Contract Medical
Device Manufacturing

Contract medical device manufacturing refers to outsourcing the production of critical medical devices, tools, and related components to dedicated manufacturers. This can lead to faster, more efficient, and scalable production, essential for healthcare professionals and organizations to meet growing industry demand.

Unity Precision Manufacturing specializes in turnkey medical device production and manufacturing services, starting with Design for Manufacturability (DFM) support and prototyping and extending through full-scale production, assembly, and distribution. Explore key ways we serve customers with contract medical device manufacturing and why we’re a trusted partner for OEMs and Medtech startups throughout the medical world.

Key Considerations for Contract Medical Device Manufacturing

Choosing the right medical device production processes is critical for any organization’s long-term growth strategy. As a trusted provider of medical device contract manufacturing services, we build our approach around significant considerations for the medical industry, such as: 

• Compliance with regulations. Manufacturing for medical devices is a highly regulated activity. Unity Precision complies with FDA standards and maintains ISO 9001 and 13485 certifications so customers can trust the integrity and reliability of every device they receive from us.
• Scalable capacity. At Unity Precision, we have the capabilities and resources to handle low-volume and high-volume orders for medical devices. This allows us to effectively manage varying demand and anticipated growth needs without long delays or unpredictable cycles. 
• Precision. We use state-of-the-art machining and manufacturing capabilities to achieve tight tolerances and ensure dimensional integrity with each project. 
• Supply chain management. Unity Precision maintains a reliable sourcing network for materials and components, focusing on efficiency and reliability to meet customers’ exacting quality standards. 
• Prototyping. Most medical devices begin their lifecycle with prototyping. We can provide high-quality prototypes and then seamlessly transition to larger-scale production.

Unity Precision’s Medical Device Manufacturing Process

At Unity Precision, we provide customizable manufacturing processes that meet our customers’ unique design requirements, medical specialties, and compliance needs. Our turnkey medical device manufacturing services center around seven key steps: 

1. Design. Our engineering and design team can help support product design through Design for Manufacturability (DFM) concepts.
2. Material selection. We consider the unique constraints of your design, application, and project goals to choose the right materials for every product. We commonly work with materials like surgical steel and titanium to meet biocompatibility, strength, and durability requirements.
3. Manufacturing. We provide various in-house manufacturing services, including machining, finishing, and other advanced techniques.
4. Assembly. We simplify production through complete manufacturing and assembly services. 
5. Passivation. We clean and passivate assembled components to eliminate bio-organisms and other contaminants. 
6. Quality Control. Unity Precision is ISO 13485 and ISO 9001 certified, with comprehensive CMM, optical, and tactile testing options to meet high industry standards regarding product quality and safety. 
7. Packaging & Distribution. We provide packaging services so that individual goods and larger pallets can safely reach their upcoming destination.

Benefits of Contract Manufacturing for Medical Devices

Strengthen your business by choosing a reliable contract manufacturer like Unity Precision for more efficient medical device production. Your organization can focus on research and development, sales, and other core competencies, and you can access the knowledge of professionals with years of experience producing advanced medical technologies. Using our contract manufacturing services also gives you access to more specialized equipment and scalable production systems without large, upfront capital investments. 

Unity Precision’s Medical Device Production Capabilities

Unity Precision offers a wide range of production capabilities to meet the needs of nearly any medical application. Our company provides high-quality manufacturing at a reasonable price, and we have the equipment to perform all manufacturing in-house in our eco-friendly facility that operates 24 hours a day. Our capabilities include: 

• DFM and engineering support
• Supply chain management, including material selection and component sourcing
• High-quality machining, manufacturing, and finishing services
• Product testing and stringent quality control measures
• In-house assembly and packaging

Our customer service and engineering teams are transparent and available to answer your questions and provide continuous support.

Contact Unity Precision Today for Contract Medical Device Manufacturing

Through contract manufacturing, you can send more reliable and cost-efficient products to the market at a faster pace while maintaining consistent quality and meeting high industry standards. Unity Precision is a Minnesota-based provider of contract medical device manufacturing for surgical instruments, implants, robotic surgery centers, as well as cardiac, orthopedic and many other medical devices. 

Contact us today to learn more about how we can support your current go-to-market strategy and scale your business’s reach through our medical device manufacturing process.