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So, you have just come up with the best one-of-a kind idea since sliced bread and want to start your own business. Congratulations, you are on the road to the American dream of becoming an entrepreneur! Now let me extend my deepest sympathies for the pain you will experience as you try to get your business launched.

Hey, don’t stone the messenger; I’m not the only Negative Nelly on this topic! Th

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

e facts are, as stated by the Small Business Administration, 80% of small business start ups close within the first five years. But, maybe you and your idea are different and you are prepared to beat the odds. If you still want to give it that ol’ college try read on. (My apologies to those of you whom I have completely devastated. However, keep in mind that if you are still reading and I haven’t

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

scared you off yet…you could have what it takes to start your own business.)

Have you ever wondered why we are in awe of the Bill Gates and Martha Stewart’s of the world? Have you ever wondered why they are one-of-a-kind kinda’ guys/gals and are so well known? Well, I think it has something to do with the blood and guts they had to donate to start & be successful in their own businesses. Anyon

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 can start their own business, but only 20% of those starters are still in business after five years and even fewer are actually running a successful business; that means making money. So, this journey definitely takes more than what 80% of us have. Are you still reading? Ok, you may have what it takes.

What it takes to start your business (we’ll leave the part about actually being successful to

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

nother article) is what I refer to as the “Eight Steps to A Successful Start”:
1. Determine Your Niche,
2. Identify Your Ideal Client,
3. Develop Your Unique Value Proposition,
4. Create Your Brand,
5. Prepare a Business Plan,
6. Prepare a Marketing Plan,
7. Develop a Sales Strategy, and
8. Accept failure, learn from it and re-group

Please note that

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

the first eight steps have nothing to do with what you actually want to “do” in your business. In other words, if your dream is to be a career coach, you won’t actually be coaching clients until you have been a marketer, sales person, financial expert, and strategist. Oh, and for those brave Internet entrepreneurs you will also have to become an Internet guru. Note: if you know what mega-tags ar

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

e, congratulations you are well on your way! Back to my point, what is important to keep in mind is that for most business launches it takes a full two years before you are “doing” whatever it is your business is all about and before you are ever the business owner of your dreams. Still reading? You are already beating the odds!

Let’s take a look at Step One, “Determine Your Niche.” Your niche i

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

s determined by defining exactly what group of consumers will be your customers. This group will consist of people who have specialized interests and needs, and have a strong desire for your service or product. An example of a strong need would be an attorney who needs a well organized back office system to keep track of past and current case loads. The group in this case is “attorneys” and the sp

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

cialized interest/need is all about well-organized back office systems. So, if your product is a well-organized back office system for attorneys, this guy/gal is in your niche.

Once you have identified a group with specialized interests and needs, now known as “your niche”, you have to ask and come up with answers to the following questions:

Will this group spend money for my product/service? And

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

, do they have the money to spend? A good way to tell is if they have spent money for similar products/services in the past. For instance, “moms” might be a great target market for a new type of stroller, especially since they have spent money on similar products. However, not all new moms have money to spend on a new stroller. You would then want to specifically target moms who have more disposa

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ble income – i.e. extra cash for your one of a kind stroller!

Can I easily find and then reach this group of people? Physicians are easier to locate than moms. Why?, well one reason is because physicians are listed as a group in the yellow pages. So, if your have a product/service that targets a professional group such as physicians you will have an easier time reaching your niche. Whereas, if y

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ou are targeting moms it might be harder to find that group, since they don’t yet have their own heading in the yellow pages!

Is this group large enough that I can make money selling to them? If your product/service is eye patches for one-eyed pirates, you may need to expand your group. However if you are selling a new bra to women who have had breast enhancement surgery you might have a hit!

Is

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

his group small enough that my competition would overlook it? Yes, your competition might have over-looked the one-eyed pirate market, but that is because this group is too small. However, if your product/service is directed towards a specific need that a woman who has had breast enhancement might have, you might just have the perfect small market.

Have you been a part of this group? You must kn

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ow the needs of your niche market. The best way to know those needs is if you have been in that group and understand the group’s dreams, desires and needs. If you have ever been an attorney, who had need of a well-organized back office, then you would be well prepared to create and offer this service to attorneys.

Is this a group you would enjoy working with exclusively? Maybe you once were an at

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

torney and that is where you came up with this great back office system. That’s great, but if you got out of the litigation business because you couldn’t stand your peers….you might want to re-think your idea of selling your handy dandy back office system to attorneys.

Can you see yourself creating other product/services for this group? No one wants to be a one-hit-wonder, ala Billy Ray Cyrus and

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

his Achy Breaky Heart! Once you have sold everyone in your niche one of what you have to offer – where do you go from there? If your price point is high enough, maybe you go on to retirement in Hawaii, however, if you are selling a $1.99 product, you will need a way to expand your line as your business grows.

Are you passionate about your product/service? The amount of time and energy, or as I

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

entioned earlier “blood and guts” that it will take to launch a business is huge! You had better passionately believe in what you are doing and whom you are doing it for, if you want to successfully launch your business.

Well there you have it, the first step in launching your business; Determining Your Niche. Take some time and answer all of the questions outlined above for your product or servic

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e. You might find that you want to make a few modifications to fit your niche or maybe you need to change your niche to better suit your business. Either way, just by taking the time to complete this first step you are already on the road to the American dream of becoming an entrepreneur. Congratulations! (And, a little sympathy for your time and trouble!)

In the coming weeks look for “So, You

.

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

Want to Start Your Own Business? May I Offer My Congratulations and Deepest Sympathy? Part II: Identify Your Ideal Client”

Keep in mind that a career coach can help you through all of these business launch steps. Career coaches act as guides on a journey of greater self-awareness and clarity, helping you to find your true passion. Your coach can help you create an action plan to get from where

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

you are to where you want to be in your career and in your life. Once you are working in your strengths you will find you are passionate about what you are doing and the journey is not as painful as if you had made it alone.

To find out how a coach can help you, contact SmartWork Career Coaching @ 805.376.1906. One of our Career or Executive Coaches will be happy to discuss your coaching options

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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One of the most serious considerations in mining or collection of raw materials is the transporting of these resources to processing or market. Same for oil, natural gas or mining materials; costs of transportation are important in mining. Most mines still in business today are in very close proximity to major rail lines, even with all the regulations and rules that exist some mining still exists in the United States. An example is the Borax Mine near Dagget, CA.

Little did Abbey Swisher know that a switch to fashion design degrees would help her become a fashion designer.

The words that strike fear in all working people -- fired, terminated, laid off, let go, restructured, dismissed, downsized, rightsized -- translate into only one thing: You're back in the job market and beating the street for new employment opportunities.

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