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When Innovation Outpaces Standardization – Solutions to Support Novel Wound Care Product Development



July 31, 2023

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Novel products are critical within the global medical device marketplace. These state-of-the-art devices—and industry investment in them—deliver life-enhancing therapies, diagnostics and digital solutions to patients that need them most.

Hand-in-hand with product modernization, innovative test methods support efficacy and safety claims of novel products as standard test methods may not be fit for purpose. The use of appropriate test methods can support rapid product development and regulatory approval. Conversely, incorrect test methods can slow product development and hinder, or prolong, regulatory approval.

Join NAMSA as we discuss the components of customized test methods, the trend for regulatory bodies to demand even more clinically relevant In Vitro data and a review of case studies with real-world applications.


Attendees of this webinar can expect to walk away with a better understanding of the following:

  • Wound care product categories: customized preclinical testing solutions to support innovation
  • When to consider customized approaches
  • Case Studies: proven solutions to demonstrate novel product efficacy or safety



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Hannah Thomas

Principal Senior Scientist

Hannah joined NAMSA in 2022 through the acquisition of Perfectus Biomed. She has been with Perfectus since 2013 and has held roles including Quality Manager, Operations Manager and became Principal Senior Scientist in 2021. During her time with the company, she has led the team to be the first in the world to develop and accredit biofilm test methods to ISO 17025, led collaborative projects to conduct groundbreaking research into wound care, and played a critical role in obtaining GLP accreditation. An integral part of the team with a breadth of knowledge and expertise in designing customized test methods that support MedTech product innovation.

Stefania Fabbri, PhD

Senior Scientist

Stefania joined NAMSA via the acquisition of Perfectus Biomed in 2022. She has been with Perfectus since 2018 and brings extensive experience in biofilmology. Stefania studied Biomedical Engineering at the University of Genoa before moving to the University of Southampton. Her PhD focused on investigating interfacial instability generation in dental biofilms plus several post-doctoral placements specializing in marine biofilm decontamination.