The Impact of Covid on Life Sciences
September 08, 2021
Digital transformation has long been a buzzword in life sciences, but the actual practice of digital transformation has lagged behind the buzz. For all the buzz, digital transformation has reached some industries more quickly than others. Ironically, it took the disruption of the COVID-19 pandemic to kickstart the digital revolution and accelerate the pace of digital automation in the life sciences industry.
Prior to COVID, there was very little adoption of enterprise cloud applications in life sciences manufacturing. Why was life sciences a slow adopter? It has to do with the very nature of the industry. Life sciences manufacturers operate under a slew of regulatory and compliance requirements that make change slow and sometimes onerous. For many companies who did try to implement new technology, once protocols were established, the cost to change and verify that a company’s product and manufacturing processes were safe and effective turned out to be prohibitive.
Over time, however, the FDA and other regulatory agencies recognized that validation guidance, though not intended to be burdensome, was indeed stifling innovation. With the launch of the FDA’s Case for Quality initiative in 2011, recommendations were made that manufacturers should approach quality processes from the standpoint of continuous improvement and embed quality testing and best practices throughout the lifecycle of the product. So while historically, FDA’s approach to proving quality and efficacy was rigid and intrusive, today, manufacturers are asked to prove effectiveness, efficacy, and safety relative to the level of risk to the patient.
The shift was just beginning to take hold when the pandemic hit. Many organizations struggled to keep their operations functioning effectively. They then had to deal with a remote workforce, ramping up critical care testing and diagnostic products, reevaluating new product development pipelines, verifying supply chains, and in some cases, reshoring facilities. Life sciences leaders found they needed to do more with less, and saw that cloud-based, automated technologies could help them connect the enterprise, shift strategies quickly, and make faster, more informed decisions.
COVID forced life sciences companies to accelerate the adoption of advanced technologies, including digital manufacturing capabilities to run production with fewer workers and leveraging advanced capabilities like artificial intelligence and machine learning to monitor, analyze, and proactively modify production runs and supply requirements. Technologies like cloud, AI, machine learning, IoT and automation started to be adopted and accepted. Digital solutions are being utilized in such diverse areas as field service operations, telehealth procedures, cloud conversions, AI systems for researching root cause quality trends, and the integration of enterprise systems.
Before COVID, a move to the cloud was seen as competitive but risky. Now it’s a condition of survival.
The Biggest COVID Challenges
Every industry faced major disruption and change due to the pandemic, but since the crisis was in health care, the life sciences industry was hit hardest. Every product portfolio was re-evaluated, every supplier reviewed, sometimes back to the source of raw material, and new KPIs were implemented in terms of safety stock and redundancy. The Biden administration even included pharmaceuticals and active pharmaceutical ingredients in their executive order mandating a thorough, 100-day supply chain review.
Regulatory: Though new regulations were in progress before COVID, some were delayed, such as the EU MDR and EU iVDR mandating full product traceability from packaging, labeling and marketing to post-market and end patient use. The US adopted similar regulations prior to COVID, and many other countries are coming onboard -- China, India, Canada, Brazil, and others. To do business in those markets, you have to comply with these regulations.
Manufacturing: To prevent potential supply chain issues going forward, reshoring is more likely to take place in life sciences than in any other industry. We're already seeing that taking shape; Thermo Fisher Scientific recently announced their plan to double their U.S. manufacturing footprint in the coming years.
Innovation: Just one year after COVID-19 was declared a global health emergency, there were 10 vaccines available for full or limited use and more than 80 vaccines in human trials. This extraordinary and highly anticipated effort was expedited by many factors, including eager trial participants, agile operation strategies, and extensive industry collaboration.
AI tools: AI-driven tools are available for everything from manufacturing, to patient connections. Self-reporting health trackers across mobile devices and platforms play an important role in aggregating data from widely disparate sources. These AI-driven tools, like the Centers for Disease Control and Prevention app that prompts vaccinated patients to disclose any side effects, have not only helped pharmacovigilance teams track adverse events in real time, but also capture post-vaccination adverse event trends as they unfold.
Agile infrastructure: COVID unlocked a new agile approach to more efficient product development, manufacturing processes, and supplier management. Life sciences companies have adopted advanced analytics to accurately forecast and successfully manage unexpected outcomes and market fluctuations.
Modernized processes: The pandemic propelled life science IT into more modern platforms, modular architecture and cyber governance. Mobile applications and remote/cloud monitoring of manufacturing are more widely accepted.
Real world impact: With the recent increase in demand for personalized therapies, adaptive strategies and strategic investments can make significant contributions to current and post-pandemic manufacturing capabilities, particularly through mobile apps and data analysis platforms for post-approval pharmacovigilance.
What Changed as a Result of the Pandemic?
Despite the impact COVID-19 had on life sciences, the industry is showing forward thinking and resiliency in its journey back to normal. While critical care devices, diagnostic tests, and hospital consumables saw a boost during the pandemic, cardiovascular, orthopedics, and imaging saw declines but are now back on track. M&A and IPO activity is also back, with record venture funding.
There’s a new focus on business agility that shows it’s important to the industry now and is here to stay. Digital solutions, such as cloud computing and adaptive ERP, provide the flexibility that allow life sciences companies to better connect, collaborate and automate essential business processes and information so they can run their businesses more effectively and efficiently.
This previously risk-averse industry is moving from on-premise to cloud solutions to enable better access to data and smarter process control. With AI, machine learning, and robotic process automation, manufacturing planning and execution processes can be optimized and more agile.
Even though the life sciences industry as a whole is emerging from the pandemic in a positive way and expecting to bounce back to pre-COVID numbers this year, there are lingering reminders of supply chain issues and product demands unfulfilled, such as ventilators, PPE, and certain therapeutics. As a result, we're likely to see new regulations emerging. Even without regulations, some manufacturers are looking ahead and starting to implement new risk protocols and systems to address risk, safeguard data integrity, and provide actionable data through smarter planning and forecasting.
There is renewed interest in providing business continuity to best respond to disruption and threats. That the life sciences industry has bounced back from pandemic crises and is now reinventing itself is a testament to its resiliency. These trends align well for future digital improvements in manufacturing, the supply chain, and infrastructure.