Main Subject - Business

Have you ever wondered why companies outsource? You think you know the answer? Well it is not

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

only about labor costs. It is also about over regulation in the United States, lawsuits and

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

Examples of combination products may in

raw material supply chains.

You see efficiency is the name of the game and also it appears s

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

ales in international business are also very wise to consider. Ask an executive with Boeing C

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

ommercial Aircraft Manufacturing Division; outsourcing for instance to India or China where t

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

Combination pro

hey will be buying 1000’s of new jets in the next decade.

So if some of the components are o

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

utsourced there and they can be made cheaper, and you get the sales you win times three and i

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

t also provides for good trade incentives and lowered tariffs on other imported goods. It mak

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

es fair trade more possible and likely. Also aids in stability to political cooperation and t

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

hat means fewer wars and fewer disruptions as well.

I think we should apply some Plato Philo

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

sophy to the mix when we talk about “Outsourcing” for instance in the Republic he stated that

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

Following aspects would a

each member of the society should do what they are best at [excel] and be alleviated from re

dd to the challenges in developing combination products:

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

sponsibility of that which they are not good at.

Now if you look at the world of Corporation

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

s, one company should do what it is best at and buy those things it needs from other companie

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

s who are the most efficient at doing those things.

Think of a team; the team needs the best

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

players in the right positions; consider a soccer team. The goalie should not be a forward o

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

Professional from academic institutions, pharmaceutical industries, health care indust

r a halfback. Each member of the team should be a specialist. It really is the best for effic

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

iency models and more companies should look at it this way and companies, which fail to do so

.

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

will probably be beat by those who understand this concept. I hope you will consider some of

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

Companies that provide selfless information through particip

this in your economic and labor thoughts as you address this issue. So think on this in 2006

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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Main Subject - Why do Companies Outsource?

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