Useful Advices - Business

Have you ever considered how smaller businesses and even franchisees who own franchised outlets are hurt in economic downturns? Have y

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

ou ever considered the ebb and flow of regulations and how they try to control it? We all know that the government does nothing very w

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

Examples of combination products may in

ll and yet we allow them to try to reign in the cattle and corral the raging rapids of our economy. Why?

One thing I find interesting

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

is that when the economy goes down it is always the small businesses that pull out the consumer from their demise due to scarcity of

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

urrency flows. When the economy is good they regulate the crap out of the small businesses (franchisees and small-franchisors) putting

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

Combination pro

barriers to entry up for the larger corporations to run. Still in the end the shell game can only run so long, as it is not reality b

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

sed and the sector rotations return, like river currents or ocean waves near the shore.

The real problem is that stifling competition

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

kills innovation and makes the larger companies too fat dumb and happy to get out of their own way. Then throw in a little rule maker

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

- rule maker syndrome and look at all the regulator debris? It is time to take a red-magic market to the franchising regulatory book a

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

nd reduce the barriers for fast moving new concepts. America would be the better for it.

What can a franchise organization do to prot

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

ct themselves? Well, sometimes a plan with existing franchisees, corporate owned units and co-branded deals makes more sense because y

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

Following aspects would a

ou have the brand everywhere "power of presence" yet at the same time you can control your major markets and if you take a hit in some

dd to the challenges in developing combination products:

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

markets others should pull you through.

Diversification helps too as one industry is hit with a sector rotation of landslide others a

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

re there to soften the blow. When everything is running on all cylinders it is of course time to make hay, but franchising organizatio

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

s know they better be smart about their strategies. Consider if you will the Rent-A-Car Companies which owns airport units and franchi

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

se other locations or Service Master where some brands are owned and run corporately, some by master franchises and some franchisees.

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

Professional from academic institutions, pharmaceutical industries, health care indust

There are many companies that appear to be franchisors, but were not which set up partnerships owning 51% and then later bought them b

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

ack; Kinkos or look at Outback steakhouses. If things get tough they are able to sell out with little if any legal pain as they contro

.

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

the game underneath them. Additionally these types of companies have more options to weather the storms, use economies of scale and b

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

Companies that provide selfless information through particip

attle the onslaught, where as a poor strategy can kill off too many franchised outlets and the whole system dies. Please think on this

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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Useful Advices - Small Business - Franchising and the Economic Reality of Regulation

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