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Laser-aided cutting has brought about a revolution in the manufacturing industries. These high-

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

powered optical beams are used to cut through a variety of materials such as metal, wood, glass

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

Examples of combination products may in

and plastic. The laser is directed at the required surface and moved around to cut the material

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

in the desired shape. Laser cutting gives a finer finish to the end product as compared to conv

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

ntional cutting methods.

A typical laser beam is about 1/5th of a millimeter in width and has

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

Combination pro

n intensity of 1000 to 2000 watts. Most laser cutting machines are integrated into a CAD/CAM sy

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

stem that helps the user design the end product on a computer before implementing it on the wor

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

piece.

Laser cutting devices are proving beneficial in a wide array of industries. The plasti

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

industry is no exception. These optic powered devices are used to cut precise shapes into plas

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

ic or acrylic sheets. The lasers can be used to cut plastics of varying thickness by simply alt

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

ring the intensity of the beam. Lasers are not only used to cut through plastics but also help

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

Following aspects would a

engrave on various surfaces.

Laser plastic cutting machines bring precision and accuracy to th

dd to the challenges in developing combination products:

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

entire process. Since most machines are fully automated, they can perform complex cutting oper

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

tions at high-speeds. The laser plastic cutting machines can also be used to cut polymers, poly

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

arbonates and other synthetic materials such as polyesters and rubbers.

The laser cutting meth

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

d uses a non-contact approach when cutting the material. Due to this, the wear and tear associa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ted with conventional methods is absent, preventing the product from any damage and deformation

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

The laser process also delivers a finish quality unmatched by any other process.

When using l

.

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

ser plastic cutting machines, care should be taken to avoid the use of flammable plastics such

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

Companies that provide selfless information through particip

s PVCs. These materials cannot cope with the heat generated by the laser and get damaged easily

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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