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Employee benefits jumped to 44% of total 2006 payroll costs according to a recent survey of 400 U.S. compan

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

ies released by the U.S. Chamber of Commerce. Another report suggested that almost 60% of all employees are

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

Examples of combination products may in

not fully engaged in their positions. The question that you need to answer as a business owner or business

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

executive is:

Are these continued increases in employee costs coupled with the decrease in individual per

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

formance part of your strategic plan?

Numerous reports during the last several years revealed that U.S. em

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

Combination pro

ployees wasted time and lacked the necessary skills and knowledge to take their businesses to the next leve

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

l. The bad news continues to flow from the U.S. Manufacturing Association’s report detailing how the U.S. p

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

ublic education system is contributing to the skills gap. In spite of continued increased educational fund

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

ing, twelfth grade reading scores are at the lowest since 1992. Also, three quarters of seniors scored belo

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

w the expected math proficiency level. (Source: The Nation's Report Card: America's High School Graduates)

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

With this dismal news, business owners need to run not walk back to their strategic plan and make the neces

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

Following aspects would a

sary course corrections. For example, medical related expenses rose almost 3% over the previous year. Pos

dd to the challenges in developing combination products:

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

sibly, now is the time to consider employee wellness as a potential critical success factor or critical goa

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

l category. Paid time and holiday time inched up .6%. With the push back on profit margins in almost all i

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

ndustries, any fixed cost increase is not good. Finally, employee engagement is another potential critical

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

goal category with a specific goal to increase employee productivity.

Executable strategic plans include c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ritical areas from which specific goals are committed to writing and monitored on a regular basis. Since t

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

he bottom line for any business is to increase revenues and decrease costs, ignoring this information is po

.

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

tentially fatal. With the Internet acting as viable resource to quickly capture important data, business ow

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

Companies that provide selfless information through particip

ners can quickly analyze this information to make any necessary course corrections to their strategic plans

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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