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You are the only one who controls your destiny. Yes you. And you know what; you are preprogrammed to do so. Most of the time we are the one who gets in our own way. So when you want to change what happens, how do you do it? That is what I will talk about toda

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

y. There are a few steps that you must take to become who you want to be. And that is the same in anything, a business person, athlete, teacher, coach, whatever it is; here are the steps that you need to follow. Oh, and before we get to work, I must include thi

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

Examples of combination products may in

does not come from me. This comes from people who are much smarter and much more successful then me.

1) Set Goals. You have to set goals, and they have to be specific. On top of that you have to write them down. Here is why. A goal without action is not a g

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

oal, it is a dream. A dream becomes a goal through action. Writing your goals down becomes action and action leads to attaining your dreams. It is a giant circle, and it begins with setting goals, and writing them down. Don’t be afraid to set big goals either.

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 coaching and with myself I used to think that you need to set small goals that are within reach. Reaching these small goals gives you success and pride, and a time to reassess yourself and set new goals. Although this works for some people, that is not what

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

Combination pro

I am after anymore. Small goals mean small achievement. I want something big, something huge, something so large that I have to work really hard to get it. Here is what I do. I set a goal, and attach a date to it. Attaching a date sets a time to reassess the

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

oal. If the goal is not reached, it is not a big deal as long as I know that I worked as hard as I could for that goal, and kept it in mind the whole time. As long as I made a good, honest, effort to reach it, if I fall just short, that is ok. If I set a big go

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

al, and don’t even get close to reaching it, then I need to look only one place, me. So set your goals, set them high, write them down, and keep them in a place where you can see them. That is the last step. Put them where you can see them, and keep them in min

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

all the time.

2) Write a Personal Affirmation. A Personal Affirmation is a statement that is written, and said by the person writing it. Basically it is way to pump you up. These are best read, and repeated in the morning and evening, just after waking up and

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

going to bed. That will keep the personal affirmation fresh in your head. It is a great way to start your day, and end it. A personal affirmation should be written in the positive. Always the positive! It also needs to be written in the now. For example. I

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

you want to be out of debt, don’t say ‘I want to be out of debt.’ Debt for most of us would be a negative. This causes you to focus on the negative. We want this to be an affirmation statement, focused on the positive. The next option would be to say ‘I will

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

Following aspects would a

be rich’. This is good because we are focusing on the positive, but it is bad because we are not in the now. Even if you are not rich a better statement would be ‘I am rich’ or ‘I pay cash for everything’. Both of these statements gets you out of debt, and is i

dd to the challenges in developing combination products:

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

the now and positive.

3) Do Something! Action always beats inaction. One of the toughest things for people who are transitioning from the workforce to entrepreneurship is action. It is a scary thing to put your life on the line, your financial well being, an

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

d your abilities as a creative business person. But you know what, if you try, you put things in action, and you don’t give up, you will be successful. The only way people fail is to quit. Don’t quit. It will be hard, it has to be or everybody would be doing i

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

. It is not for everyone. If you are the type of person who is completely terrified of failing then don’t start, you will fail at sometime. I was that person. It took me two years to pull the trigger. I was completely afraid of failing. So finally I just did

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

it, my reason became bigger than my fear (my next article will be on that topic). And you know what, I failed my first time. Actually I failed my first few times; it put me in a lot of debt. But all of a sudden, and from everyone I have talked to it is a sudde

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

Professional from academic institutions, pharmaceutical industries, health care indust

change, I became successful. Things started happening. Did I want to quit? Yes of course, but I stayed with it. I did not quit. This is what I found. Even making mistakes helped me in the end. I was able to learn from my mistakes, and I knew not to do that

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

again. It took a lot of education, and it took action, but eventually I learned what works for me, what my destiny is and can be. And it happened very quickly.

I am no Bill Gates, but I am happy, I am making money, and I am having fun. Those are my goals. Yo

.

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

need to set your own. I read my personal affirmation statement every morning and every night. I have it posted on my mirror in my bathroom, and on the wall next to my desk. That has been the most empowering thing I have done. Lastly, I am doing something. If

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

Companies that provide selfless information through particip

you are wondering what the next step is do these three. The step after that will present itself, and then take action. You know what, you can read all these steps in books, and guru programs all you want, but if you don’t put them in action, nothing will happe

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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Since Theodore Maiman invented the first functional laser or LASER (Light Amplification by Stimulated Emission of Radiation) in 1960, this device, which generates a strong, highly concentrated beam of single-wavelength light, has found several uses in different industries and in various fields including medicine, consumer electronics and information technology.

Work habits that will surely win you a promotion! It's not based on hype, it's all about hard work.

Whether you are in education, marketing, retail, logistics, government service, entertainment or insurance, communicating positively and proactively with your clients makes sense.

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