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Having run a franchising company for a decade and then retirin

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

g I always thought that it was quite interesting when a franch

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

Examples of combination products may in

se buyer was completely hostile and combative during the appli

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

ation and approval process. You see in franchising it is not a

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

bout selling franchises, it is about choosing the best candida

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

Combination pro

es to promote your brand name. If you get a loser in there and

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

they are hostile, renegades or mean to customers they ruin you

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

r image, team spirit and you just end up with too many problem

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

or litigation down the road.

I use to ask these hostile type

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

; “Do you really care about a win-win situation that can be ac

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

ieved in franchising? It can be done. And yes it's hard work a

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

Following aspects would a

nd it does take sacrifice on both sides to make things gel. Bu

dd to the challenges in developing combination products:

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

it's worth it.”

If any franchisee goes into a franchise with

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

hostile intentions they missed the whole point. If a franchise

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

r is greedy and is willing to sacrifice the profitability of h

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

s franchisees, they are missing the point. All the attorneys i

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

Professional from academic institutions, pharmaceutical industries, health care indust

the World and boy there are a few won't fix the problem. A fr

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

anchisor is so much smarter to get hard working, intelligent,

.

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

eam player type franchisees if it wishes extend it brand name

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

Companies that provide selfless information through particip

moothly and rapidly region after region. Consider this in 2006

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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