Advice Pool - Business

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

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

ea selection, development and commercialisation.

There are other useful definitions in this field, for exampl

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

Examples of combination products may in

, creativity can be defined as consisting of a number of ideas, a number of diverse ideas and a number of nove

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

ideas.

There are distinct processes that enhance problem identification and idea generation and, similarly,

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

istinct processes that enhance idea selection, development and commercialisation. Whilst there is no sure fire

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

Combination pro

route to commercial success, these processes improve the probability that good ideas will be generated and sel

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

cted and that investment in developing and commercialising those ideas will not be wasted.

Feasibility <

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

/b>

Task feasibility is also a part of the motivation equation.

If a task if feasible, then motivation incre

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

ses. And if a task is out of reach, then motivation decreases. This is encompassed in the philosophy of increm

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

ntal production and structure – large, complex and impossible tasks are split into smaller more manageable one

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

.

But the above goes against the philosophy of competency expansion – if a task is too easy, then challenge i

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

Following aspects would a

reduced and motivational effort is reduced. So making a task slightly out of reach optimises motivation.

The

dd to the challenges in developing combination products:

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

e have been situations where impossible tasks have created exceptional motivation (the Apollo 11 fiasco), but

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

here, arguably, only the technical challenge seemed out of reach. The possibility of the task was demonstrated

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

in that the problem was solved. The block was the illusion of difficulty and not the unfeasibility of the tas

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

itself.

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

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

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

tter by entering your email address at this site.

Kal Bishop, MBA

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You ar

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

Companies that provide selfless information through particip

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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Advice Pool - Creativity and Innovation Management - Feasibility

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