Freudenberg Medical
Unprecedented Manufacturing Expertise

The global in-vitro diagnostics (IVD) market has witnessed several changes and a paradigm shift from traditional methodologies to next-gen diagnostics in the recent past. The IVD companies today need suppliers that can support the production of parts with high precision, optical clarity, and high quality. While IVD companies also require agile suppliers that can ramp up very quickly for large, unforecasted orders, they continue to struggle with the cost pressure from reimbursement. As the pace of change accelerates, how can IVD manufacturers move ahead and account for the change as part of their future product development plans? Answering this question is Freudenberg Medical, a global innovation leader in component development and medical device manufacturing. The company is spearheading innovation in the IVD market by creating solutions that combine multiphase processes, which in turn reduce production time while still providing superior quality.

“We have the technical expertise to solve manufacturing challenges for point-of-care devices and analyzers used in a variety of sensitive applications including Molecular Diagnostics, Immunoassays, Clinical Chemistry, Hematology, and Coagulation,” says Sven Rosenbeiger, Vice President and General Manager, GBU Thermoplastics at Freudenberg Medical. “We are a full service, one stop source for device and component fabrication from design, development, and rapid prototyping through to volume manufacturing.”

Freudenberg Medical currently supplies over 80 million custom molded thermoplastic and silicone parts per year for IVD OEMs worldwide.

Freudenberg engineering teams tackle a range of projects of diverse technical difficulty, from sample tubes and lateral flow tests to intricate cartridges that require extremely precise molding with tolerances of +/- 4 microns. The firm’s prowess lies in its in-depth knowledge and experience in materials, molds, and process development to achieve the high precision needed in IVD product manufacturing. This in turn, helps clinical laboratories to meet greater testing demands, improve efficiency, and deliver reliable and quality results, thereby significantly impacting patient care.

Freudenberg Medical also adheres to the technology trends in the IVD market by simultaneously driving increased diagnostic access to point of care via compact, portable devices and disposable cartridges. Considering the requirements of point of care testing, the firm manufactures products which provide accurate results in a very short period of time at or near the location of the patient. It also manufactures innovative components that can be deployed for a portable mini lab—“lab on a chip”—for the rapid field testing of the HIV/ Aids virus used in rural areas of Africa and Asia. “Our strength lies in the development of innovative solutions for sensitive applications,” says Rosenbeiger. “Our goal is to exceed our customer’s expectations on every project.” Freudenberg’s core competencies also include its ability to develop and manufacture a myriad of mobile testing kits and single-use disposable cartridges for IVD companies worldwide.

Freudenberg Medical is recognized among its customer base as a trusted partner that helps reduce costs with lean manufacturing, automation, and optimized processes such as two-component molding, thereby creating a competitive differentiation in the global market. To ensure optimal product quality, Freudenberg has developed automated cutting (for extrusion) and an automated inspection process, which enables assembly and subassembly to validate and qualify products in high volume manufacturing. Besides delivering automation solutions like end-of-arm tooling, 100 percent vision inspection systems with assembly, and both semi and fully automated assembly, Freudenberg Medical also leverages lean manufacturing technologies which help customers to meet the challenge of low-cost requirements driven by reimbursement.

As the years ahead look promising for Freudenberg Medical, the focus will be providing exemplary customer service and the highest quality manufacturing. Fostering continual innovation, the company will continue to add new capabilities to their portfolio in the years to come via their current buy and built growth strategy.