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Choose solutions that are effective—and implement the solution completely. The solution phase i

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

s where everything gets tied together and you start to get results. This part of solving problems is s

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

Examples of combination products may in

traight-forward in concept but not necessarily easy to do. Choose a solution strategy that works, i.e.

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

, fixes the right problem and is practical for your situation. Then implement the strategy--completely

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

.

Because you’ve defined the problem carefully, identified the root causes and verified them, you kno

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

Combination pro

w what the problem is and why it occurs. You’ve also assessed the impact of each of the causes, so you

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

know which causes to focus on.

Solving the problem requires eliminating each of the root causes that

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

are important enough to bother with. Take each of them one at a time. Decide how you will eliminate t

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

hat cause and write down your action plan: the tasks that need to be done, who is responsible, when th

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

ey’re due and completion criteria that will tell you when each task is complete. Cross-check your acti

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

n plans to be sure:

• When the action plan for a particular cause is completed, the cau

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

Following aspects would a

se will be eliminated,
• When all your action plans are completed, you will achieve the success c

dd to the challenges in developing combination products:

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

riteria for the whole problem,
• Your contingency plans are sufficient to deal with any surprises

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

.

Double-check to be sure your solution plan really will eliminate the causes you’ve ide

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

ntified. This is a good time to apply the motto, Everything necessary, nothing extraneous.
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
b> Make sure each action plans includes everything necessary to eliminate the cause it is focused on.
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
Eliminate anything that doesn’t contribute to eliminating that cause.

Then execute the plan. Implemen
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ting the plans will take your best project management skills to keep everything on track. This is 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
time when you and your colleagues are most at risk of getting distracted by other projects. Don’t let
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
your action plan join the list of good intentions.

Copyright 2005. Jeanne Sawyer. All Rights Reserved

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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Digg It - Problem-Solving Success Tip: Choose Solutions that Work and Implement Them Completely

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