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Contract manufactured medical devices are widely used in a variety of markets such as critical care, emergency room, home h

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

ealth care and industrial laboratories. The critical care section includes medical devices for respiratory therapy and oper

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

Examples of combination products may in

ting rooms. The emergency room includes the medical devices for the cardiac lab, labor and delivery. Medical devices used i

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

n home health care such as a doctor?s office and medical laboratories can also be manufactured on contract basis. Contract

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

anufactured medical products usually include simple tubing sets, very complicated bio-sensors, and even ultra-precision dev

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

Combination pro

ces made from plastics, metals, electronics and ceramics.

Medical device contract manufacturing companies offer clean room

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

and non-clean room assembly, testing and packaging services for class I, class II and class III medical devices. Class I m

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

dical devices do not cause any harm to the user and are very simple in design, compared to the other two devices. In class

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

II devices there are special controls to ensure safety and effectiveness in addition to the general control. Class III devi

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

es require pre-market approval to ensure device safety and effectiveness.

Medical device contract manufacturers also provi

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

e sterile and non-sterile products. The assembly processes and capabilities of medical device contract manufacturing range

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

Following aspects would a

from simple products such as tubing sets to ultra precision electro-mechanical devices. Most contract manufacturers deal wi

dd to the challenges in developing combination products:

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

h high volume disposable and low volume reusable device manufacturing. They also have a full service injection molding prog

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

ram such as injection mold design, fabrication and clean room injection molding. The cost of machines for the injection mol

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

ing process is high. The design of the right mold is also difficult. Hence most customers go for contract manufacturers for

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

the injection molding processes.

Some medical device contract manufacturers offer ethylene oxide and radiation sterilizati

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

Professional from academic institutions, pharmaceutical industries, health care indust

on coordination. A wide range of process capabilities, giving more care towards the quality, responsiveness and efficient o

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

eration are the main features of an ideal medical device contract manufacturer.

Medical device contract manufacturers usua

.

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

lly work closely with the original equipment manufacturing companies. The contract manufacturing of medical devices include

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

Companies that provide selfless information through particip

traditional, high quality contract manufacturing services. It also introduces automation design and building capabilities

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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