Freudenberg Group

Medical manufacturers are always trying to stay ahead of the “newest and hottest” trends that could end up revolutionizing a rapidly changing industry. Freudenberg Medical, a 40-year-old contract design & manufacturing organization, has locked in on the future of silicone micro molding. While the company is currently using micro molding for advances in the ophthalmology space in particular, Freudenberg believes that micro-molding is changing medicine and enabling high-precision, low profile devices that can be used across all clinical specialties. The company has started using silicone micro molding to develop the Punctum Plug, a silicone device 0.02 in / 0.5 mm in diameter used as an alternative to eye drops by blocking tear duct drainage. While nearly 300 million people worldwide and 20 million in the U.S. suffer from chronic dry eye, until now, there have been few advancements in the space beyond traditional eye drops. Freudenberg is now optimistic that micro molding will expand far beyond the Punctum Plug. Luis Cortez, Vice President of Freudenberg Medical Specialty Components, and Tom Diaz, Director of New Program Engineering at Freudenberg Medical, spoke with MD+DI about the device, and how it could spur many more developments in medical manufacturing. Beyond ophthalmology, what other medical specialties are benefiting from advances in silicone micro molding technology? Cortez: Outside of ophthalmology, silicone molding is having a big impact in the cardiovascular space, in the diabetes, neurology space, really all segments. Silicone itself is a very biocompatible material, and it does play well with miniaturization and even some smart devices, so we are seeing an increase in use across many of the different segments. Diaz: A lot more people are learning to design with silicone as well. Silicone, the types of silicone, the materials have better characteristics that they didn't have before. So people are doing a lot more design with them, and we are seeing them used in many different ways. How has micro molding technology evolved to address challenges in implantable medical devices across different bodily systems? Diaz: Some of the biggest things for that area is that the mold making has become more capable, tooling itself has become more advanced to cut more intricate geometry and there's other things in the way of micro nozzles being used now in these molds. You can eliminate the runner, which brings more value to the customer and to the molder, and the technologies combined gives you as a mold maker and a manufacturer of these parts a lot of ability to get the quality we need. Cortez: Again with the improving technologies around tooling, that then allows us to manufacture parts around the processing equipment. Companies like ourselves have the technical expertise to go in and support customers with smaller medical components, specifically silicone molding, that then allows them to lower the overall envelope of the device, making it easier for implantation, much more wearable, longer lasting, and biocompatible with the body. Being able to make parts smaller allows customers to solve chronic conditions that in the past required surgery or an external medical device. That can then be solved with miniaturization of a device that can be diagnostic or implanted, which also helps with patient compliance, which can be the biggest issue with any kind of external device or something that the patient has to take. What unique material properties make silicone particularly valuable for micro-scale medical applications compared to other materials? Diaz: Silicone mold flows really well. With micro molding, by its definition, creating small parts and small features, the use of silicone you can mold those features much more easily than with other materials. You will also have more precise geometry and a longer length. Cortez: Obviously silicone processing itself is more niche than thermoplastic molding, so certainly it requires a lot of technical expertise. At Freudenberg, that is our advantage, as we have been doing silicone molding since 1984 and we have learned a lot about silicone processing. We have invested in the latest technologies, and we have multiple sites across the globe that support us. Specifically in silicone processing, we have three sites that deal with silicone processing and manufacturing. Combined, we have expertise, the latest technologies we invest in, and our FTI division where we focus on materials science and materials knowledge. If you combine that with the properties of silicone, we are able to come up with many solutions for our customers. What are the most significant quality control challenges when manufacturing medical components at the micro scale, and how does Freudenberg address them? Cortez: From a medical manufacturing perspective, quality is paramount to our process and to ultimately providing the right solutions for our customers. Controlling quality starts with the quality culture, it starts with the investment and the training of all of our associates to understand that quality is the most important piece and the most important thing customers are looking for, and then you combine that with the technology required to make sure you can measure and control the process for these mini silicone components. Having the latest technology in terms of vision systems is critically important, because those are small parts that you can’t necessarily hold up and see the visual defects unless they are under magnification. So having the latest technology is critically important, as well as robust validation processes. Diaz: Quality is key across all areas of our business. Everybody is trained how to look at parts. Every job that goes out, we make sure the person is trained and knows what to look for on a visual basis. Quality runs throughout the training, and we take great pride in it. How might advances in materials science further expand the capabilities of medical micro molding? Diaz: One of them that we are exploring more and more at Freudenberg is conductivity of silicones. So you can make a product, perhaps out of a conductive silicone, where you can replace PC boards and things like that. Other things that we are seeing in silicone is more and more materials that are able to meet customer specifications more readily. The durometers are changing, they are more consistent, the flow of materials is consistent, the purity of the materials is more consistent. We are right down the street from one of the biggest silicone manufacturers around, which we partner with. We talk to them all the time about what our customers expectations are and it seems like everybody is making advancements every day. Cortez: We work with all of the silicone suppliers out there. We are quite familiar with what's out in the market, and combined with our FTI division, from a material science perspective, when a customer has a very challenging application or device, we are able to support that with some of our materials expertise to evaluate and help them during the design phase. Conductive silicone is definitely a very important area, because as devices are getting smaller, smarter, and integrating electronics, things like conductive silicone are very important to being able to miniaturize the device. Is there anything else you want to expand on? Diaz: We have a project management system, so the value we bring for the micromolder, since it is unique, a lot of our customers don't have that much experience in the manufacturing process that can deliver a robust part. Using our PMO system, one of the biggest things we do is design for manufacturability with the customer. That gives us the opportunity to help them design a more robust part. We have a lot of expertise in our engineering about silicone. We have some of the best silicone molders in the world, and we have some of the best partners in tooling as well. Between all of us, we bring a unique value to our customer by helping them design a better part. Cortez: The last thing I would add is we obviously spoke a lot about silicone molding. Silicone itself is more than that. We don't only do molding, but silicone extrusion as well. Because we offer that capability as well, a lot of devices are getting smaller and we have the ability to combine silicone extrusion with silicone molding. Things like two-shot molding can even be used for smaller applications, in which we are able to mold two different silicone materials, different durometers, in some cases two entirely different materials. All of that does play into the miniaturization of devices when you can then complete an evolving process all in one cycle, one piece of equipment, versus traditionally maybe two different processes or appendages. From a capability perspective, we are able to work with our customers to offer a fully integrated solution.

NEWS RELEASE: CEO transition at Freudenberg Medical Beverly, Massachusetts – Freudenberg Medical, a global contract design, development and manufacturing partner to the medical device and biopharma industry, has announced a strategic leadership transition. Effective Jan. 1, 2025, Michael McGee, former COO, assumed the role of chief executive officer, succeeding Mark Ostwald, who transitioned to another leadership role within the Freudenberg Group. Michael McGee joined Freudenberg Medical as COO in 2022, bringing more than 30 years of experience in the medical device industry. His appointment to CEO reflects Freudenberg’s commitment to continuity and alignment with the company’s values and long-term strategy. Under Michael McGee’s leadership, Freudenberg Medical continues to prioritize customer-centricity by investing in advanced technologies, people and processes. “Since joining Freudenberg Medical, I have been deeply inspired by our company values and our talented global team with proven expertise in materials and technologies. Together, we will build on this strong foundation and drive meaningful advancements in healthcare,” McGee said. “We remain steadfast in delivering consistent strategic partnership and prioritizing customer success.” Mohsen Sohi, Freudenberg Group CEO and speaker of the management board, said: “Michael has already demonstrated his ability to drive results and success. The board of management is confident that under his leadership, Freudenberg Medical will continue to grow, innovate, and thrive.” Former CEO Mark Ostwald served Freudenberg Medical for 16 years in various leadership roles. During his tenure, the company doubled its annual revenue, expanded its global manufacturing footprint by one-third, and integrated three Joint Ventures. “Mark’s leadership has been instrumental in shaping Freudenberg Medical’s success. His strategic vision and dedication solidified the company’s reputation as a trusted strategic partner in the medical device and pharmaceutical industries,” Sohi said. “Leading this extraordinary organization was an honor and a privilege,” Ostwald said. “Michael is passionately committed to our strategy and values, developing our people and delivering high-quality products to improve patients’ lives. I am convinced that Michael is the right leader to take Freudenberg Medical to the next level of success.” About Freudenberg Freudenberg Medical is a trusted strategic CDMO partner to medical device and pharmaceutical companies, committed to delivering high-quality solutions from ideation to market launch and volume production. With over 2,800 associates across 11 global manufacturing sites in key medtech hubs and proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: from minimally invasive solutions including complex catheters, hypotubes, steerable shafts, handles as well as drug and hydrophilic coatings to precision molding, two-shot and micro molding, advanced extrusions, and solutions for smart medical devices. Freudenberg Medical is part of the Freudenberg Group, a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with its partners, customers, and research institutions, the Freudenberg Group develops leading-edge technologies and excellent products and services for about 40 markets and for thousands of applications: seals, vibration control components, technical textiles, filters, cleaning technologies and products, specialty chemicals, medical products, batteries and fuel cells. Innovation strength, strong customer orientation, diversity, and team spirit are the cornerstones of the Group. The 175-year-old company lives by its core values: a commitment to excellence, reliability and proactive, responsible action. In 2023, the Freudenberg Group employed over 52,000 people in around 60 countries worldwide and generated sales of more than €11.9 billion. For more information, please visit . The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

Freudenberg will be attending CPhI & PMEC India 2024 on November 26-28. Freudenberg, a supplier of biopharmaceutical devices, systems, high-performance sealing, and filtering solutions, services to pharmaceutical and healthcare industries in India. The booth, located in Hall No. 15 - No. A.22, will feature pioneering solutions from its firms, including Freudenberg Medical (FM), Freudenberg-NOK India (FNI), and Freudenberg Filtration Technologies. Commenting on the participation, G Sivasailam, Managing Director, Freudenberg Performance Materials, and Director and CEO of Freudenberg Regional Corporate Center India said, “Freudenberg’s longstanding commitment to innovation and collaboration drives our contributions to India's pharmaceutical and healthcare industries. Through our participation in CPhI & PMEC India, we aim to bring innovative products and technologies that meet the evolving needs of these vital sectors, delivering reliability, safety, and performance.” Freudenberg Medical, a fluid handling innovation pioneer for over 30 years, offers precision-engineered solutions made in the United States and Germany. Freudenberg Medical recently announced the PharmaFocus Premium ASTC UV-Shield Tubing, which is specifically intended for photosensitive pharmaceuticals and has a platinum-cured silicone interior and an opaque exterior to maintain the integrity and stability of light-sensitive fluids. The company also provides advanced single-use components such as y-connector manifolds, tubing assemblies, and bottle cap assemblies with numerous inlets and outlets designed for cGMP bioprocesses. The HelixFlex™ TPE Tubing is a high-performance solution for cell and gene therapies. It provides outstanding visibility, durability, and sterilization adaptability. “Freudenberg Medical is redefining manufacturing by combining Virtual Reality (VR) and Artificial Intelligence (AI) to enhance training, streamline production, and drive efficiency across global sites. With new facilities under construction in Germany and Costa Rica, this innovative approach is giving customers greater transparency and collaboration while cutting costs, reducing waste, and setting new standards for the future of production layouts,” remarked Falgun Jani, Business Head - India Region, Freudenberg Medical. Freudenberg-NOK India demonstrates its experience in sealing systems tailored to pharmaceutical applications. Among its major breakthroughs are the Radiamatic® HTS II Seals, which are hygienic PTFE radial shaft seals designed for process industries, as well as inflatable and profile seals that provide outstanding resilience to harsh circumstances, ensuring reliability in pharmaceutical environments. Additionally, its clamp seals and O-rings, which are ISO and DIN approved, are designed to reduce contamination hazards while maintaining optimal performance. Senthil Kumar E, Sr. General Manager – Industrial Services Division of Freudenberg-NOK India, stated, “Our robust local presence, combined with globally recognized sealing technologies, positions us as a trusted partner to India’s pharmaceutical industry. We are committed to enabling reliable and efficient operations across critical applications.” Freudenberg Filtration Technologies has been a producer of innovative air filtration systems to the automotive, industrial, and pharmaceutical industries since 1998. Its current product line is intended to create safe and efficient pharmaceutical settings. Key offerings include innovative Fan Filter Units (FFUs) tailored to different capacities and automation requirements, Safe Change Housing/BIBO Units prioritising containment and safety during filter replacements, and high-temperature and ISO 16890 filters designed specifically for critical pharmaceutical processes. Chinmay Korad, Country Head - Pharma, Freudenberg Filtration Technologies India, remarked, “With the rapid growth of India’s pharmaceutical sector, the company remains steadfast in its commitment to providing cutting-edge filtration solutions. These solutions are designed to meet the highest standards of safety, operational efficiency, and compliance with international regulations. As the demand for pharmaceutical products increases, FFT continues to support the industry by delivering advanced technologies that ensure the integrity of the manufacturing process and the safety of both workers and consumers.” This year marks Freudenberg Group's 175th anniversary of global operations, with Freudenberg India playing an important part in the organization's continuous expansion. The company's extensive and innovative product range demonstrates its commitment to fulfilling the crucial demands of India's pharmaceutical and healthcare industries, with an emphasis on precision, quality, and sustainability.