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Do you ever wonder why companies like the Big Three US Automakers spend millions to tell them what t

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

hey should obviously already know? They spend millions in consulting fees. Interestingly enough this

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

Examples of combination products may in

topic became a rather charged debate recently in our Online Think Tank. We all know that the US Con

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

sumer wants cars that look cool, have good performance and do not use too much gasoline or fuel righ

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

t? Yah, dah you say.

This is why last year alone Toyota captured an additional 10% market share and

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

Combination pro

Ford announced losing 16 Billion? Ouch, hello! Why is this happening, why are both GM and Ford in a

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

world of hurt? Didn’t they already learn this a few decades the prior? Now they are paying millions

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

to consultants to re-learn what they already learned the hard way?

Last time after Charles Deming

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

told them for free what should be done they did not listen, while the Japanese took him for his word

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

and the Big Three paid twice. Datsun and Honda days sure showed Detroit back then and Toyota and Ho

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

nda are doing it again now.

Amazing that the Big Three are learning the same lesson again as China

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

Following aspects would a

sells franchises in NJ of an Chinese Automaker, which is actually partly owned by the Chinese Army,

dd to the challenges in developing combination products:

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

meaning you buy a fuel efficient Chinese mini-SUV and the Treasure Fleet Sails Again only this time

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

with nuclear submarines carrying anti-satellite weapons of course?

Admiral Zheng was a great man in

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

Chinese History and his legacy is likely to rise again, China is surpassing the US Navy Fleet in nu

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

mber of ships as we speak. Why are the US Automakers not seeing the bigger picture here? What a disa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ster of inefficiency and hard lesson in failing to deliver to the customer what they desire at a pri

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

ce point competitive with the Free-Market?

Well, you are probably asking if I could do better? Yes,

.

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

that is affirmative, but after paying out all that money to others, doubt they have much left actua

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

Companies that provide selfless information through particip

lly. I hope this article will propel thought in 2007 and perhaps a re-bound for US Automakers by 200

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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