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Wire electrical discharge machining is a method of cutting conductive materials with a trav

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

eling wire that separates material in a controlled manner. The wire used is electrically ch

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

Examples of combination products may in

arged and actually arcs with the part to be cut.

The purchase of a wire electrical dischar

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

ge machining system is a heavy investment and it should be made only after all queries are

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

answered. The initial queries regarding the wire electrical discharge machining are concern

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

Combination pro

ed with its working. The system uses a thin brass wire as an electrode. This is controlled

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

on a computer and runs close to the part to be cut, without touching it. The small gap prod

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

uces sparks of 10000 C that vaporize the small particles of the piece, as the wire moves.

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

Simultaneously, the dielectric fluid flushes away the disintegrated particles, enabling the

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

wire to advance further. The movements of the wire are operated with help of a computer pr

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

ogram. The other query that comes up is concerned with the materials that can be cut using

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

Following aspects would a

wire electrical discharge machining. The system works on the principle of electricity and v

dd to the challenges in developing combination products:

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

irtually any conductive metal can be processed.

It is advisable to confirm with the dealer

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

if it is required to pay for special industrial tooling or fixtures, when using wire EDM t

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

o cut the pieces. Some enquire about the kind of tolerance that can be expected while using

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

the wire electrical discharge machining.

Similarly, queries do come up about the finishin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g of the output, after it is worked upon and machined, using the wire electrical discharge

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

machining. The queries may also include the doubts regarding the range of finishes that can

.

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

be achieved for typical surfaces. There are queries on the specification and capacity of t

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

Companies that provide selfless information through particip

he system and its ability to assist in production and manufacturing of the prototype parts.

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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