We have developed and refined our tech transfer approach over the past 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:
With more than 86,000 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 nine 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.
In this example, we partner with a medical device OEM to design, develop, and manufacture a single-use endoscope.
Our customer sees a market opportunity
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.
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.
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.
High-level outputs
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.
High-level outputs
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.
High-level outputs
At the feasibility stage, we create working engineering-level prototypes and obtain initial evidence supporting design feasibility. If approved, we freeze the design.
High-level outputs
