Process intelligence for the Life Sciences industry

Six tenets of intelligent process improvement

In an age of intense and evolving competition, along with regulatory and pricing pressures, Life Sciences companies increasingly need to sprint in new directions. To meet these immediate challenges, process improvement efforts can be deployed quickly and return results in the near term. However, companies that do this well also take a long term view and recognize the need for continual process improvement efforts over time.

Think beyond what is currently “known”

People often “know” which process improvement methodologies work, and they approach those methodologies the same as they have for decades. Yet despite those decades of history to learn from, companies are still struggling to realize success from their process improvement efforts.1

Why do some process improvement efforts succeed and others do not? This paper outlines six tenets to help companies think beyond what is currently “known” and bring more “intelligence” to process improvement.

1 3rd Biennial PEX Network Report: State of the Industry, Trends and Success Factors in Business Process Excellence,” PEX Network, Fall 2013,

Challenge conventional wisdom

Complexity in clinical trial design and management is driven by a number of factors and regulations that must be carefully considered and managed. More recently, the emergence of adaptive design—clinical trials that can be modified over the course of the trial based on ongoing findings—has introduced potential cost and efficiency gains.

Although adaptive design has many in the industry excited about the prospects of greater flexibility and cost savings over the course of a trial, it also creates an additional layer of complexity in trial design and decision making. To capture the benefits of adaptive trial design, traditional clinical trial processes need to be flexible yet optimized. Leveraging a consistent approach to eliminating waste and redundancies could help to reduce non-value added activities, rework, and effort. At the same time it can enable the adoption of adaptive trial design without introducing additional operational risks.

Tenet #1

Stretch beyond process mapping

For Medical Device manufacturers, reducing the time for product development while ensuring regulatory compliance is paramount to maintaining a competitive advantage. Especially in recent years as new entrants and collaborative models have started to accelerate the pace of innovation, many traditional medical device companies are looking for ways to streamline and accelerate their development process while maintaining quality and compliance.

This can be an overwhelming task as the steps to meet quality and regulatory requirements can add layers of complexity and variability to the process. To capture the right insights, companies should consider leveraging data and analytical tools such as detailed value stream mapping on different variants of the process to uncover “hidden” complexity and to quickly and accurately understand where the true opportunities lie.

Tenet #2

Follow the facts

Life Sciences companies generate vast amounts of data for scientific, medical, and operational activities. Quite often this information is siloed and confined to the area of the business that generates it and as a result the potential value of the data is not fully realized. Many companies are now putting greater emphasis on collaboration and leveraging data across the organization to drive faster and more accurate decisions.

In the same way data drives scientific and medical discovery, process improvement initiatives are most successful when supported by robust data. Through better access and utilization of data across the organization, companies can gain a competitive advantage on driving their process intelligence efforts.

Tenet #3

Buy runs, not players

In the movie Moneyball,2 a statistician suggests the following: “People who run ball clubs, they think in terms of buying players. Your goal shouldn’t be to buy players; your goal should be to buy wins. And in order to buy wins, you need to buy runs. Baseball thinking is medieval. They are asking all the wrong questions.” The same is true in process improvement.

In the age of big data, cloud computing, and analytics, Life Sciences organizations expect to resolve process issues and drive cost savings by implementing systems and technology solutions. However, these solutions often do not address the underlying root causes of the issues.

Whether it be clinical trial management, drug supply, or clinical contracts management, Life Sciences companies investing in large-scale technology solutions can also fall into the trap of buying the system while not adequately addressing the process. By addressing the whole value chain and understanding where the technology can enable the process, companies can unlock the true potential of their investments.

2Moneyball. Dir. Bennett Miller. Perf. Brad Pitt and Jonah Hill. Columbia Pictures, 2011.

Tenet #4

Carry it across the goal line

For many Life Sciences organizations, document management has historically been a lower priority compared to other activities. This is particularly true for the trial master file (TMF), the definitive source of clinical trial documentation that retells the end-to-end story of a clinical trial. Management of these records, which can exceed millions for large studies, can be taxing as trial-related documentation are generally spread across multiple formats, repositories, and geographies.

That being said, recent regulatory scrutiny along with new requirements around data integrity has brought TMF to the forefront and has forced the industry to put greater emphasis on transforming the TMF from a residual output of clinical trial activities to a primary driver in order to demonstrate quality and compliance. This transformation can require significant leadership and buy-in from Life Sciences organizations in order to be successful.

Tenet #5

Two heads are better than one

In a data intensive industry, one of the greatest challenges for Life Sciences companies is the management of knowledge and the sharing of knowledge effectively across the organization.

Many companies have invested in systems and repositories for the storage and dissemination of these valuable knowledge assets and while these tools lay the foundation for knowledge sharing, they often fall short of establishing a knowledge sharing culture.

Establishing a mentorship model that includes identification of key knowledge owners, processes to connect owners and seekers, and a continuous learning program that combines classroom and on-the-job opportunities can improve the likelihood that the true value of the knowledge can be unlocked.

Tenet #6

Download the PDF towards the top of the page for more on the six tenants, including several case studies, to help you on your journey in bringing more "intelligence" to process improvement.

Also, check out our other perspectives on Process Intelligence, which draws upon time-tested techniques like Lean Six Sigma that are enhanced with proprietary analytical tools and deep experience to help clients make breakthrough improvements.

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