About Our Medical Injection Molding Services
With five manufacturing locations across the U.S. and the ability to work in close partnership with original equipment manufacturers (OEMs), Seaway Plastics creates end-to end solutions for the safe and cost-effective manufacturing of a broad range of precision medical components, devices and assemblies that are used throughout the medical, healthcare and life sciences sectors. Such products are used every day in clinical settings to support life-saving and life-improving medical procedures and other healthcare interventions that ensure optimal patient health outcomes.
Providing a full range of services that enable the manufacturing of complex products for these high-stakes applications, Seaway Plastics works closely with OEMs and CDMOs to select the most appropriate material from a broad array of medical-grade plastics and silicone and provides a complete range of engineering and medical injection molding services. Each of Seaway Plastics’ facilities is ISO-13485 certified and offers comprehensive process-validation services to ensure that all operations meet the prevailing quality and regulatory requirements.
Across numerous medical, life sciences and healthcare applications, Seaway Plastics works closely with OEMs to produce high-quality products that are used in the following applications:
- Diagnostic testing
- Implant-delivery systems
- Single-use disposables
- Surgical robotic tools and platforms
- Respiratory medical products
Medical Grade Materials
With access to the most appropriate, state-of-the-art thermoplastic and thermoset options, Seaway Plastics helps OEMs to select the right materials — those that will deliver the specific suite of performance characteristics that are required by the finished parts, products or assemblies. Our customers have the opportunity to choose from a wide range of highly engineered materials, including but not limited to:
- ABS - Acrylonitrile Butadiene Styrene
- POM - Acetal
- PMMA - Acrylic
- LCP - Liquid crystal polymers
- LSR – Liquid Silicone Rubber
- PA - Nylon
- PC - Polycarbonate
- PBT - Polyester
- PET - Polyethylene
- PUR - Polyurethane
- TPU/TPE – Thermoplastic Polyurethane
- PEEK – Polyetheretherketone
- PEI – Ultem
- PPE+PS – Polyphenylene Ether (Noryl)
The Seaway Advantage
There are many important advantages to selecting a manufacturing partner that is able to take ownership of every step in the process in-house — from engineering services to prototyping to fully validated production — without the need to involve additional partners or create multiple outsourcing arrangements. Specifically, for OEMs, the demonstrable advantages such a tightly integrated approach include:
- Time savings — By streamlining the overall project management with a single manufacturing partner
- Reduced costs — By integrating all steps with a single manufacturing partner
- Reduced supply chain risk and administrative complexity — By minimizing the number of handoffs and packaging/shipping delays that would arise if multiple vendors were needed to complete the project and the number of business relationships and outsourcing agreements that would be needed with multiple vendors
Collectively, these benefits enhance reliability and reputational value — and can provide competitive advantage — for the OEM. For the healthcare professionals and patients who rely on such state-of-the-art products, the benefit of solid teamwork that consistently delivers high quality and reliability during manufacturing brings peace of mind.
To enable end-to-end project management for complex manufacturing projects, Seaway Plastics is able to manage each of these critical steps:
- DFM (Design for Manufacturing) & Engineering
- Tooling Design & Build
- Plastic & Silicone Medical Injection Molding
- Extensive post-molding operations
- Full assemblies
- Custom Validation & Qualification Packages
- Sterile Kitting, Packaging & Distribution Services
Seaway Plastics has been a trusted manufacturer of high-quality components, products and assemblies for a variety of Class 1, 2 and 3 medical devices for more than four decades. To ensure a sterile manufacturing environment, its facilities have ISO Class 7 and 8 certified cleanrooms that prevent airborne contaminants as small as 0.3 and 0.5 microns, respectively, during molding and assembly operations. This ensures that finished products that are intended for use in medical, healthcare and life sciences applications meet all industry standards and regulatory requirements.
By partnering with Seaway Plastics to streamline all steps in the complex manufacturing process, OEMs are able to be more competitive, safeguard their own brand reputation and focus on meeting the needs of their end customers — healthcare professionals treating patients in hospitals, physician practices and other clinical settings. Ultimately, this team effort is critical to support the shared end objective — which is to support and enable optimal health outcomes for patients.
Medical Segments Served
Diagnostics & Lifesciences
Medical injection molding using highly engineered materials is a proven option for creating precise industrial parts and complicated assemblies while keeping costs and risks low and quality and reliability high. Seaway Plastics has four decades of experience providing custom, end-to-end solutions to enable the manufacture of specialized products that are used during numerous diagnostic and life sciences applications.
Seaway Plastics brings precision, quality and innovation to every customer relationship. Examples of the types of specialized diagnostic products that are used to inform and support healthcare diagnosis and treatment decision making include (but are not limited to):
- Plate-based assays used for cell therapy
- Blood/plasma pathway cassettes used blood-platelet collection
- Laboratory equipment (including test tubes, petri dishes and microplates)
- Electrocardiographs used to measure the electrical activity of the heart
Implant Delivery Systems
Implant-delivery systems play a critical role in modern healthcare interventions, as they are used to support the accurate placement of therapeutic medical devices during surgical operations. OEMs that supply such specialty products to the surgical community must choose their manufacturing partners carefully to safeguard the integrity of the final products and enable optimal, consistent healthcare outcomes. 
Seaway Plastics brings precision, quality and innovation to every customer relationship. Recent examples of the types of specialized products produced for OEMs in this sector include (but are not limited to): 
- Suture anchors used during arthroscopic procedures
- Spinal-implant platforms used to both create stability during bone grafting and to restore disc height
- Implantable clips used in the delivery system for heart surgery
Single Use Disposables
Seaway Plastics has four decades of experience and a proven track record engineering, manufacturing and assembling high-purity medical devices that are designed for disposable, single-use applications.
OEMs that partner with Seaway Plastics to produce single-use disposable medical devices for use throughout the medical, healthcare and life sciences sectors gain peace of mind and reliability, knowing their manufacturing partner can handle the project from start to finish, from DFM all the way through final product manufacturing, assembly and validation.
Recent examples of the types of specialized products produced for OEMs in this sector include (but are not limited to):
- Beta bags with port attachments that provide contamination-free transfer of sterile components
- Innovative heated silicone pad devices that provide relief for patients with dry-eye syndrome
- Vitreoretinal instruments used in eye surgery
- Blood/plasma pathway cassettes used blood-platelet collection
- Continuous glucose monitor used in diabetic care
Surgical Robotics
The development and use of surgical robotic devices and platforms continue to revolutionize how lifesaving and life-enhancing surgeries are performed. Such devices are complex mechanical assemblies with many parts, all of which have extremely exacting engineering requirements and zero tolerance for deviation.
Patients benefit from the precision, quality and innovation Seaway Plastics brings to the table when meeting the unique specifications of every OEM engagement. To date, the company is helping OEMs to improve patient outcomes in the following areas:
- Urology
- Gynecology
- Prostatectomy
- General surgery
- Interventional Ultrasonic Guidance
The ability to produce precise surgical robotic tools and assemblies that meet all of the rigorous engineering and regulatory specifications is another way in which both Seaway Plastics and its OEM customers are supporting surgeons and other medical practitioners in their quest to guarantee accuracy and repeatability during surgical procedures — thereby enhancing patient safety and overall health outcomes.
Respiratory
Seaway Plastics offers a deep bench of DFM, tooling and injection molding expertise, and experience working with the broadest array of highly engineered materials. This supports the cost-effective, reliable precision manufacturing of many specialized parts, components and final products that are used to support medical, healthcare and life sciences applications.
Within the realm of medical products that are used to support the health journey of patients managing respiratory conditions, examples include:
- Portable oxygen concentrators used by patients when they are away from home
- Disposable Oro-Nasal masks intended to administer oxygen and other vapor- form medications
- Nebulizers used in converting medication from a liquid to a mist form
- Respiratory masks used in hospital settings
WIDE RANGE OF CERTIFICATIONS
An Outstanding Commitment to Quality
ITAR
FDA
Nadcap
DQS