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E-Folder - You're Killing Your Own Business
There is one thing that will absolutely kill the growth of most
businesses at one point or another. Although it is intended to
make sure that you
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
are properly prepared for the journey ahead, it
often stunts the growth of your business.
The funny thing about this is that every business class
The funny thing about this is that every business class
; 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
I've ever
taken during my coursework absolutely glorifies the importance of
this one factor. The factor that I am speaking of is "planning".
Alth
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ough, a theoretically sound plan is helpful in attaining your
business goals, it's frequently a stumbling block for growth. Why? You
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
>
THE EXPLANATION
Well,it's simple. Often tim
Well,it's simple. Often tim
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
es business owners and entrepreneurs
will spend the majority of their time preparing and not enough of
time actually implementing. We usually use
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
planning time as a
cover for procrastination, which we all know will cause failure.
If a cook spends most of his time planning the meal and not mu
If a cook spends most of his time planning the meal and not mu
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
ch
time cooking, there would be a disaster on every plate (not to
mention a plethora of food borne illnesses:)). This is the disaster
that a lot
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f entrepreneurs create within their businesses.
We often over analyze, over plan, overreact, over...you get the point. We, as entrepreneurs, have
We often over analyze, over plan, overreact, over...you get the point. We, as entrepreneurs, have
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
to learn to K.i.s.s.(Keep It
Super Simple) our business. This way you will not waste countless
hours planning to avoid some imaginary disaster; or
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
perfecting a
secondary function while neglecting a primary one.
WHAT YOU SHOULD BE DOING
WHAT YOU SHOULD BE DOING
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
trong>
Spend your time producing the basic functions of your business. These are the functions that are essential for growth. If you are a bl
Spend your time producing the basic functions of your business. These are the functions that are essential for growth. If you are a bl
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
gger...write posts. You can work on templates later. If you
are a speaker...better your speech. Don't waste time becoming
familiar with the audio
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
system.
If you concentrate on your primary functions, your business will naturally develop some "icing" as it grows. But if you don't do this, ye
If you concentrate on your primary functions, your business will naturally develop some "icing" as it grows. But if you don't do this, ye
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
ars will have gone by and you will still be "getting ready"
for action.
Many millionaires state that their successes in life did not necessarily
Many millionaires state that their successes in life did not necessarily
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
come from there most meticulously planned actions.
Nothing you plan will turn out exactly as you plan it
anyway. Success usually comes from taking
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
actions toward a goal
and adjusting to obstacles as they come.
CLARIFICATION
CLARIFICATION
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Now I'm not saying you should just make thoughtless, uninformed
business decisions. But I am saying that, during the growth
stages, you should ens
.
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
ure that your time is being spent taking
actions that directly effect your primary functions.
Because Scrutinization breeds Procrastination and Ac
Because Scrutinization breeds Procrastination and Ac
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
tion breeds
Growth. I will be discussing the difference between proactive
action and progressive actions in a future posts. Leave your
comments..
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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