Subjects - Business

Often folks build in redundancy for systems just in case Murphy Strikes and he will. The more compl

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

icated a system is the more possibilities of system failure of one of its components. In aviation w

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

Examples of combination products may in

e discuss multi-engine aircraft and what happens if you are in a single engine aircraft and the eng

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

ine quits; then it would sure be nice to be able to keep going on the remaining engine right? Sure,

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

makes sense right?

Indeed and now lets take a four engine plane; with four engines there is 4 time

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

Combination pro

s the chance of one of the engines quitting and that means once you do land you cannot fly it until

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

it is fixed. Bummer and there fore some might contend that redundant systems add too much costs an

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

can reduce efficiency and cause a worsened situation over all.

Fore if the single engine aircraft

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

’s engine is running rough, well don’t fly it! Indeed who could argue with that logic. Nevertheless

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

, in reality some redundancies are needed in systems built by the lowest bidder by humans obviously

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

But even consider the human error problem aside Arthur C Clarke often discussed the Ramans Race an

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

Following aspects would a

d their triple redundancy, which often got them out of a jam too.

Systems which can re-route thing

dd to the challenges in developing combination products:

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

s work best. For instance look at transportation in the United States of America. If a train track

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

has a landslide on it, the freight can be re-routed on other tracks or go by truck. If a highway ov

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

r pass is out the freight can go by train, the important stuff by plane. Redundancies matter.

Addi

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

tionally consider if you will electrical systems, water systems, power systems and data streams, ro

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

Professional from academic institutions, pharmaceutical industries, health care indust

uters and satellite relays. Redundancies protect the system and save humans from themselves. Redund

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

ncies are therefore needed in systems and this should be quite evident both in theory and reality.

.

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

I have numerous examples of this and too many to list probably 100 articles worth in fact. So make

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

Companies that provide selfless information through particip

your systems as best you can, Super Systems, but never forget Murphy'ism. 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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Subjects - Redundant Systems vs Super Built Systems

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