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During the course of a week I receive one similar question time and

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

time again; “Should I start my business with a concession trailer

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

Examples of combination products may in

or a vending cart?”.

The answer to the question is subject to a lo

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

t of things, but at the end of the day, if this is someone’s first

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

venture into the food service industry then I usually recommend a v

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

Combination pro

nding cart.

For the individual who has little or no experience in

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

the food service industry, a vending cart is a much easier and much

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

more economical entry point than a concession trailer. Used vendi

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

ng carts can be purchased for as little as $3K and depending on the

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

food service that the person wants to offer, little if any food co

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

king or preparation experience is required. Many vending carts are

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

Following aspects would a

little more than freezers on wheels, offering ice cream, Italian i

dd to the challenges in developing combination products:

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

ces and popsicles. Others are food warmers, offering hotdogs, pret

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

zels and other hot, prepared foods. The more complex carts are bar

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

beques on wheels, allowing the operator to cook items to order such

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

as hamburgers, sausages, hotdogs, and spareribs.

In recent years,

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

Professional from academic institutions, pharmaceutical industries, health care indust

vending cart franchises have started, offering the budding entrepre

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

neur a supposedly proven methodology to a specific product. Along

.

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

with the methodology comes training in everything from the item(s)

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

Companies that provide selfless information through particip

to be sold to an education on finding venues and bookkeeping skills

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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