The ability to navigate constant disruption is a prerequisite for success in today’s life science industries. To maintain their competitive advantage, businesses in this sector need to drastically boost their organizational agility and resilience in the face of unprecedented market conditions and operational challenges. In order to achieve this, organizational digital transformation (DX) is necessary. However, with so much in flux, it can be difficult to see the big picture in trying to plan and implement DX.
The key to success is to strategically and holistically rethink the entire operation by connecting business processes across the organization – from research and development to production and distribution. Let’s examine how best to pursue this holistic approach to DX in life sciences so organizations are able to unlock agility and realize powerful benefits in operations, security and business value for the enterprise.
Mounting Challenges for Life Sciences Companies
The life sciences industry has seen fundamental shifts as manufacturers face mounting pressure to bring products to market faster while meeting strict and highly regulated quality standards. Products and processes are becoming increasingly complex, with more rare diseases surfacing and a growing trend towards personalized medicine and targeted biologics.
These steep challenges to life science companies have been compounded further by the COVID-19 pandemic, both in terms of the heightened demands on pharmaceutical and life sciences production, as well as the pandemic’s significant disruption of global supply chains. Furthermore, with industry-specific requirements such as cold chain, life sciences supply chains face particularly acute strain in the face of increasingly strict regulations and compliance audits. It’s all happening in the midst of historic labor shortages. According to Deloitte’s 2022 Manufacturing Industry Outlookrecord numbers of unfilled jobs are limiting productivity and growth, with a projected shortfall of 2.1 million skilled jobs by 2030.
In the face of these challenges, life sciences organizations must design and implement a well-conceived digital transformation architecture, with top-tier interoperability and security safeguards. In addition, because this all must happen at scale, a DX strategy will only be effective to the extent that it is holistic – encompassing the broad range of operations, business processes and partner networks across the entire extended value chain for life sciences organizations.
Embracing a Holistic Digital Strategy for Transformation
The DX journey must be an enterprise-wide endeavor for life sciences companies – a strategy that leverages technology to increase connectivity between business functions, automate processes and, ultimately, improve profit. This strategy must be fueled by critical insights unlocked by the convergence of information technology (IT) and operational technology (OT). Intelligent processes are deployed to replace manual and paper-based processes. This helps reduce risk and improve quality by removing human errors from the equation with autonomous processes.
This holistic implementation of integrated technologies can fundamentally enhance how life science facilities operate. Automated compliance reporting and online quality testing become possible, delivering superior results while simplifying regulatory audits. Smart production control and predictive analytics across the facility, meanwhile, can automatically optimize production parameters based on operating conditions as well as predict and address machine failure before incidents even occur.
As these intelligent systems are implemented, life sciences companies benefit from significantly increased uptime and throughput. What’s more, companies can make the most of each employee in a tight talent pool – upskilling them through the use of innovative Augmented Reality (AR) solutions and user-accessible visualizations that deliver live production data and procedural guidance directly to front-line employees as they operate in production environments.
All of this is undergirded by robust connectivity. As connected facilities become fully integrated into the enterprise and value chain, they proactively adapt to the real-time needs of the business. End-to-end supply chain visibility across internal and external collaborators allows the facility to dynamically schedule production and work orders to optimize operations. This adaptive control can dramatically decrease the cost of work in progress across the life sciences enterprise.
Benchmarks for Success
How do you know your transformation is working? While every DX strategy will be customized to some extent, depending on the unique needs of the specific life sciences company, there are some common attributes and signs of success.
To begin with, a comprehensive transformation architecture must remain secure, even as new technologies are added and potential attack surfaces expand with the size and variety of technologies and processes that make up the new architecture. That’s why a “security by design” ethos must be followed to bake in security considerations early and often in the DX process, with end-to-end security and strong IT / OT security expertise aligned with the NIST Cybersecurity Framework.
Interoperability is also key. Every system and function in the enterprise must be seamlessly connected to facilitate data sharing across systems. This interoperability must extend across the digital transformation platform, legacy assets and all other cloud or on-prem systems – built around common IT and OT standards for seamless, unobstructed data flow throughout the digital transformation architecture.
Finally, the transformation should be built within a framework for co-innovation across a best-in-class partner ecosystem to solve any and all needs across the IT and OT spectrum. Your digital transformation strategy should not just help you cope with current market and production challenges, it should also ensure the organization can innovate new technologies and products well into the future. That means the digital transformation platform must be built to be future-ready – able to support the ongoing integration of new technologies over time.
Conclusion: Reaping the Value from DX in Life Sciences
Implementing a digital transformation architecture is a significant investment for any enterprise, but it’s one that pays off handsomely for life sciences companies. It’s not uncommon for organizations to see increased revenue up to 10%, decreased operating costs by up to 12% and cycle review times reduced by up to 50%.
By integrating systems, automating processes and delivering real-time access to production data, a holistic and well-designed DX for organizations in life sciences can speed time to market while streamlining compliance and reducing risk. These benefits, brought about through greater connectivity and digitization across the enterprise, are unlocking opportunities to orchestrate and optimize business functions in ways never before possible.
About Dan UpDyke
Dan UpDyke is the Life Sciences Strategic Marketing Manager for Rockwell Automation. With a background that includes system integration, product management, and industry marketing, UpDyke has 25 years of combined process control experience across industries including pharmaceuticals, biotech, medical devices, and specialty chemicals.