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However this integration impacts several aspects of the organization, this essay will examine the impli

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

cations of information technology on organizational structure. The classical notion of organizational s

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

Examples of combination products may in

ructure has been challenged by information technology which has enabled several new methods by which or

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

anizations can structure themselves.

Divisions of labor and coordination have largely shaped the class

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

cal organizational structure. It has been necessary to physically cluster people and resources which ne

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

Combination pro

d coordinate their activities at specified geographical locations. Along with coordination, the need fo

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

supervision has also necessitated this physical grouping. The design of an organization’s structure ha

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

s traditionally depended on design variables like the number of management levels, level of delegation,

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

staffing, control and report mechanisms and on design strategies like centralized or decentralized mana

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

ement. The organizational structure is also inextricably linked to the technology used, human resources

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

and the goals of the organization. Changes in any one factor will affect the rest in varying degrees. W

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

Following aspects would a

will focus on the changes in the organizational structure due to information technology.

Information

dd to the challenges in developing combination products:

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

echnology has impacted most of the design variables of the classical organizational structure. The orga

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

izational subunits need not be physically grouped together they can achieve coordination across differe

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

nt geographical locations. The reporting mechanisms, linking and control mechanisms, workflows are all

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

utomated. Consequently we come across a new set of factors which impact organizational structure. An or

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

Professional from academic institutions, pharmaceutical industries, health care indust

anization which does not manufacture a tangible product can now consist of several virtual components t

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

at coordinate their activities with the help of groupware and communication mechanisms.

Another import

.

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

nt aspect of information technology is its impact on the interaction between the various levels within

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

Companies that provide selfless information through particip

n organization and between an organization and its suppliers on one hand and its customers on the other

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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