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Brainstorming: When you and your group or improvement team wish to generate as many ideas as possible in as short a time as possible.

It’s Powerful
It’s Quick

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

It’s Fun
It’s Misused

However simple we think this tool is, if we do not set the groundrules, or fail to follow them, we will be very disappointed with the outcom

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

Examples of combination products may in

. Some team members may even be fearful to contribute fully – giving safe, guarded inputs.

This is NOT what Brainstorming is all about!

Before a project or improvement team can make

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

ecisions, it's important to examine as many options as possible. Brainstorming is one of the easiest, creative ways to generate a list of ideas through getting EVERY team member involve

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

.

Let's have a look at the structure and the process...

Your Team

Arrange the meeting for your improvement group or team - between 4 and 8 people is a good size. Please ensure the

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

Combination pro

group is like-minded, with a sense of purpose and a belief that their contribution is valued.

Establish The Groundrules / Getting Started

Session Groundrules

If people hav

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

agreed to participate, respect that

Censorship of ideas is not allowed

Never criticize ideas

Suspend judgement

Do not disrupt the flow by questioning /

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

interrupting

All ideas are valid, no matter how radical, wierd

Listen, piggy back on ideas from others

Create a free thinking, creative environment

You have

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

just read through the generally accepted groundrules for conducting an effective Brainstorming session. Take these on board, discuss them with your selected team, make sure everyone understan

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

s why they are vitally important, and seek full agreement before moving forward.

Set a time limit of say 15 minutes with the goal of getting lots and lots of ideas.

Agree the roles of

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

scribe and facilitator (they can be the same person). It is the key role of the facilitator to enforce the groundrules and keep the flow going.

Write the initial topic on a flipchart,

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

Following aspects would a

hiteboard, overhead as long as everyone can see it. The better defined, and more clearly stated the problem, the more likely that everyone will agree on the issue or statement being brainstorm

dd to the challenges in developing combination products:

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

d.

Structured Brainstorming

With this approach, every person in the team gives an idea as their turn comes up in rotation or pass until their next turn (we can often get fresh ideas b

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

sed on the inputs of our team members). This approach is useful in ‘encouraging’ the more reluctant people to participate but may create a certain amount of pressure.

Unstructured Brains

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

orming

Simply, team members give ideas as they come to mind. This method may be seen as more fun and more relaxed. It risks being taken over by the more dominant team members - facili

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

ators need to monitor this.

Ending the Session

Conclude the session. Thank everyone. Clarify any points and get a consensus on which ideas should be taken further, what the actions an

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

Professional from academic institutions, pharmaceutical industries, health care indust

timescales are. Make sure people know that ALL ideas will be kept and the team leaves the session with the sense that "something has been achieved".

NOTES

One variation is to have e

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

eryone write down their ideas, then go round the team and have each member say one of their ideas. Continue this until everyone's list is complete. With sound knowledge of the team and its dyn

.

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

mics, the team leader may prefer one method to the other.

Consensus is not a unanimous vote - consensus is finding a proposal or outcome acceptable enough that ALL members will support - NO

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

Companies that provide selfless information through particip

member opposes it.

Brainstorming is one of the all time greats in problem solving / decision making. However, it needs two very important attributes - creative thinking and open-mindedness

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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