A new CDMO called Medeologix today announced the combination of three Silicon Valley medical device manufacturing companies into a full-function service group.
New Taipei City, Taiwan-based Medeologix said it purchased Mediballoon, MedeonBio and Second Source Medical. The organizations have a combined footprint of 90,000 square feet, including a mass production facility in Taiwan.
Operating as Medeologix, the group offers services from conceptual design to high-volume production of finished medical products, the company said in a news release. The new Medeologix family offers medical tubing extrusion, balloon forming, catheter processing, final assembly, packaging and logistic services.
“The alignment of quality systems among each company and within the entire group provides seamless transition from concept stage to production scale up without costly revalidation and production delay, thus assuring their clients the most efficient services,” Medeologix said in the news release. “In addition, the in-house expertise provides regulatory submission services for 510(k), PMA and MDR, as well as help startups incubate their projects with virtual offices and quality system setup; a true major source for medtech outsourcing solutions.”
More about Mediballoon, MedeonBio and Second Source Medical
MediBalloon was established in 2016 and serves medtech firms ranging from startups to major OEMs. Union City, California-based MediBalloon offers medical tubing extrusion and develops medical balloons in different shapes and sizes using various thermoplastic materials including polyurethane, polyethylene, polyvinylidene fluoride (PVDF), polybutylene terephthalate (PBT), polyethylene terephthalate (PET), PEBAX-brand polyether block amide and nylons.
“Our goal has been to provide our customers the ultimate solution when developing medical balloon products,” MediBalloon founder and CTO Anant Hegde said in a January announcement of its partnership with MedeonBio and the formation of Medeologix. “We provide short turnaround time during the design and development phase, and now we will be equipped with a state-of-the-art facility and multiple production lines, which significantly boosts our capacity to meet the growing demand of mass production for our global customers. The partnership between MediBalloon and Medeon Biodesign benefits from the efficiency and manufacturing capabilities of Taiwan, with a highly educated and talented workforce, which will allow us to extend the top-notch medical balloon development know-how to mass production.”
MedeonBio (previously known as Medeon Biodesign) was established in 2012 and specializes in single- and multi-lumen catheter processes, including braiding, coil winding, lamination, thermal fusing, tipping, balloon bonding and pleating, and hydrophilic coating. Health providers commonly use the catheters in minimally invasive procedures for cardiovascular, neurovascular, peripheral and structural heart diseases. The company’s stock publicly trades in Taiwan, with headquarters in Taipei and operations in Sunnyvale, California.
“We are very excited to partner with MediBalloon to establish the most premier medical balloon manufacturing organization,” MedeonBio CEO and Chair Yue-Teh Jang said earlier this year. “We envision the partnership to provide cutting-edge, high quality medical products to the globe, with more efficient and effective operations.”
Second Source Medical was established in 2004 and is headquartered in San Jose, California. The FDA-registered contract manufacturer is FDA QSR and cGMP compliant for Class II and Class III PMA products and offers integrated design and manufacturing services from component, functional prototype, subassembly, process development, verification and validation leading to pilot and mass productions in support of successful clinical trial, regulatory approval and commercialization. Second Source Medical has a 2,000-square-foot clean room, plus a silicone forming lab and a yellow lab for UV-light-sensitive liquid mixing.
Second Source Medical announced this summer that it would join the other companies, saying the group would be able to offer “complete one-stop service for advanced balloon and catheter technologies for startup and large clients to take their projects from napkin to prototype and commercialization.”