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If you could have a perfect day in your business, what would that day look like? What time would you wake up and how would you feel? What would be the first thi

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

ng you would do? How would the people you come into contact with act towards you?

Every day that you do business without a visualization of how things can be yo

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

Examples of combination products may in

are losing money. Visualizations are extremely important to your success. But what are they?

Have you ever worried about something in detail? Ever play it ov

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

er and over in your mind and imagine how it will probably turn out? Well then you have experience with visualizations. You see, worry and fear are visualization

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

in reverse. So if you can worry…you can visualize.

Setting goals is extremely important in any business. You need to know what you are working towards. But y

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

Combination pro

u have to believe those goals are possible for you or you will lack the motivation to shoot for them. And in goal setting…seeing is believing. You need to see i

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

t if you are ever going to believe it. And that is where visualizations enter in.

Visualizations are a picture you have in your mind or a feeling you have about

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

something. It is what makes something real for you. It is one thing to say that a trip to the Caribbean would be nice. But it is quite another to picture yours

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

elf lying on the beach, surrounded by white sand and crystal clear blue water. To get a picture so clear that you can almost taste the Pina Colada! Now THAT is

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

otivation to take that trip! If you picture that every day and go over it again and again in your mind you WILL be taking that trip!

Visualizing is having faith

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

in something you want. Worry is having faith in things you don’t want. Remember, if you can see it, you can BE it.

Affirmations are just as strong. An affirma

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

Following aspects would a

tion is something that you write or say repeatedly and these can be either positive things or negative things. If you keep saying “I’ll never be able to do that”

dd to the challenges in developing combination products:

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

then guess what? You won’t. Typically whatever you say after the words “I am”, “I can”, “I will” will become true for you. Consequently whatever you say after

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

the words “I’m not”, “I can’t” or “I won’t” will also be true for you.

So sit down and visualize your goals. Do you want a new car? Then find one you like. S

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

e yourself in the drive’s seat. Maybe even test drive it. Make it real for you.

I asked at the beginning of this article what your perfect day in your business

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

would be like. A good exercise would be to sit down and right out your ideal day. From the time you get up in the morning until the time you go to sleep, what w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould that ideal day consist of. Put it into as much detail as possible. And read it every day. Visualize that perfect day for you.

Then write out your goals a

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

d visualize them. Remember to always write in the present tense, not the future. Don’t say “I want to have a new car”. Say “I have a new car”. Write in the po

.

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

sitive, not the negative. Say “I have more than enough money” and not “I am not broke”

Determine what your “end game” is. What do you need to achieve all your

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

Companies that provide selfless information through particip

oals?

If you can determine what your goals are, visualize yourself in that position and write out your affirmations I have no doubt you will achieve much success

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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