Cases - Business

Laser machining technology uses high intensity laser beams of varying widths for a variety of a

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

pplications such as slotting, cutting, and creating holes. It can be used in fabrication of dif

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

Examples of combination products may in

erent types of materials such as metals, plastics, vinyl, glass, marble, and graphite. Other ma

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

terials that can be fabricated using laser machining include nylon, ceramics, carbon fiber, com

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

osites, soft rubber, and thin metal foils.

Laser machining systems are used in conjunction wit

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

Combination pro

h computer numeric control (CNC), which makes it ideal for use with thin walled tubing, boastin

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

beam widths down to .0005'. In this process, the machining operator uses computers to control

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

machine tools for manufacturing complex and intricate parts in metal and other materials.

A la

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

er machining process involves the use of conventional as well as fiber optic beam delivery syst

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

ems, which allow precision positioning while cutting metal or other materials. It is used to cu

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

burr-free parts that are required in a number of industries such as aerospace, automobile, shi

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

Following aspects would a

ping, and others. The process is fast, efficient, and can be repeated any number of times depen

dd to the challenges in developing combination products:

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

ding on production volumes. It is used to create grooves that are cut to a specific depth with

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

ne pass of a laser beam without severing any material from the work piece.

Laser machining is

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

used for producing a knurled or roughened surface on hard materials such as metals and fragile

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

aterials such as ceramics and glass. The technology is also used for marking material surfaces.

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

Professional from academic institutions, pharmaceutical industries, health care indust

In the process a high intensity laser beam is passed through a stencil of a mirror and onto th

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

area of the material or work piece that is being marked.

Research is underway to develop adva

.

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

nced laser machining techniques that will allow the production of microscopic devices for use i

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

Companies that provide selfless information through particip

medical industry. This will help in fighting deadly diseases such as cancer in the near future

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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