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Cases - Of Frogs and Visionaries
It begins as an idea. Once fully developed, the idea takes on a life that has roots in marketing, research, customer service and perso
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
nal vision while wrapped in a unique blanket of promise.
The growth of the entrepreneurial spirit has much to do with creativity. The
The growth of the entrepreneurial spirit has much to do with creativity. The
; 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
following quote is not attributable to any author, but certainly goes to the heart of being a pioneer in business; “Visionary people a
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 visionary partly because of the very great many things they don't see.”
A visionary doesn’t see the obstacles. They refuse to be de
A visionary doesn’t see the obstacles. They refuse to be de
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
erred by issues others see as stop signs. Visionaries move forward because they have a dream and can’t seem to hear those who are call
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ng for their demise from the sidelines.
The story is told of two frogs that fell into a well. The other frogs came to the edge of the
The story is told of two frogs that fell into a well. The other frogs came to the edge of the
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
well and saw the futility of the effort to jump from the depths of the abyss. The free frogs told the two frogs to simply accept their
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
fate and die. One frog slumped to the side of the well and eventually died while the other frog kept jumping. The frog eventually jum
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ed high enough to clear the top of the well. When the other frogs asked why he kept jumping when it seemed hopeless he simply responde
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
, “Friends, I’m hard of hearing. I thought your were encouraging me.”
“Visionary people face the same problems everyone else faces; b
“Visionary people face the same problems everyone else faces; b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t rather than get paralyzed by their problems, visionaries immediately commit themselves to finding a solution.” - Bill Hybels
To be
To be
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
visionary a person must throw off apathy and walk forward unperturbed by common peer pressure. Each of us will have moments when we a
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
e assaulted by common sense wisdom. It is prudent to listen to the concerns of others, but the ultimate decision may rely on something
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
for which others cannot account. In some cases you must walk forward – even if you ultimately fail. Too many settle for a ‘safe’ life
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
and always wonder what they missed when dreams were never considered worth followed.
Certainly there are starry-eyed folks who seem t
Certainly there are starry-eyed folks who seem t
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
live from dream to dream and never realize a satisfactory conclusion to any of them. The end result is a lengthy list of failures wit
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
just enough dream to start something new.
The best description of the difference between dreamer and visionary comes in a quote from
The best description of the difference between dreamer and visionary comes in a quote from
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Jim Collins who said, “A visionary company doesn't simply balance between idealism and profitability: it seeks to be highly idealistic
.
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
and highly profitable. A visionary company doesn't simply balance between preserving a tightly held core ideology and stimulating vigo
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
ous change and movement; it does both to an extreme. In short, a visionary company … aims to be … both at the same time, all the time.
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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