Subjects - Business

Component Engineers Inc. is proud to add three new power presses to the plant, t

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

aking the total in the facility to 38. One of the presses added is a Minster, 75

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

Examples of combination products may in

ton straight side, which is the third of its kind at the CEI facility. The other

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

two presses are Minster 32-tons, also straight sided.

The addition of these pr

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

sses helps to expand CEI’s capacity. They will be used for small complex and pro

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

Combination pro

ressive stampings, secondary and compound stampings, as well as value added tube

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

operations.

CEI has been a leader in the precision stamping industry for over

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

5 years, and services the medical, automotive, commercial hardware, electronics,

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

and aerospace industries, among others. By incorporating a vast variety of capa

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

ilities, CEI a one-stop shop for a custom manufactured job.

CEI’s precision met

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

l stamping capabilities include progressive stamping power up to 300-tons and co

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

Following aspects would a

ining up to 600-tons. CEI has bed sizes up to 108” in length, and has the abilit

dd to the challenges in developing combination products:

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

to stamp material from .001” thin, up to .50” thick, and can progressively stam

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

p 300 parts a minute when applicable.

The two largest presses at CEI are the 30

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

-ton Minster press and 200-ton Bliss press, utilized to perform heavy-gauge stam

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 operations. Large steel surgical device components, commercial hardware part

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, and even train doors are made with ease at CEI.

At the end of last year, CEI

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

added four brand new United 28-ton OBI presses to perform secondary stampings an

.

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

d tube operations. CEI now has 10 presses in the 28-ton to 45-ton range, extendi

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

Companies that provide selfless information through particip

g its capability to manufacture almost any complex stamping or tubular component

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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