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Imagine running a Think Tank with members and interested parties submitting hundreds of new ideas to be consi

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

dered. Some are brilliant, some are genius and some are down right wacky. Indeed, going over the endless stre

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

Examples of combination products may in

am of the latest innovative concepts is not easy at all, but it must be done. Recently an innovative entrepre

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

neur submitted an idea for review; An Ocean Wave Energy Conversion Infrastructure Concept.

We looked closely

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

at the idea and reviewed it and then I said; I can see you are passionate about energy, environment and solu

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

Combination pro

tions for humankind. Yes, I think your design makes sense and is very self explanatory by your visualizations

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

on your website. Great stuff! Your concept is simple and easy to build saving costs, meaning faster ROI, mor

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 profit and some savings can be passed on to consumers in the normal costs of energy.

You see, being a capi

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

talist, I consider efficiencies and ROI first, because if you do not have that, you cannot put 1000s of these

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

units across the planet. Luckily your design and concept solves both issues in a Win-Win situation and that

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

is the value of non-linear thought. Excellent work. His concept was all that and more and he submitted his en

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

Following aspects would a

gineering data to prove these efficiencies.

His device can be seen at Fieldstone Energy; dd to the challenges in developing combination products:

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

.fieldstoneenergy.com/" target="_blank">http://www.FieldStoneEnergy.com

Of course this is not my only re

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

ason for writing this article, rather to alert all up and coming inventors to consider another point and that

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

is that reviewing other potential solutions, innovations and concepts will help you come up with ideas of yo

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

ur own.

In fact, simply considering this concept of ocean wave generator propels thoughts for other things a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd thus is important to consider where ever those thoughts lead, even if they are different designs or concep

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

ts, they might be used for all sorts of things? Like making a Water motor for a car, motorcycle, aircraft, et

.

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

c, as it is only physics and thus the barriers of possibilities only exist in one's mind, ironically that is

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

Companies that provide selfless information through particip

indeed where you find the solutions to mankind's challenges too. I hope this article propels thought 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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