Developing a Technology Roadmap for Pharmaceutical Manufacturing Systems

The challenge: In 2010, pharmaceutical leader Merck & Co., Inc., launched Target ’15, a five-year plan to transform manufacturing operations. One of its key goals was to develop new manufacturing technologies that would enable at least one critical therapy to reach a minimum of 80 percent of the world’s population by the end of 2015. To accomplish this, we needed a proven technology strategy framework that would:

  • provide effectiveness at size scales that could span global enterprises and supply chains;
  • accommodate time scales that would cross long-range, multi-year planning targets;
  • manage complexity and deliver clear guidance to the organization on where and how to focus;
  • build on key lessons from multiple industries; and
  • provide insight that could transcend different technical disciplines.

The approach: SDM’s Technology Strategy course, taught by MIT Senior Lecturer Michael Davies, provided essential tools and methodologies to help Merck craft its first-ever long-range technology roadmap for manufacturing. Merck’s roadmap included:

  • identification, selection, acquisition, development, exploitation, and protection of key technologies; and
  • development of an organizational structure for continued alignment and action toward Merck’s access goals.

The tools: We created a blueprint that allowed Merck to drive technology development and investment activities across a global manufacturing operation with hundreds of connected supply chains within time frames that reached years into the future.

Our steps included:

  • developing a concrete, shared definition of manufacturing technologies as combinations of knowledge, processes, and equipment that transform raw materials into products and deliver them in a useful form to patients and customers; and
  • creating global operations-level systems views that allowed for holistic management and consideration of systems changes.

Taken together, this created a visual of the larger system that is the subject of Merck’s technology transformation and deployment.

In this global view, process unit systems up to the plant scale can exist within each box, while site- and enterprise-level integration occurs along pathways defined by the connection of different boxes. Each processing unit box can be further blown out as necessary, but the overarching scheme allows for the taxonomy of future roadmaps for each node and each pathway (see Figure 1).

Figure 1: An example of a pathway is AKOQR, which represents the pathway for a small-molecule pharmaceutical oral dosage form.

We followed stakeholder mapping processes to account for external and internal constituencies and to clearly identify key stakeholder groups. Evolving global trends were mapped inward from the customer market and societal needs and outward from the business drivers and manufacturer requirements (see Figure 2).

Figure 2: Stakeholder map for Merck’s global operation.

Stakeholder mapping also enabled us to develop key performance indicators (KPIs) for the global system, thus collapsing the trends and drivers identified into workable and measurable goals. These KPIs produce very precise operational definitions around which global operations-level changes can be made.

During the needs and requirements definition phase, subject matter experts created technology inventories that we were able to use as repositories of internal and external technology efforts and innovations. The KPIs, trends, and drivers were used to prioritize technologies by time order and importance. This enabled us to create our initial manufacturing technology roadmaps. Individual technologies were generally at the single- and multi-phase system- and process-unit level; thus, the roadmap visualization allowed for plant-, site-, and enterprise-level integration and planning (see Figure 3).

Figure 3: Stylized example of a technology roadmap.

Some stakeholder needs were well-articulated (e.g. a solution needed for a distinct problem), and others were not (e.g. a desire to impact a problem in a big way). As we assessed transformation at a global operational level, it was vital that our efforts combined technologies and defined value drivers. These dual dimensions and the trade-off space defined the risk posture clearly for our investments in various areas (see Figure 4).

Figure 4: Technology maturity is shown by extent of need.

A key technology management challenge was lack of visibility concerning how different efforts affect each other, including ones that need information from others to make a larger, more holistic transformation possible. In helping manage these interdependencies, we applied the multi-domain matrix (MDM). A mock version of an MDM is shown below for a sample manufacturing pathway.

Figure 5: Multi-domain matrix applied to manage interdependencies for technology initiatives.

The MDM shows relationships within like elements (e.g. the process to process connections in the design structure matrix [DSM] shown in the red box, or the operand to operand connections in the DSM in the blue box) or across unlike elements (e.g. operand to initiative, as shown in the area labeled 1).

Understanding the relationships between some of the most important potential efforts and the process or operands at the enterprise level was critical to managing multi-year efforts and to fostering the right knowledge-sharing and connections required as internal and external entities consider the portfolio of choices. The crosshairs within the matrix can represent the nature of the connection, e.g. “supporting,” “connected to,” or “integral.”

The importance of these technology initiatives and their ability to address multiple needs at the global operational level would not be seen if not for the mapping effort. Interactions between different global pathways were analyzed using DSM and MDM analyses. This created a portfolio of technology projects that is now managed through maturity by an enterprise-wide technology management process and governance, with information and knowledge refreshed annually as implementation progresses.

The results:

  • Merck has mapped and assessed more than 800 technologies with this process—focusing on 42 technologies in various time horizons organized into eight clear domain challenges.
  • The MIT SDM Technology Strategy class mindset, methodologies, and tools have helped Merck create a manufacturing-wide framework, language, and process by which strategies and investments can be discussed, debated, and ultimately managed.

As 2015 begins, Merck is well-positioned to meet its five-year goals for manufacturing and, more importantly, the company now has a robust and bullet-proof way of managing technology for the next half decade.

Editor’s note: The author wishes to thank Leigh Gautreau, SDM ’08, research manager at Endeavour Partners, LLC. As a teaching assistant for the SDM course, she was a critical reviewer of Chowdhury’s series, as well as of this article.

About the Author
Anando Chowdhury, SDM ’09, is director of Product Design: Innovation to Operations at Merck & Co., Inc. His four-part paper written for SDM’s Technology Strategy course when he was an MIT student laid the groundwork for Merck’s manufacturing technology roadmap.

Anando Chowdhury, SDM ’09