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Wire EDM technology plays an important part in the competitive manufacturing sector. A strategic

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

investment in wire EDM machinery and technology can greatly enhance the accuracies and surface

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

Examples of combination products may in

finishes, reducing cycle times.

Many mold makers are opting for this more advanced application.

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

Most of them are manufacturing parts, which cannot be made in low-cost labor countries. The twin

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

wire technology assists greatly in manufacturing these intricate parts and proves to be of grea

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

Combination pro

t help in reducing the operating cost and increasing autonomy. The twin wire technology enables

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 user to roughly cut the work piece with a larger diameter wire and then automatically switch

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

to the smaller diameter wire. The twin wire technology is highly recommended for making intricat

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

e parts.

Similarly, with the use of the advanced filtration process, operating cost can be redu

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

ed significantly. The use of an integrated filter capacity and new filter designs reduces the do

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

wntime of the wire EDM and enables it to run longer, unattended. This improvisation is very impo

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

Following aspects would a

rtant for high-speed cutting generators that are capable of manufacturing more parts per hour.

dd to the challenges in developing combination products:

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

he latest development is the five-axis wire EDM, which is also called the turn and burn technolo

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

gy. It has opened up many new avenues for designing complex 3-D mold components.

The latest wir

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

e EDM s are capable of accomplishing the limits desired in speed, accuracy and finish, thus redu

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

ing the scope for further improvisation. Currently mold makers are focusing on finding better wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ys to make their existing equipment more efficient. Most of them are opting to run one machine i

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

n a three-shift workday, instead of running three machines on a one-shift working day. Simultane

.

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

usly, with the integration of robotic tools and work changers that allow an unattended, lights-o

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

Companies that provide selfless information through particip

ut operation of the additional two shifts, a significant increase in fixed overheads is achieved

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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