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I opened the registered letter and was shocked. My best clients were joining together in a class-action suit against me. The letter stated that I had promulgated a false illusion of success by having them follow the 80-20 rule. I

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

t alleged that I brainwashed them into thinking that the 80-20 rule was a basic law of business and nature. They followed my advice and many of them had gone bankrupt.

I confess, I do quote the 80-20 rule like it is divinely ord

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

Examples of combination products may in

ained. Called by whatever name, the 80-20 rule reminds us that the relationship between input and output is not balanced. The rule states that a small number of causes is responsible for a large percentage of the effect, in a rat

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

io of about 80-20. For example, it could be said that 80 percent of your profits come from 20 percent of your customers or 80 percent of your budget comes from 20 percent of the items and so forth.

The 80-20 rule is definitely b

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

iblical in its origins. It’s my mantra. I start all my training sessions with a simple question. Although there are Ten Commandments, which ones do you think generate most of our sins? “Do not covet… ” is obviously No. 1. The gro

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

Combination pro

up usually argues over No. 2. Lately “Honor thy father and mother” has been the runner-up. (I guess with the increase in life expectancy, it has become much more difficult to follow this commandment.) We have a few laughs, and I

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

make my point. Each commandment does not generate an equal amount of sins. “Do not covet” and at least one more could well make up 80 percent of our daily transgressions.

My audience loves the story. True, they would initially a

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

rgue that the 80-20 rule does not apply to them. Their businesses are unique and such sweeping rules could not include them. However, I show them data and a lot of anecdotal evidence. I can be very persuasive. Finally they succum

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

b and buy my book, training tapes, and subscribe to my Web site in order to follow my latest advice.

I reread the letter. I’m flabbergasted. I call my best customers, but they won’t talk to me. They refer all my calls to their a

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

ttorneys. My attorney warns me that this is not a frivolous lawsuit. I need to have a strong defense. We live in times when consultants are being sued by their clients for a lack of ethics, conflicts of interests, and down right

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

lain stupidity. Consultants are paying hefty fines, even getting jail time.

I started working on my defense at the library. I researched the great scientific discoveries of the Renaissance. I believed that the 80-20 rule could b

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

Following aspects would a

e found in the footnotes of Sir Isaac Newton’s manuscripts on the universal laws of gravitation. I was wrong.

An alternative, for sure, would be Charles Darwin’s law of the survival of the fittest. The 80-20 breakdown seemed lik

dd to the challenges in developing combination products:

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

e a natural outgrowth of his studies of competition, genetic mutation, and the animals of the Galapagos Islands. Again no luck. I was starting to worry.

I did find some stuff on an Italian economist of the late 19th century, Vil

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

fredo Pareto. He developed “Pareto’s Law” which he presented as: log N = log A + m logX. When dumbed down it is the 80-20 rule. I was very excited. I showed it to my lawyer. “Forget it.” I would lose the jury with any math beyond

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

third grade.

I decided to tell my lawyer the truth.

My pals in high school promulgated the 80–20 rule. We were trying to figure out the probability of getting dates on any given Saturday night. We collected data from our class

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

mates. Surprisingly a small percentage of the guys (20 percent to be exact) dated most of the girls (80 percent to be exact). These guys were considered the “in crowd” and always had dates. On the other hand my friends and I, “th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e nerds,” the other 80 percent of guys, were always competing to get one of those few girls (the 20 percent that would date a nerd) to go out with us.

The rule applied in college too. Eighty percent of the beer cans could be fou

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

nd in front of only 20 percent of the dorm rooms. We knew because we collected them for recycling. (OK, we did it to get the five-cents refund available in politically correct California). It just seemed that everywhere I went th

.

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

is 80-20 thing worked.

My lawyer sounded encouraging for the first time. He could use this type of information to convince a jury. Initially, his strategy was to plea bargain and ask the judge for community service. Now he was r

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

Companies that provide selfless information through particip

eady to go for an acquittal and threaten to counter sue my former clients for defaming my professional name and character.

Did you see me on Court TV? Not only did I win, I got the judge and 80 percent of the jury to buy my book

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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If you have always dreamed of traveling to exotic locations but just do not have the budget to allow you to travel to all the places you desire than a career in the cruise ship business may be the right choice for you. Get your answers to the most frequently asked questions here...

Any idea can be a good idea, but not every idea is. Before you process that let's take the following questions into account. Why did Bavarian Motor Works (BMW) decide to produce cars? How did soft drinks become a billion dollar industry? Who would have thought you could make millions off of junk? When did the internet go from the information highway to the shopping highway? Where did Xerox go wrong with computers and what leads some to believe they should have been the personal computing tycoons of today?

Since my first consulting project almost thirty years ago, I have learned a lot about how to successfully manage consulting projects and the client/consultant relationship. Here are some ideas that may help you with your consultants (and your lawyers, accountants and other professionals).

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