Subjects - Business

When reading and watching television shows about such people like Andrew Carnegie, John R

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

ockerfeller, Henry Ford, E.I.DuPont, and Bill Gates I take note that all of them started

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

Examples of combination products may in

with a small niche market. And - for some time - when I looked at their beginnings I wou

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

ld fantasize about doing what they did and then realize that most of what I fantasized ab

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

ut was being rich like them. (Not a good thing if it doesn't help you make that first st

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

Combination pro

p.)

So recently I began to pay attention to the evolution of these niche market Mega-Ind

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

ustries and noticed that over the years the enhancements, improvements, and device add-on

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

were done by people who weren't trying to re-invent these Industries, but to help make t

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

hem better. And I might add made a good living at doing it.

So, about a couple of mont

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

s ago, I was watching a television show about a Department store in New York that holds a

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

annual contest for inventors and their inventions. One of these got my attention - a ba

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

Following aspects would a

ttery operated crescent wrench - ( you press a button and the jaws open and/or close to t

dd to the challenges in developing combination products:

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

e size of a nut you may want to tighten or loosen). In my current employment I use a man

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

ual crescent wrench on a regular basis; and of late I find it woefully inadequate and obs

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

lete, (although I ask it to hang tough until the battery operated one comes to market).

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

think now - the man who invented this wrench found his niche when he came up with an elo

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

Professional from academic institutions, pharmaceutical industries, health care indust

quent and simple enhancement that shuold prove to be useful.

Maybe soon I will find my n

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

che - who knows maybe my next generation will add to it enough to buy Microsoft; if not,

.

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

I hope to be one of those enhancers who help to improve or add value to people's lives.

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

Companies that provide selfless information through particip

wish sincerely that your niche, whether large or small, brings you closer to your dreams

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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Subjects - Understanding a Niche

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