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Useful Advices - Top 10 Stumbling Blocks that Limit Business Growth
Never in history have more entrepreneurs launched more new businesses! In America, thousands of business open their doors every single day! Unfortunately, most of them (over 90% of them) also close the
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
ir doors within two years. Businesses are started with high hopes and glorious dreams. It is easy to start a business. It is much more difficult to build it, to make it succeed, to avoid the traps and
; 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
pitfalls and frustrations, and enjoy the fruits of success over the years. In working with hundreds (probably two to three THOUSAND) entrepreneurs over 25 years, here are the mistakes I see most often.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Avoid them!
1. Fear and Confusion. There is either a sense of being over-whelmed by the size of the tasks, or a refusal to master the work of being an entrepreneur and business owner. There are spe
1. Fear and Confusion. There is either a sense of being over-whelmed by the size of the tasks, or a refusal to master the work of being an entrepreneur and business owner. There are spe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cific skills to owning and running a successful business. Learn them! You can master this! You can focus and succeed! (This is often the time to hire a coach!)
2. Lack of Capital. Capital comes in th
2. Lack of Capital. Capital comes in th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ee forms: Time, money, and energy. Some people have one or two, but not all three, and they fail because they simply can not sustain the growth phase of their business. EVERY business is a commitment
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
of everything you have. You may start “small”, but that does not mean casual or part-time!
3. Lack of Courage or Commitment. Building a business is always risky. Some people perceive the risk as frig
3. Lack of Courage or Commitment. Building a business is always risky. Some people perceive the risk as frig
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
tening, others see it as an exciting challenge, but there is always risk. Manage it. Limit your potential losses. Understand the risks and enjoy the process. You will make mistakes. Learn from them and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
go on.
4. Refusal to select and target an audience. No one can sell their services to “everyone” – a message that goes to everyone is unlikely to create a sense of urgency in anyone in particular. A
4. Refusal to select and target an audience. No one can sell their services to “everyone” – a message that goes to everyone is unlikely to create a sense of urgency in anyone in particular. A
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
torneys focus on one type of law. Physicians specialize. So should you.
5. Choosing the wrong audience. A market that can not or will not pay or an audience that is too small or dispersed is a recipe
5. Choosing the wrong audience. A market that can not or will not pay or an audience that is too small or dispersed is a recipe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
for disaster. The “poor” desperately need medical, dental, legal and other services, but who is going to pay you? The same problem exists when trying to reach an audience that is dispersed over a larg
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
e geographic area and not easily identified.
6. Fuzzy or unfocused message. What exact benefits do you provide? To whom? Under what circumstances and at what cost? How can people contact you? Be prec
6. Fuzzy or unfocused message. What exact benefits do you provide? To whom? Under what circumstances and at what cost? How can people contact you? Be prec
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
se, be clear, be specific.
7. Lack of planning – too many random efforts. Many entrepreneurs try a little radio, a direct mailing, join a service organization, offer free samples, and then report tha
7. Lack of planning – too many random efforts. Many entrepreneurs try a little radio, a direct mailing, join a service organization, offer free samples, and then report tha
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
t they have “tried everything and nothing worked”. Pick one, and stay the course! You become identified with your marketing techniques. Choose a logo, a color-scheme, and a marketing technique and stay
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
with it!
8. Too much advertising, too little relationship building. Advertising works best for tangible products because customers can see the results. Intangible services are very difficult to adver
8. Too much advertising, too little relationship building. Advertising works best for tangible products because customers can see the results. Intangible services are very difficult to adver
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
tise and are almost always purchased based on the quality of the relationship. The more people know you, and the more they know about you and your caring, your professionalism and your quality, the mor
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
business you will do. Build networks of relationships!
9. Laziness and/or Greed. Your business ONLY exists to serve the customer! You must make a profit in order to continue serving the customer, bu
9. Laziness and/or Greed. Your business ONLY exists to serve the customer! You must make a profit in order to continue serving the customer, bu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t service is the key to success. Everything must be focused on that. The statement, “I want to be my own boss”, or “I want a business that supports me” may be true (and be totally honest and reasonable
.
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
, but they are a dangerous focus for your business. Customers first!
10. Having a product or service that fails to produce adequate benefits, or fails to serve as promised. Some professionals are inco
10. Having a product or service that fails to produce adequate benefits, or fails to serve as promised. Some professionals are inco
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
mpetent. Some don’t use current technology, or are sloppy in their delivery. Particularly with services, even ONE mistake will undermine client confidence, loyalty, and trust. Do your best – every 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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