Advice You - Business

Precision machining involves producing of metal parts, which are extremely intricate and are mainly made from thin me

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

tal sheets. Besides precision metal parts are often custom made for specific purposes. However there are distinct tec

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

Examples of combination products may in

hniques such as chemical etching, metal stamping, and RF shielding for producing precision metal parts.

The chemical

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

etching process is mainly used for producing precision metal parts. The machining system offers great flexibility fo

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

r producing precision metal parts, with unusual configuration as well as metals with tight tolerance within .0005". B

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

Combination pro

sides the chemical etching machines are capable of producing, small holes and bars that are not possible with most st

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

amping process. The chemical etching machine uses state-of-the-art-CAD software enabled with ? mil resolution in the

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

production process, which facilitates speedy and low cost operations. The machining system is ideal for both the prot

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

otype, and production of large quantities of precision metal parts. Chemically etching machined products also play a

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

significant role in supporting the NASA research system.

Similarly the metal stamping machining process, which is al

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

o referred to as progressive die stamping, or long run metal stamping, is extensively used in production of precision

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

Following aspects would a

metal parts with thickness from .002" to .135". The technique is mainly used for processing low cost parts that have

dd to the challenges in developing combination products:

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

three dimensions.

The r f shielding machining enables processing of precision metal parts such as RF shields. The m

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

achine helps in the production of customized as well as standard RF shields. The machine is capable of manufacturing

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

product parts from a simple five-sided box, to a complex multi-cavity shield with removable lids. Besides the machini

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

g process facilitates production of flat, formed, plated, removable lids, with or without logos, and part numbers. Mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

reover, standard RF shielding are available in 54 dimensions and are provided with a prototype kit, which enables the

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

operator with the flexibility to design custom RF shields.

The advances in precision machines have provided a signi

.

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

ficant boost to the aeronautic industry, as airplanes need parts, which are designed with utmost perfection. Precisio

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

Companies that provide selfless information through particip

n machining has made it possible to manufacture improved hospital tools, thus greatly serving a social cause, as well

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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