The X Factor for Successful Digital Transformation in BioPharma: People

For evidence of this excitement, look at the plethora of terms used today that were seldom mentioned in reference to biopharmaceutical manufacturing in the past: advanced manufacturing technology, artificial intelligence, augmented reality, continuous processing, cloud-based data services, digital twin, Industry 4.0, Pharma 4.0, intelligence-based manufacturing, Internet of Things (IoT), manufacturing intelligence, model predictive control (MPC), condition monitoring, real-time data analytics, single-use systems, and smart manufacturing to name several. Impressive technologies – but what about people?

 

Much has been said about the transformative power of these concepts and how to leverage them to make operations more competitive, profitable, and effective. But how do life sciences professionals view these technologies? Will they make their work lives more efficient and rewarding or add more tasks to their already overstretched capacity? Even worse, will technology replace them altogether? Why should people embrace change if the benefits to them are not obvious?

 
Clearly, a strategy to manage change and engage people with digital transformation will be essential to capitalize on the potential for these technologies. Digital transformation technology, if designed and implemented effectively, leverages the strengths of people and technology, and combines them to create new capabilities delivering greater value more effectively, more rapidly, and with greater fulfillment for the people doing the work. If people are unclear about what digital transformation means, feel unprepared to be successful, or do not understand how it will benefit them directly, then the rate of uptake will lag.

Creating a framework to engage people across various functions, mindsets, and organizational levels is critical to facilitate the uptake and delivery of value. As Craig McKee, a coach and consultant at McKee Solutions, enlightened me many years ago, solutions to conflict are often readily available within an organization if the mindset and perspective of all involved are understood, considered, and built into the change plan.

 

McKee noted that participants in conflict discussions regarding a proposed change typically align into three focus areas: the Vision, the Ideas, or the Practice of a proposed change, his branded VIP model. All three perspectives with their associated mindsets are essential; however, the power is in leveraging these strengths collectively. Successful organizations have or engage people who can integrate these three mindsets, communicate effectively across distinct perspectives, plot a course to achieve buy-in, and lead the organization successfully through change.

 
Trust is another critical value for transformation. Trust grows when our ideas and concerns are heard and considered. By engaging people, listening to their vision/ideas/practice, and understanding their pain points, you can gain insights into how to continuously improve work processes and address many opportunities as part of the change process.

 

How and where does an organization start? It is essential to lay out a vision of how digital transformation should manifest, the problems to be solved, and the benefits to be delivered. Collecting and building on innovative ideas for how to accomplish transformation is also essential. Then it is crucial to identify a compelling solution that would result in a step change in performance upon implementation. Ultimately, and perhaps most importantly, practitioners doing the work must be engaged and provided with solutions that allow them to deliver their best. Digital transformation can provide the right information, in the right format, at the right time to facilitate their work.

 

The next step an organization must do is to identify a few key challenges where digital solutions, if proven successful, can deliver significant value for the effort required. Case studies can be developed from these challenges to demonstrate the concept and its associated value. Engage people to capture lessons learned from the pilot. Revisit the vision and adjust the pilot or vision as necessary to maintain alignment and to ensure pilots build toward realizing the vision. Modify processes and technology according to the pilot, then invest and replicate rapidly. This approach, sometimes called “fail fast or scale fast,” focuses effort on projects and approaches that deliver value.

 

Throughout a digital transformation journey, highly skilled integrators, or change leaders, are key to project management of case studies and program management for digital transformation. These leaders serve as communication specialists, translating and connecting perspectives across the organization. They capture metrics, monitor progress, solve problems, escalate major issues for early resolution, and ensure the delivery of value. They manage communication not only with those engaged with pilots but also with the broader organizational community to ensure all are informed of the goals, progress, and value being developed. As a result, the broader organization becomes familiar with challenges overcome and value delivered, increasing the probability that those not involved directly will become advocates for Pharma 4.0.

 

 

While technology is a critical tool for achieving digital transformation, it’s important to remember that it’s part of a larger effort in which people play an integral part. To gain their support, make it a point to communicate how a particular technology tool will help employees do their jobs more effectively and make their work lives easier. 

For example, let’s say your company has decided to adopt a validation lifecycle management system like ValGenesis. You could communicate that digitizing tedious validation tasks like authoring, executing, and approving validation documents will save them a tremendous amount of time and effort (50% or more) and allow them to focus on more important (and more enjoyable) tasks.

Human error is an unavoidable part of traditional paper-based validation. A tool like ValGenesis allows employees to enforce consistency with templates, business rules, and standardized workflows, helping them maintain a risk-based approach to validation and improve data integrity. What’s more, having access to accurate, real-time data that is standardized and easily referenceable will help them make better decisions and experience less stressful audits and inspections.

As you can see, the benefits of moving from paper-based to digital validation extend far beyond eliminating paper. As one ValGenesis biotech CMDO customer said in a recent case study, “Our employees don’t want to push paper. They want to change our world and transform medicine. We want to make sure they have the tools they need to do it.”