Digg It - Business

After Larry Bossidy and Ram Charan published Execution – The discipline of getting things done (ISBN 0-609-6105

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

7-0), in 2002, every business on this planet rushed out and dropped copies off to their managers and said “Exec

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

Examples of combination products may in

te” the quieter implication was, “…or exit.”

Why did this happen? Well most managers realize that there is a g

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

p between where they are and where they’d like to be.

So did handing out gazillions of copies of the book sudd

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

nly turn us into a world of executioners? No, of course not. If the managers who passed around the book had tak

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

Combination pro

n the time to read more than the title they would have realized there is a mountain of work to do to become exe

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

ution focused. Many businesses are not at the point where managers and staff can actually execute.

Developing

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

a shared vision is one thing. Living that vision in ones daily life is quite another. Companies that execute do

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

just that. Having values and living your values, is another thing. Culture, what does that mean to you? Are you

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

execution focused or trying to keep the boss out of your hair? Do you know what you should be doing?

This is i

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

in a nutshell. What are the top 10 most important things for you to be doing in any given period? Do you know?

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

Following aspects would a

Do your staff? Your boss, if you have one? Your board if you think you don’t?

Here’s the test. Figure out what

dd to the challenges in developing combination products:

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

makes you and your business, or your department, great. What makes it suck? How can you improve on both? What v

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

lues do you need to apply to be consistent with your ‘inner voice’? Now take the exercise to your team and when

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

you have 200 of the best ideas select just 10 and make them the focus of your business for the next year.

Sou

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

d simple? It is, BUT... It will take some work figuring our the metrics of each idea or goals, determine an own

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

Professional from academic institutions, pharmaceutical industries, health care indust

r and report on it weekly and monthly don’t let it slip too far below your desires or you’ll never catch up and

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

you will all lose motivation and enthusiasm for the execution. If you really can’t achieve it after three month

.

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

, you probably have a functional problem that needs attention. Resolve it soon, before the end of the year and

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

Companies that provide selfless information through particip

ou still will have some wild success that you never had before.

Go on, make your day! Make the next year yours

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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