Main Subject - Business

We all love the idea of being our own boss, setting our own working hours and answering to no-one but ourselves. However, many of us are afraid that we don’t have what it takes to be a success. For m

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

ost of us the fear of failure stops us from following our dreams but I can show you how to turn your dreams into a reality in just six easy steps.

Congratulations! You have just taken the first step

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

Examples of combination products may in

on the road to starting your own business. By the time you are finished reading this article you will be on your way.

1. Overcome the fear
Is fear of failure stopping you from reaching your go

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

ls? What makes you different from anyone else? In truth we all fear failure. Even the most successful people are afraid that things will not work out but they persevere because they do not wish to li

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

ve a life of regret. Think about it. If you never try how will you ever know? Follow this simple rule and you will overcome your fear: Each morning when you get up remind yourself: “It is better

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

Combination pro

to try than to live a life of regret!” This is the first step to overcoming your fear and just doing it!

2. Outline your goals
Draw up a list of goals for the future. What is it that you reall

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

y want in your life? Whether its financial security, independence, adventure, recognition or stability it is vital that you are honest with yourself about what you are really aiming for. Grab a pen

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

and make a list of your goals.

3. Face the facts
Now think long and hard about what is at the top of the list. If it’s security and stability you will need to be brutally honest with yourself.

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

Starting a business is always risky and you need to be prepared for tough times. If you’re after a life of adventure you need to ask yourself whether your business is really going to give you that?

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

These are the things you need to consider at length and in depth before starting down this path. If, after this step you can still see the business plan working for you, then you are ready to take th

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

next step.

4. Draw up an action plan
Write down exactly what it will take to get your business up and running. Be realistic. Don’t ever lie to yourself during this step. The aim is to make you

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

Following aspects would a

r vision a reality and not a pipe dream.

4. Research
Research, research and research some more! Market research, feasibility studies and financial planning are all crucial to starting your own

dd to the challenges in developing combination products:

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

business. If these building blocks are not in place your ideas will fold like a house of cards. Be sure that you have done your research thoroughly and if in doubt: do it again!

5. Attend a ‘Start

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

our own business’ course
These courses are an invaluable way of getting to know the nuts and bolts of small business ownership. A course like this will teach you book keeping and accounting, ta

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

xation, management, how to get funding from a lending institution and much more. They are also a great way to meet similar people so you can build up a support group and often the tutor will act as a

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

mentor.

6. Make a list
The final step is to make a list and follow it. The amount of work you need to do may seem daunting at first but the easiest way to begin is to simply get started! My mos

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

Professional from academic institutions, pharmaceutical industries, health care indust

t successful friends all swear by making lists. By putting things down on paper you will become aware of exactly what needs to be done. The most satisfying thing about a list is ticking things off as

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

you go. You will be surprised how much you get done if you make a list. This is a sure-fire way to get started and once you begin you should never look back.

- Put fear behind you
- Prioritize

.

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

br> - Get real
- Make a plan
- Research
- Take a course
- Make a list and get started

Once you have taken these six steps you will have a solid foundation for a successful

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

Companies that provide selfless information through particip

business. The most important thing is to lay the ground work and follow each step. Take these six easy steps and believe in yourself and your dream of starting your own business will become a reality

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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