CASE STUDIES

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Redesign to Improve Product Performance

Overview: A manufacturer of products used for foreign particle management in the esophagus found that the market for its product line was no longer growing. The Company decided that a redesign of the product line was the best way to increase market share.

They turned to Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, for a solution. Forefront’s team recommended converting the manufacturing process used for the tubing from a dipping process to the combined use of extrusion molding and injection molding. The team also recommended changes in the materials composition for other components used in the product. This paper discusses lessons learned in the redesign and qualification process and the overall results.

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Key Issues in High Cavity Mold Design

Overview: High cavity molds enable medical manufacturers to tap economies of scale when fabricating high volume single-use products by reducing the number of machines needed to achieve required production volumes. Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, recently designed a 64-cavity mold for a customer. This case study looks at the challenges and lessons learned in the project.

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Specialty Syringe Production

Overview: Specialty syringe production can present a range of design and manufacturing challenges since the product’s mechanism is more complex than standard syringes, and may require stronger focus on material compatibility issues and complex mold tooling. In this case, Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was designing a safety syringe for a customer who had no internal design team.

There are two different models: a 5-milliliter and a 10-milliliter safety syringe. Each model consists of ten different components for the individual syringe. This specialty vacuum safety syringe is technologically more advanced than the normal 3-component syringes available in the market with a barrel, plunger and a plunger seal.

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Specialty Drug Delivery Systems

Overview: Development of specialty drug delivery systems requires both strong materials and mechanical engineering expertise. This white paper looks at the process Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, used in designing a Class III drug delivery system used in a chemotherapy application.

In this case the customer was a Tier One contract manufacturer, who built specialty kits for an original equipment manufacturer (OEM) of specialty drug delivery systems. The contract manufacturer was looking for a medical disposable manufacturer in Asia who met FDA regulatory requirements and could supply required components for their production operations using OEM-specified materials. The contractor also wanted the supplier to provide long-term cost reductions in line with the OEM’s requirements.

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Key Considerations in Choosing a Product Development Partner

Overview: A customer wanted a pharmaceutical bottle made of a flexible, medical grade PVC material. While blow molding is the preferred choice for bottles utilizing low density polyethylene, the flexible PVC material required an injection blow molding process. The team at Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was able to design and construct a mold and machine to meet the requirements. This case study looks the process utilized to achieve the end result.

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Reduced Cost Through Supply Chain Realignment

Overview: Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was supplying a customer with infusion lines used in a drug delivery system. The bags used with infusion lines were supplied by two manufacturers in Europe. Forefront’s team suggested to the customer that sourcing the entire set of four bags and infusion lines in Asia with Forefront could eliminate redundant logistics costs, increase visibility into inventory levels, improve quality and reduce production costs. The customer had been pleased with Forefront Medical’s performance on the infusion lines and agreed to the transfer the entire project.

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Endotracheal Tube Redesign

Overview: Ventilator-associated pneumonia (VAP) is one of most significant healthcare-associated infection (HCAI) risks for patients in long-term intensive care. Traditional endotracheal tube design can contribute to this since oropharyngeal secretions that would normally be swallowed can pool on the top of the cuff of the endotracheal tube and subsequently be passed into the lungs. A number of interventions and prevention strategies are used to minimize the incidence of VAP with varying degrees of success. A least two studies have found that the use of tracheal tubes with subglottic secretion drainage in patients expected to be ventilated for 72 hours or longer, significantly reduces VAP.

In 2013, Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was selected by one of its existing clients to support the development of the single-use portion of new endotracheal tube designed to mitigate the incidence of VAP by maintaining constant pressure within the tube and providing a collection point for oropharyngeal secretions that could easily be drained and cleaned by the hospital’s nursing staff.

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