Challenges of Pre-Market Clinical Investigations of Medical Devices: A Multi-Stakeholder Perspective
Author(s)
Giuditta Callea, PhD1, Rosanna Tarricone, PhD2, CARLO FEDERICI, PhD1, Helen Banks, MA MEd1, Maria Luisa Buzelli, MSc1, Francesco Benito Malandrini, PharmD1, Franco Luigi Zurlo, MSc1, Marta Kerstan, MSc3, Monica Tocchi, PhD4, Nicolas Martelli, PharmD, PhD5, Tess Martin, PharmD5, Ornella Tangila Kayembe, PharmD5, Stephane Piat, MSc6, Laura Sampietro-Colom, PhD, MD7, Andrea Rappagliosi, LLM8, Claudia Louati, Master9, Yasemin Zeisl, Master9, Daniel Bèltran, MSc10, Adrián Valledor, MSc10, Marta Bragagnolo, Master11, Marit Erna Austeng, MSc12, Alexandra Herborg Cornelius Poulsson, PhD12, Kristian Kidholm, PhD13, Lise Kvistgaard Jensen, MA13, Benedetta Brancadoro, MSc14, Carmen Furno, MSc14, Sebastian Kuhn, PhD15.
1Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Milan, Lombardy, Italy, Milan, Italy, 2Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Milan, Lombardy, Italy; Department of Social and Political Science, Bocconi University, Milan, Lombardy, Italy, Milan, Italy, 3DePuy Synthes, Zuchwil, Switzerland, 4Meditrial, New York, NY, USA, 5Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Pharmacy Department, Paris, France, 6CARMAT, Vélizy-Villacoublay, France, 7Clinic Barcelona University Hospital, Spain, Barcelona, Spain, 8Edwards Lifesciences, Nyon, Switzerland, 9European Patient Forum, Brussels, Belgium, 10Fundació De Recerca Clínic Barcelona - Institut D’investigacions Biomèdiques August Pi I Sunyer, Barcelona, Catalonia, Spain, Barcelona, Spain, 11Global Hearth Hub, Brussels, Belgium, 12Norwegian Institute of Public Health, Oslo, Norway, 13Odense University Hospital, Odense, Denmark, 14Policlinico Universitario Fondazione Agostino Gemelli,, Milan, Italy, 15University of Marburg, Marburg, Germany.
1Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Milan, Lombardy, Italy, Milan, Italy, 2Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Milan, Lombardy, Italy; Department of Social and Political Science, Bocconi University, Milan, Lombardy, Italy, Milan, Italy, 3DePuy Synthes, Zuchwil, Switzerland, 4Meditrial, New York, NY, USA, 5Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Pharmacy Department, Paris, France, 6CARMAT, Vélizy-Villacoublay, France, 7Clinic Barcelona University Hospital, Spain, Barcelona, Spain, 8Edwards Lifesciences, Nyon, Switzerland, 9European Patient Forum, Brussels, Belgium, 10Fundació De Recerca Clínic Barcelona - Institut D’investigacions Biomèdiques August Pi I Sunyer, Barcelona, Catalonia, Spain, Barcelona, Spain, 11Global Hearth Hub, Brussels, Belgium, 12Norwegian Institute of Public Health, Oslo, Norway, 13Odense University Hospital, Odense, Denmark, 14Policlinico Universitario Fondazione Agostino Gemelli,, Milan, Italy, 15University of Marburg, Marburg, Germany.
Presentation Documents
OBJECTIVES: To inform the development of a harmonized European Union (EU) Early Feasibility Studies (EFS) Program, at the centre of a Horizon JU IHI project, we collected the perspectives of different stakeholders involved in pre-market clinical investigations (CIs) of medical devices (MDs) on challenges and barriers faced, as well as solutions to improve and promote clinical research in the EU.
METHODS: Online survey for technology developers; open-ended interviews with representatives of EU HTA agencies, notified bodies, clinical sites, scientific associations, national ethics committees, technology developers (including SMEs); focus group with patient advisory group (PAG) of the project and patient associations.
RESULTS: According to survey respondents, the EU is the preferred location for conducting pre-market CIs. Crucial preference factors refer to trialists' and clinical site teams' competencies, the site's ability to enroll patients, and the time from study submission to first patient enrolled. A main barrier identified by stakeholders involved in CIs is the lack of dialogue between stakeholders, which makes the complexity of the regulatory framework even greater and requirements more difficult to follow. Risk-benefit analysis and device risk assessment were also deemed as major hurdles, together with aspects related to clinical sites (for instance, their experience in pre-market CIs), study design, study endpoints, enrolment targets, the lack of clear templates and guidance. Main obstacles encountered by patients during clinical trials were represented by fragmented information about the study and insufficient time and information to carefully assess the risks and benefits of participating in the study.
CONCLUSIONS: The discussion with all stakeholders clearly shows the multifaceted hurdles faced when bringing medical innovation to market and suggests actions for improvement, such as fostering early collaboration to improve clarity and reduce delays.
METHODS: Online survey for technology developers; open-ended interviews with representatives of EU HTA agencies, notified bodies, clinical sites, scientific associations, national ethics committees, technology developers (including SMEs); focus group with patient advisory group (PAG) of the project and patient associations.
RESULTS: According to survey respondents, the EU is the preferred location for conducting pre-market CIs. Crucial preference factors refer to trialists' and clinical site teams' competencies, the site's ability to enroll patients, and the time from study submission to first patient enrolled. A main barrier identified by stakeholders involved in CIs is the lack of dialogue between stakeholders, which makes the complexity of the regulatory framework even greater and requirements more difficult to follow. Risk-benefit analysis and device risk assessment were also deemed as major hurdles, together with aspects related to clinical sites (for instance, their experience in pre-market CIs), study design, study endpoints, enrolment targets, the lack of clear templates and guidance. Main obstacles encountered by patients during clinical trials were represented by fragmented information about the study and insufficient time and information to carefully assess the risks and benefits of participating in the study.
CONCLUSIONS: The discussion with all stakeholders clearly shows the multifaceted hurdles faced when bringing medical innovation to market and suggests actions for improvement, such as fostering early collaboration to improve clarity and reduce delays.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
MT13
Topic
Medical Technologies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas