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Wires used in a wire electrical discharge machining system are the core of the system. These

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

wires act as electrodes that produce electrical erosion to separate the material from the con

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

Examples of combination products may in

uctive piece.

The regular economy brass EDM wire is very cost effective and especially the c

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

hoice of cost conscious operators. Though the wire is cheaper, it still promises good quality

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 is consistent, clean and straight. The brass wires are even available in the high perform

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

Combination pro

ance brass EDM wire range. This wire is mainly alloyed with a higher percentage of zinc than

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

he standard variety. Many users prefer these wires, as they believe that the higher zinc cont

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

ent promotes speed.

High performance coated EDM wires are getting increasingly popular with

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

ire electrical discharge machining users. The zinc coated brass wire is preferred, as it enab

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

les higher speed for cutting. Wires are also produced using different types of core materials

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

such as pure copper, for better electrical conductivity. The copper and zinc alloys provide

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

Following aspects would a

igher tensile strength. The coatings are mainly of beta and gamma phase brass and in layers.

dd to the challenges in developing combination products:

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

Specialty wires are also available for specific tasks, such as the Compeed EDM wire. This ED

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

wire has a steel core with an intermediate layer of copper and an outer layer of beta phase

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

brass. The Compeed EDM wire is extensively used where excessive breakage is a problem. Simila

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

ly, molybdenum EDM wire is highly favored for applications requiring a wire diameter between

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

Professional from academic institutions, pharmaceutical industries, health care indust

.002' and .006'. Molybdenum EDM wires have a high melting point and high tensile strength.

T

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

ngsten wires are widely used for applications requiring lower diameter. They too have a high

.

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

melting point and high tensile strength, but low electrical conductivity and high cost. The o

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

Companies that provide selfless information through particip

her specialty EDM wires include, aluminum and brass silicon alloyed and zinc rich brass wires

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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