Extrusion Center of Excellence
HISTORY Specialized Engineering started in Palo Alto in 1996 already having over 10 years experience in catheter assembly processes, engineered extrusion, and balloon blowing. With one Harrel extruder, one employee, a reputation for quality and quick turn around, the business quickly built up a tier-one client base. In 2000, Specialized Engineering moved to Stockton, CA. expanding manufacturing operations to 10,000 square feet. With ISO 9001: 2015 certification, Specialized Engineering is dedicated to quality, lean manufacturing with robust engineering support. Specialized Engineering, LLC 2
VISION MISSION STRATEGY GOAL Specialized Engineering is To partner with global Our business strategy is to Our goal through committed to providing leaders in the implement lean continuous improvement the highest quality healthcare industry to manufacturing with robust is to be a technology provide for the engineered products in engineering support, center of excellence to the medical device wellbeing of their reducing lead times and support the medical market to create added patients. costs. device market. value for our customers. 3 Specialized Engineering, LLC 3
VALUE PROPOSITION Yield Improvements Quality Through continuous Reduced Lead-Times Services improvement, we optimize : Efficiency Gains Cost Predictable Process People Specialized Engineering, LLC 4
SENIOR STAFF PAUL ALBA TIM CORTEZ JACOB RAQUET President, Founder of Specialized Product Development Manager, Director of Operations, Engineering, has been in the has played key roles in developing has been a Senior Manager and medical disposables industry for products throughout early stage Director for nearly thirty years over thirty years. His work start up companies. His experience within the medical device arena. experiences at ACS, Mallinckrodt spans design, prototyping, He is highly knowledgeable and Medical, Baxter Medical, AVE and preclinical testing and first in experienced in all facets of product Localmed/Perclose give him an human trials. With hands on development, engineering, new unparalleled perspective that has practical experience he is technology assessment, six sigma catapulted Specialized Engineering responsible for bringing customer’s to market leadership in the medical methodologies and manufacturing device industry. products to completion. scale-up. Specialized Engineering, LLC 5
SENIOR STAFF AGGIE ALBA TASIA CABALBAG Marketing Director, pursued Office Manager, has over 10 her Bachelor of Science Degree years of playing a key role in in Marketing from California Specialized Engineering’s State University, Sacramento. operations. She has built and Aggie joined the company in maintained strong 2006 and has made relationships with our tremendous efforts in guiding customer base while managing the brand and team in inventory, quotations and advancing our presence in the document control. medical marketplace. Specialized Engineering, LLC 6
FACILITY • Our facility encompasses 10,000 square feet of manufacturing space strategically located in central California’s non -earthquake zone. • The extrusion lab houses the primary manufacturing equipment which consists of 7 extrusion lines. • Our 650 square foot pilot production lab hosts secondary processing equipment including a 16 carrier braider, RF & thermal tipping machines, split die forming, automated precision cutting and hole punching tools. Specialized Engineering, LLC 7
CAPACITY • Currently Specialized Engineering is operating at 20% of the extrusion capacity. Daily throughput per extruder line is up to 50,000 feet. • Typical usage consists of 3 extrusion lines running one shift. 5 extrusion lines are available with 2 additional lines being installed. • Shifts can be staggered to obtain longer runs when required, up to 24 hours per day. Current staff is a total of 14 team members. Specialized Engineering, LLC 8
DEVELOPMENT PROCESS Specification Quotation Tooling Development Manufacturing Support Creation of the A formal DFM is applied Pilot runs are Lean Each lot of technical quotation is to all tooling completed to manufacturing tubing is specification supplied to the and evaluate process with online certified for supplied by the customer to development. capability. CPKs inspection. compliance. customer that define the key are analyzed for Dimensional identifies deliverables Manufacture of process verification is Customers are critical such as target tooling for improvements. carried out. notified of any requirements costs, delivery components updates to for the product. dates and risk begins to Tooling Validation is material factors. support modifications are completed to formulation or Engineering production implemented if ensure supply changes performs an Material is efforts. necessary and specifications from material analysis of all sourced if not documentation are met with a supplier. constituents in current Downstream is completed. robust process and their inventory . and secondary as defined by impact on the operation the customer. process. equipment is reviewed. Specialized Engineering, LLC 9
MATERIALS AND SIZES OFFERED • Pebax • Nylon 11, 12, 6/6 • HDPE • Beading • LDPE • 0.007” minimum OD • LLDPE • 0.125” maximum OD • Pellethane • Polyurethane • Tubing • PVC • 0.004” minimum ID • • 0.375” maximum OD Polypropylene • 0.002” minimum wall • PET Polyester • 0.050” maximum wall • PEEK • FEP • Ultem Specialized Engineering, LLC 10
CORE COMPETENCIES EXTRUSION TECHNOLOGY VALUE ADDED SERVICES • • Single lumen Coextrusion • • Multi lumen Striping • • Tri layer Textured ID/OD • • Online annealing Braiding • Profile • • Flaring Coiling • Balloon tubing • • Hole punching Tipping • Bump tubing • • Adhesive bonding Thermal bonding • Beading • • Precision cutting Catheter Assemblies • • Fixture design RF Bonding • • High Temp 3D Insertmolding Printing, PEEK/Ultem Specialized Engineering, LLC 11
HIGH PERFORMANCE SHAFTS High performance shafts are often required for tortuous and complex procedures. Braid and coil reinforcements are used to increase torque transmission and hoop strength. • Reinforcement Materials: Stainless Steel, Kevlar, LCP, Nitinol • Liner Materials: FEP, PTFE, HDPE • Single and Multilumen Profiles • Variable durometers, pick counts and TPI Polymer 1 Polymer 2 Specialized Engineering, LLC 12
TRILAYER + COEXTRUSION Trilayer and coextruded shafts are engineered shafts that incorporate discreet layers to suit a specific set of specifications. Our proprietary process for producing this type of tubing enables high crush strength with no guidewire lock up. Common polymers used with this type of construction include: • HDPE • LDPE Outer Layer • Nylon Inner Layer • Polyurethane Tie Layer • Pebax Specialized Engineering, LLC 13
HIGH PERFORMANCE BALLOON TUBING • Our proprietary process for manufacturing balloon tubing incorporates up to 3 polymers in individual layers to orient polymer chains in multiple directions to achieve thin wall high pressure balloons. Outer Layer Middle Layer Inner Layer Specialized Engineering, LLC 14
EXTRUSION TOOL DESIGN • Custom tooling is often necessary to meet the high end specifications required in todays competitive market. • Our in house engineering team has developed material specific draw down ratios along with high flow inline material filtering to ensure the highest quality components that meet exacting specifications. Specialized Engineering, LLC 15
ONLINE QUALITY ASSURANCE The addition of online ultrasonic gauging has enabled Specialized Engineering to increase yields and reduce touch time during inspection. Live scanning of the wall thickness enables closed loop control of outputs. 8 channel SPC data analysis generates reports for each lot. Inline Measurement Head Specialized Engineering, LLC 16
METROLOGY Our metrology lab houses the following equipment for characterization and analysis: • Instron 3343 Single Column Testing System Tensile, Compression, Strain, Cyclic Conditioning • MicroVu Vertex 311 Automated Precision Measurement System Optical measurement system for reliable non contact inspection • CEM LabWave 9000 Moisture content analysis for raw material analysis Specialized Engineering, LLC 17
QUALITY POLICY Specialized Engineering, LLC is committed to providing their customers with superior personalized service of their products with the highest quality standards. Our goal through continuous improvement is to be a world class leader in Medical Manufacturing for the Medical Device Industries. Specialized Engineering, LLC prides itself on meeting the requirements and expectations of our customers. We meet these goals by continually improving the effectiveness of our Quality Management System in accordance with Industry, regulatory and statutory requirements. Specialized Engineering, LLC 18
Recommend
More recommend
