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Many of us believe that the harder we work the more money we'll earn. This isn't true. In fact within reason the opposite is true.

Let

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

me give you an example. It's a fact that it's the poorest people in this world who work the hardest. Try working in a factory for 7 da

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

Examples of combination products may in

ys a week at just a few cents an hour and you'll soon realise this.

Take a look at any rich person you know or know of. How hard do th

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

y really work? Probably not very hard. If they do work hard it's often because they enjoy it.

The fundamental difference between the r

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

ich and the poor is that the poor work hard for very little money but the rich have money work for them.

The rich have assets which ea

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

Combination pro

n them more money while the poor have liabilities which cost them money.

To be a successful entrepreneur you must learn to obtain asse

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

ts and build systems which will earn money for you, not buy liabilities which will cost you money in the long term.

An example I often

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

use is the following: two men buy an expensive car from the same garage at the same price.

The first man drives it around for a few y

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

ars and after paying out thousands of dollars in fuel, insurance and tax he finally sells it on (as he can no longer afford to run it)

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

at a loss of another 20 thousand dollars. I personally know people who do this continuously.

The second man hires out the car to peopl

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

for special occasions such as weddings and parties. After having his customers pay for the fuel, insurance and tax for a few years he

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

Following aspects would a

pockets the profits he's made and trades in the car for a bigger one. Any expenses he incurs are tax deductible. He then repeats the pr

dd to the challenges in developing combination products:

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

ocess with his bigger, smarter car and in a few years time is able to buy two cars, then three...

Ten years down the line the first ma

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

has made a substantial loss and is back riding his push bike to work. The second man now has a fleet of posh cars which he hires out f

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

or a living and has quit his day job as a result.

So, if these two men both started off buying the same car at the same price, what we

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

t wrong for the first man and what went right for the second man?

It's simple, the first man turned his car into a liability as many o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f us do. The second man immediately turned it into an asset.

Next time you buy anything of any value just remember this example and es

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

tablish whether you're really buying an asset or a liability. Try to be the second man wherever possible and you'll be one large step a

.

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

ead of your friends and associates who haven't been fortunate enough to read this article.

For more entrepreneurial tips and advice pl

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

Companies that provide selfless information through particip

ease visit: http://www.entrepreneur-mindset.com

Best Regards,
Jason King BSc MBCS CITP http://www.entrepreneur-mindset.co

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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