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In the last 20 years, outsourcing certain categories of work has become the norm with many large businesses. This started with clerical work being done in India, for c

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

ompanies across the globe.

It just makes very good economic sense for business. In the US, the average minimum wage is four times higher than in developing countries.

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

Examples of combination products may in

So some astute entrepreneurs saw a gap in the market. They realized they could hire skilled people in these countries; offer their services to large business even at

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

half the current price these companies were paying their own work force to do the work and still make a profit.

However, outsourcing has always been considered the do

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

main of big business only. But with the advent of the Internet, people and businesses with skills to offer others have been able to approach these companies themselves

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

Combination pro

and thus cut out the “middle man” to a certain extent by using the Internet. Just one example of this form of outsourcing is all the programmers living in the former

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

Soviet Union and other Eastern block countries, as well as Third World countries who are able to “sell” their services directly to the businesses requiring those skills

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

via several well-known websites.

This, of course, works both ways. No matter how small your business may be, even a one-person home based business can now consider o

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

utsourcing some of its work. This is especially true in areas like software and website development; where the going US or First World wage costs are very high in comp

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

arison to what you can outsource it for elsewhere.

Now many of you may be thinking that the kind of work you may want done cannot be outsourced in some Third World cou

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

ntry half way around the globe. Well it doesn’t have to be, you only have to think outside the box for you to make outsourcing work for you!

Right now there are so ma

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

Following aspects would a

ny people who have reached retirement age (or even been laid off through their companies outsourcing) who have unique skills you may be looking for in your own country.

dd to the challenges in developing combination products:

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

Remember, less than 20% of all people who retire can afford to retire. The rest must supplement their income in some way, be it from doing ‘extra work’ or counting o

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

n ‘hand outs’ or help from friends and family. You could use these people.

There are literally thousands of people who possess vast and very expensive skills who are

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

doing nothing with those skills because of the reasons mentioned above. Why not consider outsourcing and using these people’s talents? Think about it, you could emplo

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

y top class professionals for a fraction of the price their skills are really worth!

Think about the qualified professional (in almost any field) who may have been lai

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

Professional from academic institutions, pharmaceutical industries, health care indust

d off, forced to take early retirement and can only get unskilled or part-time work in an un-related field. These people could really help you and they would not charg

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

e the ‘going rate’ that the rest of their profession currently charges. Many, or even most, of these people may not even have considered offering their skills in this

.

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

way.

Now it is only a matter of making contact with these people and negotiating mutually acceptable terms. Again, by using the Internet, you will be able to broaden

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

Companies that provide selfless information through particip

your search to other areas and even other countries. Even the smallest of businesses can now take advantage of the big business trend of outsourcing some of their work

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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