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Every industry has an association and for the most part it seems that it would be valuable for business perso

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

n to join that association. The theory here being that there is safety in numbers and when you consider the

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

Examples of combination products may in

ize of the government at all levels that is a lot of blob of bureaucracy to combat. An industry association

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

an hopefully help you navigate the myriad of rules and regulations in your industry.

However a small or medi

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

m-size business person must be aware that often industry associations are formed to help the larger fish and

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

Combination pro

he bigger players or corporations in the industry. They are not necessarily made to help small business is c

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

ombat over burdensome regulations. This causes another problem for the small entrepreneur.

Do you help the

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

ndustry association succeed by helping them with your ideas and innovations, which will most likely be borrow

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

d by larger companies and used to compete with you or do you go it alone without industry association help?

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

f you go it alone you might find yourself battling the association and the government regulations on your own

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

although you will have the advantage over the competition without leaking vital information.

There is a thi

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

Following aspects would a

ng called rule breakers and rule makers. The rule breakers are considered new entrants to an industry that m

dd to the challenges in developing combination products:

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

ve very fast and try to work around the rules and regulations finding areas that are unregulated so they can

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

ove quickly in the marketplace. Once a company succeeds and gains a sizable business then they try to make r

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

les along with the industry associations and perhaps sitting on committees for government regulation making s

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

ssions to create barriers to entry for the smaller businesses that are coming along.

If you are one of the s

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

Professional from academic institutions, pharmaceutical industries, health care indust

maller businesses trying to get a foothold you may find that the industry Association is willing to sell you

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

own the river and feed you to the dogs or rather the regulatory bureaucracy by trying to create new rules and

.

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

regulations and barriers to stand in your way. You must understand that often industry associations work on

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

Companies that provide selfless information through particip

primate politics and Machiavellian type rule. Please consider this, that is all I ask of you in this lesson

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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