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You will need certain skills and experiences to start and run a successful business. Many business owners hire personnel to supply the skills

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

that they lack. Below are a few questions you should answer to help you identify your skills. By answering the following questions, you can

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

Examples of combination products may in

identify the skills, abilities, knowledge, and experience you possess or lack.

1) Do I have any skills to start and run a business?
2)

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

Do I have any formal or informal business training?
3) Do I have any experience in a business similar to the one I plan to start?

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

r> 4) Do I know what skills to look for when hiring personnel?
5) Will I be able to determine if the applicants meet those skills?

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

Combination pro

6) Do I have the time and resources to get additional training?
7) Can I use the skills I already have in this business?
8

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

Do I have good people skills?
9) Will I make a good supervisor?
10) Do I have the financial or record keeping skills to run a bus

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

iness?

After doing an analysis of your skills, you can then determine which business is right for you. If you like working with people, you

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

would not be happy with a job working on a machine in an area where there is no contact with the public. If you want more control in your lif

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

, then you probably would not be happy in a partnership. Do you consider yourself a morning or night person? If you like working at nights,

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

hen a 24-hour copying business would be appropriate for you.

Do you consider yourself as a friendly service -minded person who is willing to

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

Following aspects would a

help others? If so, then you would do well in a business that deals with providing a service to customers on a one-on-one basis. Many people

dd to the challenges in developing combination products:

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

with these characteristics often participate at craft fairs, trade shows and conventions because they like dealing with people.

Do you like b

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

ing a leader and handling responsibilities? Then you would enjoy working in a position where you are the boss and can make all the decisions.

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

In a position like this, you will be responsible for yourself and for others. To me, “Recognizing the skills that you do not have and getti

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

g someone in your organization to do that work is a form of good management.”

Are you interested in taking my online courses?

To the new and

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

Professional from academic institutions, pharmaceutical industries, health care indust

experienced entrepreneurs, getting help with your small business is very crucial to your success. Getting the right help will cause you to av

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

oid costly mistakes, and it can also help you to save a lot of time, money and energy. You will need to get the right help to form the legal

.

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

tructure of the business, financial, management, procurement/certification, marketing, pricing products, preparing a business plan, and more.

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

Companies that provide selfless information through particip

If you are a business owner who is wondering if you can take your business to new heights, contact Dr. Waters at tina.waters@waienterprises.co

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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