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Creativity can be defined as problem identification and idea generation whilst innovation can be defined as idea selection, development

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

and commercialisation.

There are other useful definitions in this field, for example, creativity can be defined as consisting of a numb

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

Examples of combination products may in

r of ideas, a number of diverse ideas and a number of novel ideas.

There are distinct processes that enhance problem identification and

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

idea generation and, similarly, distinct processes that enhance idea selection, development and commercialisation. Whilst there is no s

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

re fire route to commercial success, these processes improve the probability that good ideas will be generated and selected and that inv

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

Combination pro

estment in developing and commercialising those ideas will not be wasted.

Six Crucial Steps

a) Immediate action. All existing

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

products are on the road to maturation, competitors are hungry, you have to keep moving just to maintain market share, technological cha

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

nge is not getting any slower; you need to have at least the processes for adaptation in place.

b) Better value from data – rigorous an

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

lysis helps identify the right problem. Time on problem identification should at least match time on idea generation.

c) Idea generatio

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

n requires a large number of people, a large number of diverse people and a large number of novel people. A large number of competencies

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

a large cross section of stakeholders and good leaders who know how to maximise creative output. All the elements of people productivit

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

Following aspects would a

y apply.

d) Idea selection requires a large cross section of stakeholders. The Economist (2003b) states that 3000 bright ideas are need

dd to the challenges in developing combination products:

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

d for 100 worthwhile projects, which in turn will be winnowed down to four development programmes for new products. And four such develo

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

pment programmes are the minimum needed to stand any chance of getting one winner. Requires good due diligence.

e) Good ideas have stil

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

to be reduced to the only the great ideas – refine the processes of development: stage gates, experimentation, tinkering, prototyping,

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

designing and redesigning. Requires good due diligence.

f) Commercialisation – requires a large section of stakeholders to be involved.

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

Professional from academic institutions, pharmaceutical industries, health care indust

These and other topics are covered in depth in the MBA dissertation on Managing Creativity & Innovation, which can be purchased (along

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

with a Creativity and Innovation DIY Audit, Good Idea Generator Software and Power Point Presentation) from http://www.managing-creativi

.

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

y.com/

You can also receive a regular, free newsletter by entering your email address at this site.

Kal Bishop, MBA

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

Companies that provide selfless information through particip

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You are 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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Shrink wrap can help protect and organize a gift fruit basket, but if your gift is a boat and not a fruit basket, do not fear. Boats can be shrink wrapped too, using the same technology.

After completing their translation training programmes at higher professional education or university level, many students can’t wait to set up as a freelance translator.

With the shortage of school funding these days it is necessary to come up with creative ways of raising money for programs that have been cut due to lack of funds. Just because a program does not have funds doesn't mean...

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