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Pain Map

International Pharmaceutical Company

Overview: New Product Development for a Pharmaceutical Company

A multinational developer and commercial supplier of injectable drug delivery systems approached EFE in need of an ISO-certified partner to assist with the development of a new product.

The Challenge

As part of the validation process—a particularly complex and time-consuming product development phase—the customer had designed a twin-syringe pump to deliver precise amounts of the drug under test. The controller and all related components required Good Manufacturing Practices (GMP), as well as ISO-certified hardware.

The company located a third party to manufacture a pump controller based on their designs. This included a complex interface with a number of menu-driven operations. As the company initially prepared to go to trial, however, they realized that the European-based supplier of the embedded printed circuit board was not ISO-certified and had no plans to obtain certification.

The Solution

Working within a strict timeline, EFE essentially became an extension of the customer’s electrical engineering, software engineering, manufacturing, and documentation departments, adapting to satisfy their internal practices and procedures.

First, EFE developed specifications for the embedded printed circuit board and identified an ISO-certified supplier. Next, they modified the board to fit the existing controller, made the necessary wiring changes, and wrote and validated the system software. The result was an ISO-certified controller that would meet the customer’s needs and enable them to move forward with the system validation.

As part of the modifications, EFE also eliminated the controller’s hardcoded delivery rate and dose settings.

By changing the software to allow simple increase/decrease adjustments, the controller now could also be used for other projects.

Finally, EFE was able to write the system software, perform that portion of the validation, and create ISO-traceable reports written in the format needed for direct validation submission.

The Benefit

Because validation—of software in particular—is the most time-consuming part of the development process, the customer benefitted significantly from EFE’s “one-stop-shopping” approach.

EFE not only handled the software validation (a process which can take up to a month), but they leveraged their ability to design for manufacturability in order to provide time- and cost savings. Because the controller no longer had hard-coded setting steps, that unit is ready for immediate use for other tests without further revalidation.

In all, EFE’s ability to specify hardware, assemble the product, and write and validate software will not only offer significant labor savings on this project, it will prevent future validation expenses as well; using this delivery system will eliminate or greatly reduce time and expense for future studies.

“They won’t have to reinvent the wheel for additional protocols,” says EFE Labs Engineering Manager John Thomas.

“That can be a very painful process, so this new design represents a good deal of avoided expense. It will also shorten development time by a few months for subsequent trials—which corresponds to improved time-to-market.”

For companies seeking a partner with the ability to shorten delivery cycles, this point is especially critical. Many manufacturers worry that outsourcing will consume valuable time; that is, they will spend time developing specifications for a third party when they could simply manufacture in-house. They also fear that handing over their designs could limit their ability to support the product in the future.

EFE not only has the ability to deliver turnkey projects, it can also rely on its experience to anticipate specification requirements and hit the ground running in the design phase.

Put simply, as shown in this case, EFE has a proven ability to partner with its customers in order to save them time and money.

“These savings are not atypical,” says EFE Labs President, Kip Anthony.

“Over the last half century, EFE has developed the ability to deliver value to a wide variety of industries. Our design, manufacturing, and assembly expertise have allowed us to become not only the industry’s manufacturing partners, but their technical problem solvers as well.”

About EFE Labs

EFE Laboratories is a Horsham, Pennsylvania-based enterprise with a more than 50-year history. The company is an established, experienced contract manufacturer providing innovative solutions for customers across a number of markets. As part of its solutions-based approach to contract manufacturing, the company leverages design, engineering, and production expertise to maximize value while minimizing cost.