Advice You - Business

It has often been said that bigger is not always better. That may be true when considering automobiles and the current price of gas, but it is never true when it comes to new

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

ideas or personal dreams where thinking big is always better.

Let me illustrate. Think back to when you were a child. Perhaps you dreamed that one day you would grow up, ge

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

Examples of combination products may in

t married, and have children. A nice dream, right? And many of you have likely achieved some version of that dream. But what if you had dreamed instead that you would grow up

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

and marry a billionaire? Sounds crazy, right?

It wasn't for Caroline Bessette Kennedy, the late wife of John F. Kennedy, Jr. While growing up she dreamed of marrying a billi

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

onaire. The result? She landed one of America's most eligible bachelors who also happened to be a millionaire to boot. Some of you are probably saying, "That may be true, but

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

Combination pro

look at the tragedy that befell them." My response: at least she died living her dream. That's the power of thinking big.

In my survey last month, I asked my readers to shar

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

e their opinions on the power of thinking big. Seventy-five percent of respondents agreed that they don't think big enough about their work or business, and of those that do

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

have big dreams, 75% of respondents indicated that they lack the follow-through in order to make them happen. Further, over 85% of respondents noted that they don't know wher

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

to start or what steps to take to make them happen.

According to Kathy Gillen, an executive coach who helps successful entrepreneurs become dynamic leaders, in order to thi

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

nk big, you need to " remove the ‘heebie-jeebies' about stepping forward and doing what is uncomfortable." How can we do that? Gillen recommends a simple technique. She says,

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

"Change your focus from your internal fears ("I might make a mistake or look stupid"), to an external focus ("I'm making a huge contribution!") It's that simple."

When worki

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

Following aspects would a

ng with clients, I always suggest that they do the following:

1. Write down all of your big ideas/ dreams. Say them out loud. Share them with a trusted friend or advisor.

2

dd to the challenges in developing combination products:

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

. Visualize yourself successfully bringing your idea or dream to life. What will you look like? How will you feel? Where will you be?

3. Establish goals for how you will go

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

bout achieving them. Make them "SMART" goals and you will be more likely to achieve them. (Click here for more information about setting goals.)

4. Determine what action ste

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

ps will help move you forward. List them and include a target start date, target end date, and resources for completing them.

5. Select one action step and do it today! Her

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

are some additional tips for thinking big: Don't seek validation from others (they may not always agree with you or support you). Do seek out and create a support infrastruc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ture (role model, coach, other big thinkers) to support your ideas and dreams and to help you craft and implement your plan of action. Do take risks and step out of your comf

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

ort zone. People who are comfortable taking risks typically experience increased autonomy, heightened self-esteem, a more positive attitude toward life and an increased sense

.

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

of personal power. The positive outcomes of thinking big and taking risks far outweigh any discomfort or fear you may have.

When it comes to thinking big, remember the words

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

Companies that provide selfless information through particip

of Mother Theresa, "The biggest person with the biggest ideas can be shot down by the smallest person with the smallest mind. Think big anyway." So, what are you waiting for

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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When I first started this article, I asked several people what kind of experiences they had had with poor customer service. Some of their experiences were extreme – with one instance where a photographer punched an unsatisfied customer – but most relayed occurrences consistent with my own. I narrowed it down to three behaviors of customer disservice. When these behaviors are continually maintained, the ability to drive people away will surely be in the bag.

Finding the resources to buy or build a business is within your grasp. The garage can be your warehouse, you daughter's pick-up truck can be your delivery van, and your son can get the computer working. And there is always money available for a good idea or a good plan to improve a poor business.

This is an article about sales as much as it is about challenging the Grand Canyon. I have ventured into the belly of the world wonder seven times. Each time it has been a different experience. The experience of each journey is like a sales experience because, although the journey is similar, it is never the same.

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Advice You - The Power of Thinking Big

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