Medical Device Manufacturing FAQs

Global MedTech original equipment manufacturers (OEMs) select Viant because of our unmatched scale, technical rigor, and risk-mitigation framework. Key competitive advantages include:

• Extensive Global Footprint: 26 facilities spanning North America, Europe, and Asia with 2.3 million square feet of operational footprint.
• Vertically Integrated Insourcing: Complete control over raw material selection, tooling, molding, extrusion, metal fabrication, and finished device packaging under one organization.
• Uncompromising Quality: ISO 13485 certified cleanroom environments backed by rigorous Lean Six Sigma quality management systems.

Viant extends beyond traditional CDMO models. While we provide high-precision contract manufacturing, we operate as a full single-source strategic operational partner. We assist MedTech leaders from initial proof-of-concept through pilot manufacturing, commercial scale-up, regulatory submission packaging, and ongoing product lifecycle management.

Yes, all manufacturing lines at Viant are tailored to meet unique client product specifications. Our dedicated engineering teams collaborate with OEMs to engineer custom molds, design high-precision extrusions, establish automated robotics lines, and create specialized metal fabrication processes for complex medical device designs.

Viant manufactures highly complex medical technology across eight specialized clinical markets:

• Orthopedics: UHMWPE joint components, surgical power tool components, instruments, implants, and delivery trays.
• Surgical Technologies: Robotic surgical end-effectors, minimally invasive surgery (MIS) instruments, laparoscopy, and endoscopy tools.
• Cardiac & Interventional: Catheter shafts, nitinol stents, balloon catheters, and electrophysiology devices.
• Drug Delivery: Wearable auto-injectors, pen injectors, IV connector sets, and infusion pumps.
• Bioprocessing & Bioelectronics: Single-use fluid handling systems, containment systems, neurostimulation devices, and wearable sensors.
• Diagnostics & Respiratory: CT diagnostic injection tubes, laboratory labware, tracheostomy tubes, and airway management systems.

Quality and patient safety drive every operation at Viant. We enforce stringent Quality Management Systems (QMS) across all global manufacturing facilities. Our quality frameworks include:

• ISO 13485 Certification across all manufacturing facilities.
• FDA Registration and compliance with 21 CFR Part 820 Quality System Regulation (QSR).
• EU Medical Device Regulation (EU MDR 2017/745) alignment.
• Complete Process Validation protocols: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Full trace-level lot control, bioburden monitoring, and automated 3D optical inspection technologies.

Intellectual property security is a cornerstone of Viant’s operational integrity. We protect proprietary client innovations through comprehensive Non-Disclosure Agreements (NDAs), encrypted CAD/CAM engineering servers, segregated physical production cells, strict role-based data access controls, and cybersecurity protocols compliant with enterprise standards.

ViaLaunch™ is Viant’s standardized, cross-functional program management model engineered specifically for medical devices. ViaLaunch™ provides dedicated program managers who oversee risk mitigation, regulatory milestone tracking, tooling development, validation steps, and line transfer operations to ensure seamless market entry and predictable timeline execution.

Viant continuously invests in cutting-edge manufacturing automation, robotic material handling, real-time in-line vision systems, multi-shot molding, and novel alloy fabrication techniques. By combining engineering ingenuity with advanced manufacturing technologies, we streamline production yields, lower cost of quality, and shorten market intro schedules.

Sustainability is integrated into Viant's operational philosophy. Recognized by EcoVadis, we implement energy-efficient HVAC and cleanroom systems, practice responsible raw resin management, maintain active industrial recycling initiatives, and audit supply chain partners to support corporate ESG goals without compromising regulatory compliance.