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Ants are the most fascinating creatures. Their colonies are intricate. Each ant is capable of performing tasks that seem impos

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

sible for its size, weight and body mass. Together, an ant colony can bring down an insect 100 times its size. Together, the a

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

Examples of combination products may in

ts can build huge colonies to feed and shelter hundreds of thousands of ants per colony. They are always gathering food and pre

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

paring for the next season.

Imagine for a second an ant by itself. If it did not live with other ants, work with other ants.

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

ould the ant be as powerful? Would it be able to eat when it’s cold outside? Without other ants to leverage the food gathering

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

Combination pro

job, will one ant be able to gather enough food to keep it going? What about the colonies. Is there a place such as a colony

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

or 1 ant?

Compare for a second, ants and people. Like ants, people also have the power to leverage the work of others. Which

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

leads to the million dollar question: How can some people gather massive amounts of wealth when others who seem like generous, k

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

nd people barely seem to get on with their lives? The key is Leverage.

Every one has the same 24 hours in a day. Yet Donald T

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

rump builds skyscrapers while another person with the same amount of time can barely survive. What’s the difference?

When a pe

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

son decides to earn more wealth, the first thought that often enters their mind is a job. It can be a higher paying job, a diff

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

Following aspects would a

erent career, getting paid more in a job they’re currently making. Work more hours, work overtime, work longer or wait for a ra

dd to the challenges in developing combination products:

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

se… This thinking usually leads to an early grave. Everyone has the same 24 hours in a day, meaning that the efforts of one per

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

son can only go so far. No matter how hard you work, the 24 hours puts a capstone on the amount of results a single person’s ef

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

orts yield.

Do you think Robert Kiyosaki or Donald Trump are rewarded on solely their efforts and theirs alone? No! They leve

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

rage their time and money. They own businesses with employees whose efforts contribute to the growth of its respective owners.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Call them employees, advisors, bankers. There are countless people who provide each other service and together create more. Cr

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

eate more than the sum of their individual parts.

That is why 95% out of the wealthy 3% of the population own businesses. Thes

.

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

businesses in turn provide leverage creating more wealth even when the owners of the business are sleeping, 24 hours a day, 7 d

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

Companies that provide selfless information through particip

ays a week. When a person begins to think in terms of leverage, a whole new world of freedom, and opportunity becomes available

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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