A Skill based Educational Program for Future Regulatory Affairs

Professionals in the Medical Devices Industry: A Top down Approach

at Polytech Lyon University, France

Norbert Noury

, Emmanuel Perrin

and Claire Gaillard

Université de Lyon, Polytech Engineer School, Villeurbanne, France

Université de Lyon, Université Claude Bernard Lyon I, INSA Lyon, CNRS, MATEIS, UMR5510, 69008 Lyon, France

Keywords: Medical Devices, Regulatory Affairs, Education.

Abstract: The Medical devices industry is facing a shortage in the professionals in Regulation Affairs who are in charge

with the regulation steps to bring their MD to the market. The Master ATRDM at Polytech Lyon 1 University,

France, was elaborated following a top-down approach based on the development of competencies of the

learners, with an agile iterative process to update the contents.

1 INTRODUCTION

The industry of Medical Devices (MD) is facing a

shortage in Regulatory Affairs (RA) professionals.

Medical Devices need professionals to fulfil each step

of the agreements, in order to obtain the CE Marking

and to deliver their MD in the market. The transition

from the directive on MDs (MDD 93/42) to the

regulation on MDs (MDR 2017/745) challenges

manufacturers because new requirements require an

added budget and human resources for manufacturers

and other actors in the medical device supply chain

(

Bayrak, 2022

). Therefore, the MD industry is seeking

for professionals in charge of RA for qualifying their

MD. The notified body are also seeking for specialists

to run the audits of MD devices organisations.

Although in the past, the persons in charge with

RA were partially the professionals in charge of the

Quality Affairs (QA), the RA of MD has strongly

specialised with the MDR and needs the professionals

to go through a specific training.

Furthermore, the person in charge with RA of MD

needs to be able to drive the project of bringing the

MD on the market, involving various actors from

Marketing, from RTD, from QA, etc. Therefore, the

MD-RA professional needs to develop transversal

skills in communication and project leadership.

https://orcid.org/0000-0002-0037-2256

https://orcid.org/0009-0002-4501-4863

https://orcid.org/0000-0002-0630-510X

In the global context of the impact of human

activity, the MD-RA professional must consider the

sustainability of the production of their MD and its

carbon impact.

Actually, there is a plethora of training companies

- universities and private operators - offering MD-RA

contents. At Polytech Lyon, the School of

Engineering of University Lyon 1, we have

developped a 'top-down' approach starting with from

the identification of the various skills needed by the

future MD-RA professionals.This approach is at the

heart of the Master Degree “Affaires Techniques et

Réglementaires du Dispositif Medical” (Regulatory

and Technical Affairs for MD) labeled ATRDM.

2 CONTEXT OF THE MEDICAL

DEVICES REGULATION

The MDR 2017/745 (MDR, 2017) comes with

stronger requirements and is more demanding that the

MDD 93-42-CEE (MDD, 1993).

First the MDR adds more rules to MD than the

MDD for considering the development of software,

nanomaterials, and combined MD at the frontier

between MD and Medicaments.

858

Noury, N., Perrin, E. and Gaillard, C.

A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at Polytech Lyon University, France.

DOI: 10.5220/0012616100003657

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 858-863

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

Second, the classification of MD, in Annex VIII

of the MDR, now includes 22 rules and 80 criteria

whereas Annex IX of the MDD contained only 18

rules and 56 criteria. It directly impacts the strategy

of classification of the MD. The MDs at higher risks

suffer stronger costly controls, but therefore are not

accessible to smaller, less competitive, industrial

structures.

Eventually, a Post Market Surveillance policy

must be settled in order to gather, correct and

timestamp each malfunction and non-conformities.

The MDR was not deployed until May 2021 and

should be definitively implemented in May 2024 - for

MD concerned by a notified body – and 2028 for most

MD. But the notified bodies are not numerous

enough, and they also lack skilled professionals to

face the deadline.

A recent survey by France's leading medical

device trade union, SNITEM (Syndicat National des

Industriels des Technologies Médicales), showed that

3 out 4 companies in MD are struggling to recruit

such regulatory executives.

There is also a huge need for educating the

competent professionals in most MD industries to

meet the new profile of “person in charge with

Regulatory affairs” set out in the MDR.

2.1 QA Versus RA?

Historically, the first professionals in charge with

MD-RA were integrated with the Quality

Management System (QMS). Therefore, they were

mostly located in the manufacturing departments. But

the QMS professional is a manufacturing generalist,

not specifically MD oriented.

Nowadays, the MD-RA manager must be

involved in each step of the life-cycle of the MD. And

because the Regulatory requirements are

continuously evolving, he must stay informed and be

dedicated to the MD-RA. Of course, in small

organisations (SMEs, start-ups), there is a strong

temptation for the “Swiss knife approach” with

professionals acting in various domains. Therefore,

MD-RA certified professionals are needed.

2.2 Executives Versus Managers?

Although the management of MD-RA may look like a

“filing-forms” tasks, actually the person in charge with

MD-RA has a wider field of action, interacting with all

the department of companies from research and

development to the marketing department. The MD-

RA professional impacts the strategy of the MD

company. He must have a global vision of the life cycle

of the MD, starting with the marketing, preclinic and

clinic studies, supplies, manufacturing, controls,

marking, packaging, logistic, reconditioning…

To bring a MD to the market is a project.

Therefore, the person in charge with MD-RA must be

a project leader, interacting with various stakeholders

from various departments in the company, e.g.

commercials, buyers, quality management and

control. The function of MD-RA can be seen in terms

of entrepreneurship as he is involved in creating

value. Nevertheless, there is still a need for MD-RA

officers assisting the MD-RA entrepreneurs. The later

can be internal officers, becoming operational after a

short training.

2.3 Cross-Functional vs Longitudinal

Approach to the MD Life Cycle

The MD specialist must have a global vision of the

life cycle of the MD. Starting with the knowledge of

the regulatory texts, the MD-RA professional must

also understand the various technologies involved in

the large domain of the MD (physics, electronics,

chemistry, materials, informatics) and their principle

of actions on the pathology, in order to be able to

perform the analysis and mitigation of the risks

associated with the use of the MD.

The MD professional must be aware of the

economic aspects of the MD market and the health

ecosystem economy, which obviously follows

specific rules.

He must know the manufacturing processes,

including the supply chains, and the QMS, in order to

interact smoothly with them professionals.

Some additional knowledges concern the MD

marking technics, the logistic for maintaining the

integrity of the MD and the sterilization if needed.

Also, the end of life of the MD with reconditioning.

On top of the knowledges, the person in charge

with MD-RA must behave as a project leader. He

needs to be familiar with management tools and

methods. He needs communication skills, in

particular oral presentation skills. He needs the skills

for piloting the project meetings. He also needs to

know basics of crisis management.

3 METHODOLOGY

3.1 Identification of the Skills for

Future RA Executives?

When designing a new curriculum – leading to a

A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at

Polytech Lyon University, France

859

professional qualification - the architect of the

curriculum must start with considering the objective

of acquisitions in terms of skills and competencies

(

Makulova, 2015). Only then should he consider the

knowledges (contents) that learners will need to

acquire.

The need for training, anticipated in France in a

proposal from CSIS (Conseil stratégique des industries

de santé), was defined in 2020 by a national working

group led by the MESRI (Ministère de l’Enseignement

Supérieur, de la Recherche et de l’Inovation) with

numerous stakeholders (SNITEM, Conférence des

doyens de Pharmacie, Conférence des écoles

d'Ingénieurs en biomédical, EUROPHARMAT,

Tech4Health network, Inserm F-CRIN clinical

research infrastructure, Association des étudiants en

pharmacie, etc.), and has been endorsed by both the

French Ministries of Health and Industry.

From these recommendations, we propose the

following list of skills which we consider essential for

future RA executives in the MD industry.

Firstly, the learners should be able to understand

and mobilise a wide range of scientific and technical

knowledge in the field of MD, to identify and

translate regulatory requirements into product

requirements, compliance actions and marketing

strategies. To achieve this, they will need to be able

to keep abreast of scientific, technological, and

regulatory developments, in order to acquire and

apply new knowledge and know-how, including in

the field of medical practices.

They will need to collect and interpret data to

identify and solve problems. To do this, they will need

to know how to gather information, analyse a complex

situation and update the regulatory text database.

Because the accreditation process of a MD is a

project that involves a wide range of professionals,

they will need to know how to manage a team. To do

this, they will have to implement a project

methodology. They will have to manage risks,

uncertainties and regulatory constraints. In addition,

they will have to implement a continuous

improvement approach.

They must be able to communicate orally and in

writing in French and other languages - including

English - both face-to-face and remotely. They will

be required to practise interpersonal communication

adapted to each professional context, and to know

how to interact in a group.

3.2 How to Bring the Skills to Future

RA Executives?

It comes naturally with bringing the theory from

experts in the main domains of Medical Devices and

Regulatory Affairs. Then the learners will have to do

practical exercises on selected academic cases, under

the direction of experienced professionals. And on

top, the learners must alternate with a professional

practise in the RA department of a MD company

during 12 months of their education.

3.3 How to Evaluate the Acquisition of

the Skills?

The question of evaluation is central in the approach of

competences because educators need to deliver

degrees to the right person. It is of major importance

that the graduates be involved in their own evaluation

so as to feel involved in their education process, rather

than only lean back on their experienced teachers.

Formative evaluations must be provided so that

learners can practice in autonomy along their learning

paths to evaluate their own progression (e.g. MCQS -

Multiple Choice Questions and Solutions).

A useful method to evaluate the acquisition of

knowledge, is solving professional situations through

their students' projects. Their productions are usually

evaluated from a written report and oral defense in

front of their peers.

Eventually, individual terminal examinations

must be set to evaluate both the knowledge

acquisition (contents) and their capacity of synthesis.

At the end of their 12 months apprenticeship, a

final oral defense in front of professionals of the

domain of MD-RA, is compulsory to evaluate their

implication and their ability to communicate

efficiently. It is useful that their peers will be invited

to listen to other’s presentations to learn by example,

and also to develop their own skills through the

evaluation of each others’ production.

3.4 How to Maintain a Sustainable

Employability?

A main pillar of professional education at University,

is to prepare the future graduates with a solid

background of knowledge, to be prepared to face the

constant technical evolutions of their professional

domain. Also, to bring to the future graduate the soft

skills which will guarantee him with flexibility and

adaptation to the evolutions of his professional

activities.

Actually, the engineering pedagogy for

professional domains is facing 2 contradictory

challenges:

• To produce professionals in order to face

immediate needs in industry

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

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• guaranteeing the future of graduates in a rapidly

evolving professional world

The Methodical approach that we put in practice

consists in:

• Bring a wider range of knowledge (than needed

for graduation)

• Bring information on the latest technologies

developed in research labs, by researchers who

show the orientations to follow.

• Take a step back on the needs

• Help the learners to draw perspectives on their

own skills

• familiarize the learners with the concepts of Soft-

skills vs Hard-skills

3.5 Recruit the Right Learners?

Obviously, the learners shall be recruited from their

academic skills (biography, academic results) and

their motivations (written letter, personal professional

project).

Furthermore, after a selection of the best profiles

from their written elements, it is essential to conduct

individual interviews to address the non-technical

skills of future learners.

In the particular field of MD-RA, a key point is to

mix the backgrounds of learners (engineers,

pharmacists and biologists). Also, the diversity of

profiles gives usually some good results when

involving both young learners and retraining

professionals.

The building of a team of learners is of utmost

importance from the beginning. Each member

playing a role in his own education but also acting on

the learning paths of their peers. The students projects

are good opportunities to challenge the students.

To strengthen the team spirit (team building),

social events must be organized, such as after-work

parties and visits to industrial establishments. The

alumni network is also a structuring tool. Newcomers

should be encouraged to join the network quickly, so

that they can experience what it's like to belong.

4 THE MASTER ATRDM AT

POLYTECH LYON SCHOOL OF

ENGINEERING

4.1 The Polytech Lyon School of

Engineering

Polytech is a network of 16 public schools of

engineering from 16 French universities. It graduates

annually 4,200 students and already has 90,000 active

graduates. The Polytech Network covers 12

engineering domains (energy, electronics, electrical,

applied mathematics, Information Technologies,

biology, Biomedical, Civil, material, environment,

industry) with 100 specialties (6 specialties at

Polytech Lyon: Biomedical, MD-RA, IT, Materials,

Mathematics, Mechanics, Robotics).

Polytech Lyon is the School of Engineering of

Claude Bernard Lyon 1 University and member of the

Polytech Network. Polytech Lyon, as a full part

faculty of Lyon 1 university, also proposes Master

Degree as a specialization of its Engineer Diploma.

The Polytech Lyon Biomedical Engineering

Department graduates Engineers and Master (Perrin,

2007). Considering the wide spectrum of MD, the

need for MD-RA is to train Engineers, Scientists and

Pharmacist, and this is naturally achieved with a

strong collaboration with Lyon 1 Faculty of

Pharmacy (ISPB).

4.2 A Time-Based Organisation

The Master ATRDM (Noury, 2022) covers a 12-

months training period alternating between a

professional activity in a private company and the

academic training in university. The later consists in

300 hours of face-to-face education and 150 hours of

projects. The projects playing an important role in

skills acquisition and evaluation. During the Fall

Semester (September to February), the rhythm of

alternation is 3 days of training each week and 2 days

in the company. After the academic evaluations in

February, the students start the Spring semester which

consists in a full-time professional education in their

companies. In this last period, only 3 days each month

are dedicated to projects of student in groups in the

University.

4.3 An Elaborated Curriculum

The curriculum is based on a core education on the

MD-RA and side trainings.

The core education on MD-RA (140h) is

composed of 3 parts:

• The generalities of the ecosystem: industrialists,

organizations, stakeholders, notified bodies,

understanding requirements,

• Regulatory Aspects: MD classification,

European standards (MDR 2017/745,

93/42/CEE), Risk Analysis, clinical evaluations,

UDI, PMS…

• Technical aspects of various MD: materials, active

electronics, implantable, software, combined

A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at

Polytech Lyon University, France

861

The side (corollary) trainings (160h) covers

complementary aspects:

• Project management

• Quality management (ISO 13485)

• Legal aspects: Contract laws, Competition law,

Best practices, Sunshine Act

• Security aspects: clinical evaluations, materio-

vigilance, radio-vigilance, reacto-vigilance,

traceability, PSUR, Risk management (ISO

14971), electro-devices (IEC60601-2-62),

software (IEC62304), GDPR, Biocompatibility

(ISO 10993)

• Economy of MD: the French Health system,

Hospital Purchasing, pricing of MD (Market

price), reimbursement, Market Access

• Data strategy: Stake and approach of the

company's strategic information management,

patents, lobbying,

• MD Regulatory in other countries (US, China, ,

Canada, Brazil, Japan, South Korea, Australia,

…)

• And of course, Professional English practice.

4.4 Evaluation of the Skills

Acquisitions

Following the methodology introduced in section 3.3,

the evaluations are done through formative

evaluations, individual examinations and

professional situations during the students’ projects.

The first “individual project” focuses on the study

of the Technical and Regulatory aspects of a selected

Medical Device. The learners must demonstrate they

were able to gather relevant scientific and technical

information to explain how the MD operates and what

is its “principle of action” on the patient, with the

targeted population, and to produce an analysis of the

risks associated with the use of the MD. Then they

must collect the complete book of regulations

associated with the lifecycle of their MD, including

the classification strategy.

The second one is a “Group project”, namely

“Bring an innovative MD on the Market”. On top of

the technical aspects of the technical file, the group of

students must address the European Regulatory

Aspects and the regulations in one or several other

countries (USA, Middle East, Asia, Russia,

Africa…). This project also includes

“entrepreneurial” aspects such as a market analysis.

In addition, the group is evaluated specifically on the

elaboration of his project management strategy, and

his QMS plan.

4.5 Master ATRDM in a Few Figures

The Curriculum was first elaborated in

collaboration with SNITEM, which is the main union

of MD industrialists in France (snitem, 2023). The

first opening was in September 2013. The average

capacity is 24 students each year, in order to maintain

constructive interactions between the classmates and

their teachers. Since 2013, over 200 learners were

graduated (

Figure) and their majority are now active in the RA

departments of the MD industry in France.

Figure 1: Demography of learners in Master ATRDM.

5 CONCLUSIONS

The elaboration of the academic curriculum of Master

ATRDM at Polytech Lyon, is following an Agile

development process with annual iterations (e.g

MDDMDR). This is compulsory because the MD-

RA evolve frequently and also because the missions

of MD-RA managers are constantly changing.

It was based on an important Partnership with

professionals from the industry of MD and with

SNITEM, the main union of the French MD industry.

Networking between students is strongly

encouraged through projects and with their individual

adherence to our private group on Linkedin (Alumni,

2016).

Each student is closely monitored by 2 tutors,

including a company tutor and an academic tutor

from the university. They correspond with each other

via an electronic website and during compulsory

visits in situ.

We participated in 2013 to launching the French

national network of Masters in Regulatory Affairs,

Quality and Clinical evaluations of MD (ARClimed

project) under the auspices of the AMI-CMA, a

French national initiative to foster the development of

Total Apprentices

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new training programs for new occupations in the

digital industry. We can now envision a possible

European deployment of our Master in MD-RA.

ACKNOWLEDGEMENTS

The authors would like to thank the education team

for their dedicated involvement in the development of

the ATRDM Master's programme, in particular Ing.

Alexia GARIN, Manager RA-DM, Ing. Benjamin

ROCHETTE, VP RA-DM and Professor Xavier

ARMOIRY.

REFERENCES

Bayrak T., Yilmaz S.E., What Will Be the Economic

Impact of the New Medical Device Regulation? An

Interrupted Time-Series Analysis of Foreign Trade

Data, Value Health Reg Issues. 2022; 29:1–7

MDD: https://www.legislation.gov.uk/eudr/1993/42/

MDR: Regulation (EU) 2017/745 of the European

Parliament and of the Council of 5 April 2017 on

medical devices, amending Directive 2001/83/EC,

Regulation (EC) No 178/2002 and Regulation (EC) No

1223/2009 and repealing Council Directives

90/385/EEC and 93/42/EEC

Perrin E. et al., "Biomedical engineering degrees at Lyon 1

University," 2007, 29th Annual International

Conference of the IEEE Engineering in Medicine and

Biology Society, Lyon, France, 2007, pp. 5932-5935,

doi: 10.1109/IEMBS.2007.4353698

Noury N., “Developing an educational program for future

Regulatory Affairs professionals in the Medical

Devices industry”., European Medtech 2022, March

2022, Brussels.

Makulova, AT, Theory and Practice of Competency-Based

Approach in Education, International Education

Studies, 2015, vol 8(8) p183-192

Snitem:, https://www.snitem.fr/

Alumni: https://www.linkedin.com/groups/8979939/.

A Skill based Educational Program for Future Regulatory Affairs Professionals in the Medical Devices Industry: A Top down Approach at

Polytech Lyon University, France

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