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EDM machining actually stands for electrical discharge machining. This is the term used for

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

a machining process that is used in the process of manufacturing those parts that are made f

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

Examples of combination products may in

rom very hard metals and their alloys. Some of the parts or objects that are produced with

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

the use of EDM machining include dies made of hardened steel, critical components of engines

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 compressor blades of jet engine fans. EDM machining is a thermal process that is able t

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

Combination pro

o remove as well as re-deposit material on top of the object that is being machined. The are

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

a that is recast is characteristically much tougher than the regular or original surface. It

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

also will have a desirably higher resistance to wear and tear like abrasion and corrosion.

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

In the process of EDM machining, an electrical discharge is made to occur between the objec

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

t surface and the tool used for finishing. This discharge induces high temperatures that ran

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

ge between 10,000 to 20,000 degrees centigrade. In this manner a dielectric field is created

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

Following aspects would a

that, as long as it exists, it constantly removes and then re-deposits material to the obje

dd to the challenges in developing combination products:

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

ct's surface. The process allows you to introduce metal or elemental powders into the dielec

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

tric stream and this causes an alloy to be deposited.

EDM machining is a process that is al

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

so put in use in order to cut, shape and alter exceptionally hard metals. It is used to turn

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

metals into tools that can in turn be used to cut and machine those objects that are made f

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

Professional from academic institutions, pharmaceutical industries, health care indust

rom softer metals. In this kind of machining, a wire that is electrically charged is moved e

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

xtremely close to the object that is under machining and it is at that point that the electr

.

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

ical discharge actually begins. EDM machining is a technology that is extremely useful to me

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

Companies that provide selfless information through particip

chanical industries today and is used in almost all tool making and metal cutting processes.

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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