Advice You - Business

Laser cutting is a technology that uses a laser in cutting different kinds of materials, mostly metals

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

such as carbon steel, aluminum, stainless steel and copper alloys. It is widely used in the metal fab

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

Examples of combination products may in

ication industry to increase cutting speed and cutting capacity, reduce production costs, increase pro

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

uctivity and improve cutting quality.

A laser or LASER (Light Amplification by Stimulated Emission of

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

Radiation) is a device that generates a highly concentrated monochromatic and coherent beam of light.

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

Combination pro

The light is produced through the process of stimulated emission.

Among the most commonly used laser

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

n cutting is the carbon dioxide laser (CO2 laser), a kind of gas laser that is also used in welding. I

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

is capable of emitting a maximum of 100 kilowatts at 9.6 µm and 10.6 µm and of cutting 20-30 m of one

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

millimeter-thick material in a minute.

Cutting is done by aiming the energy produced by the high-powe

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

r laser at a small portion of the object to be cut. That small portion is pierced first before a cut i

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

made.

From the small hole, a cut is created either by moving the beam across the area of the materia

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

Following aspects would a

being cut, or by moving the object while the laser is kept still. One can employ both methods. As the

dd to the challenges in developing combination products:

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

intense beam of light strikes the part of the object or material, the latter?s temperature rises, caus

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

ing it to melt, burn and evaporate even without sufficient amount of heat.

Not all materials require

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

he same amount of laser power (the rate at which energy is delivered by the light). Thicker materials

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

eed more laser power while thinner ones need lesser laser power. Usually, carbon dioxide laser cutting

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

Professional from academic institutions, pharmaceutical industries, health care indust

is done with 1,000 to 1,500 watts. Materials such as steel need more than two kW.

Compared to other m

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

etal cutting procedures, laser cutting is far more advantageous, although it has some disadvantages, t

.

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

o. Its primary advantages are precision, cutting quality, cutting speed and economy. Among its disadva

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

Companies that provide selfless information through particip

tages is its high voltage requirement. There is also risk of getting serious burns from the laser beam

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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