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When was the last time you spent excessive time and money solving a problem only to discover the problem you thought you had wasn't really the problem at all?

Recognizing the real problem is crucial to any problem-solving ve

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

nture. John Dewey said, "A problem is half solved if it is properly stated." Below are two simple tools that can help you figure out the real problem behind the problem. One tool, ask "Why" questions and a second tool, "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

ange the Action Verb."

Ask Why?

Simply ask the question, Why? A man bought a pair of tan suede leather shoes. About a week after he bought the shoes, he was in the grocery store reaching to a top shelf for a contain

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

r of cooking oil. Unfortunately, the screw-top of the oil bottle was loose and when tipped a big, fat drop of oil fell right on the suede of the man's shoes. There, smack in the middle of the tan suede was a dark circle of oi

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

about the size of a quarter. The man was beside himself because his new shoes were ruined. Before he tossed the pair, however, he would try to remove the stain. He tried dishwashing and dishwasher soap, bath soap, laundry d

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

Combination pro

etergent, baking soda as well as various blends. The stain would not budge. The question, "Why do you want the stain out?" was asked. Ah, suddenly there were new possibilities. The reality was that the stain itself was not

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

a problem. The fact that the shoes were not a consistent color was the problem. "How to make the shoes a consistent color" deserved attention. Quickly, there was an idea to put oil on the rest of the suede so the shoes woul

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

be one consistent color. Oil made especially for shoes was purchased and applied. It worked! The shoes were a little darker than previous but all one consistent color. The real problem was solved with minimal cost and min

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

mal effort. The suede shoes are a good example of how considering why a "problem" exists may lead to an underlying issue and, in turn, shine a new light on additional opportunities for solutions.

Change the verb

W

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

hen considering problem solutions try changing the action verb. Changing the verb may open the statement up to a broader interpretation, resulting in a greater array of solutions. For example, I woke one recent morning and f

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

und my way to the kitchen in search of my usual fried egg white omelet. Every morning of a good day I have a fried egg white omelet. I cracked the eggs, separated out the yolks, and put the whites in a pan. The pan went to

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

Following aspects would a

the gas stove top. I turned the knob but was bewildered by the fact that no fire started. Then I saw it, a gas truck was parked in the alley behind my house. I spoke to the driver who informed me that a city worker had pen

dd to the challenges in developing combination products:

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

trated the gas line while digging. It would be hours before the gas could be restored. What was I to do? My fried egg whites were in jeopardy; my "good" day was at stake. I quickly looked around the room to see what other

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

resources were available to fry my egg whites. I thought, "the coffee maker has a heating element." I could put the pan of egg whites on the coffee-maker. Unfortunately, the element did not get hot enough to fry the eggs.

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

I looked around again. I spied a popcorn popper. I could use the bottom of the popper, put the eggs directly on the element and the eggs might fry. Success! The eggs did fry, the consistency was a little unusual and they

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

did taste somewhat corny but they fried!

I was so excited about my creative problem solving skills. When my husband came home that evening I said, "Guess what I did today!" I eagerly told him of my fried egg dilemma and ho

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

Professional from academic institutions, pharmaceutical industries, health care indust

I tried the coffee maker and the popcorn popper and ultimately was able to eat my fried eggs. He looked at me with a confused expression. Finally he spoke, "Why didn't you just use the microwave?"

What happened to my grea

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

t plan? I was so focused on the idea of "frying" the eggs that I completely overlooked my real purpose which was to "heat" the eggs. If I had changed the action verb from "fry" to "heat" I would have immediately went to the

.

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

microwave.

Two simple tools, 1) Ask "Why" and 2) Change the Action Verb can save much time and effort when problem solving.

Maybe when on your next problem solving mission you should also wear suede shoes while eating an eg

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

Companies that provide selfless information through particip

white omelet….. can't hurt.

Copyright 2005. Toni McNutt. All rights reserved

This article may be freely distributed and reprinted as long as the author's information and web link are included at the bottom of the article

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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