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Digg It - What is a Key Indicator and How Will it Impact my Business?
Key Indicator, as referred to in this article, applies to both KPI: Key Performance Indicators and KSI: Key Strategic Indicators
Key Indicat
Key Indicat
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
ors allow you to track the health, growth and performance of your business. By looking at what values are important, then tracking and measur
; 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
ng them over time, you can determine exactly where you are in your progress towards your business development goals.
Most business owners be
Most business owners be
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lieve they have a ‘good feel’ for the way their business is running. This is probably true but it is not really enough for your business to b
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
successful. The Key Indicators in your business need to be developed and scheduled to track and measure your progress over time.
Key Indica
Key Indica
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tors can be used to track both measurable and non measurable areas of your business. They can also be categorized as Performance (Key Perform
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
nce Indicators) and Strategic (Key Strategic Indicators).
Measurable Key Indicators are values that you can actually measure or calculate by
Measurable Key Indicators are values that you can actually measure or calculate by
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
looking at the operations of your Business including the inputs and outputs. Typical examples include: - Net Profit, Growth Rates, Sales Per
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
on Calls and Production Rates etc.
Non Measurable Key Indicators are values where you establish the best case and worst case values and then
Non Measurable Key Indicators are values where you establish the best case and worst case values and then
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
assign a measurement value at a point in time using your best judgement. These values may not be able to be determined by looking at the ope
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ational metrics of your business. It may be useful for you to document exactly how to arrive at a value. Typical examples include:- Customer
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
atisfaction, Market Leadership and Employee Moral etc.
To begin tracking Key Indicators in your business:
1) Quantify your Business Develop
To begin tracking Key Indicators in your business:
1) Quantify your Business Develop
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
ment Goals.
2) Determine the areas that need tracking in order to reach your Business Development Goals.
3) Determine the range of values y
2) Determine the areas that need tracking in order to reach your Business Development Goals.
3) Determine the range of values y
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
u will use to measure a Key Indicator, these may change as your Business Develops.
4) Develop a description for the Minimum and Maximum valu
4) Develop a description for the Minimum and Maximum valu
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
es that you will use to measure the Key Indicator (This will assist you when measuring the values).
5) Measure the current value of the Key
5) Measure the current value of the Key
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
ndicator.
6) Schedule a task for the regular measurement and evaluation of your progress with the Key Indicator so you can track where you a
6) Schedule a task for the regular measurement and evaluation of your progress with the Key Indicator so you can track where you a
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
re over time.
You should share the measurement and evaluation responsibilities of Key Indicators with employees and managers in your busines
You should share the measurement and evaluation responsibilities of Key Indicators with employees and managers in your busines
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
. You will find that once you start using Key Indicators to set the goals and parameters of your business, you and your employees will become
.
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
aligned and begin working towards achieving your Business Development Goals.
Be bold but realistic in setting your Business Development Goa
Be bold but realistic in setting your Business Development Goa
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
s. By defining and then measuring Key Indicators there is a good chance you will reach and exceed what you have set as the best case scenario
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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