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Creativity can be defined as problem identification and idea generation whilst in

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

novation can be defined as idea selection, development and commercialisation.

Th

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

Examples of combination products may in

ere are other useful definitions in this field, for example, creativity can be de

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

fined as consisting of a number of ideas, a number of diverse ideas and a number

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

of novel ideas.

There are distinct processes that enhance problem identification

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

Combination pro

and idea generation and, similarly, distinct processes that enhance idea selecti

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

on, development and commercialisation. Whilst there is no sure fire route to comm

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

ercial success, these processes improve the probability that good ideas will be g

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

enerated and selected and that investment in developing and commercialising those

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

ideas will not be wasted.

Idea Progression

Beyond feedback, there is

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

dea implementation itself. If individuals do not see any of their ideas implement

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

Following aspects would a

ed, then the effects are:

* Decreased motivation

* Sense of futility

* Slow do

dd to the challenges in developing combination products:

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

wn of future problem solving processes

* Reduced trust

* An indication of ineff

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

icient work processes

These and other topics are covered in depth in the MBA dis

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

sertation on Managing Creativity & Innovation, which can be purchased (along with

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

a Creativity and Innovation DIY Audit, Good Idea Generator Software and Power Po

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

You can also receive

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

a regular, free newsletter by entering your email address at this site.

Kal Bish

.

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

op, MBA

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

You are free to reproduce this artic

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

Companies that provide selfless information through particip

le 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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