Main Subject - Business

"A group problem-solving technique that involves the spontaneous

contribution of ideas from all members of the gr

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

oup"

-- Merriam-Webster Dictionary

Brainstorming is one of many creative problem solving techniques. While you c

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

Examples of combination products may in

n use any size group, we believe it works best when done in a facilitated group of 5-10 people. The more diverse the gro

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

p the more diverse the input. The group members don't need to be experts in your field. In fact, they don't need to know

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

anything about the problem topic at all! The following steps I use in my Many Good Ideas Brainstorming Seminars:

Ste

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

Combination pro

1: Define Your Problem

You need to get really clear on what your problem truly is (and is not). Keep asking "why?"

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

until you feel that you've identified the root of your problem. For example, if your problem is "I need more money?" Ask

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

"Why? To do what? And then what?". Once you have the problem, state the brainstorming topic as:

"I would li

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

e to _________ but it's difficult because ________"

The more time you spend in defining your problem the b

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

tter the results will be.

Step 2: Uncover Solutions

Now is when the group starts contributing ideas. The group

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

hould some pre-agreed rules. Here are some:

I will listen to others' ideas.

I will not be attache

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

Following aspects would a

to my idea.

I will attempt to find the good in someone else's ideas.

I will give myself permissio

dd to the challenges in developing combination products:

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

to be wrong, insane, and stupid.

I will respect that the person with a problem is best judge as to quality o

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

the idea.

I will not tell someone else what to do, I will only offer suggestions.

Make sure you

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

have someone responsible for recording the meeting (that person should definitely not be the person who's presenting the

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

r problem).

Brainstorm for a set time. Initially, a lot of obvious ideas will be suggested. After this initial flurry,

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

Professional from academic institutions, pharmaceutical industries, health care indust

hings will quiet down. Be patient. Risk saying something that makes no sense to you. The better ideas usually arrive aft

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

r people have relaxed and listened to others.

Step 3: Evaluate Solutions

Here is where the solutions that were

.

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

uggested can be evaluated. What ideas are the most exciting? If any of the ideas seem incomplete, go back to step 1 and

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

Companies that provide selfless information through particip

e-brainstorm.

Remember that brainstorming can be an intensely intimate encounter. Thank everyone for their contribution

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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