ClinMed 2021 Abstracts

Area 1 - ClinMed

Full Papers

Paper Nr:	2
Title:	Meeting an End-user Need in a Collaborative High Risk Medical Device Software Development in Accordance with Future European Regulations
Authors:	Stéphanie Py, Thomas Lihoreau, Marc Puyraveau, Sylvain Grosdemouge, Nadia Butterlin, Stéphanie Francois, Morgane Eveilleau, Aurélie Camelio, Gérard Thiriez, Floriane Ciceron and Pauline Ecoffet
Abstract:	Caring for a child in life-threatening distress is very stressful and error-prone for the caregivers. An end-user need for a software that would free the child from human error and support the caregivers in the care of the child has thus emerged. Free from the time-consuming and stressful constraints of calculating constants or medication doses and consulting emergency protocols, caregivers could be more available and focused on the vital care of the child. The extension of the scope of medical devices to software for medical purposes is one of the important new points of the future European regulations. The very important overhaul of the previous classification system with the addition of new rules or updating of old ones reinforces the regulations applicable to software. The impact is considerable for the development and market access strategy of high-risk classified software, and participate in a better security and efficacy of the marketed products, for better healthcare. In this article we propose then to detail the strategy used for the development of a high-risk medical device software intended to be used in pediatric intensive care units.
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Paper Nr:	3
Title:	Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations
Authors:	L. Pazart, S. Pelayo, T. Chevallier, G. Gruionu, P. Mabo, Y. Bayon, F. Barbot, T. Lihoreau, C. Roussel, N. Maglaveras, E. Lekka, H. A. Ferreira, I. Rocha, L. Geris and C. Lavet
Abstract:	This position paper analyses the threats from the current situation of the clinical investigation to the expectations of the new European regulations focusing on high risk medical devices (HRMDs). We present also some opportunities to improve the feasibility and quality of clinical investigation. In summary, investigation protocols of medical devices, advised and authorized by the competent authorities, are few and heterogenous. There is a lack of quality in the existing studies, a lack of methodological knowledge and consequently high expectations for assistance from those involved in the design of clinical study protocols on HRMD. Guidance that is specific to the different type of devices is missing. Adaptive designs, pragmatic trial, usability methods, computer modeling and real world data are gaining more and more traction for assessing the safety and performance of high risk medical devices from a regulatory view-point.
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Paper Nr:	6
Title:	Exloration of High Risk Medical Devices Methodologies for Optimized Evaluations
Authors:	Thomas Lihoreau, Chrystelle Vidal, Tianguang Wang and Lionel Pazart
Abstract:	Medical devices are developed by manufacturers that need to provide proofs of safety, efficacy, efficiency. In the same time they could be specialists in the technologies, they could not be necessary experts for the targeted medical field and need to be surrounded to build the correct clinical evaluation strategy. Skills required are specific to these particular instruments, and need to be optimized and innovative, as there is as much different devices than the start-ups in the arena. Even if works are performed on the methodological aspects since years, we propose to state a snap of the situation thanks to clinical trials databases exploration, with the aim to extract typical cases for future help and support for the actors. The current article offer to present our strategy of work as well as first quantitative results.
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Short Papers

Paper Nr:	5
Title:	Usability Evaluation of Medical Devices during Clinical Studies: First Results of a Scoping Review
Authors:	Laura Douze, Jessica Schiro and Sylvia Pelayo
Abstract:	This scoping review is interested in mapping the clinical studies protocols of medical devices on usability evaluation. The research question is as follows: How is usability of medical devices evaluated in clinical studies? The paper presents some first results from a sample of 47 protocols within a set of 188 potentially eligible protocols. Results highlight that a non-negligible part of usability evaluations are carried out combined with clinical studies. Very often, usability outcomes are part of the secondary outcomes of the clinical study. The most claimed usability-related outcomes are ease of use, handling and satisfaction. Usability is mainly addressed through questionnaires which provide actually perceived usability (not usability per se). Some protocols appear to be quite comprehensive in terms of usability evaluation methods.
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Paper Nr:	7
Title:	Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device
Authors:	K. Charrière, C. L. Azzopardi, M. Nicolier, T. Lihoreau, F. Bellivier, E. Haffen and B. Wacogne
Abstract:	Medical device development is often understood as a linear process with design stages occurring sequentially. First stages are usually performed in order to specify the future device definition through interviews/meetings of the end-users, researchers and manufacturers. Because the medical device is original, these first stages mainly involve end-users and researcher. However, regulation constraints and economic reality sometimes makes manufacturers hesitant to base the industrial development on this initial basis. Functional analysis, well known by manufacturers, is a method used to accurately define the final functions of a medical device. In this conference, we estimate that the functional analysis can be put to profit in a more efficient way if researchers and end-users get familiar with it prior to the interview/meeting stages. Although the results of such knowledge democratisation is not demonstrated here, we present the function analysis conducted on a lithium monitoring device according to this multidisciplinary approach. We also show that function analysis can be used not only to drive research actions but also to identify regulation requirements.
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