By Nigel J Smart PhD, Smart Pharmaceutical Consulting
To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common English language, where the emphasis is on the Lean & Mean interpretation associated with just being efficient.
As we all know this is a big misconception associated with our terminology and unless we pay attention then there is a real danger that we will miss the boat and create something that’s going to hurt our companies and the industry as well.
Lean manufacturing in medical products, which should include but need not necessarily be limited to pharmaceuticals, vaccines, biotechnology products and medical devices is all about producing the highest quality products for consumers. As already noted, this is frequently missed out when one talks about Lean because out culture is often heavily geared towards the efficiency component. This is naturally understandable in a highly competitive global market where cost, time to market and short cycle times play such a critical role in the success of a product. However, with that being said, the focus on product quality has at least as much an impact on success because this is so tightly bound with product safety and the eventual successful deployment of the product as a medicinal agent.
The social responsibility associated with making a safe medical product is extremely important as the consequences of a defect are connected to the damage of patient’s lives. From experience we know that these situations kill the product commercially and ultimately harm the brand of the company for future pipeline products. So the case for building and maintaining elements necessary to assure appropriate quality standards in a medical products manufacturing process are integral in the overall strategy for production and sale of the product.
In more recent times Toyota’s Lean approach to manufacturing has been blamed for the fall in quality that resulted in the failure of some of its automobiles and these resulted in significant product complaints.
It’s important that the medical products industry learn lessons from this experience as the consequences for failure due to perceived short cuts would be devastating for consumer confidence.
Lean programs in Biomanufacturing should always take a conservative approach as any issues that have a safety element connected with product quality with be heavily scrutinized by the industry regulators.
It is our thesis that it is not a conflict to be able to attain a Lean manufacturing process that meets efficient COGs and uses available resources effectively without sacrificing anything associated with product quality and safety. In fact, it’s out contention that through the appropriate application of Risk analysis advocated in many of the newer ICH documents, that the concepts of Quality by Design, will bring about both product quality/safety and process efficiency goals simultaneously.