End-to-end services,
tailored solutions
We leave the choices up to you by bringing our team of experts and engineers to any stage of the process where you need support.
Product Design Services
Product Design and
Development
Bringing design, prototyping, simulation, and testing under one roof, fully integrated development enables us to offer an optimized design control package in line with FDA guidance. Our engineers take your idea from concept to completion, incorporating the most sophisticated techniques in the industry. We lead reviews, hazard identification, and risk analysis throughout the process.
510K Generation
Whether you need assistance with design, 510K generation, or a finished device, Seisa has your solution. Seisa supports and creates FDA 510K registration documentation, and provides ongoing support through customer reviews until registration is finalized.
Prototyping
With 3-D printers, rapid mold generation, and in-house tooling capabilities, Seisa can produce samples quickly and efficiently from a variety of materials for rigorous and reliable testing.
Process and Tooling Design
We design the assembly process, including material selection, tooling, and fixture development, to optimize for manufacturability and efficiency.
New Product Introduction
Upon design completion, we move your device into production, performing process validation, procuring materials, and scaling up for volume manufacturing.
Testing and Sterilization
Prototypes can be subjected to dimensional analysis, surface coefficient of friction, burst, simulated use and other assessments within our laboratories. Our network includes sterilization management services, bringing your product from prototype to fully functional.
Product Development Expertise
Seisa offers completely customized solutions backed by more than 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 to build the right combination of design, prototyping, simulation, and testing solutions to meet your goals.
- Carotid & Neurovascular Stents
- Coronary Applications
- Dialysis Devices
- Orthopedic / Arthroscopic Devices
- Neuromodulation
- AAA/TAA Devices
- Peripheral Stents (SFA/Popliteal, Illiac, Tibial)
- Introducer Sets
- Stent Delivery Systems
- Delivery System Components & Sub-Assemblies
FDA 510K Registered Products
Seisa has developed a range of fully patented and certified products as well as the capacity to execute any stage of the process.
- Microcatheters
- Guidewires
- Support Catheters
- Guiding Sheath
- Guiding Catheters
Design and Development Services for
Delivery Systems and Components
Our experienced engineering team is able to design concepts from a basic idea or
a preliminary 3D model into an optimized prototype for manufacturability.
Design Services for
Interventional Devices
- Rapid prototyping
- Finite element analysis
- Design for manufacturability
- Verification and validation for clinical/pre-clinical tests
- Project management
- Design controls
- Risk management
- Experienced development team
Material Selection
- Material sourcing
- Nitinol (NiTi)
- Cobalt Chromium (CoCr)
- Stainless steel (SS 316L, SS 316VLM…)
- Specialty Alloys (L605, Phynox, MP35N…)
- Tantalum, Platinum, Gold
- Full Incoming Inspection
Testing Capabilities
- Dimensional and Functional Testing
- Delivery System Dimensional and Functional Testing
- Deployment Testing
- Packaging Testing
- Catheter Testing
- Shelf Life Testing
Collaborative Transfer Process
Upon design completion, we move your device into production, performing process validation, acquiring materials, and scaling up for volume manufacturing. Seisa manages product transfers through a systematic product transfer process, utilizing standardized tools and guidelines to ensure consistent outcomes and provide risk mitigation.
Seisa Transfer Model
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Project Feasibility
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Transfer Planning
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Material Assessment
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Process Development
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Transfer Execution
Supply Chain Solutions
Our supply chain experts are deeply integrated within the customer team structure to ensure materials management remains at the heart of operational planning.
Seisa provides a customized solution for your project. We capture all elements of the optimized supply chain including inbound and outbound logistics, vertical integration, supplier selection, and vendor management.
Disciplined management of Key Performance Indicators (KPIs) ensures early detection and prevention of any supply chain disruption. We monitor lead time, availability, material obsolescence, prices, supply trends, and other variables to maximize supply chain effectiveness.
Tracking and metrics, not only of our own operations, but those of our suppliers as well, keeps our supply chain lean and reliable. We deliver advanced materials to the production line, in the right quantities, on time, every time.
Case Study
Scalability
Challenge
Seisa Medical was challenged to increase production output of an implantable device by 50% within just four months.
Seisa’s customer — a large multinational medical device player — introduced an improved version of their Class III device to incredibly strong market demand. As a result, Seisa Medical was challenged to significantly increase production output of the implantable device while sustaining quality levels and operational KPIs. The product required a highly specialized skill set for operator certification. Historical data indicated several thousand people would need to be recruited for intensive training before final selection of the few hundred required. All this needed to be done within a four-month period.
Seisa created a customized solution, including investment to accelerate its recruiting cycle while leveraging an existing, robust training process. A cross-functional team was formed with Seisa’s customer to define project deliverables such as headcount, training, and layout configuration changes in compliance with regulatory requirements. The solution was supported with a milestone-based tracker with specific tasks and timelines to accomplish the required increase with no delays and without compromising quality or delivery. Using historical training data, Seisa implemented a plan to recruit and compensate more than 5,000 people to undergo Seisa’s rigorous training and certification program. Ultimately Seisa was successful in yielding the several hundred highly skilled operators needed to support the increased output requirements. Seisa’s success resulted from its robust recruiting and training practices, its investment in its people, and its experience in manufacturing Class III products.
By leveraging Seisa’s customized solution, including advanced recruiting and training methods, the customer gained significant market share and increased sales on a high margin product line that is still growing.
Project Transfer
Challenge
Seisa helps customer with product transfer for higher profitability.
A small division of a large healthcare company approached Seisa for assistance with a portfolio of disposable products. The customer was facing profitability challenges and growing concerns related to regulatory compliance. The product mix included a variety of sterile single-use devices and the customer possessed limited experience with production transfers.
Seisa proposed a tailored solution to support the customer’s plan to drastically reduce the product mix, while bringing the product into Seisa’s established medical device assembly facility, taking over turnkey supply chain management and leveraging Seisa’s fully compliant Quality Management System (QMS). Seisa mapped the customer’s QMS and adapted a customized and fully-compliant quality plan to support the customer’s refined product portfolio.
Following Seisa’s standardized transfer process, a special team lead the review of all customer requirements and built a documented transfer plan. The Seisa transfer manager conducted daily project reviews with the extended team including both Seisa and customer representatives. The cross-functional transfer team included subject matter expertise in all relevant functional areas and addressed specific manufacturing techniques for bonding, mechanical assembly, ultrasonic welding, and plastics processing.
- The Seisa team completed the transfer plan within 4 months, 2 months ahead of plan
- Made customer’s implantable device profitable by reducing overhead and improving inventory management
- Alleviated customer’s quality and regulatory concerns by producing device under Seisa’s proven QMS
- Seisa continues to deliver a high-quality product on time and at a lower cost than the customer’s previous process
