Main Subject - Business

In the business world, people often hear the term "Think outside the box", with little or no explanation as to how to actually do that. Everyone is just expected to know how

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

, figure it out, or find another job. Brainstorming sessions often lead to a slew of ideas from a group, but with little or no structure, it's difficult to tell what ideas a

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

Examples of combination products may in

re worth pursuing and which are wasting space.

There is a brainstorming strategy that, when used with a couple of other follow-up methods, will allow for creative thoughts t

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

o come from the group and still home in on the ideas that will actually benefit the overall goal. The three steps of the strategy are mind maps, t-analysis and action plan c

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

reation. Let's look at the first step, mind maps.

This step does a couple of things for a group brainstorm: it acts as an ice breaker, it gets people's brains pointing in t

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

Combination pro

he right direction and it can produce ideas that might not otherwise surface during just a normal call and response brainstorm session. Break your group up into smaller grou

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

ps of at most 4 or 5. With each group should be a large sheet of paper (lecture board paper will do fine) and several different colored markers. The groups should be instru

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

cted to write the focus of your brainstorm in the middle of the paper and draw a circle around it. So if you were interested in brainstorming new ways to market a particular

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

product, you'd write the product name in the middle of the paper. If you wanted to brainstorm on ways to control costs, you'd write Costs in the middle of the paper.

Once

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

this is done, instruct the groups to draw lines branching out from the center and to write down anything that relates to the central thought. Remind them several times durin

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

g the exercise that it doesn't matter how relevant or not it is, simply write down what comes to mind. As groups write down different items, they should circle those and bra

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

Following aspects would a

nch off these sub-topics as well. What ends up happening is groups will get a large network of ideas branching off the central thought, some of which may interconnect as wel

dd to the challenges in developing combination products:

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

l (and if they do, instruct the groups to draw a line connecting the two sub-topics). While the initial sub-topics will be things that are likely already being done or are a

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

n obvious connection, the branches off the sub-topics are where the true ideas start to emerge and some new thoughts are likely to present themselves here.

Once the groups h

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

ave completed their mind maps, open up discussion and have each group step through their mind map. Highlight new ideas and encourage discussion on items that may initially s

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

eem unrelated, to be sure there isn't a potentially great idea hidden in there. Also highlight common sub-topics listed between groups, as this indicates things that are eit

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

Professional from academic institutions, pharmaceutical industries, health care indust

her already in place, or things the group thinks should be in place. Discuss the effectiveness of these items and what will ultimately happen is a list of actionable items w

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

ill begin to surface through discussion. Between the mind maps, the discussion and the list, your group will have their minds actively engaged in coming up with action steps

.

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

to put some of the new ideas into place. Once this is done, your next step will be to conduct a T-analysis on the topics.

So to lead a powerful brainstorm session, it's im

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

Companies that provide selfless information through particip

portant to have a game plan in place. Mind maps help focus the group in the right direction and enable discussions that will help everyone as a group "think outside the box"

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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