An Example of Personalized Pathway in Medical Device Evaluation

for a Master Student in Clinical Research

Guy Carrault

1,7 a

, Thierry Chevalier

2,3,7 b

, Bruno Laviolle

, Lionel Pazart

5,7

and Sylvia Pelayo

6,7 d

Univ. Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, CIC 1414, F-35000 Rennes, France

CHU Nîmes, Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology,

30029 Nîmes, France

Univ. Montpellier, INSERM, UMR 1302, Institute Desbrest of Epidemiology and Public Health, Montpellier, France

Univ. Rennes, CHU Rennes, INSERM, IRSET - UMR 1085, CIC 1414, F-35000 Rennes, France

Univ. Franche-Comte, CHU de Besançon, INSERM, UR LINC "Neurosciences & Cognition",

CIC 1431, Besançon, France

Univ. Lille, CHU Lille, ULR 2694 - METRICS, INSERM CIC-IT 1403, F-59000 Lille, France

Tech4Health-FCRIN, France

sylvia.pelayo@univ-lille.fr

Keywords: Pedagogic Personalized Pathway, Reverse Training, Medical Device Regulatory Diploma.

Abstract: The aim of this paper is to explore the possibility of combining several training lessons to offer students a

personalized pathway in the field of medical device regulation. Feasibility is demonstrated through an

experiment currently being conducted between the universities of France-Comte, Lille, Montpellier and

Rennes.

1 INTRODUCTION

For several years now, with the advent and

democratization of the use of communications and

distance training tools, the idea has been to design

personalized lessons for students. With the help of a

tutor, students can build their own pathways and

specialize in the area of their choice, while

maintaining the coherence of their training. This

article summarizes the experiment currently being

conducted by the universities of France-Comte, Lille,

Montpellier and Rennes. This experiment is intended

to serve as an anchor for the AMI-CMA project

named ARCliMeD which proposed the structuration

of a Training Pathway for Regulatory and Clinical

Affairs in the Medical Device Industry. After an

initial description of the general framework and

objectives of the ARCliMeD project, the two training

diploma are briefly introduced. The difficulties

https://orcid.org/0000-0003-1482-2067

https://orcid.org/0000-0002-5110-6273

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https://orcid.org/0000-0003-2830-2548

encountered during the experimentation are then

presented and some conclusions are drawn.

2 GENERAL CONTEXT

Recent European regulations on medical devices

require the identification of people responsible for

ensuring compliance with regulations within

companies and notified institutions (which issue CE

markings for medical devices). A recent survey by

France's leading medical device trade union,

SNITEM (Snitem, 2020), showed that ¾ of

companies find difficulties to recruit such regulatory

executives. This sector, constituted of 93% of start-

ups and small and medium companies, urgently needs

support to meet the regulatory requirements. The

need for training was defined in 2020 by a national

working group (Medical Devices Coordination

Carrault, G., Chevalier, T., Laviolle, B., Pazart, L. and Pelayo, S.

An Example of Personalized Pathway in Medical Device Evaluation for a Master Student in Clinical Research.

DOI: 10.5220/0012590500003657

Paper published under CC license (CC BY-NC-ND 4.0)

In Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2024) - Volume 1, pages 837-841

ISBN: 978-989-758-688-0; ISSN: 2184-4305

837

Group, 2020), led by the national research and

teaching ministry, with numerous stakeholders

(SNITEM, biomedical engineering school,

EUROPHARMAT, Tech4Health network, …). The

aim is to train 1,000 regulatory affairs executives for

the medical device industry over 5 years. This

objective meets companies' needs in terms of training

and new skills for the professions of the future. It is

fully in line with the France 2030 re-industrialization

plan (France 2030, 2022), to create the tomorrow

medical devices in France and to support companies

in their market access initiatives.

With the rapid evolution of digital health, every

medical device company already has, or will soon

have, digital products in its medical device portfolio.

The qualification criteria for regulatory affairs are

generic. It is then important to train staff able to

manage digital products and on all the aspects of the

company's products such as risk, quality

managements and clinical evaluation.

2.1 The ARCliMeD Project

The ARCliMeD project purpose, funded by ANR, is

to elaborate individual pathways for students and

professionals in activity, who want to specialize in the

3 domains of Quality, Regulatory Affairs, clinical

evaluations for the Medical Device industry. The

project targets professionals already working in the

health products industry, and to students who have

completed a Master 1 degree. The diploma will

enable them to meet regulatory requirements and to

apply for positions as regulatory affairs managers,

particularly in digital health, but also in notified

institutions or health authorities (ANSM, HAS, …).

The proposal is based on existing, complementary

training lessons at national level, which already have

close links with manufacturers and their

representatives. A computerized coordination

platform will serve as a shared resource for defining,

with applicants the personalized training path. These

actions will be offered both in initial training and in

continuing education as part of a professionalization

or apprenticeship contract. The teaching methods

used (e-learning, streaming, visio, webinars, reverse

training, Masterclasses, in-company and hospital

internships, ...) will determine the optimum path for

the learner, with the necessary modules.

2.2 Objectives and Target Groups

The need expressed by medical device companies is

to train qualified staff in regulatory affairs. To reach

this main objective, the ARCliMeD project will

deploy the following actions:

i) Draw up a detailed map (content, hourly volume)

of the offerings proposed by the project partners,

and recompose the training offering based on

feedback from previous learners, updating the

existing offering in line with changing skills

requirements,

ii) Create a 3D skills matrix, based on job profiles

and proposed training units,

iii) Submit these proposals: for consultation

(healthcare competitiveness cluster, student

networks, and so on),

iv) Adapt lessons/skills/trades to the needs and

constraints (size, structure, organization) of

companies or organizations.

v) Accelerate the training process by combining

several master's degrees

vi) Increase the number of student trained, by raising

awareness among students in initial training.

Three target groups are involved:

i) staff performing this function within companies

(around 1,440 companies),

ii) staff of competent authorities (ANSM, HAS) (30

students are expected before 2024),

iii) students in initial training.

3 THE EXPERIMENTATION

To demonstrate the feasibility of the ARCliMeD

project an experimentation was conducted. The

experimentation is based on the DIU (Inter-

University Diploma) EvalDM: Evaluation des

dispositifs Médicaux dans le contexte du Règlement

Européen (Montpellier, Franche Comté and Lille

Universities) and the Master II Biology and Health

from Rennes University, Pathway clinical research

(Master BS ReClin, 2023).

The aim of the DIU EvalDM is to describe the

regulatory context and provide the basis for

understanding and designing clinical evaluation

methods for medical devices throughout their

development and life cycle (from proof of concept to

post-market clinical follow-up including CE marking

and reimbursement applications in the context of

European regulation 2017/745-2017/746). The skills

acquired are multiple and concern knowledge of i) the

general basics of the life cycle of a Medical Device

(MD), ii) methodologies specific to the clinical

evaluation of MD in pre-CE marking or CE marking,

iii) the basics of usage studies, iv) the principles of

post-marketing studies (Moreau, 2019). It also covers

ClinMed 2024 - Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of

Implementation?

838

the importance of Economics and Epidemiology

training. Indeed, the notion of materioepidemiology

is an integral part of Post Market Clinical Follow-up.

Materioeconomics (or medical device economics)

and materioecology are new disciplines in which

expertise is important. Both should be developed and

taught in future years. Finally, it provides the tools

needed to fulfill a clinical evaluation document in line

with European regulations, to critically analyze the

scientific literature on the MD clinical evaluation and

to propose appropriate investigation schemes.

It is open to students in initial training (residents

in medicine studies, students in biomedical

engineering or Masters) and continuing education

(engineers, doctors, pharmacists, odontologists), as

well as industrial project managers who manufacture

medical devices (regulatory affairs managers, R&D

teams) and assessors from notified authorities. The

course has been running since 2018, with one session

per year, and has continued to evolve in terms of

content and format. Twelve students follow in

average the DIU every year representing a total 60

students already trained.

Today, it is organized in 2 main blocks: general

methodology from September to November and

specific methodology from December to March. Each

block is organized in 3 stages: i) knowledge

acquisition via asynchronous videoconferencing; ii)

3-day face-to-face seminar with practical courses

illustration previously seen; iii) summative

assessment. A dissertation on a topic of interest, with

oral defense, closes the course.

The Master's degree in Biology and Health at

Rennes University provides training in research: in

Cancerology, in Pharmacology, in Health Nutrition,

in Clinical research. This is this last pathway that has

been selected for experimentation and denoted

ReClin Master in the following. The courses alternate

theoretical sessions and personal homework projects.

The various training units are briefly presented in

Figure 1 below. Two options Units (10 ECTS) are

proposed for traditional students (Students who do

not participate to the experimentation). The year ends

with a research internship. Evaluation is based on a

continuous assessment and a dissertation.

The aim of the Master's program is to train high-

level clinical research professionals capable of

supervising the practical implementation of a trial.

The courses cover clinical research methodology, the

organization and regulatory aspects of academic and

private clinical research, pharmacology and

preclinical studies. The ReClin Master’s degree

prepares students more specifically for careers in

clinical research, professions at the interface between

research and health, and the pharmaceutical industry.

The ReClin Master has been running since 2017.

Fifteen students follow in average the ReClin Master

every year representing a total 108 students already

trained.

The idea of a personalized pathway between the 2

trainings diploma is to provide students in the

Master's degree in Biology and Health in Rennes a

specialization in MDs. In the context of the

experiment, it was decided then that students in the

Biology-Health Master's program in clinical research

could follow the DIU instead of the two optional UEs

(since these skills are already part of the DIU but

MDs-oriented).

Figure 1: The different UE of the Biology and Health

Master. ECTS stands for European Credit for Transfert

System and UE for Training Unit. The two optional UE are

replaced by the DIU training Courses.

4 EXPERIMENTATION RESULT

Thirteen students were enrolled for the DIU EvalDM,

and 4 students over 20 students from the Master 2

Biology-Health chose to follow the DIU. It should be

emphasized that, like the other candidates, the

Master's students were selected on the basis of an

interview and a motivation letter.

The 4 students selected came from a variety of

backgrounds: Master 1 Biology and Health, Master 1

Integrative Biology and Physiology, Master 2

Biotechnology. The choice expressed by the students,

through a quiz, to follow the DIU EvalDM was

motivated by the fact that they would benefit from

comprehensive training in clinical research and thus

meet the requirements of the new European directive.

They also want to participate in the development of

new knowledge on innovative technologies. They

would like to take advantage of the career

opportunities offered by this field and the possibility

of contributing to the development of innovative

treatments or medical devices.

UE TRAINING LESSONS IN THE MASTER RECLIN ECTS

DBT Biotechnology in Therapeutic and Diagnostic Research

EN English

RISP or TAC

COM Communication, Management

MPP Management and Planification

MR1 Methodology for Clinical Research 1

MR2 Methodology for Clinical Research 2

RPT Precinical and Translational Research 5

SPT Monitoring and Treatment individualization 5

Intership InternShip 30

MANDATORY

OPTIONAL

Professional Insertion or Advanced Technics in life

sciences

An Example of Personalized Pathway in Medical Device Evaluation for a Master Student in Clinical Research

839

As described previously, the reverse training

proposed by the DIU EvalDM, with the acquisition of

prior knowledge based on documents and video clips,

represents real pedagogical potential and fits in

perfectly with the logic of a Master degree with

differentiated courses. In addition, the face-to-face

sessions enable students to reinforce and consolidate

their skills.The DIU EvalDM teaching volume is 60

hours, fully compatible with the two clinical research

master's lessons that students will not follow. It is

important to mention -and this is a crucial point of the

experimentation- that the two face to face session do

not alter the students' Master's training insofar as the

chosen date for the first face to face session coincides

with a dedicated week focused on orientation,

insertion and entrepreneurship and the second date is

proposed during the students' long study internship.

The experiment also highlighted several critical

points. Solutions were proposed to solve them and are

summarized in Table 1.

Table 1: Synthetic presentation of all critical points and

solutions provided.

Critical points Proposed solutions

Distinct back-to-

university dates

between the two

diplomas

The two back-to-university

dates were synchronized at the

beginning of September

Access to courses in

different geographical

sites and temporal

constraints

Asynchronous video courses

were proposed

Registration at

University level.

Registrations were proposed in

both university

Managing official

student e-mail

addresses

A generic official student e-

mail address was used

Registration fees at the

university in charge of

the DIU

The ARCliMeD Project

covered the additional costs

Extra costs introduced

by the two 3 days face

to face seminars

(travel, hotel, ...)

Additional costs were covered

by the Montpellier University

and Lille University through the

ARCliMeD project, depending

on the seminar location.

Internship sites

The 4 students took an active

part in finding internships. This

is a critical point to look

forward to in the next years.

Dissertation defense

date

Examination dates were

differentiated to take account of

the longer internship in the

clinical research master's

degree

In summary, the analysis of the above table

illustrates the points to keep in mind and to take care

when building courses across several universities. A

deeper analysis is reported in the discussion section.

From the students' point of view after a quiz, they felt

that the implementation was effective, that the video

capsules were clear and that the face to face seminar

was very well organized. Only small difficulties were

encountered concerning the reimbursement of travel

expenses.

5 DISCUSSION

The first critical point was to know what selection

process would be used for students volunteering to

follow a combined course of this kind between the

ReClin Master degree and the DIU EvalDM. Would

they have to go through both selection processes, as

each diploma has its own recruitment criteria? The

two teaching teams agreed that the Master's selection

process alone was sufficient for admission. But

students who were interested and volunteered for this

combined pathway would benefit from a specific

question and answer information session followed by

written confirmation from the students. These

confirmation letter should have expressed their

motivation to follow this combined pathway. Five

students had initially expressed an interest in this

blended pathway and four of them confirmed and

justified their choice to pursue this pathway.

A second critical point in the experiment was also

not to overload the students with a simple

accumulation of the expectations of two existing

training programs. The training teams try to optimize

and to adapt a training transformation of the existing

lessons. This critical point can be illustrated in

particular with the dissertations that students were

required to produce during their year. For ReClin

Master, the expected dissertation was a placement

covering clinical research activities around 6 month

in a professional environment. The dissertation

required to validate the DIU EvalDM is of a different

nature. It has to attest a reflective skill in applying

specific regulatory and methodological knowledge

focused on medical devices and/or in vitro diagnostic

medical devices. The ReClin Master and DIU

EvalDM teaching teams were agreed that students

should not have to complete two dissertations (a work

placement dissertation and a cognitive dissertation),

which would overload the students. A solution has

been found so that students have to write one

dissertation that meets the criteria expected by both

courses. As a result, the orientation of the internship

ClinMed 2024 - Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of

Implementation?

840

(only offered in the ReClin Master program) has been

adapted to also meet the criteria of a cognitive

dissertation as expected for the DIU EvalDM. Thus,

the ReClin master dissertation would propose a

section on the design of a clinical investigation study

within the meaning of the European Regulation on

Medical Devices. The work placement itself had to

include, at least in part, activities geared towards such

a design. This training transformation was approved

for ReClin Master students wishing to complete and

validate the course with the DIU EvalDM. Other

logistical issues then arose, which were also resolved

by the two teaching teams, in particular concerning

the procedures and dates for dissertations defense.

6 CONCLUSIONS

This initial experiment showed that, for a small

number of students, a personalized training program

offering a double diploma could be offered, with a

few adaptations. The experiment clearly

demonstrated the difficulties to be overcome, such as

registration, but also the advantages of offering a

training program based on existing, complementary

training courses at a national level. The DIU EvalDM

and ReClin Master's degrees were used as an

experimental resource to define, with students, a

personalized training pathway for the acquisition of

identified skills. The sharing of content, via Moodle

for example, can be considered as a success and a

guarantee of completion for the future. The next step

will be to fuse several degrees from several

universities and to offer a truly personalized course

pathway.

Even if it is, at this stage of the experimentation,

too early to draw more specific clues to this particular

double training approach dedicated to the MD

industry, it could be interesting to mention that the

students participating in both programs develop new

skills and competencies compared to traditional

students. As examples among others, we can cited:

Knowledge of the life cycle of a Medical device,

Knowledge of specific methodologies to the Medical

device clinical evaluation before CE marking, Basis

for usage studies, Know how to establish evaluation

document, Propositions of investigation plans

adapted to Medical device.

In terms of training, and from the industrial point

of view, the two degrees combined here enable the

students to meet regulatory requirements and apply

for regulatory affairs managers or regulatory focus

position within digital health companies but also in

notified health authorities (ANSM, HAS, ...).

Next steps will be to enlarge to any European

equivalent initiatives and establish any bridge

possible between different training from different

countries and identify abilities of the students that

will be trained to match expectations not only in

France but also in Europe.

FUNDINGS

This publication takes part to the ARCliMeD ANR-

23-CMAS-0002 project funded by the France 2030

program "Skills and Professions of the Future" with

the support of the Agence Nationale de la Recherche.

ACKNOWLEDGEMENTS

This article would not have written without the

contribution of the 4 students who agreed to take part

in the experiment. We hope that this article will

reflect their feelings. The authors would like to thank

them. The authors also express their gratitude to the

administrative staff of the various universities taking

part in the experimentation.

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