Advice You - Business

Many executive business management teams with to propel their product or service thro

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

ugh the marketplace and their brand name through franchising. This makes sense for ma

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

Examples of combination products may in

y reasons, although we must also consider that franchising is a highly over regulated

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

industry. To top it off, it is not easy selling franchises. Why is that you ask?

We

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

l in franchising it is harder than hell to get someone to buy the first franchise, on

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

Combination pro

ce you sell the first one it is much easier to show people that unit instead of a com

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

any owned unit and then they are much more interested. In my franchising company, whi

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

ch I founded, I gave away my first franchise and sold the second one on terms, I fina

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

ced them and the third one for half price and made deals for the next 10 to get the d

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

arn thing going. Really that is the reality of Franchising Start-ups, although no one

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

seems to talk about it.

Anyone who has ever founded a franchise knows this. And to t

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

Following aspects would a

hat point most under financed franchisees fail anyway and a franchisor in the long-ru

dd to the challenges in developing combination products:

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

, does not help himself or the franchisee in doing this, but unless you have millions

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

to start then that is the way most franchisors do things. I would say that is why on

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

y 1 in 5 franchisors makes it for 5-years? You think franchisee failure rates are hig

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

h or even small business for that matter? Try entering the letigious world of being a

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

Professional from academic institutions, pharmaceutical industries, health care indust

Franchisor?

It is for these reasons that I would advise executive business managemen

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

t teams considering franchising as a way to distribute their product quickly through

.

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

he marketplace to be forewarned that you will need at least $1-$2,000,000 to get your

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

Companies that provide selfless information through particip

franchising strategy and business model up and running. Please 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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