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The appraisal should measure performance in accomplishing goals, plans and performance, in rega

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

rds to corporate performance management. No one wants a person in a managerial role who appears

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

Examples of combination products may in

to do everything right as a manager but who cannot turn in a good record of profit making, mark

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

ting, controllership or whatever the area of responsibility may be. Nor should anyone be satisf

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

ed to have a performer in a managerial position who cannot operate effectively as a manager.

I

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

Combination pro

assessing performance, systems of appraising against verifiable preselected goals have extraor

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

inary value. Given consistent, integrated and understood planning designed to reach specific ob

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

jectives, probably the best criteria of managerial performance relate to the ability to set goa

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

s intelligently and to plan programs that will accomplish those goals and to succeed in achievi

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

g them. Those who have operated under some variation of this system often claim that these crit

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

ria are inadequate and that elements of luck or other factors beyond the manager’s control are

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

Following aspects would a

aken into account when arriving at any appraisal. But, in too many cases, managers who achieve

dd to the challenges in developing combination products:

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

esults owing to sheer luck are promoted, and others, who do not achieve expected results becaus

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

of factors beyond their control, are blamed for failures. Thus, appraisal against verifiable o

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

bjectives is, by itself, insufficient.

The system of measuring performance against pre-establi

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

hed objectives should be supplemented by an appraisal of a manager as a manager. Managers at an

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

Professional from academic institutions, pharmaceutical industries, health care indust

level also undertake nonmanagerial duties, and these cannot be overlooked. The primary purpose

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

for which managers are hired and against which they should be measured, however, is their perfo

.

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

mance as managers- that is, they should be appraised on the basis of how well they understand a

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

Companies that provide selfless information through particip

d undertake the managerial functions of planning, organizing, staffing, leading and controlling

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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There is an adage that people leave managers not companies. A recent study confirms this, but the real cause is not management skills. What do you think it is?

Each organization adopts its own concepts which help it develop rapidly, effectively and easily.

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