Useful Advices - Business

As an entrepreneur you are faced with the daunting task of not only having to have a deep understanding of your product or service, you also must have a sound general knowledge of business management, record keeping, accounting, business finance, marke

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

ting, advertising, sales and law. There is also a host of other areas of business that can you must learn and many of these can only be learned by hands-on experience. This requires you to have at least above average intelligence and above average de

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

Examples of combination products may in

ication to learning and personal growth. This is tough to do when you are juggling the details of setting up a business, studying and learning, trying, failing and starting all over again across a spectrum of activities. Daunting, very daunting.

As

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

hard as you may try, there is simply not enough time in a day to be good at everything. In fact, it is impossible. You may excel administratively in 1-3 areas but not all. For example, you may be a great manager and know little or nothing about acco

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

nting and law or sales. And if you try and perform all these business tasks yourself, you will eventually crumble under the workload and you and your business will fail.

One way to overcome this problem is to surround your self with professionals and

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

Combination pro

people with specialized knowledge you lack. For most start ups this means you need professional assistance with accounting, law and marketing.

Let’s assume your hands are tied financially (which they are most often for small start ups) and you don’t h

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

ave the money to recruit these professionals. What do you do? The answer is simpler than you would think. The key to getting the pros to join your team is to offer them a piece of the business in exchange for their services. Now, you want the trans

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

er of equity in your business to happen over time contingent upon the performance of the professionals rendering services on your behalf. In other words, you want to “pack the board of directors” with professionals that have a financial interest in th

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

health and well being of your business and have them perform high quality service on behalf of the organization.

The most strategic first associate you should seek is an attorney. First, a lawyer can give you legal advice and produce legal documents

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

you may need to run your business including legal compliance with state and federal authorities. Additionally, lawyers tend to be well networked with accountants and bankers.

The second most strategic associate is finding a good accountant. You att

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

rney may suggest some possibilities or you may already have an accountant (who may be able to recommend an attorney to join your mastermind group). Besides handling your accounting, accountant's tend to be well networked with lawyers, bankers and poten

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

Following aspects would a

ial investors.

Ideally you want to “pack the board” with a banker too. Your lawyer and accountant may be able to help draw a banker into your organization and this will be a real benefit if you plan on seeking investment capital for your business bec

dd to the challenges in developing combination products:

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

ause investors will look at the credentials of the management “team” rather than you individually. And don’t forget to seek out a marketing person or firm to join your team.

This is called forming a mastermind group and it is critical to large succes

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

. Your organizational thinking capacity is far greater with the collective intellect of your board pondering the issues facing your business, rather than you alone. Your board of directors, if selected carefully, can be an unstoppable force toward su

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

cess.

There is only one requirement for this process to work: Your business idea must be sound. You must have a written business plan backing that idea and that business plan must meet generally accepted standards. Without a sound idea and a plan, yo

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

u will not recruit these associates. More important then the business plan is the soundness of your idea. The lawyer or accountant can write the plan if you can convey the idea well. Make sure you have a non-disclosure, non-competition agreement befo

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

Professional from academic institutions, pharmaceutical industries, health care indust

e you start telling everyone your idea. Another good reason to get an attorney first!

The key to success is knowledge. You need your knowledge base and you need to understand how to get other people to use their specialized knowledge to help you ach

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

eve your goals and objectives. And if you have no money, then all you have is your idea and the power to give away fractional amounts on interest in the business to people in exchange for their services. Remember that 100% of nothing is nothing and i

.

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

t is often better to have a controlling 51% of a business and dole out 49% of stock or equity in exchange for the people with which you can pack your board.

Can you do it? Yes, if your idea is sound.

Do you like this tip? You haven’t seen anything y

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

Companies that provide selfless information through particip

t! Check out our Smart Books Business products by clicking the link below. We have business kits, books and ebooks to help you get smart-fast. Check us out…. We’ll save you a TON of time and money.

Copyright © 2006 James W. Hart, IV All Rights reserve

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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The ability to make the right decision at the right time is the most desired quality in any business entrepreneur. And there are certain business decisions that can take your entrepreneurial ambitions further ahead than others. The decision to incorporate your business is one such decision that can affect the future of your business in a positive direction.

Ever wonder how many disposable lighters are tossed in a garbage can every day? Probably not, but I have found a unique product that will show you just how useful some trash can be!

Companies must take certain issues into perspective before franchising a company. The first would be to get the franchise registered with the U.S. Trade Mark office. A Trade Mark attorney would be able to take care of this process. The company needs to register the names of all the states where the franchisees are most likely to be opened. They must register for multiple units if relating to more than one franchise operation.

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