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The MV-22 Osprey testing began at the greater Wilmington airport in Delaware over twenty years ago; where the Del. air Nat. Guard holds their monthly dri

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

lls. This was where it had its first crash. Testing was then transferred to another location. All the marines and marine pilots I have spoken with, feel

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

Examples of combination products may in

hat they would rather fly it than a fix wing cargo plan.

It's a great aircraft with an unrealized potential. You have a butt load of cashbook jocks, soo

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

n to be without jobs, in a hot hybrid rotor-fixed wing that are only comfortable at 1-3000 ft and 100 or so kts. Flying the wings at 45 deg and 120kts ju

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

t isn't what the designers had planned, or what the grunts want. The plane will go 300+ if you flat the wings, but the fixed wing jocks in transition are

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

Combination pro

't the majority, nor will they have the input when the TTPs get ironed out. I say have one of each in the cockpit (fixed and rotor jocks) and let them do

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

what they do best during the three phases of sortie.

Some of the marine pilots have logged 9,000 hours on fixed wing aircraft and as I see it, the MV-2

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

OSPREY is an Accident looking for a place to happen! The V-22 osprey might not be as safe as the DC-3 but is the safe DC-3 capable of keeping up with to

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

ay's military requirements?

As with every other aviation platform it will take time to over come the bugs, heck look how long it took the 53 to work rig

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

ht and then hunted by substandard parts etc. Oh and let's not forget the harrier... Gees-o-petes the happiest Harrier Pilot I ever met were flying a desk

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

for G-2 Ops at IIIMEF. We sure could have used it for that Rawanda Op. It works and will work better.

Lots more range than 53 or 46 and lots more versat

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

Following aspects would a

le than c-130 or previously mentioned helos. Again, once the bugs are worked out. Well obviously they have/are being worked out. The USMC is now replacin

dd to the challenges in developing combination products:

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

g there Sea Knights with them. It's a great new capability. As I said previously it has taken over twenty years to get to this point. This shows a future

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

need for this type of aircraft.

I'm sure after all this time, if not already, the bugs left can be worked out. We know that there would be no use for th

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

m while in plane mode. You could at least put the guns on the side and fix to front of the engines to give some kind of suppressive fire, instead of noth

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

ing. last thing is what difference does is it make not having a chin mounted gun, the thing already costs too much you might as well give it a gun or it

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill be defenseless and most likely be shot down.

It was one of the unfortunate ones in Dec 2000 at one of the Osprey crashes. At that time I felt it was

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

best to "DUMP" the osprey. But after seeing much work being done on this aircraft and learning how it truly does fly, I now think we must push forward an

.

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

d transudation to this aircraft. If you look back at other aircraft you too will see that there will believes lost. Nobody wants that but how much longer

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

Companies that provide selfless information through particip

can the USMC depend on the 46 and 53. Yes, there may in fact be more deaths. But that's life just like driving down the street you could always be killed

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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