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Our team has a regular weekly brainstorming session, and some truly great ideas come out of this telephone get-toge

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

ther. And a big reason these brainstorming sessions work so well is, everybody understands the ground rule. New gro

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

Examples of combination products may in

up members are quickly advised.

But when you set up brainstorming get-togethers with groups who are new to the pro

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

ess, here is what happens: somebody comes up with a cockamamie idea, and somebody else says, "OK. That won't work b

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

ecause ..."

Nothing kills the thought process faster than having your idea shot down in front of a group of your p

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

Combination pro

ers. The idea-provider has learned an important lesson: it's dangerous to talk. Not only that ... everybody else on

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

the line has learned the same lesson.

Result? A very brain-less brainstorming session.

So the MLM Team Brains

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

orming Rule is: NO Devil's Advocates allowed!

Brainstorming is a time for ideas, ANY ideas, no matter how craz

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

y, outlandish, impossible, etc., etc., etc. All these fertile minds must be free and encouraged to go in any crazy

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

irection they want. And they must know there will be absolutely NO "idea criticism" tolerated. When they really get

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

that feeling, the joint starts rockin'. Ideas flow like lava from a volcano, and they get farther and farther "out

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

Following aspects would a

there."

That's OK. That's great. Some of the weirdest ideas touch off a response in another of your network marke

dd to the challenges in developing combination products:

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

ing team member's mind, and all of a sudden, you have a very exciting, workable possibility.

But as soon as someon

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

e says, "Yeah, but ...", the moderator must STOMP on the thought of anybody playing Devil's Advocate in a brainstor

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

ing session, or you will have a very boring, mostly silent phone call. You don't want to stomp on the person, but y

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

ou must obliterate the criticism.

This moderator role is absolutely crucial to the success of the call.

E

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

Professional from academic institutions, pharmaceutical industries, health care indust

plain your reasoning exactly ... that the threat of criticism will cause people not to participate, and you'll all

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

be wasting your time. Make sure everyone on the call is crystal clear on your "No Devil's Advocates" policy.

Later

.

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

on, after all the ideas have been transcribed, THAT is the time to focus in on the best ones and go after them in m

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

Companies that provide selfless information through particip

ore detail. And even ridiculous ideas sometimes have a kernel of something worthwhile in them, that you can harness

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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My father told me never to discuss politics when conducting business. I've followed his advice for decades -- but will dip my toes in just a little bit. President Bush was recently embarrassed when his nominee for the Supreme Court, Harriet Miers, withdrew her nomination. Why did it happen -- and where did the administration go wrong?

Each day there are multiple individuals who think about developing their own small business. A small business can include selling merchandise or offering personal services. With a goal and a great business plan it is possible to develop a small business, but due to financial reasons may business owners make the decision to work from home. Owing and operating a small business from home has its advantages, but there are disadvantages as well.

A little while back, a friend of mine asked me how to sell to his e-newsletter list without coming off as being pushy, obnoxious and caring only about extracting as much cash as possible from his customers. I don't blame him for being concerned, either. If you talk to enough people, you'll discover people are unsubscribing left and right from e-newsletters and lists who do nothing but sell, sell, sell. But here's the thing...

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