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A pocket knife is a folding knife with a blade that fits inside the handle and that is small enough to fit in a pocket, with blades no larger than 3 to 5 in. in length. Th

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

ese knives are very versatile tools, and can be used for anything from opening an envelope, to cutting rope, to slicing fruit.

Pocket knives can cost anywhere from $1 at

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

Examples of combination products may in

convenience stores, to thousands of dollars for custom, hand-crafted pieces. Well-made knives start at around $20.

Most light duty pocket knives are slip joints, which me

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

ns the blade does not lock, but once it's opened it locks in place by a spring device that allows the blade to fold with a certain amount of pressure applied.

These knive

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

s often have more than one blade, (serrated, plain edged, saws) as well as a other tools such as bottle openers, corkscrews and scissors. A large tool selection is the si

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

Combination pro

nature of the Swiss Army Knife. These knives are issued to the army and sold to the public.

The German Army knife is large but light, with two blades opening from each s

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

ide. It has hard plastic grips and aluminum liners. The United States Army knife used to have blades susceptible to rust and brass liners but now all Stainless Steel and v

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

ery heavy and rugged. It has four blades opening from the same side. The handle, has rough edges, but can be rounded.

There are many traditional types of folding knives:

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

A pen knife: a small, thin knife with one or two pen blades, that does not interfere with the appearance of dress clothes, when carried in a pocket.

The Leatherman: si

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

milar combination of tools compete with multi-bladed knives, but most of these are too large for carrying in a pocket. The "main blade" is typically a pair of pliers and t

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

ere is typically one non-locking knife blade.

Locking Knife: medium-sized lock back knife with deer-antler grips, nickel-silver bolsters and brass liners

Locking Pocket

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

Following aspects would a

Knives became popular in the 1900's. Companies like Buck, Benchmade, Camillus, Gerber, Kershaw Letherman and Spyderco, to name a few, have created a wide range of produc

dd to the challenges in developing combination products:

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

ts with locks of all types. This most popular form is similar to a slip joint, except that instead of the user releasing the blade with pressure, the user has to press on

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

lever on the back of the knife handle to release the blade, adding a level of safety. There are other types of locks; some of the more popular ones are the liner lock, t

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

he frame lock, and the Axis lock.

Even the Swiss Army knife has adopted the locks on some knives. Leatherman tools are now available with locking blades. Most locking kn

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

ves have only one blade, as large as can be fit in the handle. An electrician's knife typically has a locking screwdriver blade but a non-locking knife blade.

Nearly all

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

Professional from academic institutions, pharmaceutical industries, health care indust

pocket knives are legal to own, but they increasingly face legal restrictions on their use. While pocket knives are almost always used as tools, they do have the potential

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

to become weapons. In many places it is illegal to conceal knives larger than a certain size, or with certain locking or opening mechanisms.

They are often banned or hea

.

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

ily restricted in secure areas, such as schools and airports. Switchblades and other "auto-openers" are banned from interstate shipment by the U.S. Government and prohibit

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

Companies that provide selfless information through particip

ed entirely in many places, including 37 US states. Nevertheless, they retain a significant following, associated with those who enjoy camping, hunting, fishing, and so on

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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