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Most business people feel that Non Profits are highly inefficient like government agencies. Few wo

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

uld deny that government agencies are inefficient, yet many hold short when criticizing non-profit

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

Examples of combination products may in

; why is this? Well we know from watching disaster response that many non-profit groups operating

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

on a shoestring get the job done. They are often much more efficient than government throwing huge

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

amounts of money at each problem.

Are all non-profits inefficient or just the large organizations

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

Combination pro

? Are non-profit groups inefficient in all nations? One business management consultant recently sp

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

ke of the situation in Canada; Rather, I have seen governmental and non-profit agencies around us

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

here in Canada that are wasteful and inefficient.

That happens everywhere bureaucracy is. So, NGO

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

, Government and the largest non-profits are always having this problem. But on the flip side look

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

at GM, IBM, etc. Corporations also are often inefficient; even cheat to hide that fact to keep up

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

shareholders equity and quarterly profits by calling in favors from government regulators, switche

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

Following aspects would a

roos on book-to-bill ratios or even cooking the books. Many are top-heavy, slow to get out of thei

dd to the challenges in developing combination products:

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

own way and such.

You know the school systems, United Nations, even the US Military has its mome

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

nts and you just look and say; "Oh my gosh, can't they do better than that?" All bureaucracies of

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

umans stagnate. Sports teams, which get too cocky, legislatures, committees? Our Canadian Business

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

Management Consultant is right; I see it too.

Nevertheless many non-profits are much more effici

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt than Government Agencies and it is good to see that government agencies realize this and subsid

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

ize them with funding rather than trying to do it themselves. Most businesses with a profit motive

.

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

run more efficiently than both non-profits and governments. This should be discussed in all Busine

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

Companies that provide selfless information through particip

ss Management Schools even those which are the most liberal in thinking. Consider all this in 2006

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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