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Contract electronics manufacturing service or EMS providers typically work with customers in a wide range of industries with differing requirements for inventory control, testing, product packaging, and product support. In some applications, the EMS

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

provider simply assembles the printed circuit boards and then ships the boards to the customer. In other applications, the EMS provider will assemble the printed circuit board, load firmware/software into memory, test the board, and then assemble t

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

Examples of combination products may in

e board and associated cables, enclosures, and documentation into a finished product that is shipped to the customer. Some customers will provide all of the materials, raw boards and electronic components, required for a job and the EMS provider ass

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

emblies the printed circuit boards, performs any required testing, and ships the finished boards to the customer. This is generally considered as inventory provided on a consignment basis where the EMS provider basically provides labor and expertise

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

only. Some customers provide some portion on the materials, such as specialty or high cost integrated circuits, proprietary parts such as transformers or coils, raw printed circuit boards, etc. and rely on the EMS provider to purchase the remainder

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

Combination pro

f the components needed to assemble the boards. Most EMS providers prefer to use their own purchasing power, their extensive contacts, and their existing parts inventory where applicable to provide all of the required materials for a customer's part

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

icular project. This method is generally considered as inventory provided on a turn-key basis.

But before any of this can happen, the EMS provider must provide an assembled board quote or pricing estimate to the customer for the project. In additio

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

to the quantity commitments, production release quantity and annual usage quantity, this pricing process also requires a detailed bill of material from the customer along with a set of the Gerber files for the printed circuit boards. The BOM should

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

define all of the components along with the approved vendor and vendor's part number for each component. This information allows the Materials Management group to determine availability, packaging, and pricing for each component based on the quantit

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

ies and vendor information. The BOM information is also needed to allow a technical review to determine the amount of labor and the equipment required to place the parts and to solder the components to the board.

The Gerber files for the printed ci

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

cuit board design provide Materials Management with the information they need in order to get raw board pricing and lead times from the printed circuit board manufacturing vendors. The Gerber files also provide the Manufacturing Group with the infor

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

Following aspects would a

ation they need to develop the manufacturing plan, are components on top only or top and bottom of board; surface mount, thru hole, or mixed component types; wave solder or reflow oven processes required, etc. The Manufacturing Group also has to est

dd to the challenges in developing combination products:

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

imate time to program the component placement equipment and to load the components in the placement feeders, set-up costs, costs to order the solder paste stencils, and must also quantify test plans, procedures, and required test equipment. In order

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

to correctly place components on the printed circuit board with each component properly oriented, the EMS provider will need silkscreen files to know the correct orientation of the parts on each side of the board. The screen paste file for surface m

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

unt applications will be required to order the stencils for the solder paste application to the board prior to the part placements.

All of this may seem to be a lot of information, but each piece is needed in order to provide the most cost effectiv

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

e pricing for the finished product. Fortunately, the Gerber files are usually readily available from the pcb design system as the Gerber format is the industry standard output format. The BOM is usually in the form of an Excel spreadsheet or formal

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

Professional from academic institutions, pharmaceutical industries, health care indust

rawing. Assist your EMS provider by providing the approved vendor's name and part number for each component.

In Summary:

The information required to prepare an accurate quotation for a typical printed circuit board assembly project includes:

-Def

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

nition of inventory method, consignment, partial consignment, or turn-key.
-Complete Bill of Material with at least one manufacturer's name and part number for each component along with notes identifying any components to be supplied by the cu

.

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

stomer.
-Gerber files for the printed circuit board designs.
-Estimated Annual Usage, EAU, quantities and production release quantities.
-Name of technical contact person, along with their telephone number, fax number, and email addre

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

Companies that provide selfless information through particip

s.

Additional information that may be helpful if you have it available:

-Assembly, schematic, and PCB drawings.
-Sample board assembly or prototype board assembly to review. -Test requirements and procedures required by the customer.

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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