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Other Articles - Back To Square One!
If you look, see, hear and think you will learn.
Sounds obvious but how many do it? I am a self confessed infoholic. My addiction is information on
Sounds obvious but how many do it? I am a self confessed infoholic. My addiction is information 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
topics that interest me; world affairs/politics, business and sport. I am interested in ‘cause and effect’ so the net result is I read a lot.
Not ju
Not ju
; 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
t novels like most people but what interests me. It’s amazing what you see, what it means and what you learn.
Recently I came across two short artic
Recently I came across two short artic
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
les in the same journal on facing pages and they said so much about why people fail in business and yet, do people ever learn?
One article gave stat
One article gave stat
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
stics on businesses failing from cash flow problems and the other was about a business that went down because it’s single largest customer placed it’
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
business elswhere.
In summary it goes like this; a survey revealed that in the UK 100,000 businesses fail each year because their owners fail to do
In summary it goes like this; a survey revealed that in the UK 100,000 businesses fail each year because their owners fail to do
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
any financial planning.
25% of firms never set any financial targets and 35% have never set aside funds for employee development. 20% admitted to b
25% of firms never set any financial targets and 35% have never set aside funds for employee development. 20% admitted to b
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
ginning to plan when it was too late and 50% blamed this on not having enough time. They were surprised to learn that these causes of failure were gr
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
eater than adverse trading conditions.
The failed business was a very cost sensitive business that did sub contract machining. It had been establish
The failed business was a very cost sensitive business that did sub contract machining. It had been establish
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
d 49 years and employed 12 people.
It was dropped by it’s single biggest customer. The owner has now re started as a ‘sole trader’ doing the same su
It was dropped by it’s single biggest customer. The owner has now re started as a ‘sole trader’ doing the same su
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
contract machining and ‘working all hours’ to survive.
He says he has learned his lesson and will not carry out work for businesses in the sector of
He says he has learned his lesson and will not carry out work for businesses in the sector of
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
the company that dropped him and is now doing work for other businesses.
I admire his tenacity and wish him well for the future but these two tales
I admire his tenacity and wish him well for the future but these two tales
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
tell us so much that should be applied as normal business practice.
Never rely on a single customer, never stop marketing, prepare an annual busines
Never rely on a single customer, never stop marketing, prepare an annual busines
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
s plan with costed goals and timed targets.
Manage against that plan and review progress making adjustments in accordance with the trading position.
Manage against that plan and review progress making adjustments in accordance with the trading position.
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
At all times control cash flow and only spend when you can afford to. Simple but so effective and as important as any ‘day to day’ task.
My experien
My experien
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
e is that many business owners have a job working for themselves. They do tasks ‘in the business’ and though this is necessary when starting a busine
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
ss the objective must be to develop the business by working ‘on it’ not ‘in it’.
If our business owner had set a financial plan with a costed market
If our business owner had set a financial plan with a costed market
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ng plan to acquire one new customer in each of the 49 years history - would it have gone bust? I believe not. I am almost certain that in many of tho
.
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
se years he was busy working ‘in’ the business not ‘on’ it.
No matter what type of business you consider continuous, targeted and costed marketing i
No matter what type of business you consider continuous, targeted and costed marketing i
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
crucial. No customers, no cash flow, no business.
Tip: Look, Listen, Learn and take strong firm action. Do the thing you think you cannot do
Tip: Look, Listen, Learn and take strong firm action. Do the thing you think you cannot do
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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