Elevating medical device and pharma solutions to new heights

January 2, 2024 12:14 pm

Falgun Jani, Business Head of Freudenberg Medical India, sheds light on the company’s innovative designs, manufacturing capabilities, and initiatives reshaping the medical device sector.

Please discuss the design and manufacture of innovative medical device technologies at Freudenberg Medical. 
Freudenberg Medical operates across 11 global sites, specialising in creating and producing medical devices and pharmaceutical solutions. Our adherence to ISO 13485 quality standards and manufacturing in clean Class 7 or 8 rooms underscores our dedication to excellence. Anticipating our customer’s needs is the foundation of Freudenberg Medical’s success and a reinforcement of our commitment to continuously innovate & enhance the value for our customers.

Can you elaborate on Freudenberg Medical’s expertise and offerings in medical and pharmaceutical device manufacturing?
Freudenberg Medical has a diverse manufacturing capacity, from precise moulded components and medical/biopharmaceutical tubing to drug coatings and finalised medical devices like catheter shafts and hypo tubes. Eight of our 11 facilities are FDA-registered and strategically situated across the Americas, Europe, and Asia.

We specialise in lean manufacturing principles to exceed customer expectations, focusing exclusively on the medical device and pharmaceutical sectors.

Our comprehensive range of services spans from prototyping to final assembly, accommodating low to high-volume manufacturing needs and transitioning from manual to fully automated processes. With extensive tooling capabilities and unparalleled expertise in materials and various manufacturing technologies, we cater to diverse needs.

In the medical device market, we serve multiple therapy segments such as Neurology & neurovascular, ophthalmology, structural heart, cardiology, gastroenterology & endoscopy, urology & gynaecology, in-vitro diagnostics, orthopaedics, oncology & interventional radiology, and drug delivery. Our offerings include high-purity silicone tubing, braided tubing, TPE tubing, single-use moulded assemblies, custom tubing, and custom-moulded products and devices for the pharmaceutical and biopharmaceutical industry.

What are the unique features of HelixTC designed for pharmaceutical and biopharmaceutical applications in India, added to your pharma product portfolio?
In 2022, Freudenberg Medical introduced HelixTCTM, a novel product line featuring over-moulded Tri-Clamp® ends equipped with built-in gaskets for silicone tubing. This innovation offers a secure and distinct alternative to traditional barbed TC connections. HelixTCTM serves as an excellent choice for critical fluid transfer needs in pharmaceutical and bioprocessing operations by significantly reducing issues related to bioburden entrapment and leakage often seen in conventional barb-type TC fittings. Manufactured in a certified clean room, HelixTCTM ends guarantee material certification and lot traceability and are available in standard and custom sizes.

What application areas and industries are essentially covered by Freudenberg Medical?
For the Medical Device market, we serve therapy segments like Neurology & neurovascular, ophthalmology, structural heart, cardiology, gastroenterology & endoscopy, urology & gynaecology, in-vitro diagnostics, orthopaedics, oncology & interventional radiology, drug delivery. We offer our high-purity silicone tubings, braided tubings, TPE Tubings, Single-use moulded assemblies, custom tubings, and custom moulded products & devices for the Pharma and biopharma industry.

What sets Freudenberg Medical apart as a global contract manufacturing and contract development and manufacturing organisation? 
We offer end-to-end solutions, integrating components to create finished devices. With 11 locations globally, we operate globally while adapting to local needs. Our proprietary GROWTTH® process drives our expertise in lean manufacturing. To mitigate risks, we employ a global redundancy program that duplicates equipment, processes, and software. Supported by the $12 billion Freudenberg Group, we ensure long-term financial stability. At our core, continuous innovation is driven by ongoing research and development efforts to pioneer new processes and product technologies.

How does Freudenberg Medical ensure compliance with quality standards such as ISO 13485 and FDA regulations across its global manufacturing operations?
Freudenberg Medical’s Global Quality Team holds extensive expertise in Class I, II, and III Medical Devices, utilising diverse methods and tools to bolster various facets of the Quality System. This encompasses support for product development, product realisation, post-market surveillance, and risk management.

We’ve established, documented, and continually implemented a quality and environmental management system, aligning with ISO 13485:2016, ISO 14001:2015, MDD 93/42/EEC, MDR 2017/745, FDA QSR 21 CFR part 820, and Canadian Regulations. Our ongoing objective is ensuring compliance with FDA, ISO, and MDD regulations while tailoring validation and quality assurance systems that meet each of our customers’ specific requirements. 

Please discuss the range of Freudenberg Medical’s manufacturing capabilities, especially regarding high-precision moulded components, tubing, and drug coatings.
Freudenberg Medical’s manufacturing capabilities range from high-precision moulded components and medical/biopharma tubing to drug coatings, finished medical devices, catheter shafts, and hypotubes for minimally invasive and catheter-based devices. Some of the examples include: 

Rapid design to commercial manufacturing of a speciality balloon catheter: A multinational health technology company sought proposals for designing, developing, and manufacturing a speciality balloon catheter to rival an industry leader. The challenge was to create a design with new intellectual property while expediting the product’s entry into the market.

Freudenberg Medical’s engineers at the Carrick-on-Shannon (Ireland) facility proposed a design that leveraged their expertise in precision extrusion, catheter balloon technology, moulding, and device assembly. This design offered numerous advantages over existing technology. It fulfilled the client’s need for an innovative solution—the company’s integrated capabilities allowed for streamlined communication, effective collaboration, and swift design iterations.

The resulting solution gained approval for commercialisation due to its novel and user-friendly design, meeting the client’s requirements. From concept to a market-ready product, Freudenberg Medical accomplished the project in 18 months, including regulatory approval.

This successful product launch secured a dominant market position for the customer and became their most triumphant speciality device. This achievement forged a robust partnership, leading to subsequent product generations with diverse performance criteria. It also expanded the collaborative development and manufacturing relationship across multiple U.S. and European business units.

Freudenberg Medical expands medical tubing production to Massachusetts: Freudenberg Medical has expanded its clean room manufacturing facility in Beverly, Massachusetts, to include custom silicone extrusion and tube processing. Silicone tubing production commenced in January, with plans for additional capacity installation in Q1 to better serve customers. The primary focus is platinum-catalysed addition-cured silicones, ensuring compliance with the most stringent quality standards for medical and pharmaceutical applications.

Freudenberg Medical is a leading custom medical and biopharma tubing processor, including multi-lumen, complex single-lumen, and micro extrusions. The company has equipped its Massachusetts facility with extrusion machinery and processes identical to those in its global locations in Germany and the U.S. This uniformity ensures consistency and redundancy, effectively mitigating potential supply chain risks for customers.

Leveraging extensive expertise in silicone materials and long-standing partnerships with raw material suppliers, Freudenberg Medical stands out as the foremost partner for designing and manufacturing tubing solutions for pharmaceutical, biopharmaceutical, and medical device customers.

Please explain the implementation of virtual reality training for employees involved in catheter production at your facilities.
Freudenberg has introduced virtual reality (VR) training for catheter production staff in Ireland and the United States. This innovative training ensures that employees possess the requisite skills to maintain the high standards in catheter manufacturing required for global customers.

 Conventional training meant production lines would be disrupted to provide new operators with adequate training. Before integrating VR training, operators had three to four weeks to gain the rhythm of the production lines and hit takt time. Takt time is a key concept in lean manufacturing defined by the rate needed to complete a product. Now, after three days of VR training, operators can hit takt time, which enhances manufacturing efficiency by a multiple.

 Virtual reality training improves production efficiency, reduces raw material use, and cuts training costs. VR training builds muscle memory for trainees and educates them on materials and equipment terminology. Today, trainees do 100-plus repetitions in a virtual environment before working on the line –at their own pace, meeting individual training needs. Previously, new employees trained on the production line using raw materials. Scrap is significantly reduced as new employees initially undergo training in the virtual environment.

After a successful rollout in Ireland, Freudenberg Medical is implementing the program at a catheter production site in the U.S.The plan is to implement VR training at other sites where exact steps are done under magnification and, in the long term, to introduce the training company-wide.

Can you share about future initiatives of Freudenberg Medical to further innovate in the medical device manufacturing sector?
Despite the pandemic, Freudenberg has invested more than €2 billion in research and development. In 2022 alone, €577 million (an increase of 15 percent). Freudenberg Medical continues to invest in innovative products as well as sustainable manufacturing.

Freudenberg Medical has showcased several noteworthy advancements, including a proprietary conductive silicone compound in smart therapeutic and wearable devices. Another innovation, Helix iMC™ Breakthrough Measurement Technology for Silicone Tubes, has been a significant development.

Moreover, the introduction of HelixTwist™ Multi-Lumen Tubing is a unique technology designed to prevent kinking and blockage in multiple lumens. This tubing achieves this by evenly distributing stress across inner and outer lumens as the tube bends, ensuring uninterrupted flow.

Additionally, the company has made strides in sustainability by transitioning two manufacturing sites to operate entirely on green energy starting in 2022. Further reinforcing its commitment to growth, Freudenberg Medical expanded its medical device manufacturing at the Galway site, creating 100 new job opportunities.