Forefront Medical Technology Company Profile

Forefront Medical Technology focuses exclusively on the medical device industry and thoroughly understands the needs of this market. As a specialty contract manufacturer with a focus in disposable diagnostic, drug infusion and medical device systems, Forefront Medical has extensive expertise with injection molding, extrusion, electromechanical and mechanical assembly and packaging of specialty medical disposable devices.

In addition, Forefront Medical Technology’s technical expertise extends into collaborative product design and development, rapid selective laser sintering (SLS) prototyping, mold design and in-house tool making and isolated clean rooms for manufacturing, assembly and packaging. Capabilities also include sterilization and global logistics to provide one integrated source for the total supply chain. This world class supplier has the expertise to custom design a new product … or redesign the current one … from a conceptual drawing into a completely manufactured, packaged and sterilized product, ready for global shipment. Forefront Medical Technology employs approximately 700 employees and was established in the year 2000.

Design and Prototyping

Forefront Medical Technology’s technical expertise with medical device contract manufacturing, injection molding and extrusion, makes its team an ideal technical partner for development and prototyping of new products.Forefront’s engineering team has extensive material selection expertise, mold design expertise and a broad base of medical product development expertise. They can also provide electronics design and PCB layout, as well as software development services. Mechanical and packaging design can also be supported.

Every application is considered confidential, which ensures a robust, long term customer relationship. SLS rapid prototyping equipment is utilized for small, developmental lots required for pre-market testing. Forefront Medical's scalable automation expertise ensures a production ramp-up that matches each customer’s target cost and projected volume with the most cost efficient production process.

As part of the new product introduction (NPI) effort, Forefront also collaborates with its customers on identifying any needed suppliers; risk management; machine, tools and process validation; product bio-compatibility and stability validation; sterilization validation including sealing integrity; and packaging ship testing.

Injection Molding

Forefront Medical Technology has extensive capabilities with both horizontal and vertical injection molding processes. Materials include liquid silicone rubber (LSR), Medical grade PVC, polyurethane (PU), polypropylene (PP), polycarbonate (PC), polysulfone and other specialty materials. Silicone components are injection molded in separate class 100K clean rooms to avoid cross contamination.

If prototypes are needed prior to production, Forefront Medical Technology has invested in state of the art CAD/CAM/CAE systems, along with SLS rapid prototyping equipment and multi-jet modeling MJM, to reduce the time to market with new products. In-house tool making supports both rapid prototyping and production with EDM and high speed CNC machining.

Extrusion

Extensive extrusion capabilities enable Forefront Medical Technology to provide many types of specialty components, as well as finished devices. Components include silicone or PVC extrusions, wound with stainless steel or Nitinol wire, and formed into reinforced tubing for many unique configurations. Other types of finished devices include extruded feeding tube catheters, drug infusion systems, flushing devices and airways. Forefront’s extensive application expertise assures selection of the appropriate medical grade material best suited to the customer’s requirement.

Other capabilities include blow molding of medical grade PVC and vinyl elastomers (with or without DEHP) to form high performance, cost effective inflatable seals for disposable devices. Automated assembly and packaging for high volume production, along with manual assembly for low volume / high mix applications and kits is done in class 10K clean rooms, The testing laboratory can provide tensile testing, melt flow, dimensional verification (contact and non-contact) and accelerated aging testing for both reusable and single use devices.

Medical Plastics Expertise

• Injection molded liquid silicone rubber (LSR) components
• Nitinol and stainless steel wire-reinforced (injection molded or extruded) with materials such as liquid silicone rubber, PVC or DEHP free PVC
• Multi-lumen, wire-reinforced endotracheal tubes
• Extruded polyurethane catheter tube assemblies
• Specialty NG and J feeding tube catheters
• Airway management systems
• Respiratory devices
• Ophthalmic kits
• IV and blood collection sets
• Flushing and drainage kits
• Components & devices for specialty applications
• Drug Infusion Lines
• Disposable Laryngoscope Blades
• PEEK micro molded components

• Horizontal molding from 7 to 220 tons, vertical molding from 30 to 75 tons
• Liquid Silicone Rubber (LSR) molding from 15 to 40 tons
• Extrusion lines for Liquid Silicone Rubber (LSR), PVC and Polyurethane (PU)
• Automated blister packaging
• Custom designed packaging and assembly equipment
• Scalable assembly from low volume / high product mix to high volume / fully automated processing
• Robotic adhesive dispensing, UV curing and assembly
• Class 10K clean room assembly and packaging
• Class 100K clean rooms for injection molding and extrusion

Quality Management System and Approvals

• ISO 9001:2008
• ISO 13485:2003
• FDA Registration, ...