Answers - Home Based Business

How many times a year do you hear this from your well-meaning (?) family and friends:

“Oh! You are so LUCKY to be self-empl

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

oyed! You have no idea what I put up with everyday at the office (or the store, or the school or the loading dock - fill in t

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

Examples of combination products may in

e appropriate phrase).”

Hey! Guess what? I DO have a very good idea of what you are putting up with everyday. It’s WHY I am

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

elf-employed now. I still put up with a lot of the same stuff everyday - it’s just that now, I have the luxury of deciding ho

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

to deal with it myself, instead of being TOLD how to handle the situation.

But most importantly - LUCK has nothing to do wi

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

Combination pro

h the fact that I am self-employed and you are still in that office (or store or loading dock or whatever). You see, being 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

lf-employed means taking risks, and working your tail off -sometimes for a LONG time - before you see any reward.

Being self

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

employed means that I don’t get a paycheck from anyone every Friday, no one else contributes to my health insurance or my pen

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

ion fund, no paid two week vacation, no sick days and believe me - no paid holidays.

And chances are - I am still working ev

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

ry evening while you are watching Desperate Housewives and voting for the next American Idol.

No, being lucky and being sel

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

-employed have very little to do with each other. I took a lot of very big risks to get here, and have had more than my share

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

Following aspects would a

of the 3 am “heebie-jeebies”, wondering if I did the right thing - but I will never return to a “job” again!

I will be the

dd to the challenges in developing combination products:

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

irst to admit that I still put in some long hours - but it’s my choice. I love what I do now, I only set the alarm clock if I

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

need to catch a plane, and my income grows daily - whether I am on vacation or sitting in front of the computer. I work hard,

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

and I play hard, and life is very, very good.

I work from home, I set my own hours, and I control my income. No store to ope

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

, no products to ship, no boss hanging over my shoulder!

Thanks to the internet, my dream of a portable business with multip

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

Professional from academic institutions, pharmaceutical industries, health care indust

le streams of income is now my reality, and my reality is a wonderful and rewarding way of life - both emotionally and financ

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

ally.

There is an old proverb (I think it is Chinese) that goes something like this: “the harder I work - the luckier I get”

.

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

Can you do the same thing - break out of your rut and join the ranks of those “lucky to be self-employed” folks? You bet - v

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

Companies that provide selfless information through particip

rtually anyone can - it just takes the courage to look beyond where you are today and the willingness to create your own luck

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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Answers - You Are So Lucky To Be Self-Employed Or Another Urban Myth Bites The Dust

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