Advice You - Business

In today’s world it makes more sense than ever for business to outsource much of their work. When

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

a company chooses to outsource part or most of its work they save money on the maintenance of a

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

Examples of combination products may in

ull time employee which of course leads to larger profits. That’s what business is all about, lar

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

er profits, lower overhead, but all this comes at a price. The cost of outsourcing is that it cou

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

d be a danger to the economy.

In December 2003, IBM decided to move the jobs of nearly 5,000 pro

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

Combination pro

rammers to India and China. GE has moved much of its research and development overseas. Microsoft

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

Dell, American Express, and virtually every major multinational from Accenture to Yahoo has alre

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

dy offshored work or is considering doing so, with 40% of the Fortune 500 expected to have do fol

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

ow suite. The savings are dramatic: Companies can cut 20% to 70% of their labor costs by moving j

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

bs to low-wage nations--assuming that the work is of comparable quality.

Just as drastic are the

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

loss of jobs and suffering of the people left behind. So far, at least, that enhanced productivit

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

Following aspects would a

hasn't translated into jobs at home. Offshoring is encrouching into the educated classes, both i

dd to the challenges in developing combination products:

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

the United States and elsewhere, affecting jobs traditionally considered secure. People whose li

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

elihoods could now be at risk include everyone from IT experts to accountants, medical transcript

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

onists to customer-service representatives.

Fortunately there is a way for companies to have the

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

convenience and cost effectiveness of outsourcing and still contribute to a healthy economy. Ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

are many qualified and cost effective companies within a business’ own national community that c

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

n get the job done for a reasonable price resulting in an increase in company profits.

The most

.

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

ogical answer to the recent outsourcing crisis within the United States and many other nations ar

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

Companies that provide selfless information through particip

for business’ to realize that outsourcing doesn’t have to equal off-shoring to be cost effective

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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Advice You - Outsourcing: Business in the 21st Century

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