Building in resilience can protect against disruption: Rockwell
If the COVID-19 pandemic has offered businesses in any industry a valuable lesson, it’s that being prepared can make a tremendous difference in how an operation endures adversity. Outsourcing-Pharma recently spoke with Dan UpDyke, strategic marketing manager for life sciences with Rockwell Automation, to discuss how the digital transformation of a manufacturing environment can help an organization better handle the next crisis.
OSP: Could you please share your perspective on how the pharma manufacturing industry typically reacts to disruption? What kinds of measures do they have built in (if any), technologies and solutions do they turn to when disaster strikes, etc.?
DU: Pharma manufacturing is particularly risk-averse, and this is highly evident in their approach to digital transformation. Investment in cybersecurity, data integrity, and system resiliency is often at the forefront.
When disaster strikes, the first priority has to be to ensure production and supply chain continuity for the medicines patients count on. If the disaster is something health-related, like COVID-19, technologies that enable bringing new therapies to market are critical. In the manufacturing space, an adaptive Manufacturing Execution System (MES) and flexible automation platform like PlantPAx are key to quickly implementing new recipes, plus they can reduce the timelines for validation and qualification.
Rockwell Automation’s digital transformation experts focus on digitalizing manual processes like tech transfer to reduce time, scale up new products and enter the manufacturing phase much earlier, which can have a significant positive impact on the lives of those affected.
OSP: Then, could you please tell us about your views on how the COVID-19 pandemic impacted the industry, and how professionals responded to the challenges?
DU: The pandemic intensified the spotlight on the ability to bring drugs to market faster. It is incredible the industry was able to react with such speed to deliver safe, effective vaccines and treatments, but it was generally done by an influx of human activity. Manual processes, documentation, and testing at this scale are incredibly impressive but generally unsustainable. The ability to digitalize and automate these processes will be crucial in the future. Interoperability of equipment, plug-and-produce technology, virtual testing of automation, and the orchestration of manufacturing locations globally will be a focal point going forward based on the lessons we have learned.
OSP: How have factors like regulations and compliance audits added to the strain?
DU: It is important to acknowledge that regulation and compliance exist to keep the patient safe. The quality and efficacy of medication are non-negotiable and directly correspond to public trust. That assurance does come at a high cost, however, both in time and money.
During the pandemic, time to market was accelerated, which meant a large number of resources were dedicated to achieving the same results. Reducing this effort without sacrificing quality and safety is a key result of a good digital transformation strategy.
DU: Also, how have shortages with labor and raw materials compounded issues?
DU: Labor shortages have introduced production challenges and driven companies to consider how they can optimize production with a reduced workforce. We can improve this through digital transformation. Connected worker technologies, whether that’s digital work instructions or training through digital twins, can make operators more informed and efficient.
OSP: You suggest greater connectivity across an organization to help stem some of these issues. Could you please tell us how this can be achieved, and what it can do to ease the challenge?
DU: The steps in bringing a new drug to market — from discovery, through scale-up, manufacturing, and supply chain — tend to be siloed, both from a personnel and data perspective. Through our Kalypso business, we help manufacturers create a digital thread of information that can speed the transfer of not only data and information, but also knowledge and insights from these different groups. This breaks down those silos and helps accelerate each step of the process.
OSP: Please share what a ‘holistic’ digital strategy looks like and how that can transform an operation.
DU: Many companies take a piecemeal approach, attempting to address a single trend or challenge at a time. But the more forward-looking companies are rethinking their entire operations. They are connecting business processes across the organization—from R&D to production to distribution—to enable better decision-making and increased agility. Their aim is a holistic digital transformation that can address many challenges at once and make them more resilient in the face of future disruption. This means leveraging data across the product lifecycle and a highly flexible, scalable platform. A holistic strategy starts with the end in mind, as well as understanding the value of the insights and visibility created by the enablement of data.
OSP: Do you have any advice you could share on how to form such a strategy, and things to keep in mind when selecting digital platforms and other tech tools?
DU: The easiest answer is to find the right partner in your digital transformation journey. It is often hard to find the right place to start. Combining the product expertise of a manufacturing operation with the technical expertise of a company like Rockwell Automation can certainly help build a roadmap that leads to success.
Beyond that, it’s critical to have a clear understanding of your ultimate goals and make sound technology choices. Collaboration among systems, data-sharing, and the delivery of insights — not just information — require technology that provides open communication and can be flexible, scalable, and adaptive as your digital maturity advances. On top of that, our more connected world brings with it a broad array of threats, which makes an integrated IT/OT security approach even more vital.
OSP: Let’s not forget the people—how should leaders think of staff roles in learning and facilitating such transformations, and how it will benefit them?
DU: Digital transformation drives alignment and collaboration between operations executives and IT executives. For operations, these efforts can reduce costs while improving operational efficiency; supply chain visibility, efficiency, and traceability; and product quality. For IT, digital transformation can reduce complexity and security risk, as well as enable scalability and data-driven decision-making. While the goals of the two groups may differ, the strategy should be clear and valuable to both parts of the organization.
OSP: How can a company like Rockwell Automation help?
DU: First and foremost, we bring industry experience and expertise to every project. We know digital transformation is a solid path that will get you ahead of the demands you face because we’ve already traveled that path. We’ve seen how connecting information from across the product lifecycle can deliver data-driven insights that improve quality, ease compliance, and lower patient risk. We have helped companies create an integrated IT/OT security approach without disrupting production.
Throughout the industry, organizations strive for continuous innovation that makes them more resilient, more competitive, and better positioned to improve patients’ lives. We empower you to get to market faster by leveraging connected data from across your product lifecycle Our approach to digital transformation helps them achieve those results.