The phrase “digital transformation” refers to more than just adding software and installing high-tech equipment. It means implementing a far-reaching, forward-thinking strategy that touches every corner of a company.
Sachin Misra, principal and global practice leader at Kalypso (a Rockwell Automation company) spoke to Outsourcing-Pharma about what a digital transformation entails, and how it can lead to improved efficiency, better supply chain protection, and a more resilient operation.
OSP: Could you please share what we mean when we use the phrase “digital transformation” in a life sciences/pharma manufacturing environment?
SM: Digital transformation in life sciences is no longer just a buzzword; it is a strategic imperative that enables competitive advantage in the marketplace. Enterprise digital transformation programs challenge traditional business and operating models and abandon siloed, standalone digital capabilities/solutions for end-to-end, connected digitalization across human and machine interactions, experiences, insights, processes, and data.
Successful digital transformation enables a seamless flow of reusable and leverageable digital native data connecting business processes, systems, products, and equipment across the value chain. It increases connectivity between people, processes, systems, and the underlying data to enable a digital fabric, which ensures data integrity from discovery and ideation through development, manufacturing, and post-market surveillance.
OSP: What are the benefits of effective digital transformation strategy and execution?
SM: From an information perspective, it enables proactive decisions based on predictive insights vs. reactive retrospective analysis while blending digital and physical experiences that provide contextual information in real time. You can also have real-time automation with full visibility into the dynamic state of processes, enhanced situational awareness, and decision support. You can see increases in product quality, manufacturing capacity, asset utilization, and energy and resource usage, along with reductions in shop-floor bottlenecks and adverse events. There’s a general improvement in overall equipment effectiveness, as well as reductions in downtime events and service call time.
On the personnel side, it helps improve labor efficiency and reduces training time. Tech transfer and scale-up timelines are reduced while achieving faster time to market/volume production. When done correctly, it’s an extensive list.
OSP: How do organizations tend to fall short?
SM:
- Lack of collaboration across the enterprise. Functional organizations must work together to identify synergistic improvement opportunities that benefit the enterprise vs. focusing on narrow and siloed functional domains. Lack of alignment and collaboration can lead to an IT/OT environment that does not lend itself to a connected and pervasive digital thread that promotes data reuse and leverage or where the costs of digital connectivity are too high. You need a combination of local leadership driving the operational process and executive leaders supporting scalability to align strategic vision with actionable tactics and plans.
- Lack of baselining current maturity level and defining the aspirational state of maturity. Without understanding where an organization is today or where it wants to be in the future, the effort needed to close the gaps remains unknown, and the level of effort to achieve digital transformation becomes highly fluid. Digital transformation is a journey and is unique to every enterprise.
- Failing to plan for scalability. Many companies get stuck in pilot purgatory because they are focused on one or many technologies. Not one, not many, but the proper technologies, new technology must interface with the existing backbone and be of value to achieve defined objectives. Get beyond the pilot and assume variation. An overextended pilot stage delays full delivery of value and continued assessments across each location for a best-fit solution.
- Lack of communication on the progress and successes. Open communication of pilot programs throughout locations allows for sharing of valuable experience and knowledge that generates momentum and excitement for what’s possible. Communicate the progress and celebrate success by recognizing those successes early and clearly communicating decisions to replicate the proofs of value.
- Lack of governance. Data, people, and process governance and standards should be key considerations at the core of a digital transformation. Digital transformation creates value at the intersection of business and technology but requires people to embrace the new methods of working. Governance must incorporate organizational and people change.
- Lack of demonstrated experiences enabled by digital transformation. Once value is proven using new technologies, create widespread demonstrations of the use cases to create a thirst for change driven by transformative digital solutions.
- Not establishing a sense of urgency. Create opportunities for key stakeholders as early as possible. Communicate and demonstrate that you cannot return to “the old way.”
- Adhering too rigidly to the plan. You can’t boil the ocean out of the gate. Embrace learning throughout the journey and establish a vision while remaining agile to build on proven value as it emerges. While it is important to have a long-term plan and vision to execute, broad transformation efforts stall because sponsors and staff don’t see a return on investment quickly. Build a plan of successive wins that march toward the aspirational vision and adjust along the way.
- Focusing on technology over outcomes. All too often, the excitement builds around new technologies but is short-lived if they are not tied to specific business outcomes. Channel the excitement to what business value could potentially be unlocked with the adoption of the technologies.
OSP: What questions should a life-sciences leader ask when looking to assess the digital fitness of their operation?
SM:
- What is our current level of digital maturity, and what is our aspirational vision at an enterprise level?
- How do my organizations/people feel about existing processes, tools, systems, and data? What’s the readiness level for change and cross-functional teams embracing change?
- Where are our bottlenecks across the enterprise, and are the latencies attributable to causal factors (people, process, systems, data)?
- Do our processes reproduce or recreate data across multiple systems? Do we have a single source of data and insights for both IT and OT data?
- How disparate is our technology stack, and what’s the level of enterprise integration that exists today?
- How do we estimate the cost of and the return on investment for enterprise integration?
- What’s our plan to get to the aspirational future state, and what’s the cross-functional level of effort?
- What opportunities do we have to transform ourselves with quick wins? What is the low-hanging fruit we can get started with?
- How will we build a business case (or cases) to justify the investments and demonstrate the returns, and how will that evolve through the journey? Do we have the baseline metrics for how we operate today as a baseline?
OSP: Could you share some ways life sciences professionals can expand their digital infrastructure beyond the factory floor?
SM:
- Evaluate pre-tech transfer domains, such as digital recipe authoring, during the process development phase.
- Tie regulatory information management to control strategy, change management, quality management, process development, and manufacturing process validation.
- Use natural language process technologies to parse legacy paper-on-glass tech transfer documents to reusable digital data sets readily consumable by manufacturing partners and systems.
- Evaluate energy and resource sustainability needs for AI-based optimization and predictions.
- Evaluate market compliance and diversion of batches to other market requirements via comparative analytics.
- Utilize product lifecycle management to establish digital product definition, change, control strategy, and variation/flavor management
- Rely on supply chain analytics to avoid over/undersupply constraints
- Drug substance and drug product requirements and risk management.
- Use process simulation and controls emulation during the process development phase.
OSP: How should they determine which components of a digital infrastructure they need, in order to guide what applications and features they should consider implementing?
SM:
- Leverage industry maturity models such as DPMM to evaluate the level of current-state maturity and map to the aspirational level of DPPM maturity.
- Assess the discontinuities across the spectrum of existing solutions that support the current operating model and product lifecycle. Then determine how the digital thread across those solutions could be seamless. If you identify gaps, evaluate how the adoption of complementary technologies could close those gaps.
- Evaluate whether existing processes could be further augmented or optimized by the removal and/or addition of emerging technologies, keeping in mind the cost of digital data integration.
OSP: How can an organization’s mindset impact the digital transformation of a company—and similarly, how can workplace culture possibly hold a company back?
SM: It is almost a given that organizations and people will be resistant to change. Establish a sense of urgency and define the value to the organization, including individuals. Create opportunities for key stakeholders as early as possible and demonstrate that you cannot return to “the old way”:
- It takes a village. Form a powerful guiding coalition. Generate role profiles for all coalition members, identify key stakeholders impacted by change, and search for common goals.
- Create the digital vision. Demonstrate how this time will be different (lessons learned). Demonstrate personal visible behaviors of thinking and acting differently.
- Communicate the digital vision. Incorporate customer and consumer messages that show why the change is important. Communicate regularly, maximizing face-to-face encounters with immediate superiors and senior managers.
- Encourage others to act on the vision. Provide forums for open communication and be prepared to take action on suggestions. Involve cynics and non-supporters in key roles and activities.
- Plan for and create short-term wins. Search out and recognize the beginning of changed behavior. Experiment with recognition and rewards to incent “small wins.”
- Consolidate improvements and produce more change. Design and implement new training and development programs aligned with desired changes. Celebrate successes and wins.
- Institutionalize new approaches. Change formal systems to reward new and desired behaviors. Institute leadership forums and activities consistent with the “new way of work.”
OSP: How can a company like Rockwell Automation help make such positive changes possible?
SM: Digital transformation is an innovation and productivity accelerator. It’s also a complex endeavor. We start with a business-first — not technology-first — approach. Our digital transformation consulting team works with clients on a strategic plan that addresses priority use cases, business justification, organizational and people change management, and an execution roadmap for technology implementation and support, all customized to a client’s unique objectives and digital maturity level.
Technology is at the heart of digital transformation. But it needs other vital organs for the entire body to function and remain healthy. Rockwell Automation not only provides core technologies and capabilities but also digital transformation consulting capabilities that are crucial for a project to ultimately succeed.
We bring together a global team of expert consultants with operations, IT, engineering, and technology expertise to deliver the outcomes our clients need. Rockwell Automation is a partner with firsthand industry knowledge, deep vertical expertise, and a trusted partner network to chart the fastest path between theory and results.
