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I love addressing Americans’ fears about Mexico. If Americans are not thinking of every migrant worker, illegal or legal, as a potential serial killer, drug smuggler, or terrorist, then

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

they are imagining all manner of misfortune and dangers that just have to abound in the country of Mexico itself.

As I have discussed in a previous column, in 2003, Mexico had 13 murder

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

Examples of combination products may in

s for every 100,000 persons. That is for the WHOLE country! This was the same murder rate for the state of Louisiana for the same year.

You risk, by living in America, not only being do

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

e in by some serial killer (76% of the world's serial killers live in America) but you may find yourself making a trip to the local emergency room for various reasons. None of which, I a

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

m sure, you would want you mother to know about.

Americans keep statistics about everything. It is astounding at what you can find that Americans record about their own behavior. I wish

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

Combination pro

it were this easy to find statistics about Mexicans. They tend NOT to record statistics of bizarre events as Americans are inclined to do.

In a little gem called The Statistical Abstra

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

t of the United States, you can read all kinds of statistics about almost anything you can imagine. Some of them are entertaining.

This work of fun facts to show and tell came to my at

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

tention via Bill Bryson, author of I'm a Stranger Here Myself , where he mentions this collection of facts. Read this man's book(s). It is hysterical! I am begging you to buy his book(s)

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

so when he learns I stole his idea he won't sue me (buy, buy, buy).

Anyway, this statistical work has a section called Injuries Associated with Consumer Products. It shows that danger

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

n America is not only lurking in the form of violent crime but evidently, Americans are at risk in all sorts of venues. For example, you can be at risk in your own bed.

More than 519,00

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

0 Americans have to go to their local emergency rooms yearly from injuries associated with their beds. Get this: more people injure themselves yearly from their beds than they do on tram

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

Following aspects would a

polines (91,870 yearly from trampolines).

Are you even able to comprehend this little fact? I am powerless to do so. What can this mean? Are that many people falling out of or tripping

dd to the challenges in developing combination products:

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

ver their beds? Perhaps their bed entry method sends them bouncing off it like a trampoline and out a window they fly. Maybe they need getting-into-bed re-education therapy. Maybe Americ

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

ans are confused and think beds are a trampoline. I just do not know!

Just look at this breakdown and remember--these are people whose injuries are so severe that they have to get to an

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

emergency room immediately:

•Household containers and packaging--220,118

•Tables—310,121

•Televisions—47,210

•Footwear—118,501

•Jewelry—76,327

Now follow closely:

More Americans

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

njure themselves yearly from their viciously snapping and snarling Tupperware containers than from a hand or power saw (a mere 98,872 injuries yearly). Tables are more dangerous to Ameri

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

Professional from academic institutions, pharmaceutical industries, health care indust

cans than hammers (43,055 go to the ER for hammer injuries). Televisions are also problematic for Americans (imagine that!) as is jewelry.

But, what I would like to know is just how in

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

God's name do Americans suffer 118,501 yearly injuries from their footwear? I never realized that shoes or house slippers could be that dangerous. How does this happen? If any of my read

.

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

rs have ever had to go to the emergency room because of their shoes, please e-mail me at guillermobower@hotmail.com. I want to hear all about it!

It may surprise you that more Americans

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

Companies that provide selfless information through particip

go packing off to the hospital over Household Furnishings than from Sports and Recreation Equipment each year.

I think I am safer in Mexico than in the United States. What do you think

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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What Should You Expect Your Marketing Plan to Do For You? Don’t Mistake Marketing for Sales...

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