Contract Manufacturing

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Global capacity,
customized solutions.

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.

Manufacturing Solutions

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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.

Plastic Injection Molding

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 200 to 850 tons, Seisa’s injection molding services are well suited 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 manufacturing.

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Extrusion

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.

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.

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Medical Device Class II and Class III Expertise

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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.

Manufacturing Products

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
  • Thrombectomy
  • Endoscopic Snares
  • Cytology Snares and Brushes
  • Urology Catheters

Other Products

  • Tubing Sets
  • Enteral Feeding Sets
  • Mother-Infant Care
  • Orthopedic Devices
  • Dental Accessories
  • Surgical Accessories

Collaborative Transfer Process

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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

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.

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watermarkSeisa 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.

watermarkBy 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.

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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.

watermarkSeisa 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.

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  • 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

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