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I have heard it so many times from so many successful people, "I made the decision and that’s when everything changed". Then they go on

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

to tell us how they made millions of dollars in business, their car never breaks down, their dog was healed from cancer, their pet rat s

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

Examples of combination products may in

rvived a week in the sewer, and basically everything in their lives is perfect.

Yet you sit there in your easy chair with nothing but d

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

ebt, and a J-O-B that is one step below misery and torture. You can’t tell what went "wrong", or when it happened, but you know that "wr

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

ng" is definitely alive and well in your home. If you don’t figure something out soon, you may need to move in with the in-laws. Your sp

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

Combination pro

ouse keeps telling you to “make a decision”… there’s that word again… DECISION.

You ask yourself, "What is this decision"? You would ma

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 the decision, if you knew what it was. The one thing that you have done is “decided” that you need more money.

Well, I feel for you,

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

and I know where you are coming from. I have been there too. Fortunately, I made the DECISION to get out of my own way. Quite often the

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

biggest problem is that we can’t get out of our way to take action. Humans seem to be lazy by nature. If a person would simply take acti

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

on, even if it was the wrong action, at least progress would be made. Progress can even be made from a mistake, if a lesson was lear

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

ed.

So here is a thought that may assist you on your journey. Focus on making a decision right now.

Here is an example of what you c

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

Following aspects would a

n tell yourself if you wanted to make a decision to wash your car today...

"I will take action and wash my car today. I will decide to

dd to the challenges in developing combination products:

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

wash it myself or take it to an automatic car wash. I will do this now. I am a person of action, I make wise choices, and I attract lea

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

ers into my life that have the answers for which I am searching. Taking action and keeping my car clean is just one small way for me to

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

reinforce the life I choose to lead and the responsibility I have for the design and influence I have on a specific outcome. Successful

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

people take action and figure the rest out on the fly. I will alter my course as I move toward my goals... and I will feel good about m

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

Professional from academic institutions, pharmaceutical industries, health care indust

y clean car as a representation of the life I am in the process of designing."

You can use this technique, and language, on any decisio

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

that you find yourself avoiding.

There, now don’t you feel better after having said that? Of course you do. That is the felling of bel

.

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

ief. Go ahead, close your eyes and think about it. You feel alive, hopeful, determined, aggressive, inspired, and motivated. You are a p

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

Companies that provide selfless information through particip

rson of action that just made a DECISION... be it a clean car or financial success.

Congratulations, enjoy the journey from here on out

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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How much experience do you really have? Many people work in a profession, scientific domain or industry for 30-35 years and feel they are experienced and consider themselves at the top of their fields and take that number of years and apply it to their credentials and strengths. I have only been in business 27 years, yet I am in my very early forties now.

According to the U.S. Fair and Accurate Credit Transactions Act of 2003, which went into effect on December 4, 2006, the retailers are not allowed to print their customers' full credit card numbers on the sale receipts in an effort to prevent consumer fraud and identity theft.

Don't scare away your customers by saying the wrong things Customers expect a certain kind of behaviour from companies and if we want to stay in business, it is our job as service providers or manufacturers to stand up to those expectations. There are certain things that are a total no-no while communicating with a customer. It will be a good idea to remember these things and have them as a ready checklist with you, always

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