As a dedicated contract manufacturer for medical device companies, Medibrane offers turn-key solutions for the entire product’s life-cycle. Providing a framework for performing all the required regulatory testing, Medibrane ensures a smooth, timely regulatory compliance process. From prototype design, through development and small-batch production; quality assurance; compliance and approval, to the finished medical device - Medibrane helps you stabilize the manufacturing process, and attain repeatable, validated products.
Committed to providing the highest level of dedicated service, Medibrane offers consultation, project management, and technical resources, aimed at delivering quality products to market. We maintain full confidentiality throughout the project and beyond, and all intellectual property developed throughout product design and development, is assigned to the customer on completion.
The prototype development stage includes:
- Creating concept prototypes evaluated by our research, design and development teams together with the customer, to establish initial feasibility.
- Modifying the prototypes according to customer and clinical requirements, forming the basis for product engineering specifications.
- Selecting the biomaterials is carried out in full transparency with the customer, sharing all the various considerations. Once the materials are selected, they are supplied by leading global material manufacturers partnering with Medibrane.
- Prototype production is performed in a controlled environment at our R&D materials lab.
- Prototype testing includes:
- Testing mechanical performance including: tensile strength, stiffness, compression, bend, burst, shear loading, suture retention and coefficient of friction testing.
- Testing dimensional properties using metrology and microscopy
- Biocompatibility screening
- In-vitro bench tests, simulating the implant’s in-body performance.
- Mechanical degradation studies
Utilizing accrued knowhow and state-of-the-art equipment, Medibrane’s experts ensure a highly-repeatable manufacturing process that yields high uniformity and flawless products, achieving wall thickness of only a few microns.
- Defining product design specifications
- Design risk assessment
- Design verification and validation to ensure regulatory compliance
- Material, component, or product specification and traceability management, including:
- Test method development and validation
- Testing execution and report generation
- Bench testing
- Predicate testing
- shelf life and stability studies
- Packaging and labelling qualification
- Transit and climatic conditioning (ISTA)
- Clinical literature reviews
The customer provides the relevant clinical regulatory requirements, and Medibrane implements risk assessment pertaining to the materials and manufacturing techniques that are selected.
In addition, Medibrane carries out risk analysis by validating processes for the purpose of risk mitigation.
Medibrane also implements verification tests according to the functional requirements, as well as carrying out toxicity studies and biocompatibility tests.
Small batch manufacturing
Medibrane carries out small-batch manufacturing intended for clinical trials. Product design specifications are transferred to production, and the production processes are established to support volume manufacturing. Following process validation, the manufacturing of commercial products can begin in our cleanroom facility, scaling up to meet commercial volume requirements.
The shift to production includes:
- Establishment of manufacturing and inspection specifications and procedures
- Establishment of routing and bill of materials
- Risk analysis
- Validation planning
- Process validation execution
- Sterilization validation
- Product microbial monitoring schedule
- Operator training and certification
Manufacturing and process development
Medibrane provides the following:
- Transferring product design specifications to production, including:
- Formulating manufacturing and inspection specifications and procedures.
- Establishment of route card
- Process risk analysis (FMEA)
- Process validation planning (MVP)
- Process validation execution (IQ/OQ/PQ)
- Before and after sterilization validation
- Establishing production processes to accommodate volume manufacturing.
- Commercial product manufacturing in our controlled ISO Class 7/Class 10,000 cleanroom facility, scaling up to meet commercial volume requirements.
Once the device or component are approved, Medibrane guides the customer through the process of transitioning to large-scale manufacturing, providing optimized, cost-effective, high-yield production solutions.
Medibrane, having invested heavily in advanced proprietary machinery, reduces the manufacturing cost of each individual product, thereby reducing the time and costs of the entire production line.
Medibrane provides contract manufacturing services for several world leading OEMs, as well as for smaller emerging medical technology companies, while also maintaining its own facilities for producing customized… to produce volumes from custom-builds.
Our manufacturing facilities are ISO 13485:2003 certified, and our development processes ensure lean methodologies implemented into the product’s design. Our manufacturing engineers provide continuous process improvements through the product’s lifecycle.