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We tend to put brainstorming in a box and assume that it is a no-holds barred, free form meeting with no structure or focus. But quite the opposite is the c

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

ase. In fact there are lots of things that can derail a brainstorming meeting and put the meeting into a permanent tailspin.

Perhaps the most important don

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

Examples of combination products may in

t for brainstorming is don't be critical or judgmental of ideas presented during brainstorming. Successful brainstorming generates massive quantities of div

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

rse and sometimes fantastical ideas. Fantastical ideas are good during brainstorming, not bad. You want a high quantity of ideas during brainstorming, not

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

uality. There will be plenty of time later to dissect and analyze.

Do make sure you have a clear purpose for the meeting and stick too it while brainstormi

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

Combination pro

ng. Tangents and off beat thoughts are great during brainstorming but your purpose should not be to solve all the problems of the universe before the meetin

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

ends. Sometimes a brainstorming facilitator has the almost impossible task of stimulating creativity and, at the same time, making sure ideas are relevant

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

o the task at hand.

Do make sure you plan for the meeting in advance. You need a skilled facilitator to run the meeting who can stimulate and maintain a fr

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

e flow of ideas. This is a lot more difficult than it sounds. Far too often, brainstorming facilitators put their stamp on a meeting and stifle creative id

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

eas even before the meeting gets going. You also need someone who can write very fast so that all the ideas get recorded. The last thing you need is for th

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

meeting to come to a complete stop while someone slowly writes down what was said. You may need a chalkboard or paper to record the ideas so that everyone

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

Following aspects would a

as a clear view of what has been said.

Do make sure you build off other people's ideas. Sometimes we think too divergently during brainstorming. But just

dd to the challenges in developing combination products:

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

s often, 3 or 4 ideas can come together and trigger a bigger or better idea. The key word is "build". Brainstorming isn't all about divergent tangents.

Do

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

n't “rear view mirror” too much during brainstorming. Looking back at the mistakes of the past and what should have been done, will almost always put people

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

on the defensive. Once the blame game starts in a meeting, it is almost impossible for a facilitator to reestablish creativity.

Do make sure that everyone

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

s comfortable and is allowed to contribute freely to the meeting. A brainstorming meeting is a social event with all that goes along with that. There will

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

Professional from academic institutions, pharmaceutical industries, health care indust

e dominant and passive personalities, egos and maybe even power plays. Sometimes only one or 2 people contribute and everyone else sits back and listens. Y

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

ou don't want that to happen. For this reason, it is generally a good idea to have someone other than the boss facilitate a brainstorming meeting.

Don't be

.

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

afraid going into a brainstorming meeting. Fear is the great killer of creativity. If other people have better ideas than yours, there is nothing wrong wit

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

Companies that provide selfless information through particip

that. Don't be afraid that you will have to change. You and the organization may have to outgrow old structures or ideas in order to solve modern problems

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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