Seisa’s end-to-end solutions are backed by our company’s history of full regulatory compliance with the FDA and international agencies. Manufacturing with Seisa means peace of mind and a better bottom line.
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, working 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.
Since 2002, Seisa Medical has delivered full-service plastic injection molding capabilities as a foundational pillar of our vertically integrated solution offering. With a broad range 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 whatever requirements your application may dictate. Whether your requirements are low volume, high volume, or high complexity, Seisa has you covered with full, 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.
- Multilumen Extrusion
Our team of highly qualified of 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
Seisa’s tool engineers possess the knowledge and professional expertise to design and manufacture prototyping tools, as well as complementary production tooling. Our team specializes in aluminum and steel tooling, in addition to the following industry-recognized materials:
8. 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 such as mission-critical medical device components and assemblies. Our machining capabilities are expansive. 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.
Medical Device Manufacturing
Our approach is proactive; as we identify opportunities to streamline production, upgrade components, or reduce material costs, we create formal proposals for your review, and collaboratively develop implementation plans to execute those improvements.
Seisa’s vertically integrated solutions deliver optimum efficiency and control throughout the manufacturing process. We handle every aspect in-house, including plastic injection molding, extrusion, assembly, packaging, kitting, and system integration with all peripheral processes.
With component manufacturing among our capabilities, quality and process control improves as costs are reduced.
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.
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.
At Seisa, we offer completely customized solutions backed by over 35 years of medical device 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.
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
- Materials: Nitinol, Cobalt Chromium, Stainless Steel, Tantalum, Platinum/Iridium, and other exotic alloys.
- Material formats: Tube, Strip, Sheet
- Wall thickness: 0.001 to 0.03 inch
- Tube diameters range: 0.01 to 1.0 inch
- Minimum kerf width: down to 0.0004 inch
- Cut tolerance of +/- 0.0003 inch
- Efficient laser cut designs optimized for exceptional dimensional
uniformity and edge quality
- Precision burr-free laser cutting
- 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, Nitinol to Tantalum
- Component assembly fixturing to hold dimensional tolerances
Shape Setting /
Heat Treatment / Annealing
- 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
- 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
- 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
- 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
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 end to end integrated solutions provide precision processing of Nitinol and MedTech metal alloy components and devices, design and development, 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.
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