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Many small business people and entrepreneurs are likely to copy the competition or grab a ho

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

ld of a new idea and run with it. It makes sense to borrow ideas that are good and use them

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

Examples of combination products may in

in business, but it is bad business to borrow ideas that will not work. A good entrepreneur

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

should have a keen sense of what will and will not work and what their customers are willing

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 pay for.

One thing I often found in business is that my middle managers in various loca

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

Combination pro

tions would often see a competitor doing something and figured that they also wanted to get

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

in on the action. Then they would implement a scheme to mimic what the competition was doing

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

. Little did they know that the competition was not making any money at it and it was a los

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

ing proposition.

Let me ask you something if your competition was jumping off a bridge woul

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

d you follow them? Hopefully not and now my friends you have answered my point of contentio

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

. Just because the competition is doing it does not mean it will work. Think how many times

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

Following aspects would a

you try new things that you thought were a good idea and they ended up not working out.

Hav

dd to the challenges in developing combination products:

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

e you ever wonder how many times your competition has copied your innovations only to lose m

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

oney at it just like you? Before my retirement my company literally changed the entire carw

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

ash industry and it was a matter of life or death staying ahead of the competition through i

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

nnovation. We always tried new things. Some worked in some did not. The competition followed

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

Professional from academic institutions, pharmaceutical industries, health care indust

us regardless.

The most fascinating thing that I found was that the competition would copy

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

me whether it worked or not and thus sometimes I would do a fake out and market some new se

.

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

rvice that I knew would not work and pretend like it was working great just to catch the che

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

Companies that provide selfless information through particip

aters and copycats. It serves them right. So I want you to think about this in your business

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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