Actual - Writing and Speaking

Imagine a professional football player the day before the Big Game. Do you think he is visualizing all the mistakes he could possibly make? Is he cringing as he

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

imagines getting tackled violently and often? Does he dwell on all the passes he won't catch, the fumbles he might make, and the deafening boo's he'll hear from

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

Examples of combination products may in

the crowd?

Not a chance.

He's totally focused on how it will feel to make numerous touchdowns, catch every ball that comes his way, execute every play perfectl

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

y and effortlessly, run faster than ever and in the end, win, win, win!

Yet, when people are getting ready to speak in public, they do just the opposite. They s

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

tart to imagine all the horrible things that could possibly go wrong. They worry about making a mistake, looking stupid, being boring, blanking out, not knowing

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

Combination pro

enough, or any number of problems that will probably never happen.

This negative, "What-if" thinking does not serve you in any way. First of all, 99.9% of anyth

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

ing you worry about will never happen. Secondly, this kind of thinking creates more anxiety, tension, and fear. Follow the football player and get your mind focu

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

sed on creating a extraordinary experience of success for yourself.

Start with the following:

Focus on What You Want

When your mind starts nagging you

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

with horror story scenarios of what could go wrong, just say, "Hey, wait a minute! I don't want this!" and start thinking about what you DO want. "I want to feel

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

great when I'm speaking. I want to make a connection with my audience. I want to feel confident about my message." That sort of thing. Get your focus on what yo

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

want.

What Do You Want To Say?

When you are creating your speech, ask yourself, "What do I really want to say? What has purpose and passion for me?" Ma

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

Following aspects would a

ny speech coaches will tell you to focus on what the audience wants to hear rather than what you want to say, and while that is good advice, when you get in touc

dd to the challenges in developing combination products:

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

h with what you really want to say, your entire speaking experience will be one thousand times more successful.

How Do You Want To Feel?

Imagine being i

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

n front of your audience. How do you want to feel? How do you want to experience this opportunity? For now, don't think about what you want to say or do. Just le

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

t yourself imagine feeling exactly as you want to feel. "I want to feel at ease, comfortable, confident, at home. Eager, excited and full of energy."

What Do

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

You Want to Have Happen?

This is where you focus on the details of each moment, how the crowd will respond, the questions they will ask, the response you w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill get. This is where you get to write the script exactly as you want it to go. Just like the football player who imagines each play being executed perfectly, y

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

ou, get to imagine each and every aspect of your speech unfolding perfectly.

What Happens Now?

Now your speech is over. What happens? Do you get swarmed

.

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

by the crowd asking for your autograph? Are you lifted on the shoulders of your fans and carried off stage? Why not? It happens to other superstars. You can ima

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

Companies that provide selfless information through particip

gine it any way you like.

You can create your experience with your thoughts. So create like the football player. Focus on what you want, not what you don't want

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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