Your Single source for medical device Development
We’ve helped manufacture hundreds of medical devices over the years, so we understand the responsibilities involved in developing precision medical device components and assemblies.
Manufacturing precision medical Devices
Quality and Consistency
Scientific injection molding
We have been serving the medical industry for nearly 40 years, specializing in handling complex, multi-part programs and medical device molding for a variety of customers. Our direct contact with doctors and other medical professionals gives us insight into their needs and helps define and assist with final product solutions.
Our medical plastic injection molding capabilities include:
Medical Device Design Development and Assistance
Design for Manufacturability
Medical Device Molding
Cleanroom Molding and Assembly, CLASS 8
ISO 13485 Registered and Compliant
FDA Registered
RJG Certified Mold Builder and Tryout Facility
Cavity Pressure Sensing and Scientific Injection Molding
Everything you need to bring your medical device to life
Product Design
Our industrial design team can be an extension of your product development team by generating concepts and advancing ideas with manufacturing processes in mind. We have found that our early collaboration in this step ensures a successful tool launch.
Design for Manufacturing
Early engagement of the DFM process provides customers with part design recommendations for improved performance, aesthetics, and overall manufacturability. This can also reduce potential project lead time and possible engineering/tooling changes later in the program. New design ideas are often uncovered during this process that may not have been considered.
in-house tooling
Our in-house tooling center can accommodate customer projects from an aluminum prototype to a multi-cavity steel production tool ranging from class 101 to 104. We can handle projects from a single part to a program with 30 or more plastic parts within the device.
Injection Molding
Whether it’s a low-volume or a higher-volume part run, our comprehensive injection molding process will deliver a quality product. We utilize scientific injection molding methods during part validation, from our high-temperature molding area to the cleanroom and beyond. Our process engineering team is well versed in a wide variety of engineered thermoplastics.
Assembly & VALUE-ADDED services
Beyond our molding operation, we offer a variety of secondary operations including ultrasonic welding, spin welding, pad printing, laser marking, device subassembly, and contract manufacturing of a complete device. Whatever your secondary assembly needs, our team is ready to add value to your product.
Automation
From collaborative robots, multi-function end of arm tooling, vision verification and sorting, and modular press side automation, we are constantly evolving to increase efficiencies. Implementation of this technology for part handling, gate/sprue removal, part separating, and insert loading within the molding operation allows for greater repeatability and a substantial reduction in scrap.
Quality / Validation
We have extensive experience in the validations and protocols for the medical device industry utilizing IQ/OQ/PQ methodologies. Our proven quality systems certified to ISO 13485 and MedAccred standards allow our customers to rest easy that their manufactured components will meet quality expectations and requirements. PTI’s standard process was developed in partnership with the best device manufacturers in the business.
Consistent and Reliable
The Medical Industries’ Value-Added Partner
At PTI we are much more than a Plastic Injection Molder. At every phase of the manufacturing process, we strive to add value to your product, from industrial design assistance through a thorough design review, whether it is a single component or a multiple part assembly. We are your single source solution for low to medium run, production quality components and assemblies. Our full-service capabilities, from design to in-house tooling, manufacturing, and value-added services position PTI to be your value-added partner.
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