Advice You - Business

Many people may not realize that in franchising companies the franchisees often act lik

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

e unions. The franchisees will form franchisee associations, with then the franchising

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

Examples of combination products may in

organization. In some ways this is good because they can talk over amongst themselves

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

all kinds of issues they have with their businesses and help each other out. It makes

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

sense the franchisees are part of the team and they are on the ground floor and have t

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

Combination pro

e best ideas to make the franchised outlets more successful.

Nevertheless, sometimes t

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

hese franchisee rights groups or unions form in order to bully the franchisor. Further

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

, if they do not get their way many of them are backed by larger groups of franchise ri

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

ghts organizations or associations, which also have members, which are franchisee assoc

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

iations from other companies. The most unfortunate thing of all is that the larger fra

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

chisee rights Association groups are generally made up of class-action lawyers.

I reme

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

Following aspects would a

mber once, I attended an annual meeting for The American Association of Franchisees and

dd to the challenges in developing combination products:

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

Dealers, which was meeting down the street in IL from Hamburger University the AAFD me

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

t there. I remember overhearing conversations with disgruntled franchisees, who had met

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

in the bar with Franchisee Lawyers, who had come to find cases at the hotel where the

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

eminar was.

Absolutely unbelievable, this is an ugly business from the adhoc Franchise

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

Professional from academic institutions, pharmaceutical industries, health care indust

e Associations within franchising companies (Unions) to the occasional franchising foun

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

der who conveniently lives on a ship off the coast so you cannot serve him a lawsuit? T

.

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 world of franchising is an interesting place and franchising companies need to be aw

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

Companies that provide selfless information through particip

are of the unseen legal side and Tiger traps, which await. Please consider this a 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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What are your ‘under-the surface rules’ that run your life and business? To explore, ask yourself: Where are you consistently stuck in your business? What are the things that always hang you up?

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