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If you do not have any money and want to start a new venture, do you give up and

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

wait or do you find a way to get it done? If you take the conservative route your

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

Examples of combination products may in

answer will be I will wait until I have enough cash to get the idea going. But ho

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

w long are you willing to wait? How long will the opportunity last?

Smal

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

questions that deserve long answers. You need to look at the problem from many a

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

Combination pro

gles.

First Analyze the opportunity. Do not just rely on your pa

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

ssion (although passion is important). Do some research and find out if there is

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

market and if money can be made from it. Survey potential customers to see if th

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

ey would buy the product or service and how much they would pay for it.

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

Second Do some more analysis by locating competitors (if it is a really ne

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

idea there may not be any). Get to know that competitor through their products,

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

Following aspects would a

the price points, and how they are sold and how successfully they are selling. <

dd to the challenges in developing combination products:

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

r>
Third If you still think there is a market, do a forecast for sales,

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

and what resources (both financial and people) are needed to make the opporunity

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

worth the effort.

Finally Find the money from different sources.

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

ou can apply for a business line of credit, private lenders, or other places. Thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s is time to be creative and find ways to make the opportunity work for you. If y

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

u are extremely conservative, then this may be too risky a venture. If you love r

.

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

isk, then go for it and see where it leads.

For me - I almost always go

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

Companies that provide selfless information through particip

or it as long as I have done my homework and know the potential wins and pitfalls

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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