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Procrastination comes in many forms. One of those forms involves simply doing too much preparation before putting something into action. In working with businesses, sports teams, and

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

other groups, I have often used the quote, “Proper Preparation Prevents Poor Performance” – or – “Proper Preparation Promotes Positive Performance.” However, there is always a potent

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

Examples of combination products may in

ial problem of having too much of anything. Too much food can be bad for the figure. Too much walking or running can be bad for the knees. Too much preparation… well, you get the pi

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

cture. Country music artist Rita Coolidge said, “Often, the opportunity knocks, but by the time you push back the chain, push back the bolt, unhook the two locks, and shut off the bur

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

lar alarm, it’s too late.”

As I have stood on the sidelines at football games, I have heard coaches admonish their running backs, “Turn it up field!” And then when runners are tackle

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

Combination pro

d while running “east or west” rather than “north or south,” the coaches get upset, call the runners over to the sidelines and tell them, “You’ve got to make a decision! You can’t run

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

around in the backfield all night!” Or, they may say, “Quit running from sideline to sideline and turn it up!”

As mentioned in a previous column, I presented my A Strategy For Winni

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

g keynote address at the Department of Homeland Security’s National Conference for Border Patrol Chiefs in July 2006. Prior to my speaking, Border Patrol Chief David Aguilar urged the

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

60 sector chiefs and others at the El Paso conference to keep the path to progress as unencumbered as possible and he would work to do the same. Involved in a continuing great task a

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

nd challenge, he encouraged conference participants: “Don’t let the process get in the way of the progress.” As I reflect on Chief Aguilar’s words now, I am reminded that this is goo

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

advice for all of us, regardless of our fields of endeavor.

Research by Dr. Michael Tushman from the Harvard Business School and Dr. Mary Benner from the University of Pennsylvania’s

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

Following aspects would a

Wharton School of Business shows that companies often sacrifice progress for process and lose out to their competitors who are spending more time and effort moving ahead and less time

dd to the challenges in developing combination products:

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

and effort determining how to move. Additional research by Dr. Robert Cole, professor emeritus at the University of California–Berkley’s Haas School of Business, substantiated the cl

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

aim. One example he gives in his book, Recovering from Success, is of a company that failed to move forward on some things. The company’s reasoning was that certain items and procedu

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

es needed to be submitted to additional process management, which Dr. Cole reveals was unnecessary. As a result of the delay, the company was passed by and lost a golden opportunity t

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

o be a market leader. Dr. Cole says that “process versus progress” was at the crux of the problem.

Of course, government is known for dealing with red tape, going through numerous ch

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

Professional from academic institutions, pharmaceutical industries, health care indust

annels, and becoming involved in all types of processes before any progress whatsoever is realized. Chief Aguilar is very much aware of this. He knew in July 2006, and he knows today

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

that his work is cut out for him. But what about us? As we inspect the various things in which we are involved, what can we do to move things along? This might be a good time to in

.

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

spect your involvements and see how you can “turn it up field” rather than running from “sideline to sideline.”

The great American writer Henry Wadsworth Longfellow (1807-1882) penned

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

Companies that provide selfless information through particip

, “Great is the art of beginning, but greater is the art of ending.” It’s easy to get bogged down with the process. That’s why Principle Nine in A Strategy For Winning is “Do It Now!

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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