E-Folder - Business

Getting up this morning ...

I was struck by the importance of motivation and true drive to accomplish ones goals in life.

A

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

ll the successful people in the world can't just decide to kill their alarm clocks every morning.

If they did, well then, we

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

Examples of combination products may in

ould all be in the alarm clock business my friends.

But honestly, how do they do it then?

There must indeed be a commonality

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

in achieving great things; A similar path we all must walk if we intend to get to the places we intend to go.

I thought abo

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

t people in business, athletes, doctors, musicians, any and everyone who attains the level of rock star success I'd like to ha

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

Combination pro

e for my business one day.

How do they do it day after day, every single day?

There's only one answer that makes any sense…

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

You don't work as hard as these people do and not bring passion for what you do to the table.

That's pretty much the bottom

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

ine. There's also a difference between excitement and passion folks.

Excitement won't take you the distance. You see all th

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

se statistics everywhere… Why do 95% of all businesses fail in the first year? Why do so many businesses fail online?

Ever

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

one's got a theory. The one's that suggest 95% of businesses fail because they didn't have this system or that system of mark

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

ting or this product or that product to market frankly I find a bit hilarious.

Of course a lot of the failure rates can be ex

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

Following aspects would a

plained by good old fashion lack of planning and know how. People start a business and they under capitalize (No.1 cause by

dd to the challenges in developing combination products:

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

he way), or they can't manage time properly, or they just plain know nothing about business to begin with.

Aside from all the

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

technical jargon, you have to find your passion for whatever you do. If you want long term success, find your passion.

There

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

are a lot of hurdles to over come between where you are today the place you'd like to be, as a success in business.

Pure exci

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

ement won't see you through that kind of transition. I think a lot of times someone might coin a particular business or marke

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

Professional from academic institutions, pharmaceutical industries, health care indust

ting method "easy", or "a no brainer", but easy is pretty relative when you're passionate about what you do.

When it comes t

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

changing your life and the lives of the people that you care about through your own success…

Be prepared to do what it takes

.

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

to succeed everyday. This is a conscious choice we all make daily.

As they say, "there is many a slip between a cup and a li

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

Companies that provide selfless information through particip

"

Don't let a few misses stop you from reaching your goals.

"Learn to Mind Your Business",

Joe Slade "The Maverick Marketeer

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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