Cases - Business

Most people have fears about starting and maintaining a business. Fear will cause you to procrastinate and constantly put 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

ings off, including starting a business. If this happens, eventually you will find out that anything you start you never fin

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

Examples of combination products may in

sh. It is important to deal with your fears so that you can get things accomplished and be able to move on with your life.

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

isted below are the top ten fears people have about going into business.

1) Lack of financial resources such as obtaining

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

oans
2) Record keeping and taxes
3) Lack of self confidence
4) Lack of self-esteem
5) Finding tru

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

Combination pro

stworthy employees
6) Business Failure such as bankruptcy
7) Security
8) Lack of knowledge on starting

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

a business
9) Rejection such as too much time away from family members and friends
10) Long hours/hard work

Jus

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

like anything else that you are afraid of doing, you will stay away from it. For example, some people are afraid to fly so

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

hey stay away from airplanes and they use other means of transportation to get them where they want to go. Even though it ta

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

kes them longer for them to get to their destinations, the fear of flying keeps some people from boarding an airplane. A few

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

people do get enough courage to face their fears’ head on and take that first airplane flight, while many others don’t becaus

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

Following aspects would a

of fear. Those who take their first flight will say later than it was not bad at all and that they do not know why they wer

dd to the challenges in developing combination products:

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

so afraid to fly. What I am saying is that your “fear is real” and it can stop you from doing a lot of things including sta

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

rting and running your own business.

Make a list of the fears that you believe have caused you to put off starting your own

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

usiness. Once you have control over your fears, you will be more successful with starting and managing your business.

Are y

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 interested in taking my online courses?

To the new and experienced entrepreneurs, getting help with your small business is

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

Professional from academic institutions, pharmaceutical industries, health care indust

very crucial to your success. Getting the right help will cause you to avoid costly mistakes, and it can also help you to sa

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

ve a lot of time, money and energy. You will need to get the right help to form the legal structure of the business, financi

.

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

l, management, procurement/certification, marketing, pricing products, preparing a business plan, and more. If you are a bus

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

Companies that provide selfless information through particip

ness 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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