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Digg It - The Pareto-Principle and ... Benchmarking
The pareto-principle or the 80/20-rule was born after observations of Mr Pareto that man
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 things in life were unequally distributed.
A famous example was “that 20 percent of t
A famous example was “that 20 percent of t
; 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
he people owned 80 percent of the wealth.”
This rule is very powerful because you can u
This rule is very powerful because you can u
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e it in many areas. One example is when dealing with projects; you know that 80 percent
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
of the work is caused by the (last) details (20 percent). So in project management it is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
common practice to uncover risks as soon as possible. The thought behind this is that i
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
you can solve the greatest risks you can solve everything.
Also the argument in favor
Also the argument in favor
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
of standardization is that 20 percent of the details or exceptions cause 80 of your reso
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
urces. Thus the more you are able to standardize, the more you can benefit from cost sav
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
ngs. This will only be the case if you sell “NO” to your customers, which is something v
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ery daring.
The question with, not only, these two cases is one where you may ask: “How
The question with, not only, these two cases is one where you may ask: “How
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
do we know whether we have reached the 80 percent level?”
Some projects are “nearly fi
Some projects are “nearly fi
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
ished” during a long time. “We are nearly there. (that's what you said last month...)” T
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
he problem might be in that case that the 80 percent level is not measured.
A benchmark
A benchmark
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
could very well serve to grasp this 80 percent level. For example, if you are to redesi
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
n your organization you may go for a best practice. This is a standard that has been in
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
the market. It is not innovative – because previously used -- but it sets a measurable
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
direction. If you choose so, you need to be sure whether this standard really is the bes
.
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
fit.
This fit analysis is something you might ask your management advisor to prepare f
This fit analysis is something you might ask your management advisor to prepare f
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
or you. If it is well selected the last 20 percent will finish on time.
© 2006 Hans Boo
© 2006 Hans Boo
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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