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Advice You - The Inside-Out Business Plan(tm) -- Your Small Business Plan in 10 Easy Questions
Writing a business plan for your Solo Entrepreneur business doesn't have to be a daunting project. If you can answer 10 straightforward qu
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
estions about your business, you can be ready to go.
The key to success is to answer all of the questions in enough depth that if a frien
The key to success is to answer all of the questions in enough depth that if a frien
; 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
asked you to invest in this business, you'd say yes. Most importantly, make sure you record your business plan somehow...whether you writ
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 it by hand, type it into your computer, or put it on stickie notes on your wall. Keep it someplace handy where you can refer to it when
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ou are making important business decisions. And, make sure you review it monthly--or, even better, weekly--and update it at least annually
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
1. Your Dreams: What do you want your business to provide for you? (think time, money, freedom, who you work with) Be specific--
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
how much money, how many hours, when do you want to "retire".
2. Customers: Who are your customers and what do they want/need?
3
2. Customers: Who are your customers and what do they want/need?
3
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
Products and Services: What products/services will you provide to meet customer's needs?
4. Markets: Where are your cust
4. Markets: Where are your cust
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mers and what do you know about them as a group? "Where" might be geographic, it might be what kind of places they hang out, or where they
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
go to find products or services like yours. What is their age, income, gender, hobbies, family structure, etc.
5. Your Style: Ho
5. Your Style: Ho
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
will you reach customers and what will you say? Your methods of reaching customers needs to match with where your customers are--and with
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
a message that they can relate to.
6. Competitors: Where else are your customers likely to get this need met? Find out all you ca
6. Competitors: Where else are your customers likely to get this need met? Find out all you ca
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
n about how your competitors price, market, and provide service.
7. Your Uniqueness: How will your product/service meet customer'
7. Your Uniqueness: How will your product/service meet customer'
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
needs differently than your competitors? Consider how your personal uniqueness impacts that.
8. Your Abilities: Of the skills ne
8. Your Abilities: Of the skills ne
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
essary to run your business, what do you do well, and what do you need help with?
9. External Resources: What people/technology/s
9. External Resources: What people/technology/s
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
ervices will support you in the skills you need help with?
10. Fulfilling your Dreams: How will your business provide the kind of
10. Fulfilling your Dreams: How will your business provide the kind of
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
working environment you desire, both in how much time you spend, how you perform your work, and how much money you make? Here's where the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ubber meets the road--make sure you can show how you will sell X amount of product or service at Y price, cover your expenses, and reach t
.
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
he goals you set in 1. above.
Once you can answer all these questions, have it reviewed by some trusted, experienced professionals who wi
Once you can answer all these questions, have it reviewed by some trusted, experienced professionals who wi
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
l give you objective feedback. Consider a business coach, as one such resource!
Copyright 2004, Terri Zwierzynski - Accel Innovation, Inc
Copyright 2004, Terri Zwierzynski - Accel Innovation, Inc
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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