The company is driven by a team with a breadth of experience in medical devices, business management, and engineering fields.
Alain was eager to bring to Novostia his multifaceted international experience in the management of industrial companies, technological innovation and the development of regional partnerships. He has in-depth knowledge of medical device production, microelectronic circuits and microsystems.
Alain has worked for multinationals (Motorola, Pfizer, Essilor), large companies (Swatch Group, Ascom), very advanced SMEs and tech startups (VHF Technologies-Flexcell, Monoclonix), companies in which he has held various positions in production, R&D, quality and plant management.
After a university education in mechanical engineering at the Paul Sabatier University in Toulouse, Alain obtained a master's degree in innovation management from the Ecole Polytechnique Fédérale de Lausanne and a master's degree in strategic management from the EM Lyon Business School.
Pomme is a PhD in biomedical engineering with a strong interest in quality assurance and regulatory affairs. She began her career as a study director and then operations manager at Aginko Research, a preclinical and clinical CRO specializing in osteoarticular diseases. She then worked as a senior business manager at Assystem Care, a consulting firm for life science and medical technology companies. Pomme holds a master's degree in bioengineering from Polytech'Clermont-Ferrand, France, a PhD in cellular and biomedical sciences from the University of Bern (Inselspital), Switzerland, and a university degree in regulatory affairs from ISIFC, France.
Pomme joined Novostia in 2019 as quality and regulatory affairs manager, with the mission to establish and maintain the quality system according to ISO 13485, and to develop the technical documentation according to ISO 5840. In addition, she is responsible for clinical affairs. For all three roles, she works closely with external consultants to establish and deploy strategies and measures in line with Novostia's objectives.
Pomme brings to the Novostia team her expertise in quality management and regulatory affairs in the medical device industry. Her academic background allows her to understand the different aspects of the project, especially biomedical. Her previous professional experience is an asset for the biological, in vivo, and clinical evaluation of the TRIFLO valve. In this project, Pomme oversees the management of several key partners on aspects of paramount importance: quality, regulatory affairs and animal and human trials.
Felix is a mechanical engineer dedicated to the development and optimization of industrial processes. He has gained an extensive experience in medical device manufacturing thanks to Johnson & Johnson, Endosense, acquired by St. Jude Medical, and Symetis, the company behind the development of the TAVI bioprosthesis, acquired by Boston Scientific.
Felix holds a Master of Science degree from Arts et Métiers ParisTech, with further training in finance and leadership from INSEAD and a Lean Six sigma Black Belt certificate.
Felix joined Novostia in the summer of 2022 as Product and Process Development Manager with the mission of coordinating the outsourced activities in view of the first human implantations and further CE marking and FDA approval. In addition, he has the key role of developing additional valve sizes and accessories proprietary to Novostia in order to accelerate and scale up clinical trials.
Felix brings to Novostia his technical expertise in various manufacturing processes, his knowledge of the medical device manufacturing players and his expertise in the regulation of Class III devices in the EU and US. His previous work experience provides him with a comprehensive overview and a deep understanding of the steps required to bring a device to market.
Corentin is a young mechanical engineer with a passion for biomechanics and heart valve technology. He started his career as a Process Engineer at Johnson & Johnson in the class 3 implantable medical devices Business Unit. He then worked at Xeltis as an R&D Engineer in charge of polymer heart valve characterization and participated in academic research on osteoarthritis at the Cartilage and Tissue Engineering Laboratory of the University of California at San Diego. Corentin holds a master's degree in mechanical and biomechanical engineering from the Ecole Polytechnique Fédérale de Lausanne (EPFL), Switzerland.
Corentin joined Novostia in 2020 as a Development Engineer, with the mission to actively contribute to the development of the heart valve and to the understanding of its performance and behavior. He now leads the verification and validation activities of the product and process compliance to standards. In particular, he is overseeing all in vitro testing that will lead to the CE submission.
Corentin brings to the Novostia team up-to-date knowledge of valve mechanics and standards for heart valve substitutes. His master's degree allows him to understand the TRIFLO valve from various aspects - its mechanical properties, materials, hydrodynamics, durability, cavitation - while using advanced investigation tools such as numerical simulation. In the TRIFLO project, Corentin intends to focus on the testing of the valve in vitro, a task that requires both the supervision of several strategic partners and the writing of numerous protocols and technical reports.
Iva-Laura is the administrative and accounting supervisor at Novostia. She is also in charge of the relations with service providers, the organization of events and, more generally, the organization of the office.
She completed her apprenticeship as an administrative assistant at the Service of Economic Promotion of the Canton of Neuchâtel. She then followed the preparatory courses for the Bachelor's degree in business management at the University of Applied Sciences HE-ARC in Neuchâtel.
During her studies, she decided to join the young Novostia team to put her fresh academic knowledge into practice.
Iva-Laura is at your service to answer all your questions or to put you in touch with a qualified contact at Novostia or in its network.