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Over the past week, I had the great pleasure of speaking with three amazing individuals who recently joined my newsletter.

It was wonderful to learn about their pas

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

t accomplishments and future goals for their home-based businesses.

Although all three were experienced and successful in previous business pursuits, the challenges

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

Examples of combination products may in

of overwhelm, lack of focus, and even a pinch of self-doubt were creating a block for each of them.

Regardless of whether you're a new home-based business owner, or

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

a seasoned entrepreneur, taking on new challenges can sometimes be daunting, to the point of almost paralyzing.

The important thing to remember is it's all a matter

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

of perspective and choice.

If you are experiencing a self-limiting belief that is blocking your progress, consider the following …

- What past accomplishments are

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

Combination pro

you enormously proud of? (Don't be humble here!)

- What strengths, skills and abilities contributed to these successes?

- Is there any reason why you would no long

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

r possess these same qualities?

I'm willing to bet dollars to donuts you not only possess those same qualities, but are also wiser and much more experienced than wh

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

n you first set out to accomplish those goals.

If you are lacking a skill required to achieve your goal, is there any reason why you can't develop it? If you don't

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

have the time or inclination, can you find someone who does and have him or her assist?

If overwhelm is creating lack of focus, confusion and a sense of spinning yo

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

ur wheels, consider the following …

What can you say "no" to starting today? Do you have to respond to every e-mail the second it arrives or answer the phone ever

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

time it rings? Can you create a pocket of time where the phone, e-mail and interruptions are not permitted?

What can you delegate, starting today? Instead of f

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

Following aspects would a

lding brochures and stuffing envelopes or opening your own mail, can you enlist the aid of one of your children or an assistant? Can you create more time for yourse

dd to the challenges in developing combination products:

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

f to work on building and growing your business instead of being detracted by daily repetitive tasks?

What can you say "yes" to starting today? Has someone offered

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

to help, but you choose to do it all by yourself? Can you relinquish control and accept the help of others? Hang up your superhero cape and take the heat off your

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

elf. Others may amaze you with what they can do!

Breaking your goals down into bite size pieces. What do you want to accomplish in the next three months? You do

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

't have to carry your five-year plan in your mind every single day. By all means, know where you're going, but focus on the immediate task at hand and deal with it

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

Professional from academic institutions, pharmaceutical industries, health care indust

nly. Creating home-based business success is a marathon, not a sprint.

If you don't have all of the answers, who might be able to provide them to you? Doing it al

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

l alone is tiring, frustrating and makes for really slow progress. If you can avoid making mistakes by learning from someone else who has already made them, what ki

.

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

d of time will you save?

All of the benefits and freedom of being a successful home-based business owner are available to you. All that is required on your part is

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

Companies that provide selfless information through particip

a strong belief in yourself and a knowing that your success will ultimately be determined by your perceptions, your choices and your actions.

You can make it happen

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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