Useful Advices - Business

All businesses start off losing money with all of t

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

he high start up costs involved and the marketing t

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

Examples of combination products may in

at has to be done in order to get the business out

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

o the public. Due to the fact that all businesses s

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

art off losing money it is sometimes hard for a bus

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

Combination pro

ness owner to understand when it is time to give up

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

and close the business down.

I was in this situati

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 before and it was difficult to determine what to

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

o. I did not know whether to keep the business goin

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

or give up and move on to a more promising venture

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

Their were several things that decision to close d

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

Following aspects would a

own an easy and smart choice.

One of the first thi

dd to the challenges in developing combination products:

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

gs that helped me decide to close the business was

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

lack of financing. I had the good credit to obtain

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

financing if I would have like to but one of my goa

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

s was to self finance the venture. In addition I wo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ld have needed around $20,000 which is more than I

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

ould have like to receive at the time. Another issu

.

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

was the fact that I had several ideas that were le

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

Companies that provide selfless information through particip

s expensive to do and had shorter break even points

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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Useful Advices - Closing A Business- When Is The Time Right?

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