We have developed and refined our component design approach over more than 25 years of working with our customers. Our phase-gate approach divides the component design process into five phases:
- Concept
- Feasibility
- Design Qualification
- Clinical Validation
- Launch
These phases are separated by decision points known as “gates.” At each gate, continuation is decided by core component design team members from Biomerics and your company. We work with you to develop a team with the right expertise for your project.
We eliminate the known pain points that can occur at every phase of component development. It’s critically important to ensure that your design will be able to be manufactured as intended. At both the concept and feasibility phases, the design goes through a development and prototype process to ensure the component is manufacturable as intended.
- Provides more cost-effective pricing options
- Brings clarity to the specifications needed in materials
- Ensures proper scheduling of the component through the manufacturing process
- Confirms the component meets the required quality and cost targets
- Makes sure that assembly lines are configured and prepared correctly
DFM also identifies other high-risk design features and proposes a process to mitigate overall risk.
At the proof of concept stage, we work with you to transform your idea, thought, or sketch into a design with a working and functioning prototype that mimics the intended component and prospective use in a device.
- Execute agreements and open a design history file (DHF)
- Capture concept development ideas
- Begin prototyping and performance testing
- Assess the manufacturability of the concept component
- Complete cost modeling scenarios
- Initiate a risk management plan
We construct a prototype to demonstrate the concept. The component design team reviews and approves the prototype and other deliverables before moving on to the next phase.
We use a detailed design development process — following established standard operating procedures and ISO requirements — to consider and plan for every requirement for your component, including user needs and indications for use, if applicable, and performance requirements. We work closely with you to discuss trade-offs, align on key decisions and find the best solutions for your goals.
At the feasibility stage, we create working engineering-level prototypes and obtain initial evidence supporting design feasibility. If approved, we freeze the design.
- Finalize the optimal design and development plans
- Develop equipment and processes
- Define package and labeling design
- Refine risk management plans
- Create component feasibility prototypes
- Review the bill of materials and component cost
The design is frozen and all aspects of the project are documented in plans and drawings. The component design team reviews and approves the design, component feasibility prototypes, and other deliverables before moving on to the next phase.
We use a detailed process to determine design feasibility—following established standard operating procedures and ISO requirements, including predictive analysis, performance tests, and validation protocols—to consider and plan for every requirement for your component, including shipping, stability, and aging requirements. We continue to work closely with you to find the best solutions to achieve your objectives.
At the design qualification stage, we provide needed data points and information to verify and validate the component. The component should work like, look like and be made like a production component, as well as meet your original design intent (incorporating all requirements and inputs). The component we build for design qualification uses representative production parts.
- Build production-like qualification component
- Test the design and prepare verification testing reports
- Complete the device master record (DMR)
- Execute the biocompatibility strategy
- Revise and finalize the complete risk management plan
- Conduct design failure mode effects analysis (FMEA)
- Review the instructions for use (IFU)
- Test biocompatibility
- Validate packaging and sterilization
Following comprehensive testing of the production-like qualification component, we have completed all quality test reports. At this point, with all designs, plans, processes, and paperwork prepared and signed off by the component design team, the component is ready for production.
We use a detailed design validation process—following established standard operating procedures and ISO requirements—to consider and plan for every requirement for manufacturing, packaging, and using your component. We work closely with you to find the best solutions for your goals, and discuss key design, production, and process decisions and trade-offs.
At the clinical validation stage, we establish that the device specifications conform to user needs and intended uses. We also conduct production readiness builds and finalize the risk management plan and production process documents.
- Conduct production readiness builds: train staff, run under production conditions
- Finalize all process and quality documents, protocols, and reports
We establish process validation and production readiness and produce process performance qualification (PQ) reports. We also finalize the supply agreement and quality agreement. The component design team reviews and approves the reports and all other deliverables. At this point we move on to the next phase.
We use a detailed process validation process—following established standard operating procedures and ISO requirements—to obtain evidence-based validation of your component. We also work closely with you to set up and run the production readiness builds, following a comprehensive process that complies with worker safety regulations, quality controls, and input and output validation.
At this stage, we launch the component into production, and Biomerics continues to assist you with post-launch quality assurance.
- Determine medical device reporting (MDR) methodology to handle post-launch issues
- Obtain management approval to release the component to production
- Begin production
- Review plan for continuous improvement
The component design management team approves the component for release to production. The component design team also signs off on the MDR methodology and plan for continuous improvement. We launch into production.
We use a detailed process—following established standard operating procedures and ISO requirements—to achieve management approval to release the component to production. After your component is in production, Biomerics continues to support you post-launch.
Visit us virtually to learn more about our facilities. You can check out our manufacturing and assembly spaces in video tours of most of the locations below.
In this example, we partner with a medical device OEM to design and develop molding for parts in steerable handles for endoscopes.
A new customer reaches out to us to help them develop component parts for an endoscope they want to produce. They value our 25+ years of experience working in plastics, and particularly our deep vertically integrated chemical engineering expertise in formulating critical polymer compounds using the broadest portfolio of medical-grade polyurethane materials, including a wide range of chemistries and durometers. They want to take advantage of our expertise and broad molding capabilities in our Center of Excellence for Injection Molding. After a few initial phone conversations, they decide to outsource the design and development of medical-grade molded parts for the steerable handles in their new endoscopes to Biomerics.
Our Design Services team meets with engineers and senior-level decision-makers at our partner’s company to discuss their requirements for high-quality, cost-effective, precision-engineered molded parts. They bring their designs and samples for the parts that the handle component parts will connect to.
Corralling our team of engineers with extensive knowledge and expertise in every aspect of molding design, we collaborate with our partner on determining the optimal chemical formulation to achieve the results they want, and the scientific injection molding development process that will work best for the steerable handle parts. We build a prototype, component feasibility samples, and finally, a production-like qualification component. We ensure that the component part fits precisely into an integrated whole finished product with the other elements of their endoscope.
We complete a detailed design validation process to consider and plan for every requirement for manufacturing and assembling the component into our customer’s finished product. We begin production. Our customer is confident in the fit, quality, and durability of the component, and knows that Biomerics is there to support them as needed after production begins.
“Customers say that we are good partners because we’re extremely flexible and they can rely on us to work through problems together. When they experience how easy we are to work with, like using their sample sizes and allowing their engineers to be physically on site, they feel comfortable. They want to stay and come back for future design needs.”
