Foster Corporation has served the medical device industry with performance compounds for nearly 20 years. In serving the medical market Foster has assumed a role in helping its customers manage risk. Risk is defined as the possibility that an event will occur that will adversely affect the achievement of an objective. Although some risk is inevitable, there are two elements of risk that can be managed, the magnitude and probability.
Managing risk can be achieved by understanding events that contain risk, determine controls and implement them.
Foster helps customers to manage risk in the following four areas:
Multiple production sites:
Foster has two state of the art facilities-one in Putnam Connecticut (47,000 square feet started up in March 2004) and one in North Las Vegas, Nevada that is 20,000 square feet and newly renovated. Both facilities meet or exceed all safety standards, are built of materials with low risk for fire and flood. The machinery in the plants are of hardened steel construction minimizing damage. Both are ISO 9001¼2000. Foster also owns their original facility in Dayville Connecticut,-effective infrastructure still exists to re¼instate the extrusion manufacturing if necessary. The existence of two facilities gives Foster the ability to move work from one facility to the other in case one plant is rendered ôout of serviceö. Significant inventory is maintained at both locations and the knowledge base of the personnel is similar at both locations.
Material sourcing and specification control:
The status of medical device manufacturers sometimes makes it difficult for them to get certain raw materials from many raw material suppliers. Foster has served as a key raw material supply chain partner for finding, procuring and inventorying many non-compounded raw materials. Foster helps their customers with hard to get materials, raw materials from ôconcernedö vendors and inventories those materials. Foster has formed a supply chain division (Supply Chain Solutions Division) to help secure raw material supply, e.g. Pebax Distribution. FosterÆs knowledge of raw material vendors and materials is valuable in making decisions on R&D specifications.
Foster always keeps stock of the following materials: Pebax/Rilsan, Pellethane TPU, and Radiopacifiers (barium, bismuth subcarbonate, bismuth oxychloride). Foster also audits all their key suppliers on a regular basis as part of ISO 9001 program. Foster has a raw material inspection process to insure quality and has strong relationships and communication with their key suppliers.
Specifications can be a major risk factor and also add cost if they are not set prudently. If a specification is set too tight it can severely limit raw material and FG (?) availability. A specification set too wide can compromise quality. Unnecessary testing can add cost and irrelevant data. Raw materials are sometimes chosen without consideration of appropriate purchase quantities, non-medical friendly vendors, discontinued or allocated. Foster helps their customers with raw material and FG specifications.
When choosing a vendor for a base polymer you need to be aware of their medical policy; some resin manufacturers consider minimally invasive applications a problem. When sourcing a material, dual source if possible especially in the volume polymers. Another consideration is the possibility of a raw material being changed without your knowledge or availability may be limited. You need to be aware of your options with regard to material sourcing and availability.
Foster works with all of the following materials: TPUs, TPEs, PVC, Nylon 11,12; fluoropolymers, polyesters, olefinics, ABS, styrenics, polysulfones, polycarbonate and PEEK. Foster publishes a medical friendly vendor/RM list and policy and updates it regularly. Foster has not to date kept any finished goods inventory. However Foster keeps raw material inventory at both plant locations and has the ability to manage KANBAN programs. Foster is currently participating in KANBAN programs.
Production and quality control systems:
Foster is open to both KANBAN and consignment inventory programs however good forecasts are important to insure adequate raw material inventory and the shortest possible lead times.
Foster works in utmost confidentiality with customers. Recipe information is never given to anyone other than the customer to whom it belongs. Should a recipe need to be given to a partner processor, Foster gets written permission from the customer before any information is passed along. Foster certifies that all compounds meet recipe and other agreed upon specifications. Complete traceability is maintained back to the RM and a BOM revision document control system is in place.
Information systems: Foster has an ERP System (ProcessPro) that assures enables improved process and product traceability and runs MRP. New data acquisition systems have been installed on production equipment. Barcode able for both RM and FG. Foster has created a secure environment for all of their information systems including backup and redundant systems. Foster is evaluating e-commerce in partnership with critical customers and will implement in the near future.
Foster contact information:
Foster Corporation, 45 Ridge Rd Putnam Ct 06260, USA; Tel 860-928-4102; Fax 860-928-4226 West Coast: 4336 Losee Rd. Suite 8 North Las Vegas, NV 89030-3380, USA; Tel 702-644-4880; Fax 702¼644-5819; www.fostercomp.com; e-mail: foster.corp@fostercomp.com
MedNet contact information:
MedNet GmbH, Borkstrasse 10, 48163 MÆ’enster, Germany; Tel +49 (0) 251 32266-0;
Fax +49 (0) 251 32266-22; www.medneteurope.com; Contact: Matthias Heinz, Sales/Marketing û e-mail:
Matthias.heinz@medneteurope.com