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E-Folder - Know What You Want and Make It Happen!
How is your life and/or your business doing? Is it stagnating, boring, going nowhere? Have you become obsessed with meeting those loan repayments or trying to just survive until the next fistful of money comes in? Are you having trouble mai
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
ntaining your positive expectancy about life and/or business?
Too many of us are living this way and it has to change! The Government won't do it for us, nor will our family or friends. So what steps do we need to take to make life worth l
Too many of us are living this way and it has to change! The Government won't do it for us, nor will our family or friends. So what steps do we need to take to make life worth l
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ving and our businesses into exciting ventures?
The way to live satisfying lives is to simply dream up the things that we want to do and then make them happen. A simple statement but so few of us can put it into practice!
You can put it i
The way to live satisfying lives is to simply dream up the things that we want to do and then make them happen. A simple statement but so few of us can put it into practice!
You can put it i
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 practice if you take these steps NOW! First, find yourself a quiet, comfortable location where you will be free from disturbances. Ensure that you have paper and pen handy as you will need to write some things down.
Brainstorm Ideas
No
Brainstorm Ideas
No
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
, let's do some brainstorming. For the next ten to fifteen minutes, write down all the things you'd like to do. A few rules for this exercise are in order. Don't evaluate as you write! For example, if you'd like to go overseas on holidays f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r twelve months - don't stop and think whether you can afford it. Just write it down. Evaluation can occur later. At this stage, write down all the things that you'd like to do assuming there was nothing that you couldn't do.
Prioritise Id
Prioritise Id
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
as
When you have finished brainstorming, you will have a list of the things you would like to do - and hopefully it will be a long list! Your next step is to review your list and sort it into priority order. Again, do not evaluate any of t
When you have finished brainstorming, you will have a list of the things you would like to do - and hopefully it will be a long list! Your next step is to review your list and sort it into priority order. Again, do not evaluate any of t
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
hese items as to feasibility, etc. while you are ranking them. At the top of a fresh sheet of paper, write the thing you would like to do most. Underneath that, write what you'd next like to do most. Continue doing this until you have sorte
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
your list into order of most wanted to least want to do. Also, put beside each one when you would like to do it by.
Take a short break before proceeding to the next step.
Evaluation
Now, look at the top three items on your list and ask
Take a short break before proceeding to the next step.
Evaluation
Now, look at the top three items on your list and ask
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
ourself the question: "What is stopping me from doing these things? It will help to clarify things if you write down these reasons. For example, if your number one choice is to go overseas for twelve months, your reasons for not being able
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o do so could be:
+ can't afford it;
+ can't leave my business unattended; and
+ afraid I won't like it when I get there.
You've got to remember that you are looking at the three things you'd like to do most! So you're not
+ can't afford it;
+ can't leave my business unattended; and
+ afraid I won't like it when I get there.
You've got to remember that you are looking at the three things you'd like to do most! So you're not
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
going to let reasons like that stop you from doing them, are you? Now spend some time thinking about what you can do to overcome these reasons. Again, brainstorming without evaluation can help. Write down all the things that come to mind th
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t could overcome these obstacles. You might write down things like:
+ sell the business;
+ cut back on personal expenditure to save the money so can afford it;
+ get more information about where I want to go;
+ hire a ma
+ sell the business;
+ cut back on personal expenditure to save the money so can afford it;
+ get more information about where I want to go;
+ hire a ma
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ager to run my business while I'm away;
+ sell the house and use proceeds to pay for the trip;
+ increase my business so that I make more money; etc., etc.
Once you have a list of solutions (no matter how silly some may be),
+ sell the house and use proceeds to pay for the trip;
+ increase my business so that I make more money; etc., etc.
Once you have a list of solutions (no matter how silly some may be),
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
you can then evaluate them. Remember, sometimes it is the modification or extension of a silly idea that holds the solution. From this evaluation process, form a plan of how you could do what you most want to do.
Do a Plan of Action
Your
Do a Plan of Action
Your
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
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
inal step in this process is to put your plan into action - and do it now! Don't wait for a more opportune time - the best time is always NOW!
However, don't let your big plans stop you from doing some of your smaller plans now. Pick a cou
However, don't let your big plans stop you from doing some of your smaller plans now. Pick a cou
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
le of activities you can do within the next month that won't cost you money. DO THEM! You will feel like a different person for having done so.
Okay, but can you apply this process to your business? You surely can. Instead of asking yourse
Okay, but can you apply this process to your business? You surely can. Instead of asking yourse
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f what you would like to do, instead ask what can you do that will make your business more attractive to your customers so they will do more business with you?
Again, use brainstorming to help you. Follow all the steps above and you will c
Again, use brainstorming to help you. Follow all the steps above and you will c
.
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
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
me up with some great ideas that will help you to revitalise your business. Also, don't forget that the best source of ideas is from your customers. Ask them what they want - then give it to them provided you can do so at a profit. If you c
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
n't do it at a profit, brainstorm ideas on how you can do it at a profit. Always aim for continuous and never-ending improvement in your service to your customers.
You will see the difference doing things can make to your life and business
You will see the difference doing things can make to your life and business
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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