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Business process management tools are comprised of planning, organizing, staffing, leading, controlling a

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

nd coordination. Planning involves selecting missions and objectives and the actions to achieve them; it

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

Examples of combination products may in

requires decision making like choosing future courses of action from several alternatives. No real plan e

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

ists until a decision (a commitment of human or material resources or reputation) has been made. Before a

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

decision is made, all that exists is a planning study, an analysis or a proposal. There is no real plan.

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

Combination pro

Organizing is a part of managing that involves establishing an intentional structure of roles for people

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

to fill in an organization. It is intentional in the sense of making sure that all the tasks necessary t

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

accomplish goals are assigned. It is hoped that the tasks are assigned to people who can do them best. T

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

he purpose of an organization structure is to help create an environment for human performance. It is a m

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

nagement tool and not an end in and of itself.

Staffing involves filling and keeping filled the position

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

s in the organization structure and identifying the work-force requirements and inventorying the people a

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

Following aspects would a

vailable do this. These people are recruited, selected, placed, promoted and appraised. Thus, both candid

dd to the challenges in developing combination products:

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

te and current jobholder’s skills are developed to accomplish their tasks effectively and efficiently.

L

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

eading influences people so that they will contribute to organization and group goals; it has to do predo

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

inantly with the interpersonal aspect of managing. All managers would agree that their most important pro

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

blems arise from people- their desires and attitudes, their behavior as individuals and in groups. Theref

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

Professional from academic institutions, pharmaceutical industries, health care indust

re, effective managers also need to be effective leaders.

Controlling is the measuring and correcting of

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

activities of subordinates to ensure that events conform to plans. It measures performance against goals

.

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

Plans show where negative deviations exist, and by putting in motion actions to correct deviations, help

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

Companies that provide selfless information through particip

ensure accomplishment of plans. Although planning must precede controlling, plans are not self–achieving

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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