Main Subject - Business

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

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

ned as idea selection, development and commercialisation.

There are other useful definitions in this

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

Examples of combination products may in

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

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

e ideas and a number of novel ideas.

There are distinct processes that enhance problem identificatio

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

n and idea generation and, similarly, distinct processes that enhance idea selection, development and

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

Combination pro

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

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

the probability that good ideas will be generated and selected and that investment in developing and

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

commercialising those ideas will not be wasted.

Time to market or time to success?

Even to

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

day Innovation Consultancies trumpet their ability to increase time to market as opposed to time to s

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

uccess:

a) It is always possible to increase time to market – one way is by not carrying out proper

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

ue diligence and thus increasing the likelihood of failure.

b) Whilst there is never enough time ava

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

Following aspects would a

ilable before pushing a product onto the market, there is always enough time to revisit what went wro

dd to the challenges in developing combination products:

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

ng and fix problems. The cost of reengineering runs into the billions.

c) Speed and cost are conside

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

rations but good decision-making should be priorities.

d) Quick time to market does not guarantee pr

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

ofit. A strategy of time to profit makes more business sense.

These and other topics are covered in

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

epth in the MBA dissertation on Managing Creativity & Innovation, which can be purchased (along with

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

Professional from academic institutions, pharmaceutical industries, health care indust

a Creativity and Innovation DIY Audit, Good Idea Generator Software and Power Point Presentation) fro

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

m http://www.managing-creativity.com/

You can also receive a regular, free newsletter by entering yo

.

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

ur email address at this site.

Kal Bishop, MBA

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

You are free to

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

Companies that provide selfless information through particip

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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