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Introduction

Very often people are curious as to whether there is a certain methodology that successful inventors are following that can be adopted by others. In my opinion, one s

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

hould look no further then Thomas Edison, one of the greatest minds of the Nineteenth and Twentieth centuries; inventor who gave the world a long-lasting light bulb and phonograph

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

Examples of combination products may in

just a few inventions that revolutionized and modernized our world. In fact, Edison patented 1,093 Inventions in US alone, not counting numerous patents obtained in European count

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

ies like Germany, France and England.

Edison And His Methodology

So, what methodology did Thomas Edison follow when he worked on his numerous ideas? Many researchers and bibliogr

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

phers who studied Edison’s life claim that the famed inventor didn’t use systematic approach while working on his ideas; in fact, many claim that Edison favored the so-called rando

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

Combination pro

approach. In my opinion, above mentioned claims are misleading and should be taken with big grain of salt.

Thomas Edison never rushed into conclusions and methodically studied an

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

available literature on the topic he was working. Edison once wrote the following –

“When I want to discover something, I begin by reading up everything that has been done along

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

hat line in the past - that's what all these books in the library are for. I see what has been accomplished at great labor and expense in the past. I gather data of many thousands

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

f experiments as a starting point, and then I make thousands more.”

Respect the Work of Others

One can clearly see that Thomas Edison had the uttermost respect for the researcher

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

who worked before him, either successfully or unsuccessfully. Famed inventor realized early on that his success heavily relied upon work done by others - Edison carefully analyzed

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

facts produced by others, noted their mistakes and learned to avoid these mistakes in the future.

Regarding Trial And Error Approach

Edison did use trial and error (or random) me

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

Following aspects would a

thod, but in a different context. Once Edison formulated and documented his ideas, inventor used trial and error approach in determining the best materials that should be used in h

dd to the challenges in developing combination products:

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

s inventions. In those days, only rudimental research was done on physical and chemical properties of most materials, including gases and metals. Edison had to rely on his own test

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

and observations in order to produce a list of materials that were strong enough to be used in his inventions.

Summary

Edison left us with the idea to not just accept what we ha

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

e, but with desire and hunger to reach newer heights. Famed inventor lived extraordinary life and managed to make our life better by improving on things that no one thought can be

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

mproved. The traits and abilities mentioned below are associated with Edison that helped him to achieve his dream of making our world a better place to live:

- Quickly grasp idea

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

Professional from academic institutions, pharmaceutical industries, health care indust

r concept
- Sketch original design and easily draw a diagram of his idea
- See the big picture and not allowing anything to stand on his way to success
- Appreciate

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

work done by others and learn from their mistakes

- Pause and quickly re-analyze his ideas, once critical facts came into light

- Test Inventions under most extreme con

.

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

itions in order to be sure that they will continue to operate properly
- To Conceiving an idea and work towards achieving it

If you are interesting in reading more, please vi

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

Companies that provide selfless information through particip

it IdeaJets website that is dedicated in bringing quality information to the inventors all over the globe

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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