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Advice You - Lessons Learned from Successful Entrepreneurs
Entrepreneurs are a special breed of high achievers. They create things, get things started: businesses, clubs, churches, associations, even nations. Their motivations vary. Not all want to be rich. Not all want to produce a For
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
tune 500 company. Some are motivated by pleasure or civic pride or the desire for fame. Mary Madden, president of Information America, told me she and Burton Goldstein started their company because it gave them freedom and flexi
; 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
bility.
Entrepreneurs see a world that is incomplete. It probably does not yet have what they intend to create. If it does, it needs something else they just thought of.
They differ markedly from one another. But there are sim
Entrepreneurs see a world that is incomplete. It probably does not yet have what they intend to create. If it does, it needs something else they just thought of.
They differ markedly from one another. But there are sim
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ilarities. One of the most prominent similarities is the ability to perceive clearly. The ability to perceive clearly is important to many high achievers, but essential for the entrepreneur. Here is what the entrepreneur perceiv
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s:
Voids. A college student, Frederick Wallace Smith, conceived of a dependable overnight delivery system for letters and small packages. It would require a vast network of planes, trucks, messengers and electronics that did no
Voids. A college student, Frederick Wallace Smith, conceived of a dependable overnight delivery system for letters and small packages. It would require a vast network of planes, trucks, messengers and electronics that did no
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t then exist. That perception led to Federal Express.
Defects. A cartoonist perceived that most amusement parks of his day were shabby and boring. Why not create something that was improved – a theme part that was sparkling cle
Defects. A cartoonist perceived that most amusement parks of his day were shabby and boring. Why not create something that was improved – a theme part that was sparkling cle
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
an and exciting? That perception led to Disneyland.
Opportune time. Ted Turner was watching Home Box Office one evening and realized that time had come for his small Atlanta-based station to go on satellite too. That perception
Opportune time. Ted Turner was watching Home Box Office one evening and realized that time had come for his small Atlanta-based station to go on satellite too. That perception
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
led to the SuperStation and later to CNN.
Syntheses. Parker H. Petit, CEO of Healthdyne, say his success as an entrepreneur comes from his ability to synthesize data. Petit believes he “can look at a set of circumstances, the m
Syntheses. Parker H. Petit, CEO of Healthdyne, say his success as an entrepreneur comes from his ability to synthesize data. Petit believes he “can look at a set of circumstances, the m
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
arket, a product or whatever and see order and opportunities in those variables that other people seem to see and just don’t piece together.”
Continuing education. When Burton B. Goldstein, chairman of Information America start
Continuing education. When Burton B. Goldstein, chairman of Information America start
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
ed the company, one of his board members told him: “If you are still in business three years from now, you’ll be in a different business.” Goldstein says that observation has turned out to be true. “You have to be comfortable wi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h the fact that you are on a road, a learning curve and you are going to learn stuff and you are going to change.”
Continuing education is really is an extension of the process that brought about the entrepreneurial venture in
Continuing education is really is an extension of the process that brought about the entrepreneurial venture in
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
the first place. That first vision may be 20/20, but it is more likely that the first vision is only a rough approximation or the “shape of the answer,” as author Horace Freeland Judson puts it.
Continuing education is essentia
Continuing education is essentia
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
l because of changing technology. A group of managers recently told me that the technological competence of the average college graduate today will be obsolete within three years or less. What they said is true in most fields be
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
cause of the pervasive impact of the information revolution. If you don’t keep on learning, somebody else will, and put you out of business.
Continuing education is essential because the target audience is changing. No creative
Continuing education is essential because the target audience is changing. No creative
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
activity is more audience-driven than entrepreneurship. If people do not buy the new product or patronize the new store or join the new organization, the venture dies. The target may be a moving one or a fickle one. Tastes may c
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
hange. People may move physically. So, the entrepreneur must keep on learning about the target audience.
Still another similarity: the ability to do mundane tasks well.
What separates entrepreneurial activity from other creati
Still another similarity: the ability to do mundane tasks well.
What separates entrepreneurial activity from other creati
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
ve acts is its emphasis on the practical. Entrepreneurial activity is a creative act, and, as such, is cerebral. It may even grow out of pure research. But entrepreneurs must do the thousand-and-one tasks involved in transformin
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
an insight into something tangible.
Xavier Roberts of Cabbage Patch fame told me that people continually approach him with ideas they believe will make a fortune. “I don’t need more ideas,” he said. “I need people who can impl
Xavier Roberts of Cabbage Patch fame told me that people continually approach him with ideas they believe will make a fortune. “I don’t need more ideas,” he said. “I need people who can impl
.
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
ement ideas.” He knows from experience, Roberts was selling his loveably ugly little creatures at flea markets and financing his business on credit cards long before the idea became a national craze.
“Think small,” an entrepren
“Think small,” an entrepren
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
eur by the name of Fred P. Burke once told me, “Many people who have these grand visions never can take their eyes from the sky and put them down to the little-bitty takes that have to be done right here, right now, this minute.
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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