive analytics, and robotics have a bigger impact in the future? After decades of getting longer and thinner, will supply chains contract and reconfigure into supply webs, with multiple production pathways, to adapt for a bumpy new world? Reality check: Resilience relies on surplus and surplus means extra costs. Will companies and governments invest in robust supply webs in the middle of a global recession? Can they afford not to?
Redesign: Medicine And Vaccine Development/Manufacturing
The world is asking when a COVID-19 vaccine will be available. Experienced pharmaceutical professionals reply, “in or around 18 months.” We then must explain the life cycle of a typical medicine according to the history we know. The public is staggered by the cost ($1 billion), the timeline (12 to 15 years), and the failure rates (90+ percent). They’re dismayed to learn that vaccine development processes have remained largely unchanged for decades, and rightfully so. We have 21st century science, managed by 20th century minds, regulated by 19th century laws. We must rethink how we develop drugs faster and cheaper without compromising safety.
Redesign: Leadership Fit For A Chaotic, Uncertain World
In uncertain times, people turn to their leaders for direction and reassurance. However, events like COVID-19 expose two types of leaders: peacetime leaders and wartime leaders. The best (and they are a rare breed) are those who can quickly alternate, depending on circumstances. In times of peace and relative certainty, the focus is on growth, expansion, and profitability across a very broad range of activities. In peacetime you can get away with tried and tested protocols, methods, processes, and ways of working, including micromanagement and centralized decision-making. You also have the luxury of more time to gain consensus and reduce uncertainty before decisions are made. In wartime, it’s about survival and resilience through the galvanization of the entire workforce around one mission. Wartime leaders are prepared to rip up the rule book and start again. They encourage a questioning attitude over blind compliance. They know decision-making must be faster than their competition, viral or otherwise. Out of necessity, they delegate as much decision-making as possible to those on the frontline. They remove silos, flatten hierarchies, suspend non-critical activities, and install fast feedback loops to fail fast and fail well. Throughout the crisis they balance unvarnished honesty about the challenges with optimism and reassurance.
In peacetime, leaders often rise through the ranks based on knowledge and competency. They have been prepared to lead in a predictable world. In the PCE, some markets will be lost, others gained. An increase in falsified medicines and cybercrime will add to the volatility. It’s going to feel like the wild west for some time and we need to select and prepare leaders who can manage uncertainty, ambiguity, and risk, with the mental resilience and agility to ignore the playbook and start again.
Reprioritize: Survival By Simplification
In an uncertain world, agility is more important than profitability. To be agile you must have simple systems and practices. Three years ago, I helped a client simplify its quality management system. A 360-page batch record was slimmed down to 23 pages, and more than 200 signatures were reduced to the 23 that mattered. Standard operating procedures were reduced by 37 percent. The simplified deviation and CAPA system reduced repeat incidents by 52 percent. The streamlined change control system allowed changes to be approved within 30 minutes, not three weeks. Two weeks into COVID-19, they telephoned me to say, “We’ve continued making product with 25 percent fewer people. We could not have done this unless we had focused on simplification. Simplification is survival.”
Post-COVID-19 we must implement simple, adaptable systems and ways of working that can adapt to the next global disruption.
Reprioritize: Rebound Through Resiliency
Most of our systems, practices, and ways of working presume a level of predictability. COVID-19 is a red flag we can’t afford to ignore. We must accept that we face unpredictable threats and plan accordingly. We must reconfigure everything to roll with the punches, so we bounce back stronger. We need what author Nassim Taleb calls antifragile systems — those that are strengthened by shocks. Our urge to reap efficiencies and impose demands for predictability has damaged our ability to bounce back when we get hit. We need to reconfigure our systems accordingly.
There are decades when nothing happens and weeks when decades happen. This is a once in a lifetime opportunity to rethink everything we do and make real and positive progress. We must adapt to this new world and make it a better place. Spoiler alert: Humankind has an unfortunate habit of saying “never again” and then forgetting. Let’s hope we can work together to break that habit once and for all.
About the Author:
Martin Lush is vice president of health sciences at NSF International, an independent organization whose mission is to improve and protect human health by supporting the development of and adherence to drug and med device manufacturing standards. Lush’s group provides training, consultation, testing, and project-specific support of pharma and medical device companies to help them stay compliant and incite them to think differently to solve chronic problems. You can contact him at firstname.lastname@example.org.