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Creativity can be defined as problem identification and idea generation whilst innovation can be defined as ide

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

a selection, development and commercialisation.

There are distinct processes that enhance problem identificati

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

Examples of combination products may in

on and idea generation and, similarly, distinct processes that enhance idea selection, development and commerci

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

alisation. Whilst there is no sure fire route to commercial success, these processes improve the probability th

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

t good ideas will be generated and selected and that investment in developing and commercialising those ideas w

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

Combination pro

ill not be wasted.

However, all too often the concept of innovation is intricately linked with radical change.

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

In fact, the opposite is true:

a) Most successful innovations take advantage of existing technology, are mode

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

ately new to market (not radically new), support existing behaviours, support customer needs and save money.

b

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

) Radical innovation is the result of incremental change. Small changes can have radical effects and when consi

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

dered over time, cause radical shifts. An example of this is looking at an old photo – very minute changes make

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

big differences over long periods. An examination of any artists work will show incremental changes for periods

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

Following aspects would a

before new knowledge or other inputs lead to radical shifts, which are then experimented with incrementally fo

dd to the challenges in developing combination products:

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

r periods.

c) Radical innovations are actually the result of invisible periods of incremental change and previ

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

ous periods of radical change. The Internet resulted from the connectivity of the PC, which developed out of th

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

mainframe, which owes its existence to the solid state transistor, which evolved from the earliest cathode ray

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

tubes and so forth.

These topics are covered in depth in the MBA dissertation on Managing Creativity & Innova

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

Professional from academic institutions, pharmaceutical industries, health care indust

tion, which can be purchased (along with a Creativity and Innovation DIY Audit, Good Idea Generator Software an

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

Power Point Presentation) from http://www.managing-creativity.com.

You can also receive a regular, free newsl

.

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

etter by entering your email address at this site.

Kal Bishop, MBA

**********************************

You ar

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

Companies that provide selfless information through particip

e free to reproduce this article as long as no changes are made and the author's name and site URL are retained

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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Thirty years ago data entry job was handled very differently from the way we do things today. From keypunch, key to disk and now one thing has not changed that is data entry remain key to success, only the tools and the workload have changed. Data entry job today is just as essential as it was 30 years ago. As business depends more on enterprise, Resource planning, customer relationship management and other enterprise applications. More and more of the information needed to run a business must be online.

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