We have developed and refined our product design approach over more than 25 years of working with our customers. Our phase-gate approach divides the product 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 Product 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 product 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 product 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 product 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 product.
- Execute agreements and open a design history file (DHF)
- Capture concept development ideas
- Begin prototyping and performance testing
- Assess the manufacturability of the concept product
- Complete cost modeling scenarios
- Initiate a risk management plan
- Develop a regulatory strategy
We construct a prototype to demonstrate the concept. The Product 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 product, 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 and regulatory plans
- Create product feasibility prototypes
- Perform any included animal trials
- Review the bill of materials and product cost
The design is frozen and all aspects of the project are documented in plans and drawings. The Product Design team reviews and approves the design, product 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 product, 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 product. The product should work like, look like and be made like a production product, as well as meet your original design intent (incorporating all requirements and inputs). The product we build for design qualification uses representative production parts.
- Build production-like qualification product
- 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 product, we have completed all quality test reports. The Product Design team reviews and approves the qualification product, as well as all designs, plans, processes, paperwork, and other deliverables before moving on to the next phase.
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 product. 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 process 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. Then we file for regulatory approval.
- Conduct production readiness builds: train staff, run under production conditions
- Finalize all process and quality documents, protocols, and reports
- Prepare and submit 510(k) file, demonstrating to the FDA that the device to be marketed is safe and effective
- Prepare technical file and design dossier for CE Mark (European Union)
We establish process validation and production readiness and produce process performance qualification (PQ) reports. We also finalize the supply agreement and quality agreement. The Product Design team reviews and approves the reports and all other deliverables. At this point we submit regulatory filings and 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 product. We 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, your medical device product receives regulatory approval, we launch production, and Biomerics continues to assist you with post-launch quality and regulatory activities.
- Determine medical device reporting (MDR) methodology to handle post-launch issues
- Obtain management approval to release product to market
- Begin production
- Post-launch, submit reports to regulatory bodies as required
- Review plan for continuous improvement
- Handle CAPA (corrective action preventative action) feedback, if any, post-launch, following FDA requirements
The Product Design management team approves the product for release to market. Once the product clears either FDA or EU governing bodies, you are ready to launch. The Product Design team signs off on the MDR methodology and plan for continuous improvement prior to launch.
We use a detailed process—following established standard operating procedures and ISO requirements—to file for and receive regulatory approval and achieve management approval to release the product to market. After your product 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, develop, and manufacture a single-use endoscope.
A new customer reaches out to us to develop a single-use endoscope, to be used to visualize the inside of the airways for diagnostic and therapeutic purposes. Our customer realizes that single-use endoscopes significantly reduce the chance of infection that occurs from reusing a sterilized endoscope, improving patient outcomes and helping surgeons sleep better at night.
Our Design Services team meets with engineers and senior-level decision-makers at our partner’s company to discuss their requirements for a high-quality, cost-effective, small-diameter, flexible, steerable, lighted single-use endoscope used for multiple applications in the airways and lungs.
Mobilizing our team of engineers with extensive knowledge and expertise in every aspect of the endoscope, we collaborate with our partner on vertically integrated designs for the electric components and visualization, the bendable shaft, the braided components for the insertion tube, microprocessing for the range of tips needed for different applications, and molding for the handle. Each part fits precisely into an integrated whole.
In conjunction with the design process, we help our customer through every stage of developing the endoscope, obtaining FDA and EU regulatory approval, and launching into production. We are with our partner every step of the way, trouble-shooting to resolve problems as they arise and anticipating every aspect of the launch, from production line procedures to labeling and packaging.
“I’m very excited about the team we put together and the capabilities we have to partner with customers in developing single-use endoscopes. We are a customer-centric company. Our customers are important to us. We always want to do what’s best for our customers, and help our customers succeed.”
