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Success in today's global, interconnected economy springs from the fast and efficient exchange of information. Sustainable compet

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

itive advantage is no longer rooted in physical assets and financial capital, but in effective channeling of intellectual capital

; 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 market value of a commercial enterprise is derived not only from its physical and financial assets, but also from the inta

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

ngible assets it creates through knowledge-based activities.

These intangible assets include intellectual property, such as pate

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

nts and copyrights, as well as the more nebulous assets such as methodologies, practices and customer relationships. These intang

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

Combination pro

ible assets are often estimated to be worth many times the book value of a firm and are known as knowledge or intellectual assets

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

. The management of these assets is referred to as knowledge management. The major shift brought about by current perspectiv

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

es on knowledge management is the shift in the value proposition between employer and employee. Yet, if knowledge is an asset, i

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

t has to be managed in the same way as financial and physical assets.

As companies grow, knowledge becomes more dispersed, and "

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

islands of information" become more common. Research has shown that once an organization grows beyond about 200 or 300 employees,

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

it loses grasp of its collective knowledge. Over time, a large quantum of knowledge resides with just a few people within the or

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

Following aspects would a

ganization. Corporate knowledge management rests on an infrastructure of data repositories, groupware, and messaging software.

dd to the challenges in developing combination products:

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

If knowledge is omnipresent, then knowledge management is the discipline that helps put information in the right context and pers

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

pective. Preventing knowledge loss is a big factor in the knowledge management equation. Ideally, knowledge can be applied and

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

reapplied— anywhere, any number of times—without reducing its usefulness.

As businesses seek to make headway in a market where i

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

ntellectual capital is as important as physical assets, channeling collective organizational learning has become one of the key c

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

Professional from academic institutions, pharmaceutical industries, health care indust

hallenges of the Information Age. The challenge comes with channeling collective learning both within the organization and among

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

its constituents. As companies outsource more activities to their supply chain partners, competitive advantage is dictated less

.

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

by physical assets and more by intangibles such as brand equity, rate of innovation, compressed product development cycles, and s

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

Companies that provide selfless information through particip

ophisticated logistics. Real value is derived from tapping into intellectual capital and harnessing the experience of employees.

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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One morning at breakfast, my four-year-old son made me realize that we often describe our businesses in terms of how we understand them, not in terms our audiences will relate to.

Related to the topic of problem-or-solution-oriented change is the topic of participation. But this issue of participation is more delicate than the previous one. This is about the amount of space for negotiation around the proposition. The proposition however is something that also needs time to ripe; or has there already been prepared one? Is the path to which the developments will lead already entered or is your organization gathered at a square and considering a next move: in any of the directions that are accessible from the square?

Proper communications instead of disregarding the concerns or needs of customers, clients, and patients, can improve retention and reduce customer defection. All it would have taken to keep me was a couple words of information.

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