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Main Subject - The Difference Between Moving Bolts and Moving People
In the two decades that I spent in manufacturing, I toured over 100 different facilit
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
ies and observed their managers in action. I saw many who were promoted from within.
; 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
Some of them struggled to make the transition from super producer to superv
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sor. Their ability to use a wrench or a hammer didn't transfer very well to mana
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing people.
To tighten a bolt you must make it or physica
To tighten a bolt you must make it or physica
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lly force it to move, first with your fingers and later use a wrench to
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
pply torque.
The wonderful thing about people is that they will m
The wonderful thing about people is that they will m
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
ve all by themselves and will actually move much faster and easier if you enable an
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
motivate them. With people, forcing or torquing damages long term effectiveness. T
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
heir threads are easily stripped.
Isn't that the difference between
Isn't that the difference between
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
coercion and inspiration? Coerced performance is second r
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
te, at best, and is not sustainable. Coerced people initially perform but eventuall
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
quit, either mentally, spiritually or literally. Sustained, peak performance can n
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
ot be coerced. Greatness comes from inspiration. Inspired organizations attract pea
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
performers. Coerced organizations repel them.
If you were choosing an investment,
If you were choosing an investment,
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
in which kind of an organization would you prefer to invest; coerced
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
> or inspired? If you are a business owner, you make that decisio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n daily. Promoting super producers without providing with training to make a smooth
.
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
ransition can turn a well intentioned decision into a disaster. You can both lose a
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
reat producer as well as diminish the productivity in the new supervisor's department
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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