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Do you know what you know? In many situation we act without even knowing why we act the way w

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

e do. If this is true for one person, what would this mean for an organizations?

In business

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

Examples of combination products may in

, the management of knowledge is not a primary business activity and therefore difficult to m

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

nage: The attention for the topic doesn’t normally last long. And than it is just another sup

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

portive task, like accounting, administration, human resources: everybody needs it, but not t

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

Combination pro

he whole organization is aware of that.

Nonaka and Takeuchi have expressed that two processe

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

are very important when managing knowledge; externalization and internalization. They refer

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

to a process of making tacit knowledge explicit (by dialogue using words and metaphors, etc)

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

and once this knowledge is made accessible to others it will be internalized – the employee w

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

ll do what he or she has learned and this “doing” will be sort of new habit. It is not the sa

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

me as “learning by doing;” that applies more to a process of implicit learning. You follow so

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

Following aspects would a

meone else and than you how to do it. You are not explicitly aware of what you have learned.

dd to the challenges in developing combination products:

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

In order to manage knowledge you should start to know what you know. This is like making an i

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

nventory. But if you make an inventory you are addressing the supply side of knowledge. The

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

demand side of knowledge is normally where the bottleneck resides. And this could be very we

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

l because of a recent change – like reorganizations for example.

As mentioned, knowledge man

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

Professional from academic institutions, pharmaceutical industries, health care indust

agement is not a primary business, so the chances are that the organizational structure has b

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

een changed and only once every thing is “back to normal”, then the knowledge management issu

.

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

is addressed. This is to fill the (knowledge) gap that has been caused by the structural cha

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

Companies that provide selfless information through particip

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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Proper management of your business' income and liabilities give you a better view of your financial statements. Assisting in business success and growth.

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