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It all started with Jane Fonda. She started an industry with a simple video tape that included a 30 minute beginne

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

rs program followed by a 60 minute full workout. For Jane it formed the nucleus of an empire that included books, a

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

Examples of combination products may in

udio recordings and fitness salons that are still in existence today. More importantly, capitalizing on Jane’s succ

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

ss, her workout tapes were followed quickly by everybody with a cut chiseled physique or a machine to help you work

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

off those extra pounds and bring out those abs which quite unbelievably is bigger today than it was yesterday but

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

Combination pro

ot as big as it will be tomorrow.

Like they say in the record biz, the hits just keep on coming. Everybody has ju

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

mped into the market through the years: Chuck Norris, Lou Ferrigno aka The Hulk from the TV show, even Governor Arn

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

old tried his hand at it. Models, celebrities and just plain folks with a machine have created exercise infomercial

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

and you can count on one thing – more are coming soon to a TV channel in your house.

There’s Pilates, aerobics, t

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

oning, step dynamics, yoga, stretch, even specialty exercise tapes for pregnant women, women who have just given bi

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

th, women who are thinking about getting pregnant, kids, seniors – and that’s only a small fraction of what is avai

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

Following aspects would a

lable. Right now there are over 700 titles currently available and at one time or another all of them were presente

dd to the challenges in developing combination products:

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

d to the public as an infomercial.

Some exercise infomercials utilized a new form of advertising called the hybrid

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

infomercial. In the hybrid infomercial the product is available immediately as a direct response item and at the sa

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

me time the item is available in retail stores. Here the infomercial is serving a dual purpose – to make a profit f

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

r the manufacturer immediately with credit card phone orders and by creating a brand name identity for the product

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

Professional from academic institutions, pharmaceutical industries, health care indust

available in the retail marketplace. With so much product available in today’s infomercial exercise tape market, it

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

’s difficult for any one tape or exercise machine to make a profit for its manufacturer. By utilizing the incredibl

.

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

power of infomercials to reach a wide public base and selling them as a direct response item and a retail item sim

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

Companies that provide selfless information through particip

ultaneously, manufacturers have learned how to profit from infomercials even though the market may be oversaturated

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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