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EDM in an engineering term referring to electrical discharge machining. Wire electrical di

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

scharge machining or EDM is a metalworking process with help of which a material is separa

; 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 from a conductive work piece, by means of electrical erosion. In this process, the wire

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

never comes in contact with the conductive work piece. The wire electrode leaves a path o

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

the work piece, which is slightly larger than the wire. Most often a 0.010' wire is used,

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

Combination pro

which creates a 0.013' to 0.014' gap. The wire electrode once passed through the work pie

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

e cannot be reused.

Wire electrical discharge machining is a complicated assembly, but ef

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

forts have been made to build this system at home. While building a wire electrical discha

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

ge machining system at home the biggest problem is breaking the wire. Often engineers use

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

the full power of 70 volts, which the wire cannot withstand. If a VARIAC is used, it can v

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

ry the alternate current output, producing varying voltages. It can also control and vary

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

Following aspects would a

he direct current out put. If the voltage is maintained at 55Volts, a spark is produced wi

dd to the challenges in developing combination products:

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

thout breaking the wire electrodes.

In the home made wire electrical discharge machining

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

ystem, the reducing gear doubles as an encoder and drills 50 holes of equal space. Mainly

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

a ? - 20 threaded rod acts like a feed screw. The counts go to a PLC, which is outfitted w

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

th starts, reverse and stop functions. It is equipped with an appropriate motor, which ena

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

Professional from academic institutions, pharmaceutical industries, health care indust

bles easy rectangular movement. The homemade wire electrical discharge machining system is

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

also supplemented with manual switches for free burning.

The homemade systems can only be

.

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

used for working on small work pieces. However, the developments have been encouraging an

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

Companies that provide selfless information through particip

ensure an ongoing process that will definitely create a market for the home built systems

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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