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Think about Apple computers, and one cannot but be baffled by its riches to rags to riches story. This company epitomizes what innovation and re

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

-invention is all about. At a quick glance, Apple seems to have adapted and learnt to fly with the winds of change. But there is more to this s

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

Examples of combination products may in

uccess than just adapting to change.

The Setting
In the early 2000's, the company was ignored by mainstream. For a long time, the

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

doomsday predictors seemed right. The company stock had hit the pits and any hope was found only in the devout, cult following they had for thei

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

r computer products, many of whom frequented the annual MacWorld show. A cult following is a great thing to have but not enough to have the w

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

Combination pro

ide appeal to have sustained growth.

This was right about the time that digital media was gaining ground in the "underground". Everything from

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

digital pictures, to music to video could now be stored on the computer. Digital still and video cameras were gradually starting to pick up in

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

sales and get a following - especially among the younger section of the population. Even the film manufacturers were skeptical about the new d

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

igital technology - they continued to reel out the film, with some sideways glance of apprehension at the small company around the corner that w

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

as busy producing storage cards for the new camera's.

Digital music was just taking off. This was a world of chaos in the start. Programmers who

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

owled out in front of their computers would crank out a nifty looking MP3 player literally overnight, or other pieces of software that would a

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

Following aspects would a

llow you to play your songs on your computer, or programs that could "RIP" (or convert) your CD collection into digital format. But what if you

dd to the challenges in developing combination products:

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

needed more music, stuff that was not already in your collection of CD's ? Well you could "borrow" that CD from your friend and convert it to

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

digital format for your enjoyment.

Borrowing - redefined
Companies emerged overnight that would make this "borrowing" process a lo

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

t easier, They produced programs which would allow you to "share" your digital music collection with your "friends". A "friend" could be someon

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

e sitting on the other side of the globe, who had the honest desire to "share" his/her music with other friends. So now we had technology that w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould allow, hitherto unacquainted people to upload their songs to a virtual "friend's" computer and similarly download their friend's songs i

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

nto theirs. Even the law of the land was relatively "toothless" to curb this illegal "sharing" at first.

This was the world of exciting,rapidly

.

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

changing technology. You had to be a geek to understand and use the technology. And you literally had to owl out in front of a computer to enjo

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

Companies that provide selfless information through particip

y the music or watch that digital video. But we still did not have the portability of a "Walkman" - where you could take your music with you.

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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