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One of the biggest concerns and the reason why so many consultants and MBA busine

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

ss schools study change management is because it directly affects the productivit

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

Examples of combination products may in

of the company and the efficiency and the use of the organizational capital, whi

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

ch has been already established at the management levels.

How does change manage

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

ent affect the productivity of a company or corporation? It is simple really, you

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

Combination pro

see, when a manager who is well-liked is moved to a different part of the company

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

, leaves the company because he is disgruntled with his superiors or is fired due

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 lack of performance or corporate politics you can begin to see the dynamics an

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

d complexity of change management and human behavior.

If the manager was not per

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

orming and was let go, then perhaps he was too easy on the employees and the new

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

anager may not be well-liked and therefore this could cause productivity to decli

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

Following aspects would a

ne. Perhaps the manager was not performing because he was a jerk to his employee

dd to the challenges in developing combination products:

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

and productivity was not up to speed. A new manager put into place with the pro

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

per management skills will see a direct and immediate increase in productivity in

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

this case.

If an efficient manager was moved to a higher position in the company

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

or slotted into a different management position and productivity could drop if th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e new manager does not pick up or shadow the old manager to ensure a smooth trans

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

tion. Needless to say change management very much affects the productivity of a

.

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

company and executives would be well advised to consider the social aspects, prod

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

Companies that provide selfless information through particip

ctivity and efficiency of any change in management. Please consider this in 2006

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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