ClinMed 2020 Abstracts

Area 1 - ClinMed
Full Papers Short Papers

Area 1 - ClinMed

Full Papers
Paper Nr: 2
Title:

End-user Need based Creation of a Medical Device: An Experience of Co-design to Struggle Pathological Scars
Authors:

Thomas Lihoreau, Brice Chatelain, Gwenaël Rolin, Chrystelle Vidal, Nadia Butterlin, Emmanuelle Jacquet, Aflah Elouneg, Jérôme Chambert, Xavier Bertrand, Christophe Meyer and Aurélien Louvrier
Abstract: Scar is a common visible mark of human tissue healing. Sometimes pathological phenomena lead to abnormal hypertrophic or keloid scars, with evolutions varying depending on different conditions: origin of the tissue barrier disruption, concerned body area, or ethnic origin. Based on these statements, care procedures have been developed to avoid aesthetical or functional impairments: drugs injection, surgery, cryotherapy or mechanical compression. The story will relate the matching of a multi-disciplinary team that focused on covering an unmet need for ear lobe keloid treatment, providing patients an optimal and holistic care. The benefits researched lied in improving the understanding of the disorder, avoiding the recidivism of the scars, diminishing the frequency and duration of care, and in end improving patients’ quality of life. The paper will not only narrate the building of a health innovation, on technological, clinical, user points of view, but will also try to detail the evaluations planned at the different stages of development, as well as the challenges, conditions and prerequisites allowing to produce concrete solution.
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Paper Nr: 3
Title:

Design of an Innovative Medical Device to Improve Quality of Life in Lymphedema Patients
Authors:

Katherine Wang and Angeliki Kopsini
Abstract: Lymphedema is a disease that is a common side effect of breast cancer, affecting up to 70% of breast cancer patients. Currently there is no known curative treatment; management of the disease is based on symptomatic therapy such as Complete Decongestive Therapy (CDT). Current devices and compression garments used in CDT are often heavy and cause discomfort and bacterial infections due to poor skin care. Along with the long-term physical problems, it also causes serious psychological and social problems for patients, affecting their quality of life significantly. There is an urgent need for innovative approaches for the treatment of lymphedema. In this paper we propose a novel solution in the form of a light portable pneumatic device “Lymphmotion”, along with a complimentary compression garment designed to reduce bacterial infection to address this problem.
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Paper Nr: 4
Title:

Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study
Authors:

Catherine Roussel, Alexandrine Salis and Sylvia Pelayo
Abstract: Medical Devices are health products that combine complex technologies and new organizations. They are under high constraints, both economic and regulatory, but also in terms of quality and safety requirements. The new European regulation comes in addition and questions all of the actors of the maturation process from the idea-to-market for medical devices (MDs). The objective of this qualitative study was to collect and analyze feedback from various European stakeholders involved in the clinical evaluation of medical devices, with a special focus on innovative high-risk medical devices. This paper presents the results of the first phase which scope was limited to France with sixteen interviews. Results show the complexity of the clinical evaluation of MD, particularly when dealing with an innovative, high-risk medical device. The need for training and support of actors through specialized platforms was highlighted, as well as the need for coordination between public and private actors, from the upstream phases of R&D. The collection of clinical data must be part of an overall strategy considering the maturation cycle of the product and its different dimensions. The collection of real-life data must be amplified and structured, with the contribution of new digital technologies opening up new fields of research. This approach must be strengthened by (i) the development of methods based on choices justification, and (ii) making it possible to capitalize on and cross-reference data on the Medical Device throughout its life span. The brief overview provides convergent conclusions, but the understanding of the required level for the evaluation of medical devices and of the way to reach it was not uniform. This reflects a heterogeneous sector and it introduces the need of compromises regarding development strategies and methodological approaches.
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Paper Nr: 5
Title:

Contribution of Methodologies Adapted to Clinical Trials Focusing on High Risk Medical Devices
Authors:

C. Vidal, R. Beuscart and T. Chevallier
Abstract: High risk medical devices clinical trials are complicated, expensive, time-consuming and need an improved clinical evaluation with better scientific evidence throughout the European Union. The purpose of this study is to identify methodologies whose use could facilitate the evaluation of the medical device. Adaptive methods and Bayesian approaches are expert tools that can accelerate access to innovation providing more flexibility but they are insufficiently used because of a lack of expertise and training in the trial community (clinicians, statisticians and regulation authorities). Involving stakeholders (regulation authorities, industrial, clinicians, biostatisticians, end-users) early in the conceptualization of the adaptive design improve adoption, implementation, feasibility and overall quality of that trial.
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Paper Nr: 6
Title:

Xtrace: Novel Bioresorbable Device for Patent Foramen Ovale Closure
Authors:

Sara A. Ajamieh, Diana Mindroc-Filimon, Irene Mozo and Isabel Rocha
Abstract: Patent foramen ovale (PFO) is a congenital cardiac lesion, affecting about 25% to 30% of the adult population. It is associated with several serious complications, including cryptogenic strokes, transient ischemic attacks, and migraine. The prevalence of PFO has significantly increased in patients with cryptogenic stroke; up to 40% of ischemic strokes with an unknown cause have a PFO. Recently, technical advancements in medical engineering have made the percutaneous transcatheter closure of PFO a feasible treatment option. However, current PFO closure devices may lead to complications such as the need for replacing the device after several years, sudden migration of the implant, erosion, infection, or arrhythmias. Attempts are needed to produce a safer and more effective closure devices. Here, we propose an innovative medical device called Xtrace. It consists of a biodegradable material that will be partially degraded by the host body while substituted by autologous host tissue. This innovative device will potentially fulfill the essential unmet clinical need, as well as provide a safe and effective delivery of therapy for the general population.
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Paper Nr: 7
Title:

Place of High-risk Medical Devices in European Recommendations with a Focus on End-users
Authors:

G. Brunotte, R. Beuscart, A. Pariset and L. Pazart
Abstract: As shown by recent incidents and scandals related to the use of high-risk medical devices an adapted regulation throughout the European Union is important. The European directives and the regulation issued by the member states include recommendations which apply to high-risk medical devices. The present study aims at collecting the recommendations regarding high-risk medical devices and specific to each country. Legislation, guidelines, scientific publications and grey literature have been searched. Different trends seem to appear in the states with the most advanced legislation: an increase of controlled trials, a better traceability, development of specialized registries, an improved vigilance system and an increased involvement of end-users. Although poorly present in the legislation, the end-users are more and more integrated to the development process of medical devices. Ergonomics and user experience can be seen as key factors of a successful medical device. Several important issues are stressed regarding the training and information of healthcare practitioners for implantation of the medical device and its initial setting if required. New avenues have also to be envisioned such as context of use analysis and user-centred design.
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Short Papers
Paper Nr: 1
Title:

Overcrowding in the Emergency Department: Could a Patient-centred Mobile App Change This Paradigm?
Authors:

Inês Margarido, Ntumba K. Alpha, Nduami Junior and Jan Marin
Abstract: Overcrowding in the emergency department has been a growing worldwide problem. Some solutions have been put forth in the several points of the patient’s path mostly in order to provide a more efficient flow of patients within the ED. We propose, in this paper, a mobile app that could integrate real-time information of patients, emergency departments, medical emergency teams and general practitioners. This could help scatter the non-linear flow of patients before they arrive and ultimately improve not only quality of care but also better patient outcomes.
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