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Define the Problem First. It seems obvious, but how many times have we gone

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

to a problem-solving meeting and the discussion started with either whose fault wa

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

Examples of combination products may in

it or an assertion about the proper solution?

Explain what the problem is—what we

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

t wrong, what are the symptoms, what is the impact on your business and your custom

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

r’s business. These are the things that someone knows at this point in the problem

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

Combination pro

olving process. If the someone is not you, and you’re leading the problem-solving e

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

ffort, you need to do some research to find out. No guesses or assumptions allowed:

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

the problem description must give the facts clearly and accurately.

Write it down.

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

Writing the problem down forces you to describe it carefully, completely and unambi

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

uously. The statement is a valuable tool to help focus your team on the real proble

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

and avoid wasting time on extraneous issues. Everyone who reads it should understa

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

Following aspects would a

nd what the problem is and why it’s important. No jumping ahead, either: you don’t

dd to the challenges in developing combination products:

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

now yet what caused the problem much less what you will do to fix it.

The written

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

tatement can also be used as a “sales tool” to explain what problem you’re solving

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

nd why it’s important. Use it to make sure you have the support you’ll need from ma

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

agement, your customer and any other key players. This is especially important if t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he significance of the problem is not universally understood or accepted.

The prob

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

em is defined when everybody who reads your problem statement, including you, under

.

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

tands what will be different when the problem is solved and your team agrees that i

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

Companies that provide selfless information through particip

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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Package design is not decoration. Did you know that 80 percent of all purchasing decisions are made in-store? As traditional media is being revolutionized right before our eyes, your packaging will most likely be the first introduction a consumer has to your product and we all know how important first impressions are. Your package is a valuable asset that can make or break the sale of your item and should be considered as important as the item itself. There are 4 key attributes to ensure a successful package design.

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Workers compensation secrets are hidden deep with piles and piles of bureaucratic mumbo jumbo. They sometimes are used as high prices paper weights for over paid government workers who may or may not have been able to get a job in the free market society.

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