Life sciences manufacturing faces various challenges, from regulatory inertia to cultural barriers. Mark Venables reports from Rockwell Automation Fair on how industry leaders drive innovation through collaboration, technology adoption, and a human-centric approach to problem-solving.
There are numerous challenges in the life sciences industry, but innovation remains a powerful tool for navigating these difficulties. This was the core discussion at the recent fireside chat at Rockwell Automation Fair in Anaheim, featuring insights from Daniel Ricardo Matlis, president of Axendia, alongside James Heckmanski, Associate Director of Global Engineering at AstraZeneca Pharmaceuticals, and Christopher Sandusky, Director of Automation Solutions Product and Lifecycle Management at Cytiva. Together, they explored how technology, culture, and regulatory frameworks shape life sciences manufacturing and how innovative solutions help overcome barriers.
Technology and its role in life sciences manufacturing
Daniel Matlis opened the conversation by highlighting the evolution of technology within the life sciences industry. Reflecting on his early days at Johnson & Johnson, Matlis spoke of developing computer system validation (CSV) procedures, which remain largely unchanged decades later. This, he explained, underscores the challenge of adopting modern technologies due to regulatory inertia. He posed the critical question: How has the evolution of technology frameworks impacted operational models in the sector?
Heckmanski addressed this question by noting how technology has changed every three years. “They used to call it Moore’s Law,” he states. “In an industry like life sciences, however, adapting to such frequent changes is very difficult. Technology for the sake of technology does not benefit us.” Heckmanski emphasised the importance of evaluating where the greatest benefits lie and focusing on technologies that ensure robust and long-lasting legacy systems. In life sciences, where system lifecycles are measured in decades, simply following every technological trend without careful evaluation is not sustainable.
Sandusky expanded on Heckmanski’s point, discussing the duality of technology consumption. “In our personal lives, we replace devices frequently, phones, computers, cars,” he says. “But in biotech, the product is not the technology itself; it is the drug product, and any changes are heavily scrutinised.” He described how it is more practical to maintain existing production methods rather than incorporate the latest technologies, especially in Brownfield facilities. “For Greenfield facilities, the latest technology is implemented where it makes sense and within budget, but biotech lags in adoption due to the complexity of transitioning from Brownfield to Greenfield setups,” he says.
Heckmanski adds, “The key to technology adoption in our field is not just about implementing the newest gadget or software. It is about understanding the long-term impact on operations, regulatory compliance, and patient safety. We cannot afford to make mistakes when people’s lives are at stake, so every decision must be weighed carefully.” He elaborated on the risk of adopting technology without proper evaluation, “I have seen scenarios where new technology was hastily introduced, and it ended up causing more setbacks than benefits because it didn’t align with the operational needs or the regulatory landscape.”
Regulatory challenges compound this lag. Sandusky noted that regulations like 21 CFR Part 11 have enabled technological advancements like electronic signatures and created inertia. “The adoption of electronic signatures was groundbreaking, but the regulatory landscape still causes delays,” he says. “Regulations like those governing biosimilars offer new opportunities, but balancing technology, regulatory requirements, and evolving business models remains a significant challenge. It constantly balances between maintaining compliance and staying agile enough to adopt new innovations.”
Continuous improvement vs. regulatory inertia
Matlis then addressed the concept of continuous improvement, or rather, the lack of it in the life sciences industry. “We have developed a ‘set it and forget it’ mentality,” he observes. “Once we receive regulatory approval, there is a reluctance to touch anything for fear of triggering a re-approval process.” However, he highlighted that guidance such as ICH Q12 allows for continuous improvement without excessive regulatory burden. “The challenge is that most people in the industry are unaware of this.”
Heckmanski weighed in on this mindset, highlighting the importance of compartmentalising technology. “It is not always about replacing an entire system,” he said. “We need to evaluate which specific component of the process can provide the best return on investment and make targeted improvements accordingly.” He provided an example from AstraZeneca, “We recently evaluated an existing manufacturing line, and instead of replacing the entire system, we focused on upgrading a key component, the automation controls. This allowed us to boost efficiency significantly without the extensive downtime and costs associated with a complete overhaul.”
Sandusky added, “Innovative solutions are not always about new technology; they can be about re-engineering or optimising what already exists. It’s about smart decisions, not flashy ones. Regulatory compliance should be seen as a framework that allows for smart, incremental improvements rather than as an obstacle. We can achieve significant gains without risking compliance by working within the regulations and finding innovative areas.”
Cultural challenges in technology adoption
The discussion moved to the cultural barriers that hinder technology adoption. Matlis cited Peter Drucker’s famous quote: “Culture eats strategy for breakfast, lunch, and dinner.” He explained how different departments within life sciences organisations, such as quality assurance, IT, and operations, often have conflicting approaches to technology adoption, derailing even the best strategies.
“Culture is the toughest barrier to overcome,” he continues. “You can have the best technology and the best strategy, but if your organisation’s culture is not aligned, progress will be incredibly difficult.
“Quality assurance might be focused on compliance and minimising risk, while IT is pushing for digital transformation, and operations just want stability and reliability. Without alignment, you are not going anywhere.”
Sandusky echoed this sentiment, describing how organisational silos between IT and OT (Operational Technology) create barriers to effective implementation. “The boundaries between IT and OT are blurring,” he says. “Companies need to break down these barriers and establish a shared purpose. It is not about how IT or OT can run the company better but how we can run it better together.” He stressed the importance of leadership in driving cultural change, noting, “Leaders need to foster collaboration and ensure that everyone understands the shared goal. It’s not about protecting one’s domain; it is about achieving something greater for the company and, ultimately, for the patients we serve.”
Heckmanski further stressed the need for collaboration across all organisational levels. “How often do executives, IT, engineering, QA, and operations all sit in the same room to make a technological decision?” he asked. “Having everyone aligned is critical, especially when the ultimate focus is patient outcomes. Technology should not be treated as a ‘trickle-down’ directive from executives but as a collaborative effort involving all stakeholders. We have seen success when the operators, the people who use these systems day in and day out, are part of the decision-making process. Their input is invaluable because they understand the practicalities of day-to-day operations.”
The human-centric approach to manufacturing
The conversation then shifted to human-centric approaches in manufacturing. Historically, systems have been designed to ensure compliance, often at the expense of usability. Matlis highlighted the importance of moving towards human-centric design, where systems are compliant and intuitive for the people using them. “We need to ensure that the people running the processes can easily follow them,” he explains.
Sandusky provided an example of how human-centric design is being applied to training processes. “Traditional SOPs are often dry and difficult to retain,” he continues. “By incorporating virtual reality into training, we allow operators to engage with the process hands-on, which greatly improves retention and understanding. Imagine an operator who can virtually practice complex maintenance procedures before they perform them. It reduces anxiety, improves confidence, and ensures that they know exactly what to do when they are on the real equipment. This immersive learning makes training more effective and ensures operators are better equipped to handle the complexities of life sciences manufacturing.”
Heckmanski agreed, adding that human-centricity also involves providing the right tools for the job. “You can train someone extensively, but if they do not have the tools to do the job effectively, that training is wasted,” he said. “We have advanced technologies like AR and VR at our disposal; using these effectively can simplify the operators’ and the engineers’ jobs.
“At AstraZeneca, we deployed augmented reality for troubleshooting, allowing remote experts to guide on-site personnel through complex procedures. This improved efficiency and empowered our staff to solve issues that required an expert to be physically present.”
Overcoming regulatory barriers to innovation
One of the most significant barriers to innovation in life sciences is the perception that regulatory requirements prevent the adoption of new technologies. Matlis pointed out that this perception is often more restrictive than the actual regulations. “The current CSV guidance, which was last updated in 2002, already allows for a risk-based approach,” he notes. “Yet, we’re still validating systems as though it were 1999, and we blame the regulators for it.”
Sandusky suggested that collaboration with OEMs can help streamline the validation process. “We test our products rigorously and provide customers with all the documentation they need to validate processes quickly,” he says. “By using these pre-validated components, companies can significantly reduce the time and cost of validation. It is not just about providing the equipment anymore. We work closely with our customers to ensure they understand the validation process, and we offer continuous support to adapt to any regulatory changes that might arise.”
Heckmanski added that early engagement with regulatory teams is key to overcoming these challenges. “If we bring them in early and ensure they understand what we are trying to do, it makes the entire process smoother,” he said. “Regulators are not the enemy; they are partners in ensuring that what we do is safe and effective. Early and transparent communication can make all the difference.” He shared an example where involving regulatory experts early helped AstraZeneca expedite the approval of a new automation system. “By having an open dialogue, we addressed their concerns upfront, ultimately saving us months of back-and-forth after implementation.”
Innovation begins with people
In their concluding thoughts, both Sandusky and Heckmanski emphasised that innovation is ultimately about the people behind the processes. “Identify the problem you are trying to solve first,” Sandusky advises. Then determine which tools are best suited to solve that problem.” He stressed the importance of using tried-and-true technologies where appropriate rather than always opting for the latest, untested solutions. “Sometimes, the most innovative solution is the simplest one, something that just works and seamlessly fits into your existing process.”
Heckmanski concluded with a reminder that innovation starts with individuals. “We can show you all the latest technology, but that does not mean it is the right solution for you,” he concludes. “The key to innovation lies with each of us; it is about how we think and apply the tools available to us. Fostering a culture of innovation means empowering employees at all levels to contribute ideas. Innovation is not just a top-down initiative; it should come from every corner of the organisation. The people on the shop floor often have the best insights into what will make their jobs easier and more effective.”
Matlis ended the session by reiterating the importance of involving all stakeholders early in the process. “Whether it is quality assurance, safety, or regulatory teams, everyone needs to be involved from the outset,” he says. “We are all in this together, and that is the only way we will succeed in bringing innovative, effective solutions to life sciences manufacturing. Remember, innovation is not just about technology; it is about people, processes, and, most importantly, the willingness to challenge the status quo.”
