Every industry faced major disruption and change due to the pandemic, but since the crisis was in healthcare, the life sciences industry may have been hit hardest. Given the demand for critical care equipment like ventilators, personal protective equipment, and key medicines, life sciences companies were left scrambling to produce and in some cases source these important life sustaining products at an unprecedented rate. While the collaboration amongst manufacturers both within the life sciences domain and across the ecosystem was truly admirable, the question that now remains is what happens next? Are manufacturers ready for the next disruption?
It seems like every product portfolio is being re-evaluated, every supplier reviewed, sometimes back to the source of raw material, and new KPIs are being considered in an effort to plan for safety stock and redundancy.
Post-Pandemic Recommendations for Life Sciences Manufacturers
Here are some of the top trends we’re seeing in the life sciences industry post-pandemic:
Regulatory: Though new regulations were in progress before COVID, some were delayed, such as the EU MDR and EU iVDR requiring full product traceability from packaging, labeling and manufacturing to post-market and end patient use. The U.S. adopted similar regulations prior to COVID-19 around unique device identification (UDI), and many other countries are now accelerating deadlines, including China, India, Canada, Brazil and others with the ultimate goal of improving patient safety. Companies seeking to support global product demands in these countries should consider leveraging enterprise wide systems that connect teams and their suppliers with business operations, and ultimately product and patient use data.
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 take shape; Thermo Fisher Scientific recently announced their plan to greatly increase their U.S. manufacturing footprint in the coming years. But how do companies scale up operations to keep up with demand more quickly? And vice versa, if voluntary procedures and elective surgeries are curtailed with short notice, how do you pivot existing manufacturing operations to support new demands?
Modular manufacturing, or discrete “component” modules is most commonly used in the development of biologics but is now seeing adoption in the rapidly growing injectables market. Automation and Pharma 4.0 adoption are other trends we’re seeing as well. A recent McKinsey article stated it perfectly saying, “digital and analytics tools and automation will be the engines that accelerate agility and transparency.” Companies that have automated workflows, synchronization of assets, and improved tracking and scheduling in the factory will reap the rewards of increased flexibility and yield along with reduced cost and waste.
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 unprecedented effort was expedited by many factors, including eager trial participants, agile operation strategies and extensive industry collaboration.
Agile Infrastructure: There’s a new focus on business agility and advanced technologies that connects the enterprise to the value chain both inside the operation and with patients. This is critically important to the industry now and it’s here to stay. Digital solutions, such as cloud computing and adaptive ERP, provide the flexibility that enables life sciences companies to better connect, collaborate and automate essential business processes and information so they can run their businesses more effectively and efficiently.
COVID-19 forced manufacturing leaders to adopt a new agile approach to more efficient product development, manufacturing processes and supplier management. For example, one life sciences company Laerdal is leveraging digital supply chain and planning with advanced analytics to accurately forecast and successfully manage low inventories and market fluctuations.
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. AI 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 event trends as they unfold.
Modernized Processes: Pre-pandemic, life sciences manufacturers were slow to adopt enterprise cloud applications. Life sciences manufacturers operate under a slew of regulatory and compliance requirements that made change slow and sometimes onerous, and the impetus to change was just not there.
But COVID-19 paved the way for greater use of digital technologies. Manufacturing leaders needed cloud-based, automated technologies that could help them connect the enterprise, shift strategies quickly, and make faster, more informed decisions. And faced with an extended quarantine, business leaders and users became more accepting of digital solutions.
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.
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.
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.
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-19 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.
Better Responding to Future Disruption
There is renewed interest in providing business continuity to best respond to disruption and operational 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.
If you’re a Life Sciences manufacturer looking to start your Digital Transformation journey, download our latest white paper, “Achieving Digital Transformation Success in Life Sciences” and discover opportunities that could be hidden in plain sight.
