Advice You - Business

Brainstorming is one of the oldest of the modern creative thinking techniques. Originally developed in 1941 by Alex F Osborn, it was first called "thinking up". Later Alex Osborn coin

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

ed the term "Brainstorming". Brainstorming is primarily a technique of using ideas from a group of people to provide ongoing stimulation to that group in order to create more ideas. T

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

Examples of combination products may in

ese ideas are then combined or developed into a practical answer to a challenge that was presented to the group at the beginning of the brainstorming session.

One of the key concepts o

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

brainstorming is that no criticism is allowed during the session. In fact, wild and unusual ideas are encouraged, in part because some of these odd sounding ideas become useful ideas

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

nd partially because these kinds of ideas can inspire other members of the group to come up with good ideas. Sometimes all a strange idea needs is some polishing. Part of the brainsto

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

Combination pro

rming concept is to build on other people's ideas.

Often these brainstorming groups are an assembly of people with different backgrounds. These different backgrounds can enable the in

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

roduction of perspectives that might not usually be brought to bear in solving a particular problem. This can stimulate new ideas and can also allow the group to move beyond familiar r

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

adblocks.

Some studies have suggested that brainstorming is little better than any normal meeting. These studies point to productivity as a measure of effectiveness. Some of these st

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

dies have even suggested that an individual working alone can be more productive than a brainstorming group.

It is true that an individual brainstorming alone can produce more ideas th

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

an a group, but the ideas are less well developed than they would be in a group environment. This is probably because the experience and knowledge of a diverse assembly would be used t

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

build on ideas in the group setting. An individual alone would not have access to this expertise.

Advocates of brainstorming would argue that part of the problem with these studies t

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

Following aspects would a

at downplay the effectiveness of brainstorming, is that these groups being studied are not applying brainstorming principles properly. One key concept is that the initial challenge pre

dd to the challenges in developing combination products:

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

ented to the group must be very precisely and accurately worded. A poorly worded challenge can lead the group in all kinds of unproductive directions.

Another important key concept is

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

that authority figures that are directly above the participants in the work environment cannot be present at the brainstorming sessions. The presence of bosses tends to inhibit any of

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

the unusual ideas that can really get a brainstorming session going. This absence of other egos to contend with probably explains why individuals can produce more ideas when brainstorm

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

ng alone.

An important component of brainstorming is the use of a facilitator. The facilitator presents the initial challenge to the group. The facilitator may also be the one who re

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

Professional from academic institutions, pharmaceutical industries, health care indust

ords all the ideas. One of the important concepts of brainstorming is to aim at quantity of ideas. The quality of ideas can be sorted out later.

The facilitator will also try to get

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

the group going again as it slows down. This is usually accomplished with a series of previously prepared questions. The facilitator might present ideas for further development at the

.

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

e points where the group slows it's pace.

Brainstorming is a useful creative thinking technique. Many innovations and new ideas have been developed as a result of brainstorming. If a

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

Companies that provide selfless information through particip

individual or a group is looking for a way to develop new ideas, brainstorming is certainly worth a try. Just remember to apply the technique properly in order to get the best results

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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