EWMA Innovation Team

EWMA Innovation Team offers support to companies within health care and medical devices assisted by our global network of high-level experts. We ensure a smooth process of the projects wherever you involve us on the value chain from innovation idea to market access.

We align with perspectives of payers, health systems, expert end-users and patients by delivering emerging technology reviews (ETR) in collaboration with Excite International.

We assist with planning exploratory, first-in-human (FIH) trials, expert lead investigator advisory, proposals for trial site and lead investigator together with choice of CRO.

We advise on FDA and EMA requirements, analyze product health economy, create bridges to US and EU regulatory contacts and assist with medical writing and statistics.

We ensure effective communication to consumers, health care professionals and payers by user group tests, expert input, data, and stakeholder dialogue.

Jan Apelqvist is a senior consultant and an associate professor at the Department of Endocrinology University Hospital of Skåne in Malmö and division for clinical sciences University of Lund (Sweden) coordinating a multidisciplinary foot care centre (national centre of excellence) for prevention/ treatment of the diabetic foot. Jan is an experienced lead investigator of clinical trials in collaboration with industry.

Alberto Piaggesi is director and professor of the Diabetic Foot Section of the Pisa University Hospital, Department of Endocrinology and Metabolism, University of Pisa (Italy). He has a long-lasting surgical experience on diabetic foot conservative surgery, and he performed more than 5000 interventions in this specialty as first operator. Alberto is an experienced lead investigator of clinical trials in collaboration with industry.

Sebastian Probst is Full Professor of Tissue Viability and Wound Care, Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland. In addition, he is Adjunct Professor at the College of Medicine Nursing and Health Sciences at the University of Galway, Galway, Ireland. He is the Immediate Past President of the EWMA association. Sebastian Probst's output is broad ranging and covers trials consisting in innovative therapeutic approaches for wound management in patients with venous leg ulcers, targeting the management of risk factors to prevent recurrences and enhance quality of life of this patient population. in addition, he is an expert in wound care informatics.

Prof Thomas Bjarnsholt is a global expert in the role of biofilms in chronic infections, with over 250 peer reviewed publications in the biofilm field.  His research focuses on biofilm formation and the role of bacterial biofilm in chronic infections, both in vitro, animal models and ex vivo material from chronic infections. Bjarnsholt is interested as to how bacteria initiate biofilms in the human body and why the immune defense seems to fail both in the initial infection and later in the chronic infection.  His research also seeks to develop tools and methods to enable fast diagnosis of these infections, for better treatment and possible prevention. 

Klaus Kirketerp-Møller, MD, Orthopaedic surgeon and Ph.d., heads the Copenhagen Wound Healing Center at Bispebjerg University Hospital. The CWHC is an interdisciplinary tertiary wound healing center treating all types of difficult to heal wounds, including venous leg ulcers, diabetic foot ulcers and inflammatory ulcers. The research at the center includes clinical as well as experimental research in bacterial biofilm, wound exudate, prevention and digital solutions for wound monitoring. He has been chairman of Diabetic Foot Study Group under European Association for the Study of Diabetes and European Bone and Joint Infection Society. He is co-founder of the International Association of Diabetic Foot Surgeons. He is affiliated with Steno Diabetes Center Copenhagen. He has participated in writing the IWGDF guidelines on off-loading and has been involved in development of new antimicrobial solutions and new wound dressings. 

Head of EWMA Innovation Team, Director of EWMA.

hjn@ewma.org

Business consultant and regulatory expert.

eb@ewma.org

EWMA Innovation Forum and general inquiries.

pf@ewma.org