Making medical miracles
Benefitting from distinguished technical expertise and a vast global footprint, Freudenberg Medical is becoming a market leading developer and manufacturer of components and devices for the medical sector
A member of the Freudenberg Group, Freudenberg Medical is a trusted partner in the innovation, design and manufacture of premier medical and pharmaceutical devices, components and tubing. A global CMO/CDMO with 11 development and manufacturing facilities and more than 1700 associates worldwide, the company’s roots can be traced back to 2004 when the Freudenberg Group purchased a small silicone processing site in Massachusetts. Additional acquisitions followed in the US in 2006 (Helix Medical) and 2008, along with entry into a joint venture in Ireland in 2010 with VistaMed. Finally, in 2012, Freudenberg combined all the operations into one global business group under the Helix Medical name, which was later changed to Freudenberg Medical. That same year, Freudenberg opened an operation in Costa Rica and acquired MedVenture Technology, a catheter developer and manufacturer in the US. The group continued to expand by establishing joint-ventures in Ireland for hypotubes, a key catheter component, in 2013 and for medical coatings in Germany in 2015.
In 2021, nine years since it was established as a business group, Freudenberg Medical operates across the Americas, Europe and Asia as one of the medical device and pharmaceutical sector’s largest players. Alongside its presence in the major US medical clusters of California, the Midwest and Boston, the company boasts molding and assembly capabilities in Costa Rica; two catheter-focused facilities in Ireland; a silicone molding and extrusion operation, plus a coatings site in Germany; and a thermoplastic molding operation in Shenzhen, China. Covering the entire value chain from initial design to device manufacture, Freudenberg Medical prides itself on understanding client requirements and delivering effective solutions. Furthermore, the company’s global manufacturing footprint gives its customers the opportunity to have devices manufactured in local or strategically advantageous locations.
“At Freudenberg Medical, we have a core competency in molding and extruding silicone and thermoplastics, so we operate over 130 molding machines worldwide, all in cleanroom environments,” explains company CEO Max Kley. “On the catheter side, we are very heavily involved in processes like micro-assembly, where we put together very intricate catheter systems that go deep into the body. Complex multi-layer catheter shafts are made out of different extrusions and often include a braid or metal tube, which is something we really excel at.
“In short, clients can come to us with the proverbial ‘idea on a napkin’ and we can translate that into a successful product for the market,” Max continues. “We have vast technical expertise and we bring that expertise to the market via technology platforms we build and make available to our customers. These might include advanced coatings for the medical device industry or catheter modules and components that are not only more cost-effective than alternatives, but help our clients achieve faster, improved functionality and better clinical outcomes.”
In November 2020, Freudenberg Medical completed construction of a new 36,000 square-foot medical manufacturing operation in Massachusetts. A highly modern production center for medical devices and components in medical implant grade silicones and high-performance plastics, the site also functions as the company’s new headquarters.
“Boston is one of the strongest medical device clusters in the world,” Max says. “We are offering local silicone molding services to this cluster and due to increasing demand, we decided to expand the manufacturing space and move closer to the Boston metropolitan area with the new building at Beverly. Additionally, we felt it was very important to give us one central hub holding all our corporate services, hence the decision to make Beverly our new HQ.”
Of course, the modern world is ever-changing and, in particular, Industry 4.0 is transforming the medical marketplace and manufacturing environment. Many of Freudenberg Medical’s current products are manufactured at extremely high volume – for example, the company produces upwards of 90 million components for dialysis devices and millions of diagnostic cartridges – and to handle these volumes and ensure that quality remains perfect, automated handling, assembly, quality and vision control have become key areas of focus for the business. In line with this approach, catheter manufacturing processes, which are traditionally highly manual and often require more than 50 operators in a single assembly line, are currently being re-evaluated by the firm. Working in collaboration with Limerick Institute of Technology in Ireland, Freudenberg Medical is aiming to link different processes, harvest quality data and documentation, and share this information with customers.
“Self-adjusting processes in molding and extrusion are one of the newest parts of the technological revolution,” Max remarks. “We’ve recently succeeded in becoming the first in the world to measure the inner dimensions of a silicone tube with a new technology called Helix iMC™. The next phase will be to tie this data together with the process data of the extruder and get to a self-adjusting process that incorporates elements of artificial intelligence. The advantage there is that we can ensure consistent quality for these tubes, which are for example used for pacemaker electrodes, where any failure could have potentially fatal consequences for patients. It will also improve cost considerations by decreasing scrap and reducing start-up times.”
As a business-to-business solution provider, Max insists that Freudenberg Medical aims to stay out of the spotlight and let its customers take the plaudits, but the firm’s long history of success is hard to overlook. Among the company’s recent projects is the launch of a drug-coated balloon for peripheral interventions in the US, the most demanding market for these types of devices. Released in conjunction with an OEM partner, the new product was made possible by Freudenberg Medical’s prominent position as a contract manufacturer able to meet the very challenging quality requirements for high-risk drug-coated Class III medical devices.
Elsewhere, Freudenberg Medical continues to help customers bring products to market in the introducer and guide catheter sectors. Using the company’s own proprietary handle and hemostatic sealing technologies, these products allow safe, precise and efficient access to patient vessels.
“We’ve also been working for highly innovative customers like Signifier Medical Technologies to help them develop a device that allows for electrical stimulation of tongue muscles to help reduce snoring,” Max adds. “That device has just earned approval in the US and we believe it has very strong market potential. Sleep apnea and snoring are widespread conditions and the sector seems highly receptive to effective novel solutions.”
In January 2021, Freudenberg Medical expanded its injection molding operations at its Baldwin Park, California site, adding six injection molding machines, a work cell for two-shot molding and a Wittmann Battenfeld micro-molding machine. The upgrade is another positive sign for the company’s future as it looks to increase its capabilities in line with growing demand. Still, though the firm is optimistic about what lies ahead, Max is conscious that Covid-19 maintains a significant presence on the current business landscape.
“Unsurprisingly, 2020 was a difficult year for many people in the medical device industry because elective surgical procedures were pushed out or cancelled. Even procedures we didn’t think would be elective, like placing stents in patients with heart failures, or treating strokes, suddenly decreased in numbers, putting many patients at risk,” Max reveals. “The hangover from 2020 is likely to continue in 2021 and we expect some difficulties to remain for at least the first half of the year. Saying that, it’s worth noting that even with the obstacles presented by the pandemic last year, we experienced double-digit growth over the course of 12 months. It was our most successful year on record and we continue to see a lot of interest, especially in Covid-related products.”
As Max suggests, Freudenberg Medical’s standing as one of the world’s biggest producers of diagnostic cartridges and pharmaceutical tubing means that the company’s services are in high demand from in-vitro diagnostic companies and Covid-19 vaccine manufacturers. This trend, along with a rise in the call for miniaturized medical solutions and the development of smart devices for interventions in the vascular space, means that the company will have plenty to think about in the years ahead.
“Our goal is to be the market leader for every segment in which we are active,” Max declares. “The medical device and medical device component market is very diverse, so we are choosing areas that have high growth potential and where our technology can really make a difference. Our expectation going forward is to deliver double-digit percentage growth. We are very confident about that and I think emerging countries in territories like Asia will definitely play a part.
“Freudenberg Medical is a privately held business, independent from the stock market, so we take a very long-term view approach and have an incredibly stable financial foundation,” Max summarizes. “We are a long-term partner to our customers and that is especially important in the medical device industry where product cycles tend to be lengthy and where quality and stability are very high on the priority list. We tick those boxes and that’s a key reason why we are gaining so much momentum at present.”
Products: Components and devices for the medical sectors