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Summary: Even with a wide variety of sources available, coming up with an idea as the basis for a new

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

venture can still be a difficult problem. The entrepreneur can use several methods to help generate

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

Examples of combination products may in

nd test new ideas including focus groups, brainstorming and problem inventory analysis.

The followin

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

are some of the key methods to help generate end test new ideas:

1. Focus Groups – these are the gr

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

ups of individuals providing information in a structural format. A moderator leads a group of people

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

Combination pro

through an open, in-depth discussion rather than simply asking questions to solicit participant respo

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

se. Such groups form comments in open-end in-depth discussions for a new product area that can result

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

in market success. In addition to generating new ideas, the focus group is an excellent source for in

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

tially screening ideas and concept.

2. Brainstorming – it is a group method for obtaining new ideas

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

and solutions. It is based on the fact that people can be stimulated to greater creativity by meeting

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

with others and participating in organized group experiences. The characteristics of this method are

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

Following aspects would a

eeping criticism away; free wheeling of idea, high quantity of ideas, combinations and improvements o

dd to the challenges in developing combination products:

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

ideas. Such type of session should be fun with no scope for domination and inhibition. Brainstorming

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

has a greater probability of success when the effort focuses on specific product or market area.

3.

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

Problem inventory analysis– it is a method for obtaining new ideas and solutions by focusing on probl

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

ms. This analysis uses individuals in a manner that is analogous to focus groups to generate new prod

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

Professional from academic institutions, pharmaceutical industries, health care indust

ct areas. However, instead of generating new ideas, the consumers are provided with list of problems

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

and then asked to have discussion over it and it ultimately results in an entirely new product idea.

.

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

The entrepreneur is not limited by only the three methods presented in this article. There are other

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

Companies that provide selfless information through particip

reative problem solving methods and techniques that are also available.

Copyright 2005 Stephen Pierc

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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