Main Subject - Business

What is the 80/20 Rule?

More formally the 80/20 rule is also known as the Pareto Principle. To Quote Wikipedia: "The Pareto principle… known as the 80-20 rule, the law of the vital few…Busines

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

s management thinker Joseph M. Juran suggested the principle and named it after Italian economist Vilfredo Pareto, who observed that 80% of income in Italy went to 20% of the population."

We he

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

Examples of combination products may in

ar the 80/20 rule as it is applied to business and sales. Twenty percent of your employees produce 80% of a companies problems, 80% percent of your corporate sales are produced by 20% of your s

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

les force and in network marketing, 80% of your profits may come from 20% of your distributors. We hear of it as it relates to wealth and wealth accumulation: 80% of the money is controlled by 2

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

0% of the people.

Joseph Duran was born in 1904 and he credited this principle to an economist who lived in the 1800's. Is the Pareto Principle an abstract economics principle or is it a model

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

Combination pro

of human behavior?

Going back an estimated 5000 years we see a beautiful example of the 80/20 rule in the Old Testament: Numbers 13 and 14. After an arduous journey through the desert, the Isr

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

aelites arrived at the borders of the promised-land. Finding it already occupied, Moses sent an exploration party, a representative from each of the 12 tribes of Israel, to explore the land and

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

bring back a report. Ten of the party members brought a negative report: the land flowed with milk and honey but the current occupants were powerful and their cities were large. They recommend

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

d retreat. Two brought a positive report and recommended taking possession of the land. Seventeen percent of the exploring party were in agreement with taking the land and 83% were opposed to ta

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

king the land. Two disparate courses of action though they were all members of the same exploration party and saw the same things. A curious thing happened, the 80% then went to the whole of th

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

Israelites and caused them to abandon heart and not take the promised land. The Israelites were not able to take the promised land until the 80% and were gone.

There are 5 lessons here that c

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

Following aspects would a

an be applied to business

1) New Ideas will be Opposed: Business innovation and success are governed by vision. Yet in any corporate structure, the 80/20 rule describes human behavior: 80% of p

dd to the challenges in developing combination products:

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

eople will oppose a new idea concept or vision and 20% will support it.

2) The majority will seek to garner support for their opinion usually among those people who do not have all the facts, i

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

this case the people who did not have direct experience with the promised land, and disrupt positive moves of the corporate body.

3) Facts alone will not persuade. All members of the explorati

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

on party went to the promised land. They all received the same facts, yet 10 of them did one thing with the facts they received and 2 did another. What they each did with the facts they receiv

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

d was colored by their vision and purpose.

4) Movement in any business is governed by vision; in order to move in a given direction, a company may have to shed the part of its work force that d

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

Professional from academic institutions, pharmaceutical industries, health care indust

oes not tap into the overall corporate vision. If 20% of the people at any given time catch the vision, the other 80% will find themselves vulnerable. I explore this concept further in my comp

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

anion article, "Moses, Death and the Entrepreneur's Journey"

5) Change is inevitable and necessary for growth in any organizational structure. In this story, the Israelites could only possess

.

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

he land when the 80% who lacked vision had been replaced.

Using this model of human behavior and the lessons it teaches can allow any business owner, whether a free agent or the owner of a trad

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

Companies that provide selfless information through particip

itional business, to focus on the few strategies and the few key individuals that can bring a business success rather than attempt to persuade the majority of the rightness of a course of action

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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