Answers - Home Based Business

Many small and home based business owners I know are control freaks. Now in their defe

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

nse, it’s because they wear many hats. They started the business and took care of it a

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

Examples of combination products may in

l, that is how the saying “the business owner wears many hats” came about. He or she i

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

the owner, accountant, secretary, payroll administrator – you get the idea.

Unfortun

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

ately what happens when the business becomes successful and a business owner has to st

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

Combination pro

rt hiring employees or using independent contractors is they can’t let go of the contr

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

l, they don’t know how to delegate.

Now, this is not only a problem with small and ho

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

me based business owners it also happens with larger businesses too. How do I know, be

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

ause over the years before we ran our own business, I worked for many of them in Corpo

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

ate America. I have had the perfect boss who gives me credit for having a brain and le

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

ting me use it. However, I have also had to work for those who wanted me to check with

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

Following aspects would a

them for every little thing, sometimes as mundane as office supplies. As a business o

dd to the challenges in developing combination products:

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

ner you want your employees to be happy, creative and productive, however, they can’t

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

o that if you are hampering their abilities. If you didn’t trust them to do the job yo

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

u hired them for, why did you hire them.

Business owners as hard as it might seem, yo

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

need to learn to let go and let the person you hired do their job. Otherwise, fire th

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

Professional from academic institutions, pharmaceutical industries, health care indust

m and do it yourself, because all you are doing is paying for someone you are not usin

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

g to their full potential. Sweat the big stuff and not the small stuff, and let them

.

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

o their job.

So let this be the day you start to delegate and you will find you will

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

Companies that provide selfless information through particip

ave more time for the jobs you want and need to do.

Copyright DeFiore Enterprises 200

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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