Advice You - Business

When we think about lean manufacturing we think about work cells, kanban cards, TQM and so on. But many people do a basic mistake. That

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

is the mistake of not understanding the concepts on which lean manufacturing built on. Many people who copied lean manufacturing failed

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

because they did not understood the concepts behind lean manufacturing.

We shall give a simple definition to lean manufacturing before

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

we go further. Lean manufacturing can be defined as a systematic approach to continuously identify and remove the wastes from the system

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

. All the tools and techniques are based on fulfillment of this simple requirement.

To identify the conceptual difference between lean

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

manufacturing and conventional manufacturing, we will have a look at the definition given above. There is a very important word to note.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

That is “Removing”. Removing of waste from the system might not sound very different to minimization of wastes in the system, what we t

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

alk in conventional manufacturing. But think carefully. These two words are very different in the context of manufacturing (or even serv

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ices).

When you think about minimizing of waste, you are thinking about the current system where you have wastes. You think about minim

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

izing those wastes by fine tuning the system. When you think about eliminating or removing wastes from the system, you will have to find

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

the causes for the wastes and remove them from the system. This means that you will have to redefine the process in a way that there are

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

no wastes generated. So in the first case you live in the system where there are wastes, and struggle to get some improvement. In the l

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ater, you change the system so that system itself will not have the wastes. Aren’t they really different?

I will give you one more exam

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ple to clarify the conceptual difference between lean manufacturing and traditional manufacturing. Think about Work In Progress (WIP). I

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

n a traditional manufacturing process WIP is treated as an asset which helps to run the process smoothly. Lean manufacturing though, tre

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ats WIP as a waste itself. Further, lean manufacturing treats WIP as a mirror which reflects the imperfection of the system.

I can go o

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n and on explaining conceptual differences these systems have. But it is very important to understand one thing about lean manufacturing

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

. Lean manufacturing is not a fine tuning to the traditional manufacturing system you had. It is a completely different system. To be ab

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

le to implement lean manufacturing correctly, understand the conceptual differences between lean manufacturing and traditional manufactu

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ring.

To lean more about lean manufacturing and get your free e-book “lean manufacturing basics” visit www.leanmanufacturingconcepts.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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