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The ability to solve complicated problems quickly is more important than ever in today’s competitive world.

From

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

the time we’re little kids, we’re taught to solve problems by trial and error. That’s fine if the problem is as

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

Examples of combination products may in

simple as a burned out light bulb. When the problem is a muddle of business, technical and political problems, 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.

need something that helps us untangle the mess. Unless you’re Harry Potter, treating a mess like a burned out lig

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

ht bulb is as effective as wishing for magic.

Fortunately, there are alternatives to magic. Many key concepts in

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

Combination pro

problem solving seem obvious but are often overlooked, causing delays and frustration in getting important probl

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

ms solved. Here are some tips and reminders that will help you solve messy problems quickly and easily.

** De

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

fine the problem first. Explain what the problem is—what went wrong, what are the symptoms, what is the impac

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

t on your business. Write it down. Everyone who reads it should understand what the problem is and why it’s impor

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

ant. Caution: describe the problem, not what you will do to fix it.

** Use your time for problems that are tr

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

uly important. Just because a problem is there doesn’t mean you have to solve it. If you ask, “what will happ

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

Following aspects would a

en if I don’t solve this problem?” and the answer is, “not much,” then turn your attention to something more impo

dd to the challenges in developing combination products:

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

tant.

** Test your assumptions about everything. Check the facts first. Be sure that you and your team un

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

derstand the problem the same way, and that you have data to confirm that the problem is important. Test the assu

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

mptions about proposed solutions to improve the chances your solution will actually solve the problem.

** Mea

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

ure. The key question to answer is, “How will you know when the problem is solved?” If you don’t measure, you

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

Professional from academic institutions, pharmaceutical industries, health care indust

won’t know for sure. Use measurements to learn and portray the truth—the real truth, not what you wish were true

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

.

** Measure the right things. A common measurement trap is to measure something because it’s “interestin

.

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

.” If knowing a measurement won’t change anything (e.g., help you make a decision, verify an assumption or prove

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

Companies that provide selfless information through particip

the problem is solved), then don’t waste your time measuring it.

Cpyright 2005 Jeanne Sawyer All Rights Reserve

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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Delaware corporations are corporations that have their charter in the state of Delaware. Delaware has long been known to be a corporate-friendly state, and its long tradition of successfully applying corporate law allows it to score over rival states even though other states too are sometimes as corporate-friendly as Delaware, if not more. It is also widely acknowledged that the Delaware General Corporation Law is the nation’s most flexible and developed corporation act. Together with this, the fact that these acts and corporate laws are periodically revised and updated makes it easier for companies to do business in Delaware. The business-like attitude and customer-friendliness that characterize the government offices that handle corporations in Delaware are additional factors that influence corporations when they decide on Delaware as the location of their businesses.

Mike Litman Discusses Success Secrets from Jim Clark. Jim Clark is the founder of Netscape Communications Corp., Healtheon/Web MD Corp., and Silicon Graphics, Inc. Currently he serves as Chairman of the Board for myCFO, which he also founded.

Perhaps you have wondered why anyone would hold a meeting that wastes everyone’s time and produces nothing. There are easy answers to this question, such as 1) they don’t know that their meetings cou...

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