With 220,000 square feet of cleanroom space across the company, we have the facilities, equipment and expertise to handle a full range of assembly needs in our technology Centers of Excellence. Our 12 facilities are in key medical device hubs to serve our customers, each with excess manufacturing capacities.
In particular, our recently expanded Costa Rica facility offers high-volume, low-cost options, maximizing cost efficiencies throughout the process.
As a midsize company, we’re well positioned for manufacturing line transfers that help large companies free up manufacturing space and help small companies that have grown and need to scale up. We’re in the “sweet spot” of being large enough to offer resources to scale while remaining focused on maintaining relationships with customers and team members.
We have developed and refined our tech transfer approach over more than 25 years of working with our customers to successfully transfer hundreds of manufacturing lines. Our phase-gate approach divides the tech transfer process into five phases:
- Design transfer plan
- Transfer the manufacturing line
- Validate the process
- Start up the line
- Continue to improve
Improvement is continuous as we always look for ways to make existing processes better. The other phases are separated by decision points known as “gates.” At each gate, continuation is decided by core Tech Transfer team members from Biomerics and your company. We work with you to develop a team with the right expertise for your project.
Technology transfers involve a “sending team” and a “receiving team,” with members from your company and Biomerics’ engineers and project managers on both teams. To simplify and expedite the process, Biomerics assigns a primary, single point of contact Project Manager to work with a Project Manager from your company. We leverage the sending team’s historical knowledge and the Biomerics receiving team’s process expertise—including operators, technicians, supply chain planners and buyers, and quality team members—for a complete knowledge transfer.
- Provides technical expertise and manufacturing process depth
- Performs initial knowledge transfer and coordination with the team at the new location
- Provides technical training and support throughout the phases of the transfer
- Travels to the sending site for knowledge transfer, coordination, and training
- Integrates the manufacturing process into the new location’s operations
- Performs a customized list of more than 80 transfer activities
- Participates in process validations, ramp-up, and stabilization
We work closely with you to eliminate known pain points that can occur during tech transfers. We mitigate risks and proactively solve problems together throughout the process.
At the initial planning stage, we work with you to capture your needs and expectations. Together we form the project team, define the scope of work, and plan every aspect of the project, including resources, quality, production, and communications.
- Develop project schedule
- Create resource, staffing, and training plans
- Determine facilities plan and timing of site visits
- Design quality plans and agreements and master validation plan
- Assess risk and create a mitigation plan
- Determine regulatory requirements
- Prepare supplier qualification plan, supply agreement, and inventory plan
- Design equipment transfer and development plan
- Develop capacity plan and production forecasts
- Prepare production ramp up plan
- Complete the post-launch continuous improvement plan
Through a facilitated, multi-day planning session, our collective team will accelerate the planning with an in-person kick-off meeting. We develop requirement documents for review and approval by the Tech Transfer team before moving on to the next phase, and achieve strong alignment in a short amount of time.
We use a detailed tech transfer process—with checklists and forms, following established standard operating procedures and ISO requirements—to consider and plan for every requirement for the tech transfer. We work closely with you to discuss trade-offs, align on key decisions, and find the best solutions for your goals.
At the line transfer stage, we transfer knowledge, prepare the receiving site, implement quality and inventory plans, and mitigate risk.
- Receiving site shadows sending site during knowledge transfer (in-person visits)
- Sending site visits receiving site to train and fill in gaps in the knowledge transfer process
- Biomerics Centers of Excellence develop processes as needed if gaps exist
- We transfer, develop, and install equipment, tooling, fixtures, and work areas
- We implement the staffing plan (hire, transfer, and train)
- We develop and implement test methods, monitor risk triggers, and implement contingency plans if needed
- We integrate the supply chain and implement inventory plans
The physical plant and knowledge transfer is complete, quality at the receiving site is verified, inventory plans are underway, and the production line is on-site in the new Biomerics location, ready for validation. The Tech Transfer team reviews and approves the validation plan before moving on to the next phase.
We use a detailed process to conduct and track the tech transfer—with checklists and forms, following established standard operating procedures and ISO requirements—to consider and plan for every requirement for your new or transferred production line. Throughout the process, we continue to work closely with you to find the best solutions to achieve your objectives.
At the process validation stage, we perform formal process validations, continue to manage risks, and complete the integration of the supply chain.
- Complete equipment installation qualifications (IQ)
- Prepare operational qualifications (OQ)
- Continue implementing training plan
- Conduct production readiness build
- Capture performance qualification (PQ)
- Conduct additional inspections per risk mitigation plan
- Finalize supply agreements
- Implement ramp up plan (with daily stand-up meetings)
- Implement performance metrics
The process is validated via process validation protocols and reports that provide objective evidence that all acceptance criteria have been met. The Tech Transfer team reviews and approves the validation reports, as well as all documentation of other deliverables, before moving on to the next phase of production start-up.
We use a detailed process validation process—with checklists and forms, following established standard operating procedures and ISO requirements—to consider, plan for, and validate every requirement for manufacturing, packaging, and delivering your product. We work closely with you to find the best solutions for your goals, and discuss key production and process decisions and trade-offs.
The day has come to press the Start button! We begin production and execute the production schedule according to the ramp up plan.
- Execute to production schedule per ramp up plan
- Update inventory plans and adjust monthly
- Monitor quality inspections per risk mitigation plan
- Implement daily stand-up meetings during ramp up phase
- Monitor performance metrics
- Perform quarterly business reviews (or other frequency that you prefer)
Production is underway, and we monitor quality, mitigate risks, monitor metrics, and report to you.
We use a detailed startup and launch process—with checklists and forms, following established standard operating procedures and ISO requirements—to begin production and report on results. We work closely with you to ensure the production quantity and quality results meet your expectations.
Our comprehensive manufacturing line transfer process includes a built-in continuous improvement program that guides our team in identifying, implementing, and evaluating opportunities for vertical integration, cost reductions, labor efficiency, scrap, and other improvements. We leverage our engineers from multiple teams across our Centers of Excellence on your behalf.
- Identify process improvement team members and leader
- Confirm and update the continuous improvement plan
- Evaluate equipment, tooling, methods, and overall process for waste and potential improvements
- Implement improvements with appropriate approvals
- Identify vertical integration opportunities for cost improvement opportunities
- Monitor performance metrics
- Perform quarterly business reviews (or other frequency that you prefer)
We follow the continuous improvement plan and make recommendations. The Tech Transfer team must review metrics and recommendations and approve plans for improvement.
We use a detailed process—with checklists and forms, following established standard operating procedures and ISO requirements—to continue to make ongoing improvements.
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 our customer, a medical device OEM who has been manufacturing a single-use steerable catheter that we recently helped them design, develop, and launch. We help them transfer their technology to set up manufacturing at our Biomerics facility in Costa Rica.
The steerable catheter has been very successful in a hospital setting for a large hospital network. Physicians are raving about the ease of use and successful patient outcomes for heart valve replacements. Our customer has reached the stage where they are successful in the interventional device market and they need to scale up their production quantities.
Our Design Services team meets with engineers and senior-level decision-makers at our partner’s company to discuss their requirements for large-scale production. We create a design transfer plan with comprehensive requirements documents and a project schedule, leveraging our experience from hundreds of manufacturing line transfers we have successfully completed for our customers. We align with our partner’s expectations, and anticipate and mitigate risks. We are familiar with the customer’s product and with our comprehensive production facilities in Costa Rica, and the planning stage goes very quickly through an on-site cross-functional kick-off meeting.
Harnessing our team of engineers with extensive knowledge and expertise in every aspect of the steerable catheter’s design, we transfer, develop, and install equipment and work areas to prepare the receiving site. We collaborate with our partner to transfer knowledge from their production line to the new production team in Costa Rica through reciprocal visits, capturing tacit knowledge not always captured in process documentation. We help set up the supply chain and obtain inventory. We complete process validations to validate the production process and ensure production readiness.
With everything in place and processes validated, we start up the line and begin producing the steerable catheters. We monitor quality, ramp up production levels, and perform regular reviews, adjusting and continuously improving the process. The tech transfer is complete.
“Our customers appreciate the engineering expertise in our Centers of Excellence, which provides a depth and breadth of support as we transfer production lines, including transfers to Costa Rica, where we have an extremely talented and dedicated team who manufactures best-in-class medical devices. They also value our robust transfer process and talented team members who help them execute successful line transfers in a thoughtful and efficient way.”