Cost- and time-effective risk assessment tools needed for biomaterials
Biomaterial-based solutions compromise a significant portion of remedies offered by the healthcare system. However, the currently available methodologies are not sufficient for proper risk assessment of even for most common biomaterial applications. The EU-funded project PANBioRA (Personalised And/or Generalised Integrated Biomaterial Risk Assessment), that started in January 2018, aims at providing a set of tools, protocols and instruments, that can standardize the evaluation of new biomaterials. Moreover, this method will allow for pre-implantation, personalized diagnosis for biomaterial-based applications that will ensure better clinical outcomes and minimize the risks related to the use of established and new biomaterials.
The PANBioRA consortium is composed of 17 partners from 11 European countries. The multidisciplinarity of the consortium consisting of SMEs, academic and scientific RTD partners, clinics and technology transfer organisations, underlines the complexity of the innovative concept of PANBioRA. Aalto University is one of the key consortium members. Its main role in this project focuses on experimental evaluation of different biomaterials, covering dental and laryngeal implants, and novel coatings, assessing potential complication and usability risks demanded by the new EU Medical Device Regulations (2017/745). Professor Michael Gasik (Department of Chemical and Metallurgical Engineering) acts as Aalto’s Project Manager, and other principal researchers are Dr. Annukka Santasalo-Aarnio and M.Sc. Alexandra Zühlke.
The project has received funding from the European Union´s Horizon 2020 research and innovation programme under grant agreement No. 760921 under the topic titled "Development of a reliable methodology for better risk management of engineered biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices".
The PANBioRA consortium is composed of 17 partners from 11 European countries:
Steinbeis 2i GmbH (Coordinator), Germany
Dolmen Design and Innovation Limited, Ireland
Biodevice Systems s.r.o., Czechia
Protobios OU, Estonia
Elvesys SAS, France
Steinbeis Advanced Risk Technologies Institute doo Kragujevac, Serbia
Steinbeis R-Tech, Germany
Commissariat A L’Energie Atomique Et Aux Energies Alternatives, France
Turgut Ozal Education SHA, Albania
The University of Nottingham, UK
Agencia Estatal Consejo Superior de Investigaciones Científicas, Spain
Dublin City University, Ireland
Institut National de la Santé et de la Recherche Medicale, France
Centre Hospitalier Universitaire de Liège, Belgium
Protip Medical (Scientific Coordinator), France
Professor Michael Gasik
+358 50 560 9511