Advice You - Business

I don’t know how many times I’ve flipped through the channels and heard Lou Dobbs talking about “Exporting America.” Now, I know Lo

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

u is discussing the political and economic context of American companies outsourcing their jobs overseas. However, this new one-dim

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

Examples of combination products may in

ensional definition of outsourcing has other implications to some of us in the States.

I am no expert on politics, economics or Lo

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

u Dobbs, so I’ll keep my opinions on those subjects to myself. However, what I would like to discuss is the negative connotation th

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

at the word “outsourcing” has taken on in this country.

There are thousands upon thousands of small businesses in this country who

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

Combination pro

se sole survival depends on other companies outsourcing their needs. Just think about it for a moment. How many companies in the se

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

rvice industries only exist to support the needs of other businesses?

Imagine if every company had to act as a fully self-sufficie

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

nt corporation. They must handle all of their own HR issues…no more employment agencies, payroll companies, etc. They must employ a

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

full-fledged IT department to handle all of their own web design, networking, software and database designs. Each enterprise has 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

o have enough administrative assistants, data entry specialists, desktop publishing experts, marketing gurus. The list is endless.

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

If American companies were to completely eliminate all forms of outsourcing, life as we know it would end!

Now, we all know that

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

Following aspects would a

this is not what Lou or anybody else who has defined outsourcing as one of the most popular buzz words of the last few years is tal

dd to the challenges in developing combination products:

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

king about. I understand that most people know that the business to business outsourcing within America is not a bad thing. Nonethe

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

less, it seems strange to me that one word can take on such a life of its own. It’s really not a new phenomenon, yet it is the firs

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

t time that I’ve encountered one of these controversial terms in my own ventures.

Let me say that as a business person in a field

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

that is solely based on other businesses looking to my company to meet their needs, I find myself quite often searching for synonym

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

Professional from academic institutions, pharmaceutical industries, health care indust

s to outsourcing. Not that there’s anything wrong with it, but when I’m advertising, I’m forever brainstorming for words to replace

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

that one that starts with o and ends with source! After all the talk that’s been spinning around Washington and the rest of the co

.

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

untry, it seems that it’s turned into a dirty word.

Obviously, most people understand that there are all types of outsourcing. On

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

Companies that provide selfless information through particip

the other hand, when you’ve got limited time and space are you going to choose a “hot button” word to describe what you’re selling?

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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