Actual - Computers and Technology

By now, the whole world knows about the iPhone, Apple’s first stab at the mobile phone business.

Not even on sale yet, the phone has stirred up a feeding frenzy in the press

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

on the strength of Apple’s remarkable success with the iPod and Steve Jobs’ legendary marketing skills. Jobs, Apple’s chief executive, has promised a revolutionary product t

; 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 will shake the industry, and most of us are willing to give him the benefit of the doubt.

Of course, there are niggling details.

Like the iPod, the iPhone will have no

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

replaceable battery. This may be acceptable on an MP3 player but less so on a cellphone. Also like the iPod, the iPhone is designed to be a closed system. At least in the beg

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

inning, there will be no third-party applications on the iPhone.

Almost the exact opposite is the Neo1973, a phone you’ve probably never even heard of, from a Taiwanese comp

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

Combination pro

any called FIC, better known for making computers and PC motherboards.

Relative obscurity isn’t the only thing that sets the Neo1973 apart, however.

Unlike the iPhone and m

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

ost other mobile handsets in the market, the Neo1973 smart phone uses open source software developed on a platform called OpenMoko. In this sense, it is even more revolutiona

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

ry than the iPhone.

“For the first time, the mobile ecosystem will be as open as the PC, and mobile applications equally as diverse and more easily accessible,” said Sean Mo

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

ss-Pultz, architect of OpenMoko and a product manager at FIC. “Ringtones are already a multi-billion dollar market. We think downloading mobile applications on an open platfo

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

rm will be even bigger.”

These expectations are by no means a sure thing. Service providers, long accustomed to subsidizing phones that can be set to lock out their competit

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

rs, may not welcome an open source phone that anyone can hack.

The first fully supported OpenMoko phone, the Linux-based Neo1973 is expected to start shipping in March. Base

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

Following aspects would a

d on information available on the OpenMoko Web site (http://www.openmoko.com), the Neo1973 will be a touch-screen, quad-band GSM/GPRS phone with a Global Positioning System c

dd to the challenges in developing combination products:

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

hip and Bluetooth built in, and sell for about $350. It will have no camera, but it will have a replaceable battery and a micro-SD slot for extra memory.

Pictures of prototy

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

pes show a sleek, modern phone.

In the beginning, the Neo1973 is more likely to appeal to hackers and geeks, but the OpenMoko Team doesn’t want to stop there. In a post on

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

the OpenMoko list, Moss-Pultz expounds on the philosophy behind going open in a proprietary industry.

“Mobile phones are closed environments created with a mobile context in

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

mind,” he writes. “But this concept is limiting; a mobile phone has the potential to be a platform that can do anything that a small computer with broadband access can do. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

f mobile phones were based on open platforms, they would have the potential to bring computing to people in a ways traditional computers cannot. Mobile phones can become ubiq

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

uitous computers.”

He also explains that the Neo1973 got its name from the year that Dr. Marty Cooper, the inventor of the mobile phone, made the first call. “We believe th

.

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

at an open source mobile phone can revolutionize, once again, the world of communication,” Moss-Pultz concludes. “This will be the New 1973. Join us. ‘Free Your Phone.’”

Nob

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

Companies that provide selfless information through particip

ody knows if OpenMoko will succeed, but right out of the gate, it sounds more revolutionary than yet another closed-system phone, even if it has the letter “i” in front of it

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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