Product Development

Feasibility · Mock-ups · Prototypes · Design · Testing · Validation

From Concept to Manufacturing

The seasoned Development team at Via Biomedical combines over 100 years of medical catheter design and development experience. Whether you need a single prototype for initial concept evaluation or a comprehensive product development program, our development staff can assist you in quickly and efficiently reaching your goals.

Utilizing our Product Development Lab, equipped with a full array of catheter processing and testing equipment, Via Biomedical can quickly move the development process from design concept, through verification and into manufacturing. Whether you have your own design or want the assistance of our experienced development team, Via Biomedical has the resources to support your goals.

Product Development Services

Via Biomedical offers the following design and development services to facilitate your new product market launch:

  • Early-stage feasibility studies, including design and fabrication of models
  • Product design
  • Prototype fabrication and testing
  • Development of custom product specifications
  • Design verification, including development of test protocols and testing
  • Tooling, equipment and fixture design and fabrication
  • Process development and validation, including documentation and testing
  • Packaging design and validation support
  • Sterile validation support
  • Component and raw material selection and sourcing
  • Design history file
  • Biocompatibility testing support
  • Regulatory support; 510k, CE Mark technical files, PMA
  • Technology Transfer

Developmental Product Testing

Via Biomedical offers a full range of compliance and performance testing capabilities to fully support the development of catheter-based systems and medical devices including:

  • Test protocol and custom test method development
  • Tensile testing
  • Leak and pressure testing
  • Dimensional testing
  • Balloon compliance testing
  • Biological testing support
  • Comparative catheter performance testing (i.e. track, push, torque, etc.)
  • Stent component - deployments, radial force, dimensional, foreshortening, etc.

Whenever applicable, our test protocols incorporate the latest ISO standards.

Project Management

Via Biomedical employs a range of project management tools for tracking and reporting project milestones to our clients and this support can be adapted to meet the needs of your specific project. Regardless of the size or complexity of the project, we encourage and promote open lines of communication between the Via Biomedical development team and the client to assure the best project outcome, on time and on budget.