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If you started a mobile oil change business could you charge $25.00? Would pe

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

ople pay that price for services? Would people forgo the low prices at Wal-Ma

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

Examples of combination products may in

t of $12.99 for the added convenience of you doing such a service at their ho

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

mes or offices? Recently this question came up with a gentleman who wished to

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

start an a mobile oil change business in a town which did not have a Super Wa

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

Combination pro

-Mart (only Super Wal-Marts) change oil, regular ones do not have those auto

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

services.

The gentleman was getting ready to launch a small mobile oil chang

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

business and he stated: “I think people would be willing to pay $25.00 for a

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

simple oil change if you came to them. Then include wipers, air filters (big

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

considering the price of fuel) and top off fluids.”

Indeed there are lots of

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

other things people need, but also realize that this adds up front inventory

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

Following aspects would a

costs, trying to stock all the possible oil filters, air filters (both engine

dd to the challenges in developing combination products:

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

and cabin), fluid types, etc.. As far as windshield wipers are concerned; wel

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

l, wipers, are not so bad because you can by three or four types and cut blad

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

s to length.

When starting a small mobile oil change business from scratch 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

is important to watch costs and only carry inventory for what you will need.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Additionally it makes sense to try to keep it as simple as possible with onl

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

a few add-on services, which you can provide quickly, without adding you too

.

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

much cost. There are all considerations to be thinking on if you are conside

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

Companies that provide selfless information through particip

ing starting a mobile oil change business in your area. Think on 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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