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You've heard that new sport, geocaching, is fun. Or, you're tired of getting lost on your travels. Welcome to the 21st century. Global Postioning System (GPS) has been around long

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

enough that prices are reasonable and the technology is user-friendly. With myriad brands and models, how to choose?

If you want a GPS for both hiking and driving use, then a hand

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

Examples of combination products may in

held unit would be the way to go. Some handhelds even have accessories to allow them to be installed in an automobile. But don't rule out a PDA. More on that in a moment. For drivi

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

ng only, there are GPS receivers made just for vehicle use.

Handheld GPS receivers are either mapping or non--mapping. A basic, non--mapping unit can often cost less than $100 US

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

and usually has/displays the following:

Location
Compass heading
Elevation above sea level
Accurate time
Satellite location and s

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

Combination pro

ignal strength

The ability to calculate distance traveled

The ability to record your path as a set of waypoints

The ability to navigate routes

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

li>The ability to retrace your steps

Handheld mapping receivers do all the above plus have the ability to display maps. The maps are either pre--loaded or uploaded fro

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

your PC. Prices are reasonable for mapping units, starting at around $150 US.

Paper maps are strongly recommended whether you're using a mapping receiver or not. Paper maps do no

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

t require batteries and probably won't go defective. Also, a paper map gives you a "big picture" view of your situation -- something lacking on the small screen of a GPS.

I mentio

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

ned earlier your considering a PDA with GPS capability. A PDA is bulkier and the battery life is usually shorter, but if you're using a PDA anyway, then there are several ways to t

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

urn a PDA into a GPS. Some PDAs accept a GPS "sleeve." That is a device that the PDA nestles into. Another choice is one of Garmin's PDAs. Garmin is probably the most popular GPS m

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

Following aspects would a

aker and they have one PDA/GPS that is Palm--based and one that is Pocket PC--based.

Prices for automotive GPS start at around $250 US. These provide turn--by--turn guidance. Spen

dd to the challenges in developing combination products:

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

d a little more than that and you get voice guidance. These are larger than handhelds in order to accommodate a screen large enough to be seen while driving. They are powered by th

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

e car's electrical system and because of this, they can only be used in a vehicle.

Many automobile manufacturers now offer built-in GPS receivers as an option. Because they are bu

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

lt-in, the big advantages are security and aesthetics. They are quite a bit more expensive than add-on units and often have fewer options. I've also heard some stories of people ha

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

ving a hard time getting map updates.

A PDA/GPS is a good alternative for automotive use. Its screen is about the size of an automotive unit, so seeing the display is not a proble

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

Professional from academic institutions, pharmaceutical industries, health care indust

m. They can also be powered by the car, eliminating battery worries. The Garmin PDAs mentioned above both come with the hardware and software for automotive use.

If you're hiking,

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

a basic handheld unit (without maps) will be fine since you'll always have paper maps with you anyway (you will, won't you?). An advantage to a handheld mapping unit is that they

.

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

usually have more advanced features than the basic units. For driving, you have the choice of a handheld, in--car dedicated, or PDA. The handheld does have limited usefulness in a

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

Companies that provide selfless information through particip

car, as it does not provide turn--by--turn guidance. For a more detailed look at how to choose a GPS, click here

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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