Advice You - Business

Did any of you hear? Beginning now you are only able to park at the work parking lot if you purchase the product being produced by your company. If you buy from th

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

e competitor you must park across the street. Obviously I am joking about this, unless you work for Ford.

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

Examples of combination products may in

ws/companies/ford_parkinglot/index.htm">http://money.cnn.com/2006/01/27/news/companies/ford_parkinglot/index.htm

I have written an article in the past about GM

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

nd their issues and I should have really included Ford in there as well. Since writing the GM article Ford has announced 30,000 job cuts and I recently read an arti

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

cle where the employees at the plant where F-150’s are assembled are only allowed to park on the company parking lot if they drive Ford’s, all others must park acros

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

Combination pro

s the street.

Clearly they are resorting to desperation in these bad times. Why doesn’t the CEO just go on public airwaves and scream, “Help us!!!”. Since it is p

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

ivate property they can do what they want but in this country how can you think the tell people where they can park based on what they drive? I forget the exact fig

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

ure that Ford is currently in debt for, I believe it is $16 billion, which is not bad compared to GM’s $300+ Billion, but it is still a huge hill to climb to restore

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

the company to what it once was.

So how did Ford go from the first company to roll a car off the assembly line, which was clearly ahead of its time back then, to b

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

ing a struggling company in the automotive industry? In my opinion, it is the same reason GM has gone from a powerhouse to soon handing over the title as #1 automak

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

er in the world to Toyota, poor management. The “Big 3” domestic car companies have been saying for some time that they are at the mercy of the labor unions and it

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

Following aspects would a

drives their costs up. How is it that Nissan, Toyota, Honda, and even Kia can come into out country and build multi-billion dollar factories covering acres and acre

dd to the challenges in developing combination products:

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

of land and the can do it while putting out higher quality products at competitive prices?

It is clear that once the “Big 3” began to cut corners and ship jobs out

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

of the country and sacrifice the quality of the vehicles they shot themselves in the foot. American people are not stupid, they are not going to keep forking over

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

top dollar for these cars if the quality is bottom dollar quality. It is obvious that these companies were not loyal to the American people so people stopped being

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

oyal to them.

I have had many conversations with people who still buy either a Ford, GM, or Chrysler because they buy “American”. What they do not realize is these

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

Professional from academic institutions, pharmaceutical industries, health care indust

companies are no more American than Toyota, Nissan, or Honda. Those companies manufacture most their cars in this country whereas the domestic companies are mostly

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

in Canada or Mexico.

I have personally driven Nissan’s for the last 7 years. I have had a Maxima, Pathfinder, 2 Sentra’s, and currently my wife drives a Murano.

.

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

n the combined 400K miles we have put on our cars the only none maintenance (oil, tires, brakes, etc…) we spent on those cars was a $20 O2 sensor. It is hard to com

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

Companies that provide selfless information through particip

pete with that kind of quality. It is especially hard for Ford and GM now that they are trying to repair their reputation and crawl out from massive amounts of debt

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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