Medical Device Assembly Services
Life Science Outsourcing offers turnkey medical device manufacturing and assembly services that can be combined with our engineering and process development solutions to create a streamlined and comprehensive process.
Life Science Outsourcing’s deep expertise makes us the industry’s leading “one-stop shop” for medical device needs with noted expertise in four major manufacturing techniques – Precision Assembly & Testing, Catheter Assembly, Electromechanical Assembly, and Combination Product Assembly.
Precision Assembly and Testing
Life Science Outsourcing provides comprehensive precision assembly and testing services for medical device manufacturers.
- Ultrasonic Bonding
- Solvent Bonding
- UV Bonding
- Leak Testing
- Performance Tensile Testing
Life Science Outsourcing specializes in the assembly of single-use catheters. We have assembled a variety of catheters for a diverse range of functions, from basic Foley and angiography to radiofrequency and balloon cardiology catheters.
All Catheter Assembly is performed at one of our many Cleanroom spaces (Class 100, 1000 and 10000). Our team can produce catheters of varying materials and design.
- Diagnostic catheters
- Ablation catheters
- Delivery catheters for lead placement
- Delivery catheters for endovascular replacement of aortic heart valves
- GERD – Catheter Systems
- Micro coil delivery system used for the embolization of aneurysms
- Radiofrequency Catheters
- Balloon Cardiology Catheters
- Electrophysiology (EP) Catheters
- Angiography Catheters
- Foley Catheters
- Drug Delivery Systems
- Lubricious Coated Catheters
To provide clients with single sourcing of finished catheters, Life Science Outsourcing offers:
- Tube Bonding & Welding
- Balloon Bonding
- Heat Forming
- Tipping / Tip Forming
- Swaging of RO’s
- Pad printing
- Folding / Fluting
- UV bonding
- Plasma Surface Treatment
Life Science Outsourcing provides comprehensive electromechanical assembly and testing. Our capabilities include dedicated assembly facilities, in-process, and final testing capabilities. We have a dedicated and trained staff with a proven track record for ensuring high-quality products at a competitive price, with an extensive network of highly rated vendors.
Electromechanical Assembly services include:
- Material Procurement
- Prototype production
- Wire Panel Assembly
- Design & Engineering Services
- Complete Electromechanical Assembly
- Turnkey production services
- Complete integration and testing of electronic components, PC boards, and discrete components
Electromechanical Assembly Process Capabilities:
- Electrical and mechanical testing
- Failure analysis
Electromechanical Assembly Engineering Support:
- Design for Manufacturability (DFM)
- Design for Testability (DFT)
- Production Engineering
- Quality Engineering
- Service and Maintenance Engineering
- Test Engineering
- Value Engineering
The Food & Drug Administration defines a Combination Product as: “Therapeutic and diagnostic products composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.”
Some estimates suggest that up to 30% of recent FDA submissions are combination products. As a result of this growing trend, the FDA has set up a separate department for the review of such products.
The potential benefits of Combination Products include:
- Localized treatment labor
- Reduction in labor and time
- Reduction in risk of contamination, and
- Precise dosage control
At Life Science Outsourcing, all Combination and BioPharm product activities such as Fill / Package are performed in a Class 100 Cleanroom. All manufacturing and warehousing is cGMP compliant. Our featured services include the low-cost and rapid scale-up manufacturing of Phase I Pharmaceuticals and Combination devices.
Combination Product Specialties:
- Aseptic Transfer-Vials and Syringes
- QC Testing
- Compound Blending
- Stability Testing
- Biocompatibility Testing
- Endotoxin Testing
- Packaging and Sealing
- Packaging Validation
- Sterilization Validation
- Fulfillment and Distribution (GMP Compliant Warehouse Controls)
Life Science Outsourcing offers startup companies a unique service – access to space, equipment, and a skilled staff in our FDA registered / ISO 13485 certified facility.
LSO allows startups to build prototypes and small lots in Class 10,000 (ISO 7) and Class 100 (ISO 5) clean room space, with numerous benefits:
- No contractual obligation
- No minimum quantities
- Hourly rate for facility use
- Engineering assistance
Life Science Outsourcing offers a comprehensive set of process development services:
- Project management
- Tooling /Exterior Development
- Equipment Services
- Validation Services
Scale for growth with LSO's nearshore capabilities
Nearshore medical device manufacturing is an increasingly popular strategy, offering cost efficiencies and the ability to accommodate high-volume production. As a partner in your growth, LSO brings several distinct advantages to the table:
- Strict adherence to U.S. Regulations and quality systems ensuring FDA-approved quality standards.
- Skilled labor pool.
- Expertise in healthcare production procedures, fully adhering to Good Manufacturing Practices (GMP).
- A modern and resilient infrastructure, complete with contingency plans and backup systems.
- Mastery of customs and regulatory compliance for smooth import/export operations.
- Strategic proximity to the U.S., allowing for efficient logistics and communication.
- Zero language barriers.