Technology

Proxy Biomedical Limited provides project management and product manufacturing capabilities. Our services range from feasibility development to manufacturing and commercialization support. Experienced medical device professionals and project managers work within state of the art facilities and provide a timely response to customer requirements.

Product Development

Applied Research

The Applied Research phase will evaluate the potential for success based on the information gathered at the early stage of the project. Activities during this phase may include, but are not limited to, the following:

Feasibility Development
Determination of factors, which may impose time constraints. (e.g. Resources, Facilities)
Initiation of R&D Documentation Process, including early prototype Development and Testing.

Pre-Development Phase

Activities during this phase may include, but are not limited to, the following:

The execution of an Engineering Design Specification based on the Product Specification. The procedure details physical and mechanical characteristics of the product.
Build advanced prototypes, which have sufficient detail that customer reviews can be accurately obtained.
The Team will develop tests for the prototype device. These tests must include: mechanical testing, pre-clinical biocompatibility in small animal models, and OTHER (to be determined based on the intended application)
Agreement on Design lock.
Design verification shall be performed via the execution of approved protocols.

Development & Pre-Production Phase

The goal of this phase is the generation of Design Outputs that satisfy the requirements as defined in the Product and Engineering Specifications. Activities during this phase may include, but are not limited to, the following:

Part refinement.
Design Validation via the execution of approved protocols.
Clinical Evaluations.
Regulatory Filings.
Pilot Scale Production

Manufacturing & Commercialization

The goal of this phase is to ensure that the device design is correctly translated into production specifications. The following requirements must be addressed during this phase.

Process Validations
Training
Sales Forecasting
Initial Production Builds

Concept Phase

This phase considers all of the tasks relevant to identify the idea, develop it sufficiently to project customer fitness and medical benefit, understand and forecast business implications, consideration of patent and legal issues. The out-put of this exercise is to generate a Product Specification, detailing the intended use of the product, biocompatibility, sterility, shelf life, packaging, labeling, regulatory, user and patient requirements as well as reviewing market opportunities.