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Just Answers - Nothing Ventured - Nothing Gained!
One thing is for sure if you keep doing what you did you will keep getting what you got.
When I started my consultancy business I was struck by the reaction of people who knew me and knew my exper
When I started my consultancy business I was struck by the reaction of people who knew me and knew my exper
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
iences and background. The reaction of my wife was totally supportive and my children were neutral. (they were going thro' college at the time!)
Many friends were not surprised because as an indep
Many friends were not surprised because as an indep
; 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
ndently minded person with my own views and thoughts I was a bit of a free wheeler.
However, one friend was askance and a conversation on the golf course explaining what was going on created the c
However, one friend was askance and a conversation on the golf course explaining what was going on created the c
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
mment “I could not do it, I need the support of a corporation around me”.
Having left employment in the corporate world behind his comments stayed with me. About six months later he called to ask
Having left employment in the corporate world behind his comments stayed with me. About six months later he called to ask
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hat he should do as the secure corporate world had just decided to dispense with his services.
Discussing his alternatives with him – employment or independence, I advised that to secure further e
Discussing his alternatives with him – employment or independence, I advised that to secure further e
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ployment could take a while so he may as well get busy on his own account as well. He was/is a talented electronic engineer with vast commercial and training experience, which could be commercially
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
exploited.
Helping him through this phase was rewarding because he never went back to employment. He became confident in his abilities and consulted successfully. Specialising in management traini
Helping him through this phase was rewarding because he never went back to employment. He became confident in his abilities and consulted successfully. Specialising in management traini
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
g. Now he and his wife spend a good part of the year in their house in Mediterranean, even though they still work together in the business the rest of the time.
Another downsized accountant friend
Another downsized accountant friend
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
now has a thriving business helping small business owners with their accounts and tax matters. When discussing our corporate backgrounds and subsequent good fortune in being able to set our own age
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
da he made the observation that we would not have been able to succeed so well without our home computers.
This is so true because the computer as a business tool has revolutionised the opportunit
This is so true because the computer as a business tool has revolutionised the opportunit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
es for so many all around the globe. Knowledge based service businesses are particularly suited to the use of computers.
Having said all of that how about these true successful ventures? I recentl
Having said all of that how about these true successful ventures? I recentl
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
read of a 21year student who needed new spectacles but was astounded by the cost. He decided to see if he could do better and is now a millionaire. How? He ventured to believe that he could and wo
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
ld do something to reduce the high cost of what is an essential for most people.
Using the internet to source spectacles he found he could supply direct at about 20% of the cost on the high street
Using the internet to source spectacles he found he could supply direct at about 20% of the cost on the high street
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
stores. His new venture was spawned when he founded Glasses Direct. With the support of student friends he set up a web site and supplied his customers from a spare room in his parents’ house. He s
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
ill lives at home.
The business now has more than 8,000 customers and sells more than 300 pairs a day. The venture has had it’s problems from the established industry but if it continues to grow a
The business now has more than 8,000 customers and sells more than 300 pairs a day. The venture has had it’s problems from the established industry but if it continues to grow a
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
the present rate this young man will become even more wealthy as someone buys him out.
Another great venture is the housewife who wanted to buy her husband a present. He is a model train enthusia
Another great venture is the housewife who wanted to buy her husband a present. He is a model train enthusia
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
t. She found some difficulty in getting advice and sourcing the present. So she spotted a niche and set up a web based business. It now employs twelve people and she has a supply for her husband wh
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
works in his job while she runs her new venture.
This article entitled ‘venture nothing – gain nothing’ came very much on the spur of the moment, I guess my thinking is ‘lets get on with it’. If
This article entitled ‘venture nothing – gain nothing’ came very much on the spur of the moment, I guess my thinking is ‘lets get on with it’. If
.
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
e keep doing what we did we will get what we got. The opportunities are out there even in the most unlikely places.
Tip; some of the tips we come across can sound a bit trite but even so they are
Tip; some of the tips we come across can sound a bit trite but even so they are
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
prompt to our thinking and applicable to this weeks’ bulletin is ‘if you never begin you will never win’. All of the true cases mentioned won because they started. Some in adversity went on to win
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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