By GIRISH MALHOTRA, PE, EPCOT Intl.
Steve Jobs passed away recently and the tributes that have been forthcoming are breathtaking. This is in spite of his early-career shortcomings. Besides creating amazing products, he was a simplicity genius.
He took an industry that was looked at as complex to all of us in a different direction. In the ‘60s and ‘70s, computers were complex monsters humming in air-conditioned basements. He just simplified them. There were many contributors who participated in his simplification process, but his vision changed how the world interacts and socializes. He mesmerized us with the simplicity of complex products. He created a progressive revolution and we all waited for the next storm when he came on-stage. We anticipated the next best thing. He always had one last thing, we waited for it and he delivered.
Apple products are simple and intuitively operated without a written manual. Yes, there are people who do not like what he did, but it’s very likely they own some of his products. Complexity to simplicity became Steve Jobs’ hallmark.
We need a similar simplicity revolution or creative destruction in pharmaceuticals. Actually, the pharmaceuticals industry needs a double revolution that has to be carried out in parallel, first in API manufacturing and second in the formulation of a drug dose.
Is a Pharmaceutical Revolution Possible?
Yes, it is, and it has to start in the laboratory where we react chemicals to produce active pharmaceutical ingredients (APIs) and mix them with inert excipients to create a dose. Many will say we have been successfully doing this for more than 50 years, and the processes work.
Yes, the processes do work, but we go through many hoops, iterations and gyrations to produce a quality product. We recognize these deviations and anomalies, and explain them using different acronyms. We are enamored with them and discuss them at every opportunity. We overlook how these can be eliminated and what is possible. There are many proposals on how to get out of the rut, but there is more talk than action. If there were action, we would see results and instead of discussing the various acronyms, we would be discussing the results.
If we step back, look and listen to the chemicals, we will realize that they individually and collectively are telling us how to create a simple process. We are ignoring their shouting and hand-waving as we are influenced by what our textbooks tell us and what we are practicing in the laboratories. All of this is being manifested by stoichiometry and yield of the process.
Textbooks teach us general principles. We have to combine what is in the textbooks and what the chemicals are telling us, along with our own creativity,m to develop a process that is simple and creates a product that is exactly the same, irrespective of where on the planet or who produced it.
Our inability to react to what the chemicals are telling us has led to processes that are inefficient, unsustainable and complex. Since our customers have no choice for cheaper alternates, we have passed our costs on to them. Our comfort with our profits does not give us any incentive to simplify our processes.
I suspect, and it is inevitable before long, some “pharmaceutical nerd” will come along and challenge the pharmaceutical manufacturing technology status quo, creating a pharma-iPod or iPad. It could be by someone from any of the developing countries that are on the tail of the developed countries. It would not be surprising if it happens sooner rather than later.
Steve Jobs would say to us pharmaceuticalites, “Stay hungry. Stay foolish.”