The term “lean manufacturing” was first coined by James Womack, a professor at MIT, in his 1990 book titled The Machine that Changed the World. Lean manufacturing techniques have gained a growing number of advocates within the pharmaceutical industry since then, but there has also been controversy, as well as a residual reluctance to implement these principles in certain areas.

For example, people can readily see the value of a lean manufacturing process for manufacturing, supply chains, and other aspects of the industry that involves formally standardized processes. When it comes to R&D, however, the perception is that application of principles developed in the auto industry – principles designed primarily to aid in the improvement of manufacturing line processes and project management – won’t really work and may even be a hindrance in an area that is inherently innovative and intellectual. What isn’t readily apparent, however, is the fact that R&D also requires a significant degree of standardization in processes.

The fact is there is a dynamic, reciprocal relationship between innovation and standardization in any R&D department. Innovation requires reproducibility of results which, in turn, requires standardization or Standard Operating Procedures – SOP. If there is to be successful, ongoing improvement in the innovative processes within R&D, then there must also be standardization to insure accurate, unbiased results. This is where the implementation of lean manufacturing solutions can be extremely beneficial.

Further, the process of identifying and developing potential new drug candidates comprises both scientific and business elements. Teams have to be optimally aligned, various activities must be coordinated, information needs to be adequately disseminated and easily accessible, and decisions must be properly coordinated in a timely manner. These are just a few of the process pieces, and they all require considerable managerial skill and business acumen.

The implementation of lean principles, along with the assistance and guidance of knowledgeable lean manufacturing consultants, can be immensely beneficial due to the estimated 20% reduction in cycle time.With respect to R&D, here are just a few of the areas where lean manufacturing implementation can benefit the innovative processes:

  • Reduction of bottlenecks and concurrent resource requirements
  • Implementation of single-piece flow instead of batch testing of compounds, which decreases testing time, thus allowing faster feedback, and reduced time and effort
  • Simplification of the management review process, resulting in greater efficiency
  • Setting up regular reviews of screening cascades, thus improving decision-making and the ability to jettison weak information models early in the process
  • Exploration of methods to reduce lead-in time

Information and communication aspects can be improved in these ways:

  • Ensuring an effective communication flow within and between teams in different areas to ensure a thorough understanding of criteria and requirements for making decisions
  • Putting in place relevant technology to track compounds and minimize delays

And management/personnel can be aided by:

  • Developing and nurturing the competencies of project leaders and managers
  • Empowering members of project teams to make decisions related to resources and budgeting

What this means is that application of lean manufacturing principles is not limited to actual manufacturing line processes. These principles can also be profitably applied to the innovative processes, as well as the standardization and business aspects, of R&D in the pharmaceutical industry.

To learn more about how lean manufacturing strategies can streamline your business and improve your bottom line, visit Smart Lean Manufacturing