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

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

fined as idea selection, development and commercialisation.

There are other useful definitions in

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

Examples of combination products may in

this field, for example, creativity can be defined as consisting of a number of ideas, a number of

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

diverse ideas and a number of novel ideas.

There are distinct processes that enhance problem ident

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

ification and idea generation and, similarly, distinct processes that enhance idea selection, devel

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

Combination pro

pment and commercialisation. Whilst there is no sure fire route to commercial success, these proces

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

ses improve the probability that good ideas will be generated and selected and that investment in d

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

eveloping and commercialising those ideas will not be wasted.

Motivation and Management Layers

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

A rule of thumb is that idea generation and motivation are inversely proportional to the num

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

ber of layers between creator and decision maker. So if an individual has to push the idea past one

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

gatekeeper, then:

* The idea is diluted by half.

* The chance of a positive response reduced by h

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

Following aspects would a

alf.

* The time to valuable feedback is increased by two.

* Time to implementation doubles.

* Tr

dd to the challenges in developing combination products:

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

ust is reduced by half.

* All aspects, such as securing finance, become twice as difficult.

This

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

knowledge helps us to design organizational structures, for example – make sure the decision maker

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

is close to hand.

These and other topics are covered in depth in the MBA dissertation on Managing

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

reativity & Innovation, which can be purchased (along with an Innovation Management Bible, a Creati

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

Professional from academic institutions, pharmaceutical industries, health care indust

vity and Innovation DIY Audit, Good Idea Generator Software and Power Point Presentation) from http

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

://www.managing-creativity.com/

You can also receive a regular, free newsletter by entering your e

.

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

mail address at this site.

Kal Bishop, MBA

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

You are free to re

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

Companies that provide selfless information through particip

produce 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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Keeping a record of all your spending is also important for any new business. Keeping all your receipts and invoices in a ledger can help you keep a track of the money coming in and going out of your business account, as well as being able to notify you when money is owed to you.

Pt 3 in a series of articles discussing hot to make money online by working at home and following a simple 3 step process.

What kinds of people start businesses? Their skills are seldom different from those of people who succeed at working for others. The more successful entrepreneurs tend to be proactive, assertive, and highly observant.

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