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Main Subject - It's Time For Plan B - Brainstorming!
Our workgroup was in the middle of a spirited brainstorming session — a free form session where creativity is encouraged, judgment is suspended, and the best ideas often come after ten or more minutes. The ideas
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
were flying fast and furious, as they should, when the group gets momentum. The energy was intoxicating. And, in a fit of inspiration, I one employee suggested, "Why don't we reverse the order of the deliverabl
; 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
s!?"
While nine other people energetically accepted this offer as worthy of inclusion on their flip chart of ideas, their manager scowled "That will never work!"
Thus ended a productive bra
While nine other people energetically accepted this offer as worthy of inclusion on their flip chart of ideas, their manager scowled "That will never work!"
Thus ended a productive bra
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nstorming session. Sadly, the manager was unclear on the concept at play. She replaced a brainstorm with a brain fart and stunk up the entire process.
A Different Kind of Collaboration
A Different Kind of Collaboration
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Brainstorming is a special type of meeting, with its own ground rules, tempo and ethos. It's also an invaluable tool for idea generation, problem solving, innovation, teambuilding and creativity. Whether you a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e tasked with creating new sales contests, new strategic initiatives or simply trying to break the doldrums of your day-to-day routines, brainstorming carries the day.
Rules That Rock!
Rules That Rock!
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
By definition, brainstorming is unlike your typical meetings. Its unbounded by traditional rules where pre-determined people speak on pre-determined subjects for prescribed times. Like a jam session of Jazz mu
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
icians, all you need to do is begin recording and let the sounds begin. Remember, the key is to record it all. Later you can go back and edit out that which might not be considered beautiful music.
In
In
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Brainstorming sessions everyone is equal, all ideas are worthy of consideration, all judgment is suspended and a person's rank or status is irrelevant. The goal is to fill the air with ideas, depart from convent
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
onal thinking, and allow the smorgasbord of strategies, ideas, inspirations and epiphanies to cross-pollinate each other. Think of brainstorming meetings as magnificent melting pots, a veritable giant stew bowl
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
here bouillabaisse bubbles and bursts, unleashing new, exciting and innovative initiatives. Consider a skilled facilitator for best results, though this isn't a requirement.
The B-List: Preparing f
The B-List: Preparing f
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
or Your Meeting
The following recommendations will insure a successful session, whether it's a stand-alone brainstorm or part of a larger meeting or event:
- Adorn your environment with
The following recommendations will insure a successful session, whether it's a stand-alone brainstorm or part of a larger meeting or event:
- Adorn your environment with
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
art, toys, games, crayons, colored markers or other stimuli to get the juices flowing and invite fun, free thinking and playfulness.
- Consider special written invitations in advance to set the tone,
- Consider special written invitations in advance to set the tone,
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
xpectations and goals for the session
- Create a mental and/or physical ice breaker to loosen everyone up.
- Consider lava lamps, beanbag chairs and even bubble-gum and bubble makers to loo
- Create a mental and/or physical ice breaker to loosen everyone up.
- Consider lava lamps, beanbag chairs and even bubble-gum and bubble makers to loo
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
en everyone up.
- Encourage participation by all
- Language is key. Use sentences such as "What if we…?", "How about…", "Let's try…", or "Suppose we…"
- Check your skepticism, ne
- Encourage participation by all
- Language is key. Use sentences such as "What if we…?", "How about…", "Let's try…", or "Suppose we…"
- Check your skepticism, ne
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
ativity and ego at the door. It's not about whose ideas are embraced. All ideas should be received, for the benefit of the group your mission.
- Employ the "Yes, AND…" approach instead of a "Yes, BUT…
- Employ the "Yes, AND…" approach instead of a "Yes, BUT…
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
stance in response to others' ideas.
- Remind people to suspend judgment throughout the session
- Assign a scribe or tape record the meeting. Consider a graphic recorder. (Visit www.Graphi
- Remind people to suspend judgment throughout the session
- Assign a scribe or tape record the meeting. Consider a graphic recorder. (Visit www.Graphi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Recorders.com for one I recommend.)
- Allow enough time for people to loosen up. Often the best ideas occur once the group has gotten over any self-consciousness and gathered momentum
Remem
- Allow enough time for people to loosen up. Often the best ideas occur once the group has gotten over any self-consciousness and gathered momentum
Remem
.
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
er, like mastermind groups, brainstorming sessions rely on the reality that when multiple brainpower is applied the results are greater than the sum of their parts. You will generate great results from the blend
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
of talent, experience, ideas and perspectives that naturally result from giving everyone equal footing and freeing them of the usual restrictions of time, structure and rules.
By the way, what if…?
By the way, what if…?
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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