Founded in 1996, Specialized Engineering has more than a decade of experience in catheter assembly processes, engineered extrusion and balloon blowing for medical devices.
The business quickly built up a tier-one client base with only one Harrel extruder and one employee, earning a reputation for a high level of quality and quick turnaround.
In 2000, Specialized Engineering moved to Stockton, California, expanding its manufacturing operations to 10,000ft².
With the International Organization of Standardization (ISO) 9000: 2015 certification, the company dedicated its mission to quality manufacturing and management processes.
Personalised service for catheter assembly, extrusion and balloon products
For the quickest turnaround in the medical extrusion industry, while meeting clients’ precise quality expectations, Specialized Engineering delivers research and development (R&D) short runs and manufacturing runs exceeding one million feet. Furthermore, the company exclusively runs microprocessor-controlled Harrel Geartruders.
The company is committed to providing its customers with superior personalised service of its products with the highest quality standards, aiming to be a world-class leader in medical manufacturing for medical device industries through its continuous improvement.
Catheter assembly, engineered extrusion and balloon blowing experience with unparalleled perspective
Specialized Engineering founder and president Paul Alba has been in the medical disposables industry for more than 20 years.
His work experiences at ACS, Mallinckrodt Medical, Baxter Medical, AVE and Localmed / Perclose gave him a unique perspective that has launched Specialized Engineering to market leadership in the medical extrusion industry.
Health and safety, and environmental management
Specialized Engineering recognises that the disciplines of quality, health and safety and environmental management are an integral part of its management function. Central to the company’s development is the operation of an effective management system that meets all these requirements.
We promote a professional atmosphere of continuous improvement and always strive to do better. We know and believe that the customer comes first and support them through employee empowerment and continuous improvement.
Quality assurance
Quality is paramount at Specialized Engineering. Through years of experience, we developed a process for continuously creating quality products. This development process has produced millions of feet of precision tubing used in many commercial devices by both large and small companies.
Through driving culture change, this process has enabled us to focus on throughput, quality, reducing costs and lead times while developing a lean manufacturing methodology.
Our quality management system ensures consistency in all phases of our operation and the quality of our products. The company’s management team continues to support and provide direction to exceed this goal.
We strive to be a technology centre of excellence and a leader of engineered solutions for the medical device industry through customer service, technical excellence and continuously improving the effectiveness of our quality management system following industry, applicable regulatory and statutory requirements.
Manufacturing facility for catheters, extruders and balloons
Our facility encompasses 10,000ft² of manufacturing space strategically located in central California’s non-earthquake zone. The extrusion lab houses the primary manufacturing equipment, which consists of seven extrusion lines.
Our 650ft² pilot production lab hosts secondary processing equipment, including a 16-carrier braider, radio frequency (RF) & thermal tipping machines, split die forming, automated precision cutting and hole punching tools.
Specialized Engineering currently is operating at 20% of the extrusion capacity. Daily throughput per extruder line is up to 50,000ft. Typical usage consists of three extrusion lines running one shift. Five extrusion lines are available, with two additional being installed.
Shifts can be staggered to obtain longer runs when required, up to 24 hours a day.