Advice You - Business

Ever since human civilization came into existence, there have been innumerable inventions. Th

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

e wheel is one of the most important inventions that changed the fate of human civilization.

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

Examples of combination products may in

Ironically, we still do not know the name of the person or group of persons who invented it.

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

In earlier days, many inventions were the result of a process of evolution of ideas. As stand

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

ardization of scientific methodologies started taking shape, many inventions and inventors em

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

Combination pro

rged.

One of the most influential inventors in human history has been Thomas Alva Edison (18

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

47-1931). There are more than 1,000 patents in his name, a rare feat to be achieved by an ind

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

ividual. His genius also helped the commercial use of his inventions. His contribution in thi

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

context is invaluable, as he is credited with initiating mass production of innovative produ

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

cts.

Edison was from a poor family. So were many other inventors. It is the streak to do som

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

thing different, to create something new, that differentiates an inventor from an ordinary hu

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

Following aspects would a

man being. It is still debatable that whether inventors are born geniuses, or if people of av

dd to the challenges in developing combination products:

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

erage IQ be trained to become inventors.

Past experience has shown that it is not necessary

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

o be a trained scientist or an expert to be an inventor. The two basic elements that go into

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

the making of an inventor are an inquisitive nature and logical thinking.

Until the early ye

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

rs of the 20th century, inventors didn’t earn much money from their inventions. They often in

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

Professional from academic institutions, pharmaceutical industries, health care indust

vented useful things and died unsung heroes. But today, with increasing focus on new inventio

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

ns and the inclination of industry to customize them for commercial purposes, many inventors

.

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

ave turned from paupers to billionaires. New patent laws all over the world have ensured that

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

Companies that provide selfless information through particip

an inventor's future generation could continue to reap the benefits in the form of royalties

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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