Advice You - Business

Electronics contract manufacturing is not suitable for every type of electronics product in the mark

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

etplace today. However, for electronics company products, where suitability for outsourcing manufact

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

Examples of combination products may in

uring to a qualified contract manufacturer exists, companies can immediately save 10% to 15% off the

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

ir internal costs of producing their products.

Changes in product and component lead times can have

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

adverse impacts on a company's product launch and supply chain into the marketplace.

It's in an or

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

Combination pro

ganization's best interest to manage the flow of materials into the manufacturing center so that fin

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

ished good inventory (FGI) can be built-up to meet end market demands.

Product and component long l

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

ead time management reports by the contract manufacturer will contribute to helping make sure the or

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

iginal equipment manufacturer (OEM) outsourcing programs have a better chance of meeting scheduling

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

and shipping requirements.

Typically, contract manufacturers will purchase specified quantities of

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

long lead time material and OEM customer-unique materials only when the OEM customer authorizes such

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

Following aspects would a

in advance and in writing.

Meanwhile, it is reasonable for the OEM customer to ask the contract ma

dd to the challenges in developing combination products:

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

nufacturer to compile, and maintain, a lead time report concerning product and component long lead t

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

ime management (and provide an updated version of the report to the customer on a monthly basis to r

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

eflect the OEM’s most current requirements)

An example of some of the information a contract manufa

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

cturer's product and component long lead time materials report to be submitted to the OEM customer m

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

Professional from academic institutions, pharmaceutical industries, health care indust

ay include:

Lead time period

Product or component manufacturer name

Manufacturer description

Man

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

ufacturer part number

Quantity required per unit of product

OEM customer part number

Contract man

.

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

ufacturer's part number

Where the part is used (i.e., location on printed circuit board (PCB))

Pur

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

Companies that provide selfless information through particip

chase quantity authorized by OEM customer

Purchase price authorized by OEM customer

Extended price

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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