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 DevelopmentBringing 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 GenerationWhether 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. Read More…
PrototypingWith 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. Read More…
Process and Tooling DesignWe design the assembly process, including material selection, tooling, and fixture development, to optimize for manufacturability and efficiency.
Testing and SterilizationPrototypes 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
- Carotid & Neurovascular Stents
- Coronary Applications
- Dialysis Devices
- Orthopedic / Arthroscopic Devices
- AAA/TAA Devices
- Peripheral Stents (SFA/Popliteal, Illiac, Tibial)
- Introducer Sets
- Stent Delivery Systems
- Delivery System Components & Sub-Assemblies
FDA 510K Registered Products
- 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 sourcing
- Nitinol (NiTi)
- Cobalt Chromium (CoCr)
- Stainless steel (SS 316L, SS 316VLM…)
- Specialty Alloys (L605, Phynox, MP35N…)
- Tantalum, Platinum, Gold
- Full Incoming Inspection
- 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
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. Read More…
ChallengeSeisa 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.
ChallengeSeisa 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.
- 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