Medical Device Design and Development Services
With over 70 years of experience in regulated medical device manufacturing, Primo Medical Group partners with startups, early-stage OEMs, and companies transferring manufacturing to new providers to deliver medical device contract design and development. Our vertically integrated operations enable us to engage your project at any stage, from design refinement to production preparation. For decades, we have worked with industry leaders and developed our own products, offering an unrivaled range of experience to address the challenges of designing and developing medical devices.
Some recent additions to our capabilities include a Plastic Tray Vacuum Thermoforming System. If packaging options for your product are still being evaluated, nothing beats having the ability to quickly get thermoformed packaging prototypes in your hand!
Vacuum Forming Specs
| Forming Area | Sheet Size | Max Depth | Max Thickness |
| 482 x 432 mm / 19 x 17” | 508 x 457mm / 20 x 18” | 185mm / 7.3” | 6mm / .25” |
Our Rapid Prototyping capabilities are now even better. We acquired one of the best Dual Extruder 3D Printers on the market which enables us to provide you prototypes of exceptional print quality, large build volume, and excellent multi-material capability.
Contact Primo Medical Group today to discuss the requirements of your medical device design and development project.
Medical Device Design for Manufacturability Services
To produce high-quality medical devices that meet stringent industry standards, we offer comprehensive engineering support designed for production requirements. Our engineering and manufacturing teams collaborate to ensure medical device designs are manufacturable, minimize risk through compliance, and prepare for production through vertically integrated processes. Medical device design services include the following operations:
- Product Conceptualization and Design Input Requirements Generation
- Design/Manufacturing Engineering
- 3D Solid Modeling (SolidWorks, CREO by PTC)
- 2D Detailing
- Finite Element Analysis (FEA)
- Rapid Prototyping
- Verification Testing and Protocol
- Development/Execution
Development Services for Precision Medical Devices
Our development services provide support for validation, documentation, and manufacturing readiness. Backed by ISO 13485 compliance and operating in FDA-registered facilities, we understand the critical standards and regulatory requirements for manufacturing high-quality medical devices. We offer extensive medical device development solutions, such as:
- Design and Process Failure Modes and Effects Analysis (dFMEA/pFMEA)
- Primary and Secondary Packaging Development
- Simulated Distribution Testing
- Accelerated Aging
- Sterilization Validation
- Process Development
- Automated Test Fixturing
- Standard Operating Procedures
- Work Instructions
- Inspection Plans
- Device Master Records
- Process Validations
- Tooling and Fixture Design/Development
- First Article Inspections
Benefits of Integrated Medical Device Design and Manufacturing
Primo Medical Group offers extensive experience across a range of medical device applications, providing comprehensive, vertically integrated services for the design, development, and manufacture of critical medical components. Working with a variety of industry partners, we have assisted in developing medical products to continuously innovate our operations and provide compliant, precision-manufactured solutions. As a full-service contract partner, we support the entire lifecycle of production to meet your needs.
Contact Primo Medical Group for Medical Device Contract Design and Development
For decades, Primo Medical Group has built a legacy of precision as a manufacturing partner for medical devices and other critical products in demanding, highly regulated industries. We are ISO 13485:2016 certified and operate in an FDA-registered facility to deliver high-quality solutions that meet stringent requirements and are made to your exact specifications. With over 70 years of machining and engineering experience, we have supported startups and large-scale OEMs with essential services for the design, development, and manufacture of precision products. Contact us to discuss your project requirements or request a quote to get started.