IME co-author of ASTM Standard

27 May 2021

IME Medical Electrospinning announced the publication of the first standard for fiber-based medical scaffolds, published by international standards organization ASTM. The standard was co-authored by IME’s CTO Ramon Solberg and will guide the design and manufacture of fiber-based medical products used to improve patient care.

F3510-21 – Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products

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 organisations, 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 IME 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.

IME sets the standard with its technology

Since its establishment in 2008, IME has pioneered advanced solutions for the precise control and scalable production of fiber-based medical scaffolds. Optimizing fiber and scaffold properties such as fiber diameter, porosity, and mesh thickness is vital for the intended functionality of these scaffolds. If left uncontrolled, fluctuations in environmental parameters, like temperature and humidity, can greatly influence scaffold properties, leading to inconsistencies in the final product. Within the ASTM standard, the precise control of environmental parameters is a central tenant of guidance for producing highly consistent fiber-based products, with therapeutic safety and efficacy in mind.

With the MediSpin® XL, IME’s industrial production platform for fiber-based scaffolds, the company has already incorporated a wide variety of technical solutions to meet the highest standards for industrial production of fiber-based scaffolds. The platform therefore includes innovative technologies, protected by multiple patent families, such as rigorous climate control, in process thickness measurement and in-line quality monitoring systems to ensure a consistent end-product.

 

Judith Heikoop, Chief Executive Officer at IME Medical Electrospinning, says:

“Having been on the forefront of developing standards in medical electrospinning, ensuring safe, scalable and reproducible scaffolds for medical devices and drug delivery solutions, we applaud the introduction of these new standard by NIST and ASTM. This will help to further advance ground-breaking solutions and bring them to patients as fast and efficient as possible. And we’re very proud that the contribution to the technological innovations in the field by our founder and CTO Ramon Solberg, were instrumental in these new standard.”

Ramon Solberg, Chief Technology Officer at IME Medical Electrospinning, adds:

“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.”