Main Subject - Business

If you’ve made the leap into entrepreneurship then congratulations! If you are thinking about becoming an entrepreneur then you need to keep reading this because I’m going to tell you a

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

bout what life is like as an entrepreneur from an insider’s perspective.

Most of the time entrepreneurs find that life is very different in several ways than that of an employee’s. I d

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

Examples of combination products may in

finitely do. Some of the things that are usually different in an entrepreneur’s life are responsibilities, feedback, time management, cashflow, and potential.

Responsibilities

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

> As an entrepreneur your job description could go something like this… “Brian Watkins – Responsible for taking care of EVERYTHING!” That’s right! Especially when you are just starting

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

out, your responsibility in your business may be to do everything. Your non-entrepreneur friends are definitely not in charge of handling the entire business of the company they work fo

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

Combination pro

. Be proud of it. It can be tough but sometimes it is necessary in order to reach the point where you employ others who handle everything for you. I’ve spent a good amount of time in th

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 Everything” position and am finally transitioning into a position where I can hire others to handle certain tasks for me.

Feedback
As an entrepreneur you are taking a

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

non-traditional path. When you veer off of the beaten path of being an employee you tend to get some special feedback from people on your decision. Most people will be very supportive o

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

you and wish they had been like you when they were your age. The younger you are, the truer this is. On the other hand some people will turn your entrepreneurial dreams into a negati

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

e. You will come upon these people at some point. Ignore them. In fact go as far as feeling sorry for them and tell them that you do. These people are pessimists. They consistently see

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

hings worse then they really are. The bad thing is that sometimes these people can be those who are closest to you. Keep your mind focused on the positive encouragement you’ve received

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

Following aspects would a

nd ignore the pessimists.

Time Management
When and how much time you have to commit to your business venture is going to depend on the current state of the business. Unlike m

dd to the challenges in developing combination products:

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

st jobs this can be very volatile and unpredictable. This goes double if you are handling most of the work in the business. There may be times where you have to work really long hours a

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

d sometimes pull all-nighters on occasion. Certain business situations don’t just affect you like school work does and your business may need you past the normal amount of working hou

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

rs of your peer’s W-2 jobs. But a benefit of this volatility is that sometimes you can be flexible and work your business tasks around your personal life.

Cashflow
Cashflow

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

for entrepreneurs is a variable. You don’t have a steady paycheck to count on. I’m totally okay with that. Sometimes you will have more money in your hand than you need and sometimes yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

won’t have enough. You may make $100 one week yet make $5,000 the next. Keep close tabs on your cashflow so your business can remain stable.

Potential
One of the sweetest

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

hings about entrepreneurship is that your financial potential is unlimited. This one of the core reasons why I chose to be an entrepreneur. Those that choose to make a career out of wor

.

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

ing for others rather than having others work for them are automatically placing a limit on their earning potential.

There you have it! Those are some of the real differences involved wi

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

Companies that provide selfless information through particip

h the life of entrepreneurs. Overall these differences in responsibilities, feedback, time management, cashflow, and potential add up to an extreme advantage for capable entrepreneurs

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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