Answers - Computers and Technology

Gamers love a good console war, and so while waiting for the Xbox 360 vs PlayStation 3 debate to heat up, the fanboys have bee

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

n warming up with the Nintendo DS vs the Sony PSP match.

To date, it hasn’t been much of a contest, Sony launched its PSP in

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

Examples of combination products may in

Japan, then made us in Europe wait a year to get our hands on (sound familiar?) and when it did arrive the silence of the game

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

released was deafening.

In the meantime, Nintendo launched the DS with inferior graphics and a weird control system and then

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

promptly wiped the floor with PSP with game after game that converted both the hardcore gamers and then the mainstream with m

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

Combination pro

re accessible games like Nintendogs and Brain Training. Again, is any of this sounding familiar?

So, the war for gaming on th

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

e move was won by Nintendo and the last gamer off the PSP was due to turn out the lights. Except that isn’t happening. The PSP

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

has been constantly updated by Sony to turn it into a pretty impressive multimedia device – watch films, view your photos, lis

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

ten to music, browse the web, etc – but where its creator seems to have let it down, amazingly, is in the release of games.

S

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

ep up the third party developers. Maybe it has taken them a long time to get familiar with the peculiarities of developing for

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

the hardware. It is notoriously difficult to code for, as Steve Lycett, producer at Sumo Digital explained in issue 2 of HGZi

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

Following aspects would a

ne: “For [the] PSP we really only have 24MB of memory to play with as 8MB is used up by the system to run.”

Whatever the reas

dd to the challenges in developing combination products:

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

n, there is now a set of games being released exclusively on the PSP which are showing the console’s gaming capabilities off a

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

nd getting gamers excited, but perhaps more importantly, giving PSP owners some gamers worth playing: games like Sid Meier’s P

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

rates!, Dungeon Siege Throne of Agony and Metal Gear Solid Portable Ops. The line up of 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

rzines.com/hgzine/">PSP games previews in HGZine, the free PSP and DS magazine, also shows a brighter future, with WipEout

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

Professional from academic institutions, pharmaceutical industries, health care indust

Pulse, Worms (also coming on DS) and others generating excitement.

Whether this is going to be enough to rescue the PSP – sal

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

es of the PSP unit itself would suggest it had never been in as much trouble as people made out – remains to be seen, but if S

.

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

ny is going to release a PSP 2 (which seems likely as the rumour keeps getting denied) then the games fanbase needs to grow an

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

Companies that provide selfless information through particip

d the PSP needs to have a strong set of titles to do that. At long last, after a two year wait, it seems this may be happening

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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