Seisa’s end-to-end manufacturing solutions are backed by full regulatory compliance with the FDA and international agencies. We manufacture catheter-based products, implantable stents, pediatric and orthopedic-care devices, tubing sets, and other products. With 2,500 employees across four continents and over 400,000 square feet of medical device manufacturing space, we make sure our customers are well taken care of. Manufacturing with Seisa means peace of mind and a better bottom line.
Medical Manufacturing Solutions
Seisa offers world class outsourcing manufacturing solutions to leading medical device companies in every step of the product lifecycle, from product and process development to prototyping and production. We also provide high volume precision component manufacturing, assembly, packaging, testing, product sterilization management and distribution of medical devices.
With our comprehensive list of reliable manufacturing capabilities, Seisa is vertically integrated to improve your product’s time to market with a cost-effective approach. We are a unique full-service provider in the medical device outsourcing market.
From prototyping runs to high volume production, Seisa offers full manufacturing solutions in alignment with the Food and Drug Administration and the ISO 13485 standards to meet your most complex medical device needs. All our products are manufactured in cleanroom environments across FDA registered sites in North America and Europe.
Implantable Components and Delivery Systems
Seisa designs and manufacturers metal-based components, ranging from minute neurovascular and coronary devices to large aortic stent grafts and valve components. We work with nitinol, cobalt-chromium, stainless steel, and other biocompatible metals.
Our portfolio of capabilities includes high-yield, high-quality fabrication of implantable stents, wire-formed components, and catheter-based delivery systems. Our state-of-the-art laser machining and world class finishing processes rival any in the industry.
Seisa Medical has delivered full-service plastic injection molding capabilities through its subsidiary Seisa Plastics since 2002. With a broad assortment of multiple presses, ranging from tonnages of 30 to 850 tons, Seisa’s injection molding and prototyping services are specifically engineered for the application of medical devices.
With in-house tooling, preventative maintenance, design and development, Seisa delivers highly reliable plastics solutions to meet any requirements your application may dictate. Whether your requirements are low volume, high volume or high complexity, Seisa has you covered with in-house vertical injection molding manufacturing.
- Cleanroom Injection Molding
- Insert Molding
Providing in-house design, prototyping and volume production of extruded components, Seisa delivers medically compliant extrusions for the most demanding applications. We support a variety of requirements and materials, enabling end-to-end solutions for devices, ranging from catheter-based components to infusion sets and other medical applications.
Extrusion services include:
- Multilumen Extrusion
Learn more about our extrusion capabilities.
Our team of highly qualified tooling and molding experts are prepared to optimize your plastic part designs to ensure efficient implementation. We serve a multitude of needs — those ready for prototyping, bridge tooling and mass production. Seisa takes the guesswork out of developing the right parts for your business’ production processes.
Prototype molding processes include, but are not limited to:
3. Insert Molding
4. Two-Shot Molding
Learn more about our plastic prototyping capabilities.
Seisa’s tool engineers possess the knowledge and professional expertise to design and manufacture prototyping tools and complementary production tooling. Our team specializes in mold making using aluminum and steel tooling to create medical devices.
We use industry-recognized materials:
- TPEs and TPUs
CNC Machining and EDM Capabilities
Our expert engineers are equipped with industry-leading facilities, materials and methods. Seisa’s Metal Machining Center of Excellence, located in the San Francisco Bay Area, is responsible for fabricating and delivering a variety of products, including mission-critical medical device components and assemblies.
Our machining capabilities are expansive. Electrical discharge machining (EDM) capabilities provide substantial capacity in both wire and plunge EDM technologies.
Our offerings include:
- CNC turning
- Needle sharpening
- Wire EDM (down to .004” wire)
- EDM Fine-Hole Drilling (down to .002” diameter)
Seisa is trusted in successfully developing, testing and manufacturing virtually any machined component. Our proven experience allows us to work with a plethora of materials, including aluminum, brass, copper, steel, stainless steel, titanium, magnesium and other exotic metals.
Learn more about our CNC Machining and EDM capabilities.
Medical Device Manufacturing
We take a highly proactive approach in identifying opportunities to streamline production, upgrade components and reduce material costs. We also create formal proposals and collaborate with you to develop plans to execute those improvements.
Seisa’s vertically integrated solutions deliver optimum efficiency and control throughout the medical device manufacturing process. We handle every aspect in-house, whether it’s plastic injection molding, extrusion, assembly, packaging, kitting or system integration with peripheral processes. We help improve product quality and the component manufacturing process while reducing costs.
Our catheters come in a wide range of configurations to meet various medical needs. For example, we offer braid and coil reinforced catheters with radio opaque marker bands, thin wall construction catheters as low as 0.0045’’, steerable or deflectable catheters, and atraumatically tipped catheters. We also provide micro catheters, guiding catheters, electrophysiology catheters, percutaneous transluminal coronary angioplasty balloon catheters and delivery catheters.
In addition, we specialize in balloon forming, multiple durometers, multiple braided layers for torque and kink resistance, multiple lumens braided tubing, complex liner and wire braided termination, polytetrafluoroethylene, fluorinated ethylene propylene, pebax, nylon, and polyimide lined inner lumen applications.
Our product development and medical device manufacturing teams work together to improve the speed to market for your finished products.
Learn more about our catheter solutions.
Our catheters are available in a wide range of configurations to meet user requirements.
- Braid and coil reinforced catheters with radio opaque marker bands.
- Thin wall construction (as low as 0.0045″)
- Micro catheter, guiding catheter, EP catheter, PTCA Balloon Catheter and delivery catheters.
- Balloon forming.
- Multiple durometers.
- Multiple braided layers for torque and kink resistance.
- Multiple lumens braided tubing.
- Steerable or deflectable catheters.
- Complex liner and wire braided termination.
- PTFE/FEP/Pebax/Nylon/Polyimide lined inner lumen
- Atraumatically tipped catheters.
- Other custom requirements are also available.
Our balloon forming machines produce a wide variety of polymer balloons for angioplasty and other medical applications. We work with a wide range of balloon forming materials and dimensions that can be used in various applications.
Our balloon catheter experts understand every stage of the balloon process, from preliminary designs to product development and manufacturing. We go above and beyond in creating customized medical balloon solutions to meet your needs.
Learn more about our balloon forming solutions.
Medical Device Class II and Class III Expertise
With decades of experience, Seisa Medical manufactures a variety of Class II products and Class III implantable devices. Our expertise includes product development, transfer and volume manufacturing of catheter-based devices and a wide variety of components, stents and implantables.
Seisa Medical also specializes in the design and production of nitinol and other specialty alloys for implantable devices. With in-house laser cutting, heat shaping, forming, electropolishing, and surface finishing, we deliver end-to-end solutions for components, devices, and delivery systems.
Medical Product Manufacturer
At Seisa, we offer completely customized solutions backed by over 35 years of medical device manufacturing experience. We leave the choices to you, bringing our team of experts and engineers to any stage of the process where you need support.
We use our experience and capabilities to build the right combination of design, prototyping, simulation and testing solutions to meet your goals.
Learn more about medical product manufacturing.
Minimally Invasive Devices
- Catheters (access, diagnostic, guiding, etc.)
- Self-expanding stent delivery systems
- Guidewires and introducers
- Balloon catheters
- Micro-catheters and specialized catheters
- Atherectomy catheters
- Neuromodulation devices
- Nitinol and novel alloys components
- Nitinol peripheral and coronary stents
- Nitinol baskets
- Biliary stents
- Aortic stent grafts
- Ablation catheters
- Endoscopic snares
- Cytology snares and brushes
- Urology catheters
- Tubing sets
- Enteral feeding sets
- Mother-infant care
- Orthopedic devices
- Dental accessories
- Surgical accessories
Laser Cutting and Metal
Laser technologies are a core competency of our company. Our laser systems are able to cut the most intricate geometries and tightest tolerance designs.
Precision Laser Cutting
Some of the specifications involved in precision laser cutting include:
- Materials: Nitinol, cobalt chromium, stainless steel, tantalum, platinum/iridium and other exotic alloys
- Material formats: Tube, strip and sheet
- Tube diameter range: 0.01 to 1.0 inch
- Wall thickness: 0.001 to 0.03 inch
- Cut tolerance of +/- 0.0003 inch
- Minimum kerf width: down to 0.0004 inch
- Precision burr-free laser cutting
- Laser cut designs optimized for dimensional uniformity and edge quality
Our laser CNC welding technologies provide accurate and reliable welding in the production of medical devices. Below are the types of welding we perform:
- Weld characterization
- Spot welding
- Spot size down to 0.002’’
- Penetration welding
- Seam welding
- Rotational welding
- Welding of similar/non-similar metals
- Stainless to stainless, nitinol to nitinol, SS to platinum and nitinol to tantalum
- Component assembly fixturing to hold dimensional tolerances
Learn more about laser welding and machining.
Metal Processing Technologies
Seisa provides world class expertise in product design and development of metal processing technologies to create delivery systems, stents, implants, and other medical devices.
Shape Setting /
Heat Treatment / Annealing
Some of our shape setting, heat treatment and annealing technologies include:
- Processing of super-elastic shape-memory nitinol
- Devices of variable sizes and complex shapes
- Optimized devices for mechanical and thermomechanical behavior
- Rapid heating/cooling cycles and precision temperature control
- Furnace bath treatments
- Exceedingly fine grain size structures
- Af temperature setting
Some of our wire-formed devices manufacturing technologies include:
- Semi-automated forming
- Consistent part shape and performance
- Welded junctions
- Crimped and swaged junctions
- Wire formed devices with barbs and swaged marker attachments
Med-Class Surface Finishing
Some of our med-class surface finishing technologies include:
- Micro blasting
- Dry and wet honing
- Mechanical polishing
- Chemical etching
- Surface finishing to achieve complete removal of HAZ
- Uniform material removal and rounding of sharp edges
- Maximized corrosion resistance and biocompatibility
- Repeatability and predictability
Some of our radiopaque marking technologies include:
- Precious metals such as tantalum and gold swaged into eyelets or attached on struts
- Strain modeling performed to aid design process
- Retention force measurements
- Crimping and bonding available for radiopaque marking
Learn more about our metal processing technologies.
Nitinol and Specialty
Seisa acquired Burpee MedSystems in the spring of 2019. The strategic acquisition combines design and development of nitinol and specialty alloy-based devices with Seisa’s scale manufacturing expertise.
Seisa provides end-to-end product design and contract manufacturing services for the medical device industry using laser cutting, laser welding, shape setting, surface finishing and processing of MedTech metal components, sub-assemblies and implants.
With more than 35 years of combined experience, we support our customers throughout the full product life cycle, from rapid turnaround engineering prototyping to commercial scale production.
Our integrated solutions provide precision processing of nitinol and MedTech metal alloy components and devices. We also offer design for manufacturability, rapid prototyping, validation for clinical/preclinical testing and competitive scale contract manufacturing.
Our deep engineering expertise in nitinol and med class metal alloys, combined with our laser processing technologies, positions us as a trusted contract manufacturer through the full product life cycle, from initial concept to full commercialization.
Learn more about our nitinol medical device manufacturing.
Nitinol and Specialty Alloy
- Quick turnaround order production
- Flexible manufacturing lot sizes
- Fast pilot run setting
- Nitinol and specialty alloy-based component rapid production
Scaled Commercial Production
- Dedicated manufacturing lines
- Cleanroom Class 8
- Cost effective manufacturing