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Ever lost for ideas while working in a group? One of the most often-used technique for generating many ideas is Brainstorming. Alex Osborn, a partner in an advertising agency, developed brainstorming techniques years ago in 1941 to help his employees to come up with many, many ideas for

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

their advertising business.

To enable Brainstorming to be effective, there are certain rules to follow. One of the most important is that no one should make any judgment about anyone’s ideas. There should be a FREE-FLOW of ideas (that’s why Brainstorm is put under the WATER Element ca

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

Examples of combination products may in

egory!) and everyone’s ideas are to be respected and taken into account.

Let’s go through the steps of setting up an effective Brainstorming session:

1. Get into small groups of less than six (it was found to be more effective) and select a leader and a recorder (they may be the same

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

erson).

2. The leader must explain the focus topic and goals of the Brainstorming session. In short, he/she must make sure that everyone is clear on the topic being explored.

3. The leader should spell out the rules of an effective Brainstorming session. These will include:

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

There are no WRONG ideas!

Everyone plays a part to contribute.

No laughing and poking fun at people’s ideas. No CRITICISM!

Do not discuss or argue about the ideas given.

The person in charge must record all ideas without any biasness.

4. It is also important

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

Combination pro

o set a realistic time limit. This is to prevent wastage of precious time and the group members tend to be more motivated to give their best, without delays.

5. Start the brainstorming.

6. Usually, anyone can contribute their ideas at any time, without any restrictions. But, there are

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

groups that use a small game to enhance the effectiveness of their Brainstorming sessions. This includes getting the leader to start the Brainstorming session by throwing a tennis ball to another member for his turn to give an idea. And in turn, he/she will pass the ball to another memb

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

r for his turn to give another idea.

Whatever it is, there are no real hard and fast rules about this. As long as ideas are continuously flowing from each member, the objective is met.

7. The recorder should write down all responses and enable the other members to see them. This help

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

lot in the brainstorming as sometimes, ideas of others can help spark more original ideas form the rest of the group.

8. Usually after the Brainstorming session, the group will need to go through the results and begin to evaluate the ideas given.

Certain questions to ponder upon incl

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

de:

Are there ideas that are similar?
Can some of the ideas and concepts be grouped together for clarity?
Are there ideas that are really impossible to use at this point of time (maybe due to lack of resources or other reasons)?

Putting Your Elements to Work

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

Here are some Brainstorming exercises for you and your group to practice:

1. Ideas to start a business with less than $100 in the bank.

2. Generate ideas to make an effective advertisement for a business.

3. To improve sales of a new product.

4. Generate ideas to get people to buy

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

Following aspects would a

what I am selling (for example, Health Products) instead of flowers for Valentine’s Day.

5. To find ways to get rid of excess products (for example, food, flowers and others) that will be rotting in a week’s time.

Just a note for Solo Warriors:

Brainstorming is usually done in a grou

dd to the challenges in developing combination products:

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

for obvious reasons. In any case, if you are ever caught alone with an IDEA FLOW blockage, you can still brainstorm alone by jotting down ideas on paper or laptop. The same rules apply and that is to jot ideas as they flow without considering whether they are good or bad. The evaluatio

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

of your responses can be done later after you feel that the flow of ideas is subsiding.

The Stone Soup Legend

There exists a tale, handed down from times long ago, of two travelers on a pilgrimage. Hungry and tired from a long day’s journey, they come to a small, impoverished, mediev

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

l village, where they decide to rest by the side of the road. One of the travelers builds a small fire, upon which he places a large pot, while the other, having drawn water from the town well, fills the pot and places into the vessel a simple stone. As the two men sit by the fire, brin

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

ing their "stone soup" to a boil, the local villagers become inquisitive of the curious antics of these strangers. Eventually, several townsfolk decide to investigate the matter and approach the two travelers to engage them in conversation.

Shortly thereafter, there is heard the sound

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

Professional from academic institutions, pharmaceutical industries, health care indust

f merriment, as the visitors, who turn out to be quite friendly, share their tales of the lands and people they have met throughout their journey and pilgrimage with the local villagers.

Finally, a young boy asks the travelers "But why, pray thee, are you boiling a stone?"

One of the

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

ilgrims replies, "So we may eat stone soup."

"It must be terribly bland!" says an old woman. "But I have a cabbage, which will add some flavor!"

"And I, some carrots, which will add color!" says another villager.

"Some potatoes!", offers another, until, shortly, by the contribution o

.

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

a little by many, a hearty stew was made, upon which the entire village and the weary pilgrims dined... and while doing so, shared their tales, talents, and camaraderie throughout the night.

The very next day, the travelers (who by now could be called "strangers" no more), continued t

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

Companies that provide selfless information through particip

eir journey, leaving the little town, and its people, behind. But the villagers never forgot them, and the lesson they had learned. In fact, during the hardest of times, in such a time as this tale, that little village thrived, because the townsfolk never forgot how to make "stone soup"

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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For much of the twentieth century, state-owned utilities in the UK were favoured over privately-owned suppliers. In the last 15 years the pendulum has swung the other way favouring privatisation and state regulatory structures for monopoly activities. The management of these utilities need to recognise that the current market dominance of their firm probably owes very little to competitive success and much more to the legal privileges that are now being removed. Once markets are liberalised the incumbent former monopolies are extremely vulnerable unless they can identify and develop the competencies necessary to thrive in regulated and increasingly competitive markets. They have an advantage. Their existing size and market penetration provides time to undertake the strategic reappraisal and to experiment with strategies. The incumbent should benefit from economies of scale and scope, learning curve advantages, control of strategic assets and customer switching costs. But in the longer term such advantages are unlikely to provide sufficient protection against the effects of competition and regulatory pressures. At that time, only one thing can help these firms sustain in their markets, the power of their corporate brand and corporate reputation.

Uncover crucial information to boost your job search campaign by implementing some of the strategies outlined in this article.

So much has been written on this subject; Team Work, it’s almost hard to add any thing at this point. T E A M; TOGETHER EVERYONE ACCOMPLISHES MORE. That is really easy to say and it makes for a great acronym. It seems it has even hit corporate America. They have integrated it into TQM “Total Quality Management”. They call it “team building”.

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