Program Management and Product Development
At Biomerics, we have the expertise to manage all aspects of the product development process. With over 17 years of continuous investment in quality, precision and efficiency, we apply our cumulative expertise to every product we manufacture. Our project management approach and quality management processes ensures excellence in all that we do.
Our project teams have provided support and quality assurance to hundreds of products through the product development cycle. Working as an extension of our customers’ teams we adhere to their approved standard operating procedures while adding value at every stage. Our process expertise and project management approach help ensure the quality and success of every medical molding, medical extrusion and medical device assembly.
Biomerics employs a practical approach to project management that is proven to deliver low cost solutions to our customers quickly and effectively. We have broken our development cycle into a 5 stage process:
Idea to Concept:
At Biomerics the product realization process begins when a customer makes contact with our sales team regarding a new project. Our engineers are then engaged in the project and begin to understand the application, problems, and business goals of the project. Once we understand our customers’ needs, we work with them to convert their ideas into product concepts. Our unique understanding of material science, application knowledge, and manufacturing processes make our participation invaluable during this step.
Feasibility is the “proof of concept” stage in the development of a product that greatly improves the technical and commercial probability of success. All product and component concepts should be evaluated for feasibility to ensure the best one is selected to move on to the detailed development stage.
The development stage is what most people think of when discussing product development. It is the most expensive and time consuming step. Our engineers work with our customers early in the design process, providing manufacturability expertise and fast track prototypes for evaluation. A multi-phase development process ensures goals and timelines are met throughout the development cycle, and the process is sufficiently robust to meet quality and manufacturing requirements in production.
Biomerics uses the latest CAE tools to turn each customer’s product concept into a computerized model. We utilize 3D drafting, FEA, and other design tools to create a product that meets the highest quality standards, manufacturing efficiencies, commercial viable.
We use our production-line equipment in combination with our customers’ production-grade materials to create final-form prototypes.
On-going testing is performed to refine and improve a product’s design in an interactive process.
Qualification and Validation:
Once a design is complete, Biomerics’ engineers work with our customers to validate every process, every tool and every fixture to ensure it will achieve the desired results during full production. We optimize our master process for each customer’s unique part and run samples for inspection and statistical analysis, making improvements as necessary to attain reliability and repeatability.
Once our customer has approved the product design, tooling and process; our project team oversees a smooth transition to the production line. Semi-and fully automated processes guarantee precision during medical device manufacturing. Biomerics provides the following launch services to ensure successful product introductions, saving our customers time and money:
- Manufacturing process design
- Equipment design and qualification
- Production tooling (development and validation)
- Process, operation, and performance qualification
- Process optimization
- Supply chain management
- Quality testing and assurance