Webinar – Standardisation & Benchmarking

 

Agenda

Facilitating standardisation for cobots by COVR – Gerdienke Pranke, COVR project (15’)

Certification of wearable exoskeletons under new medical device regulation (MDR 2017/745) – Anna Mas, ABLE Quality and Regulatory Director (15’)

Harnessing robot experimentation to optimise the regulatory framing of emerging robot technologies – Eduard Fosch-Villaronga and Carlos J. Calleja, eLaw Center for Law and Digital Technologies at Leiden University (15’)

Standardizing  software for wearable robots benchmarking: the Eurobench approach – Alfonso Dominguez, Senior Researcher at Tecnalia (15’)

Round Table (30’)

 

Speakers

Gerdienke Pranke, PhD.  With maximizing patients’ performance in daily life at heart, I coordinate the research line Active Therapeutic Devices. With my ATD-colleagues and PhD students, I focus on clinical application and evaluation of rehabilitation technology to support functional performance of people with movement limitations. Rehabilitation robots, soft exoskeletons and serious games are the main focus points nowadays. My main research interests lie with understanding the impact of rehabilitation technology on neurophysiological, biomechanical and clinical levels (including safety of human-robot interaction), and supporting its application in clinical practice.

To do this, my colleagues and I run multiple research projects, collaborating closely with technical and medical partners in the Netherlands, across Europe and sometimes even worldwide. My expertise is primarily on how rehab technology improves arm and hand function, while my colleagues are experts on walking and gait. Together, we contribute to the development of effective and practically applicable rehab technology.

My activities span user input to new designs, testing prototypes with patients, setting up clinical investigations according to ethical and medical device regulations, coordinating and executing clinical trials. I also aim to contribute to implementing such innovative rehab technology into actual clinical practice, as I am doing in close collaboration with clinicians at Roessingh Center for Rehabilitation. At Roessingh we founded NovaLab: one of the first innovative tech-supported treatment facilities embedded in the clinic.

 

Anna Mas Vinyals, PhD is the Head of Quality Assurance and Regulatory Affairs at ABLE Human Motion S.L. She received her PhD in Bioengineering from IQS – URL (Barcelona) in 2018, for the development of a tissue-engineered implant for knee osteoarthritis. Right after she started working in technology transfer to support the implementation of healthcare innovative solutions. She worked as Project Manager in CIMTI, a center promoted by Fundación Leitat and the Healthcare Department of Generalitat de Catalunya to implement innovative MedTech solutions in the Public Catalan Healthcare system. She gained experience in quality management, public reimbursement, and regulatory affairs. At ABLE Human Motion, she leads the certification of the ABLE Exoskeleton for spinal cord-injured people under the new MDR.

 

Dr. Fosch-Villaronga is an Assistant Professor at the eLaw Center for Law and Digital Technologies at Leiden University (NL) where he investigates legal and regulatory aspects of robot and AI technologies, with a special focus on healthcare. Eduard recently published the book ‘Robots, Healthcare, and the Law. Regulating Automation in Personal Care’ with Routledge and is interested in human-robot interaction, responsible innovation, and the future of law.

Eduard is the PI of LIAISON, an FSTP from the H2020 COVR project that aims to link robot development and policymaking to reduce the complexity in robot legal compliance. He is also the PI of PROPELLING, an FSTP from the H2020 Eurobench project, a project using robot testing zones to support evidence-based robot policies. Eduard is also the co-leader of the Ethical, Legal, and Societal Aspects Working Group at the H2020 Cost Action 16116 on Wearable Robots and participates actively at the Social Responsibility Working Group at the H2020 Cost Action 19121 GoodBrother. In 2020, Eduard served the European Commission in the Sub-Group on Artificial Intelligence (AI), connected products and other new challenges in product safety to the Consumer Safety Network (CSN) to revise the General Product Safety directive.

 

Carlos J. Calleja is a Research Assistant at the eLaw Center for Law and Digital Technologies at Leiden University (NL). Carlos is currently working within PROPELLING, which stands for “Pushing Robot Development for Policymaking” and is an FSTP (financial support to third parties) from the Horizon 2020 Eurobench project. Carlos investigates the potential for using robot testbeds as data generators for speeding the creation, revision, or discontinuation of standards for lower-limb exoskeletons. Previously, Carlos served at the United Nations Human Rights Committee and worked as an attorney in different law firms, including Baker&McKenzie. Carlos holds a LL.M. from the University of Oslo (NO) and an LL.B. from the University Andres Bello in Caracas (VE).

 

Alfonso Dominguez is a Senior Researcher at Tecnalia, in the Medical Robotics group of the Health division. Telecommunications Engineer and Master of Science in Control, Automation and Robotics Engineering by the Basque Country University, he has worked in R&D for more than 10 years. His domain of expertise is robotics involving the human in the loop applied to the healthcare sector. In the past few years he has taken part in several national and international research projects focused on teleoperated and assistive robotics for minimal invasive surgery and the improvement of the usability of exoskeletons for the prevention of musculoskeletal disorders in working environments. He is member of the Eurobench project work team where he is participating in the definition and implementation of the Benchmarking Software platform.