Advice You - Business

T. Harv Eker, author of Secrets of the Millionaire Mind, states that the journey to

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

success is full of twists, turns, ups, downs, stops and reverses. You have to "zig z

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

Examples of combination products may in

ag" your way to success.

He is right. Once you understand this fact, you will begin

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

to understand that your own journey to success will be full of adventure and differ

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

ent roads. Roads that you may not have chosen to venture down, but roads that will u

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

Combination pro

timately lead to your success nonetheless.

We are only kidding ourselves if we real

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

ly believe that everything will be smooth sailing and will go exactly the way we wan

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

t it to.

Understanding that life presents us with sudden concerns and problems will

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

allow us to be prepared to deal with the unexpected. We won't have unrealistic expe

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

ctations that will stop us in our tracks.

We understand that as we travel the journ

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

y to success, we will have to evaluate, correct, re-align, straighten, and review co

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

Following aspects would a

ntinuously.

Releasing ourselves from the misguided belief of an 'easy road' gives u

dd to the challenges in developing combination products:

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

s the freedom to make mistakes and make corrections. People are afraid to make mista

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

kes because they might be perceived as a failure.

Don't believe you won't make mist

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

akes, because you will.

Everyone who is successful in life has made mistakes - some

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

repeatedly for years.

How you deal with the mistakes, the setbacks, the unexpected

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

Professional from academic institutions, pharmaceutical industries, health care indust

twists and turns will ultimately decide your success. Do you quit at the first sign

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

of a zig or zag? Or do you evaluate, re-group and correct?

As long as you understan

.

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

d that the journey to success is full of ups and downs, you will reach your goals. K

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

Companies that provide selfless information through particip

eep your eye on your goal, never give up, expect the unexpected and you can not fail

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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Advice You - Do You Zig and Zag?

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