|ZuzaMED Medical Device
VELOX GmbH has announced a successful product launch of Trinseo’s plastic material for medical devices application in Poland.
Trinseo plastic can now be found in an innovative mobile fetal monitoring device developed by Mo Fe Ma, a start-up medical devices company headquartered in Poland. Mo Fe Ma was formed in cooperation with Techprotekt, another Poland-based medical devices company, and Malopolska Agencja Rozwuju Regionalnego SA. for the purpose of introducing the device – ZuzaMED – to expectant mothers in the Polish marketplace.
ZuzaMED Medical Device
ZuzaMED is a small, portable device that rests on the maternal body and monitors the health condition of the fetus as it develops. It is worn across the belly and can be used without any restriction to length of time.
Trinseo’s PC/ABS Blend
- The monitor’s housing is made of Trinseo’s ignition resistant EMERGE™ PC/ABS 7700 Advanced Resins.
- The material is widely used and accepted in the medical device industry and meets the technical requirements of the application: These requirements include biocompatibility for extended skin contact, low density for light weighting, and UL 94 flame retardancy to provide for the user’s safety.
- The material also needed to be durable to withstand movement and jarring, resist dirt and grime, and be able to be cleaned with a 40% alcohol solution.
VELOX, a distributor of Trinseo medical resins in Europe with a specialty in medical polymers, successfully positioned the material. The company had been working with Mo Fe Ma since 2014 on the application, providing sample stock for assessment and evaluation and offering regulatory and biocompatibility guidance and documentation. ZuzaMED was commercialized in 2016 after a careful product development process.
François Minec, General Manager at VELOX commented:
“The material met all the requirements of the highly regulated medical devices industry and it provided the technical requirements needed for the application. Trinseo’s material was unique in that the ABS component benefited from Trinseo’s proprietary mass polymerization technology (vs an emulsion process) which results in exceptionally white base resin for coloring the ZuzaMED device.
This is the first product offered by Mo Fe Ma. It is considered by Poland officials to be of major importance for soon-to-be moms and their children.
The ZUZAMED device is CE 2274 approved by TUV Nord Polska Sp. z o.o., fulfilling both EN DIN 13485:2012 and 9342/EEC-MDD requirements. With these approvals in place, Mo Fe Ma is now focused to expand its reach beyond the domestic Polish market.
About VELOX GmbH
VELOX GmbH is among the European leaders in the marketing and distribution of raw material specialties for the plastics, composites, rubber and coatings industries. Founded in 1993 by Bernard Goursaud and N. Max Schlenzig, VELOX is headquartered in Hamburg, Germany. The company has 21 offices throughout Europe and employs over 200 experienced employees to support its customers.
Trinseo is a global materials solutions provider and manufacturer of plastics, latex binders, and synthetic rubber. It is focused on delivering innovative and sustainable solutions to help customers create products that touch lives every day — products that are intrinsic to how we live our lives — across a wide range of end-markets, including automotive, consumer electronics, appliances, medical devices, lighting, electrical, carpet, paper and board, building and construction, and tires. Trinseo had approximately $3.7 billion in net sales in 2016, with 15 manufacturing sites around the world, and nearly 2,200 employees.
Source: VELOX GmbH