Advice You - Business

OEM is short for Original Equipment Manufacturer. ODM is short for

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

>Original Design Manufacturer.

What these manufacturers do is to custom

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

Examples of combination products may in

ake product for their clients. Factories that have the capabilities to make molds for pr

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

duct. The factory's R & D Dept. ( Research & Development ) and experienced design teams, s

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

pported by sophisticated manufacturing automation and in-process testing to deliver low cos

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

Combination pro

t, high quality solutions to its clients, will make a proto-type for the client.

The facto

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

y does have their own mold making machines, plastic injection, etc.

Upon approval from 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

client, the factory will go into mass production and produce that particular item. Once th

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

order or orders have been filled, the manufacturer will see if there is still a need for t

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

hat item on the market. If so, they will market it to their existing clients as well as se

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

k new clients. Once there is no longer a market, the factory will either shelve the mold o

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

Following aspects would a

sell it off. As well as sell off the machines used to produce it.

And then it's on to th

dd to the challenges in developing combination products:

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

next product.

A manufacturing factory has many production lines and produces product in b

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

ulk quantities.

An OEM / ODM manufacturer sells these products with no brand name or "gene

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

ic" label. The manufacturer will "brand" the products to each individual client's needs.

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

ither with their name and / or logo.

For these type of factories, mainland China is a gold

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

Professional from academic institutions, pharmaceutical industries, health care indust

mine. As labor, land, rent, construction, are all very inexpensive. Compared to that of w

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

estern countries.

And to put it in a nutshell: OEMs are not the original manufacturers; th

.

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

y are actually the customizers. OEMs also modify existing products and produce as a new or

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

Companies that provide selfless information through particip

modified product.

Most OEM factories sell only to high volume distributors and wholesalers

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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