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So often entrepreneurs have a concept and yet they have not thought through all the det

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

ails. As a former founder of a franchising company, I had to know everything about my i

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

Examples of combination products may in

dustry and all the sub-sectors we competed in. I had to know all my competitors and the

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

ir ancillary markets they competed in.

I had to understand their customers and my cust

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

mers. How they bundled products and services and how they marketed their wares. I had t

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

Combination pro

know every possible pitfall and every potential risk.

Today, entrepreneurs simply do

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

not get it. In fact as the founder of an Online Think Tank, I am often amazed at the la

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

k of knowledge that they have. You ask them a simple question about their industry and

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

they just do not get it at all. They do not know the answer and they say; “well I don’t

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

know, I have never thought about that.”

Indeed, you feel like pulling them aside and s

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

ying; “Look you had better damn well know about it, because some institutional investme

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

Following aspects would a

nt banker, venture capital shark or large corporate investor partner is going to ask yo

dd to the challenges in developing combination products:

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

that. And a whole lot more questions too.

If you are searching for Capital; You bette

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

r know your Industry backwards and forwards with no exceptions. Actually you might ask

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

hy this upsets me so much. It is because you must be able to walk the talk and today so

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

many of these folks seeking capital don’t have the right stuff, they do not understand

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

Professional from academic institutions, pharmaceutical industries, health care indust

what they are talking about and have not thought it through properly.

They are basical

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

y a disaster waiting to happen. I certainly hope this article is of interest and that i

.

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

s has propelled thought. The goal is simple; to help you in your quest to be the best i

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

Companies that provide selfless information through particip

2007. I thank you for reading my many articles on diverse subjects, which interest you

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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