Advice You - Business

Erupting from the mind are often debates of challenges and issues plaguing mankind. Caught up in the sound and fury you c

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

an hear folks get worked up, by the mass media hysteria as they spar with jaded opinions jousting one another. Of course

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

Examples of combination products may in

at the Online Think Tank cooler heads prevail and indeed the topics are highly intellectual spanning subjects in nearly e

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

very domain.

Recently the topic came up with regards to patent piracy of Computer Software and Hardware. One Think Tanke

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

r asked in so many words; Is Silicon Valley Over Charging for The Products They Produce?

Well, in a way they are over ch

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

Combination pro

arging, so that all the players get paid; R and D, Venture Capitalists, Entrepreneurs and workers with a outrageous cost

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

of living there (micro-economic disaster). But remember the costs to produce technology. If you do not have to pay for th

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

e R and D and steal it for free then you can have zero-royalties and/or the whole price to the retailer.

Not just the in

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

cidental component price you were contracted to make. (of course we are talking computer technology types). But the Chine

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

se are also stealing other technologies like Laser, Military, Satellite, missile, space, submarine, biotech, nanotech, et

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

c. It poses a grave threat not only economically.

Although my uncles produce and manufacture high-tech stuff there, it i

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

Following aspects would a

s not conducive to profitability wise. They grew up there, Stanford Grads; grandfather was a Stanford scientist. The cost

dd to the challenges in developing combination products:

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

s in the valley just do not work and much has to do with the bay and the layout, without concentric rings around the area

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

, the darn bay is in the way. Look at a map and the population and you can see why economically it is an inefficient area

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

to for labor draw. Robotics only partially solve this issue and real-estate is another huge deal.

Indeed although I rea

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

lize these comments are not part of this conversation; Silicon Valley is set up very poorly land use wise and it is not s

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

Professional from academic institutions, pharmaceutical industries, health care indust

pread out like a Houston, LA or Kansas City. Cost of living is a big factor. So Silicon Valley with limited space (Bay an

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

d Mountains) is a victim of its own success.

To us they are overcharging, to them they are mass producing and offering a

.

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

fair price, due to their artificially increased prices. That said, it does not justify stealing by the Chinese and then

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

Companies that provide selfless information through particip

capitalizing on their thievery of intellectual property. I certainly hope that this article is of interest to you in 2007

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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