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What's your business vision –what you would like to become or achieve this year? Your vision is the basis for setting specific goal

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 to make your dream a reality. So often we jump into setting goals without a clear vision of where we want to go. The vision is the

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

Examples of combination products may in

inspiration that keeps you motivated when doubt surfaces. It’s the preview of coming attractions in your life, it’s the movie you ar

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

writing and producing just for your starring role. Without this movie script, there’s no obvious direction.

Why do so man

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

people fail to put their vision and goals on paper? It’s the standard excuse: “I don't have enough time for this exercise; I’m t

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

Combination pro

o busy with daily activities”. The truth is, each of us has all the time there is. It’s not a time-management problem; it’s a pr

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

ority / focus problem. We put our focus on minor distractions that pop up each day rather than follow a specific script or action pl

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

an.

What’s the starring role you want to create for yourself this year? Take just 30 minutes TODAY to sit quietly and think

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

about where you really, really want to be a year from now. Make notes of everything that comes into your mind. Then take your notes

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 write the story of your vision as though you are living it now. This narrative is your movie story line. Next, take this vision a

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

d work backwards. To be living your vision 12 months from now, what would you be doing or earning 10 months from now? Keep moving ba

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

Following aspects would a

kwards – what would you be doing 8 months, 6 months, 4 months, and 2 months from now to make this happen? Work backwards until you g

dd to the challenges in developing combination products:

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

t to actions you can do this week and today to support your vision.

Going through the "backing up" part of the exerc

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

se, lets you see specific goals to set for yourself along the way. These goals become your movie script. Each morning when you start

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

your day, picture yourself as the Star reporting to your movie set. You know the story line (your vision), what your role is (to cr

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

ate the vision) and you have a detailed script (goals that you’ve set) to follow each day. Write an award winning movie for yourself

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

Professional from academic institutions, pharmaceutical industries, health care indust

give your best Oscar winning performance and receive a standing ovation at the end of the year!

You are the Star of your o

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

n life! Make it a memorable year.

(If you want help writing your vision for your direct selling business, I have created a

.

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

Vision Worksheet" that walks you through the process. To get a FREE copy for this worksheet, just email me (vicki@directsellingleade

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

Companies that provide selfless information through particip

shipcenter.com) and I will be happy to send you the worksheet file.)

Vicki Miller, CUCG, PCC / Copyright January 2007

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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