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Main Subject - Brainwriting, A More Perfect Brainstorm
Brainstorming is a very powerful method for generating lots of ideas very quickly about almost any problem or issue that needs an innovative or creative solution.
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
However, brainstorming is also a very fragile process. It is intended to be a very free flowing non-judgmental exchange and list generator that sparks everyone's
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
creative fires but at times that is very difficult to achieve in an organized public meeting.
There are lots of distractions in most meeting situations. What an
There are lots of distractions in most meeting situations. What an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
other person says more often than not funnels down everyone else's thinking rather than opening it up. There are almost always dominant and passive personalities
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n any given meeting situation. People who are normally afraid to speak in a meeting will often shut down completely during a brainstorming session. Only one pers
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
on at a time can effectively speak in a group meeting and unfortunately that blocks other people from talking. The bigger the group, the bigger the blocking probl
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
em. Of course there is always someone in the group who will do and say whatever it takes to please the boss. Once that person speaks up others will be hard press
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
ed to do anything but agree. We tend to think of groups as more effective than each individual but the power of social pressure and conformity is usually counter
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o the process of brainstorming. We may get a warm group feeling about the social exchange that goes on during a public brainstorming meeting but the reality is it
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
usually stifles creativity.
To help overcome these problems a better method of brainstorming was created called brainwriting. As the name implies, you write out
To help overcome these problems a better method of brainstorming was created called brainwriting. As the name implies, you write out
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
your ideas rather than speak them out. Extensive research and testing has shown that brainwriting generates 40 percent more creative ideas compared to traditiona
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
l brainstorming. That is a huge increase.
The way it works is before the meeting starts blank forms are made that have the problem definition written at the top
The way it works is before the meeting starts blank forms are made that have the problem definition written at the top
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
nd a table below for listing ideas. You need at least one sheet of this form for every person that attends the meeting. There are a lot of different ways to come
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
up with a form that makes sense for the problem you are dealing with but a common procedure is called brainwriting 6-3-5.
The 6-3-5 stands for 6 people, 3 ideas
The 6-3-5 stands for 6 people, 3 ideas
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
per person in 5 minutes. The table on the form is 3 columns wide with plenty of width for writing down the ideas. Number the columns idea 1, idea 2 and idea 3.
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
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
Make the table 6 rows down the page for the 6 different people. When the meeting starts you divide the people up into groups of 6. Each person takes a sheet and
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
akes 5 minutes to write out 3 ideas in the first row on the form to help solve the problem statement. Don't put your name on the sheet. Then you exchange your sh
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
eet with someone else. Either give your sheet to the person on your right or put the six sheets in a pile in the middle of the table and randomly take one from th
.
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
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 pile. Then take the next 5 minutes to add 3 more ideas to the next row on the new sheet. You can use the ideas that are already on the sheet to stimulate new i
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
deas or create new ideas of your own, whichever works best for you. After doing this for 30 minutes you will have a total of 108 ideas from each group of 6 people
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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