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In today’s global economy, managers must show that they have imagination to create and facilitate inn

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

ovative ways of operating business. Managers can’t afford to be static. Managers are no longer compet

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

Examples of combination products may in

ng on a local or national scale. They’re now competing globally hence the need for managers to be dyn

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

mic. Managers must now look at all aspects of doing business. Some of these aspects were generally ne

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

glected by management.

How do you know if you are a traditional manager? First, one must understand

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

Combination pro

hat managers always focus on the bottom line. In a traditional style of management, the bottom line i

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

based on two sources of data, planned expenditures and actual expenditures. While this style of mana

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

gement works, it is not enough to compete with the rest of the world, because this linear style of ma

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

agement lacks imagination.

So what do managers need to do? In order for managers to compete globally

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

they must first possess the mind set for innovation. The more innovative a manager, the more dynamic

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

e/she will be at integrating all measurement of cost. These managers I like to call activist managers

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

Following aspects would a

. They are forward looking, and are generally more dynamic in their way of thinking. In their decisio

dd to the challenges in developing combination products:

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

making, they draw on different elements within the business society whether it is on the local, nati

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

nal, or even international level.

What are these elements? The elements are factors that impact doin

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

g business. These factors are many depending on the industry that one is in. Here are some examples o

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

elements that affect managers in doing business.

• Consumer credit risk
• Resources
• Pol

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

Professional from academic institutions, pharmaceutical industries, health care indust

tical Climate
• Foreign Exchange risk
• Competition
• Technology

Understanding their

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

respective elements will better enable managers to make the necessary adjustments to doing business.

.

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

hese adjustments will allow managers to achieve a viable bottom line.

This Article was provided to y

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

Companies that provide selfless information through particip

u by http://www.managementthatworks.com

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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