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From my years of coaching individuals in Direct Selling and past experience in the industry, I have made an interesting, and what h

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

as turned out to be a VALUABLE, observation...

Some people seem to steadily (and with apparent ease) have the ability to increase

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

Examples of combination products may in

heir income while others don't make enough to cover their expenses. When I observed this, I asked myself "What seems to be the prim

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

ary difference between the people who make millions and the people who struggle all their lives to get ahead?" The answer came back

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

loud and clear. It seems to have everything to do with our ability to direct our internal communication.

What do I mean by that?

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

Combination pro

Your inner 'State of being' attracts and creates your outer results! Look around you at the successful people in your business. Pay

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

attention to the words that they use when talking about their business. You will hear them use positive words and phrases consisten

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

tly and will find that they spend very little (if any) time focusing on negative thoughts. Here's an important formula to remember:

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

Thoughts lead to feelings, feelings lead to words, words lead to actions, and actions lead to results.

One of my clients, 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

new leader, expressed to me that her team was faltering and that she was to blame. I asked her to tell me what her thoughts were a

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

out her leadership abilities. She explained that she thought she was an inadequate, unskilled leader. I asked her how those thought

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

Following aspects would a

s made her feel. Her response was that she felt unworthy and incompetent and she told me she had even said these words aloud. Then

dd to the challenges in developing combination products:

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

asked her how does an "unworthy, incompetent" person act? "I guess", she said, "they act defeated". My next question to her was -

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

"Well, if someone acts defeated what results can they expect?" "Poor results" was her response.

My point to the questions I asked

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

er, was to get her to realize what her thoughts, (no leadership skills), were creating (faltering team results). When

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

she realized what she was doing with her thoughts, it was easy for her to see that a shift was necessary. I asked her to rewrite h

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

Professional from academic institutions, pharmaceutical industries, health care indust

r internal communication and to focus on her natural skills. So instead of telling herself that she was an unskilled leader, she sh

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

ifted her thoughts to seeing herself as an excellent communicator who sincerely cares about helping others. The difference this shi

.

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

t in thinking made in her results was almost unimaginable!

Remember, if you are not happy with your results, it would be wise to t

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

Companies that provide selfless information through particip

ake a good look at your thoughts and how they impact your words. Where do YOU need to make a shift?

Copyright May 2006 Vicki Mille

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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Can you honestly say you are doing something positive about the behaviors of those important external audiences of yours that MOST affect your operation?

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