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

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

development and commercialisation.

There are other useful definitions in this field, for example, creativity can be defin

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

Examples of combination products may in

ed as consisting of a number of ideas, a number of diverse ideas and a number of novel ideas.

There are distinct processes

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

that enhance problem identification and idea generation and, similarly, distinct processes that enhance idea selection, de

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

elopment and commercialisation. Whilst there is no sure fire route to commercial success, these processes improve the proba

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

Combination pro

bility that good ideas will be generated and selected and that investment in developing and commercialising those ideas wil

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

l not be wasted.

Hierarchies

Many consultants will argue that the best organisational structure to foster creati

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

vity and innovation is a flat one. This is tending towards the truth but is not absolutely accurate.

Reality tells us that

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

there are many reasons why an organisation's structure has its shape (logistics, organic growth, history, size, market shar

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

e, future strategy) and is, like organisational culture, not easily changed or restructured. Often, there are valid reasons

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

not to make structural adjustments at all.

Thus leaders require, not recommendations for complete restructure, but knowle

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

Following aspects would a

dge of fostering properties that can be easily adapted into the existing structure. This fits with research that indicates

dd to the challenges in developing combination products:

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

hat people who generate ideas on a regular basis find structure to be unimportant as long as some criteria are met. These i

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

nclude:

a) Direct access to decision makers – provides fast feedback and immediate go or kill decisions.

b) Short lines o

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

f communication – if communication gets filtered there is a loss of momentum and corresponding loss of control.

c) Tangibl

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

e progression – if ideas are not picked up at all, motivation suffers.

These and other topics are covered in depth in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

BA dissertation on Managing Creativity & Innovation, which can be purchased (along with a Creativity and Innovation DIY Aud

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

it, Good Idea Generator Software and Power Point Presentation) from http://www.managing-creativity.com/

You can also recei

.

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

ve 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

****

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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