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Is it just me or is business getting tougher? Look around gas prices are rising and all the manufacturing jobs are going elsewhere? What s

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

hould we do? The only thing certain about our economy today, is that it will look different tomorrow. How computers changed the economies

; 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 80's and 90's, today we deal with cheap foreign labor.

The North American economy used to have an advantage in that we were well 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.

ducated and technologically advanced. This allowed us to charge more, produce quicker and raise our standard of living. Margins were high

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

which allowed more disposable income, grew our middle class and led us to more millionaires than ever before. While this had it's positive

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

Combination pro

s, it also had it's negatives.

We have become complacent in our jobs and standards of living. This left a great opportunity to those who

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

could use a cheap labor force to under cut the pricing on our products. This coupled with lifting trade barriers and duties has led to the

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

tremendous growth of imports. Slashing prices at Walmart has been the result of buying more from the Orient. It is prohibitive for most i

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

ndustries to produce their product in North America. This has been a boom for importers and a disaster for manufacturers. Layoffs at huge

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

companies like Kodak, GM, Ford, as well as a host of others has started the trickle down effect. This is not a positive thing. When an ass

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

mbly worker gets laid off, this job will not be refilled. This person will have trouble meeting their house payments, their car payments,

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

Following aspects would a

and every other expense. Usually these employees are in their 40,s, 50's and 60's. The chance of them finding another well paying job is m

dd to the challenges in developing combination products:

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

inimal. Take this one layoff and multiply it exponentially and see where the economy goes. Next add the tremendous trade deficits of the U

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

nited States and the debt caused by its participation in the wars, a recent chill in the housing market and a tremendous increase in our t

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

ransportation costs and we have the beginnings of a recession.

What do we do now? Do we stick our heads in the sand? There will always be

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

smart people making money. It will take more thought and effort to reap your expected returns. We have to either develop new industries o

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

Professional from academic institutions, pharmaceutical industries, health care indust

r find ways to make it a level play ground. Competing with workers earning 30 cents an hour, working 90 hour work weeks and having no life

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

outside of their job is not in the cards for most of us. We are moving into a service economy. Paying particular attention to detail will

.

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

be vital. Analyzing every marketing expense will be critical. The use of direct marketing and databases of information on your customers

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

Companies that provide selfless information through particip

will be essential. If you need help in deciding how to best spend your next marketing dollar, drop me an email at steve@solutionsink4u.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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Tips for you, the efficient office employee who finished all your job responsibilities early. You don't want to get handed a new stack of work by the boss, now, do you?

Many corporate managers have been introduced to a corporate management system called the Balanced Scorecard. Developed at the Harvard Business School by David Norton and Robert Kaplan in the early 1990s, the Balanced Scorecard (BSC) represents the newest and most prolific performance measurement system since Total Quality Management (TQM) and Management by Objectives (MBO).

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