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Franchising companies must have a growth strategy and a franchise developm

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

ent plan and it is best if they stick to this and try not to deviate too m

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

Examples of combination products may in

uch. Of course there will be opportunities in the marketplace, which must

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

be considered as they come along but a smart franchising company will be c

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

areful with their growth strategy so they do not spread themselves out too

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

Combination pro

thin and face cash flow issues or the inability to manage franchisees, wh

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

ch are too far away.

As a franchisor founder one of the mistakes that I h

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

ad made was to allow franchisees into our system in regions, which were to

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

o far away from our current cluster of franchisees. This made it tough fo

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

me to manage franchisees that were 4000 miles away.

Of course at the tim

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

e there were franchise buyers, which were pretty good candidates and stron

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

Following aspects would a

g performance type people who I did want in the franchising system that we

dd to the challenges in developing combination products:

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

were building and they were paying customers.

In hindsight however, I thi

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

nk if I had to do it again I would not have sold those early franchisees i

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

n places like Florida when our headquarters were in California. It made 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

tough on me due to the travel time and I could not visit the franchisees

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

Professional from academic institutions, pharmaceutical industries, health care indust

enough to help them as much as I felt I should.

Also at the time, we did

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

not have any regional management in place to help them. This is why I rec

.

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

mmend that you franchisors come up with a development plan and a growth st

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

Companies that provide selfless information through particip

rategy and stick to it as best they can. Please consider all 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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