Actual - Communications

Question: you have an emergency while on the road and call 911 from your cell phone; do you have to give your location to the operator or can he locate you automatically? Answer: if your cell phone h

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

as been manufactured after 2005, he can almost certainly locate you automatically thanks to a FCC rule that went completely into effect at the end of '05.

The directive, called E911 (short for Enhan

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

Examples of combination products may in

ed 911), mandates that all new cell phones support location identification technology, meaning that when you dial 911 from your mobile, the public safety answering point (PSAP) can locate you as accu

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

ately as within 60 yards of where you are. The main technology that makes this possible is GPS--or Global Positioning System.

How GPS Technology Works

Essentially, GPS technology works this

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

way. Your cell phone emits radio waves that are picked up by orbiting satellites. It takes three satellites to work together to locate the handset, using a geometric technique called trilateration: t

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

Combination pro

e phone's waves create a spherical signal around each of the three satellites, and where these spheres intersect on the ground is the location of the cell phone.

Besides this important role in helpi

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

ng locate wireless 911 callers, GPS technology has some great commercial applications when linked to cell phones. So, although practically all new phones have basic location identification technology

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

that satisfies the E911 directive, some known as GPS phones include advanced features that give the user some unique benefits.

GPS Cell Phone Applications

One of the most popular application

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

of GPS phones is providing the user with turn-by-turn driving directions--both in the form of spoken pre-recorded indications and in the form of a map on the phone's screen. Until a few years ago, th

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

s technology was only available on luxury cars (remember the movie The Out-of-Towners?); now, it is as inexpensive and convenient as a GPS phone and a plan that supports it. Some of these services ha

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

e become so advanced that when you miss a turn, the phone instantly finds the next best route to your destination and takes you from there.

A GPS phone can also be a viable all-in-one tool in the ha

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

Following aspects would a

nds of a hiker or outdoors person who can know exactly where he is without the traditional aid of a map and compass. The only caveat is that in order for the GPS service to work, the phone must be ph

dd to the challenges in developing combination products:

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

sically located within the carrier's service area--in other words, if you are lost in the wilderness and your phone doesn't have a signal, you better have that old-fashioned map and compass as a back

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

p, or it's al fresco time.

Also, many parents are finding GPS technology to be a convenient and non-interfering way to keep tabs on their kids' whereabouts. For instance, Sprint's Family Locator Ser

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

ice uses GPS technology to locate the kid's phone and give parents the location information both in map and text format on their own handset--as long as both phones are GPS enabled.

How Much GPS

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

ell Phone Service Costs

So what does it take to have this service? The two essential things you need are a GPS-enabled cell phone

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

Professional from academic institutions, pharmaceutical industries, health care indust

a> and a service that supports it. Although practically all new phones now have the basic E911 location identification feature, only a few models are fully GPS enabled. y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

www.wirefly.com/plans/nextel/">Nextel was the first wireless carrier offering GPS-enabled cell phones, featuring either the TeleNav (Telenavigation) or the ViaMoto (Motorola) GPS systems. And as

.

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

ar as carriers, Sprint and Nextel are the ones who broke new ground by offering plans that include GPS services. Nextel is now running some interesting cell phone deals also on phones featuring GPS t

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

Companies that provide selfless information through particip

chnology.

If this technology sounds interesting to you, typical cost (beyond your regular cell phone service) is within $10 a month, which is not a lot considering the great benefits you get from 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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