VIVOLTA announced the publication of the first standard for fiber-based medical scaffolds, published by international standards organization ASTM. The standard was co-authored by VIVOLTA’s CTO Ramon Solberg and will guide the design and manufacture of fiber-based medical products used to improve patient care.
The need for standardization of fiber-based scaffolds was identified in 2018, during the ‘Workshop on the characterization of fiber-based scaffolds: Challenges, progress, and future directions’. This workshop was initiated by a consortium of industry leaders such as Medtronic, academic institutes, non-profit organizations, and governmental bodies. Following the conclusions of the consortium, a workgroup was formed, facilitated by the American National Institute of Standards and Technology, NIST, to develop an ASTM Standard, in which VIVOLTA took an active role. This published standard now provides important guidance for the development and production of reproducible, high-quality nanofiber-based medical devices, with the goal of improving patients’ health and safety.
“I’m very proud to have been part of a great team of field experts, led by NIST, to contribute to these new US standard. Obviously it will become the blueprint for further worldwide standards in our industry and will certainly help advancing large-scale manufacturing of reproducible and scalable fiber-based scaffolds. These wonderful pieces of art will substantially transform the medical device market for a wide variety of medical applications and thus revolutionize tissue engineering.”