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Digg It - Getting Over Ambiguities in Your Decision Making
How do you normally go about non-trivial decisions?
Even if you prefer to take time to do your homework and systematically clarify and prior
Even if you prefer to take time to do your homework and systematically clarify and prior
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
itize all gains or costs, you can still face many grey areas, when pure logic by itself does not arrive at one convincing conclusion.
It cou
It cou
; 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
d be that your criteria for analysis are difficult to formulate unambiguously. You have gaps or conflicts in your data. Circumstances may 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.
hanging too fast to give you enough time to systematically sort out all the data. What do you do then?
In such situations you will probably
In such situations you will probably
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
urn to your “gut feeling”, also known as your inner voice or intuition. When it comes to poorly structured problems like and ambiguities, you
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
decision making effectiveness is determined mostly by your ability to use your intuition.
In contrast to logical reasoning process, which o
In contrast to logical reasoning process, which o
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
curs mostly in your conscious mind, your intuition works at the subconscious level. The intuition grasps your decision making situation as a
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
hole, processing different pieces of information in parallel. It somehow connects the inner pattern of your new situation with various subcon
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cious pieces of your previous experiences. Then one moment you will receive the conclusion of that inner work as an intuitive message, a mess
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
ge communicated in the language of your subtler feelings.
While intuition is an indispensable tool in business decision-making, there are st
While intuition is an indispensable tool in business decision-making, there are st
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ll traps you can fall into if you are not careful.
One trap is using intuitive approach as an excuse not to do your homework. Did you ingest
One trap is using intuitive approach as an excuse not to do your homework. Did you ingest
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
all the key facts? At least those that you can get in cost- and time-effective ways. While intuition will help you work around many gaps and
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
mbiguities, even your inner voice can be misled if too many of your facts are wrong or missing.
To effectively collect and organize all the
To effectively collect and organize all the
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
elevant data, try to start with a systematic analysis in writing. As much as you can, capture on paper the ideas on the main options and the
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
riteria for evaluating your choices. Write down the key facts and factors you need to keep in mind.
Another dangerous trap is confusing your
Another dangerous trap is confusing 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
inner voice with the background noise of your current emotional state. Whenever you need to make an important decision, pay particular attent
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
on to your overall mood. If you are stressed or in a bad mood, your true inner voice will be distorted or lost in the background of your str
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ng negative feelings. A similar effect may happen with strong positive feelings. Are you also carrying a baggage of suppressed feelings that
.
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
iases your judgement?
Finally, the reliability and effectiveness of your intuition also depends on how much you let it develop. The more exp
Finally, the reliability and effectiveness of your intuition also depends on how much you let it develop. The more exp
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
riences you go through and the more attention you give to the intuitive messages in each case, the better "gut feeling" guidance you will get
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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