Ingénierie de la Santé
Licence / Master Montpellier

Training course MEDICAL DEVICES : FROM DESIGN TO MARKET

Informations :Xavier Garric

MDDM COURSE (in French DMCC)

MEDICAL DEVICES : FROM DESIGN TO MARKET

A transversal training to an extensive knowledge of the medical device sector

Xavier Garric, responsable du parcours DMCC

SKILLS AND KNOWLEDGE BY THE END OF THE COURSE

  • General knowledge of the applications of medical devices by medical discipline,
  • Extensive knowledge of regulatory and economic constraints of the MD market,
  • Ability to design a medical device based on scientific and technical skills on biomaterials,
  • Mastering the specificities of the medical device throughout its lifecycle in the company (R&D, production, Regulatory, Quality, Marketing…).

SPEAKERS

  • Biomaterials specialists (researchers and professors),
  • Hospital practitioners, Health institutions representatives (ANSM, HAS, CNEDiMTS, CEPS…),
  • Industrial experts from different sectors of the medical device..

BUSINESS OPPORTUNITIES
Project Manager in different domains of the medical device industry :
R&D • Production • Regulatory Affairs Quality • Pre-clinical and clinical evaluations of medical devices

PROFESSIONAL EXPERIENCES

INTERNSHIP : 5 MONTHS IN MASTER 1 AND 6 MONTHS IN MASTER 2 OR APPRENTICESHIP TRAINING

Manon and Nicolas, MDDM master students present their formation(FR)

Damien Stefanelli, Quality Supervisor (Maquet, Getine Group), presents the MDDM with the industry point of view (FR)

integration into the workplace for MDDM students in 2017 (FR)

Les étudiants du Master 2 parcours DMCC expliquent leurs choix de formation et leur vision pour l’avenir.

OBJECTIVES AND CONTENTS OF THE MASTER  COURSE :

MASTER 1 

SEMESTER 1

COMMON CORE (S1)

Goals:

Pharmaceutical law:

  • To know the various texts applying to the field of medicines, their origin, their legal value, their articulation
  • To have some knowledge of the various health products
  • To know the basics of innovation protection control, manufacturing, marketing and monitoring of medicines

Quality :

  • To know the quality demands and management tools

Security :

  • To know the regulations of ICPE classified installations
  • To know the classification and labelling of chemical products’ hazards

Marketing :

  • To integrate the marketing’s global approach
  • To know the diagnostic tools and the strategic directions

Financial analysis

  • To be able to analyse the profitability, the solvency and the liquidity of an economic activity (industrial company)

Content:

  • Pharmaceutical law (18hrs-Lecture)
  • Financial analysis (12hrs-Lecture)
  • Marketing (6hrs-Lecture)
  • Quality (10hrs-Lecture)
  • Safety (6hrs-Lecture)

Teachers:

  • V. RAGE-ANDRIEU
  • C. LE GAL
  • R. BARTHES
  • N. DELELIGNE
  • A. ESCANDE
  • V. BOISSERIE LAPORTE
  • O. VEYRET
  • A. GARD

Goals:

To comprehend epidemiological studies:

  • To identify epidemiology as public health tools
  • To know the epidemiological surveillance tools
  • To know the different types of epidemiological surveys
  • To be able to interpret descriptive epidemiology indicators
  • To be able to calculate and interpret the results of risk calculation (RR and OR) from analytical epidemiology
  • To be able to describe and criticise the strategies and protocols of studies implemented in epidemiology
  • To be able to assess the validity of screening tests
  • To know the behaviour and the impact of organic pollutants present in the environnement and to understand the related legislation

Databases:

  • To discover the basics of databases management
  • To understand how the information is structured thanks to the relational model
  • To recognise the different database usage patterns (administrator/client)
  • To be able to build a database including a few tables
  • To be able to define the main confines on a database
  • To be abe to use the main commands of the SQL language
  • To be autonomous on the data management system ACCESS (Microsoft)

Content:

  • Database (4hrs-Lecture+ 15hrs-Tutorial)
  • Epidemiology (12hrs-Lecture)
  • Environmental health (18hrs-Lecture)

Teachers:

  • M. VIVIEN
  • P. RAVEL
  • H. FENET
  • A. ESCANDE
  • F. COURANT
  • C. CASELLAS
  • E. GOMEZ

Goals:

  • General knowledge of the sectors of medicines, cosmetology and medical devices
  • Knowledge of the regulatory and socio-economic specificities of the medicines, cosmetology and medical devices
  • Initiation to the project management of health products development
  • Initiation to the proceedings of clinical trials in accordance with the Good Clinical Practices (GCP)

Content:

  • Development strategy: Medicines (12hrs-Lecture), Cosmetology (6hrs-Lecture) and Medical Devices (6hrs-Lectures)
  • Regulations in Europe, Japan and the United-States (6hrs-Lecture)
  • Clinical development (9hrs-Lecture)
  • Project management (6hrs-Lecture + 3hrs-Tutorial)

Teachers:

Montpellier University

  • B. BATAILLE
  • S. BEGU
  • J. COUDANE
  • X. GARRIC
  • A. EL GHAZOUI
  • P. CREMADES
  • W. AGOUMI

Goals:

  • To know the various health products produced by biotechnologies
  • To acquire the notions of therapeutic targets and biomarkers
  • To acquire the notions of medium and high throughput screening
  • To know the technologies of recombinant DNA (GMO notion) and protein engineering
  • To know the production and quality control processes
  • To have a concrete overview of the conditions of production of a recombinant protein and of the development of a cellular model that is compatible with medium throughput screening (practical works carried out)

Content:

  • Identification of the molecular or cellular targets and of the biomarkers (8hrs-Lecture)
  • Production/Quality control (3hrs-Lecture)
  • Industrial applications/examples (11hrs-Lecture)
  • Virtual cloning (6hrs-Tutorial)
  • Production, purification, characterisation of a recombinant protein (12hrs-Practical work)
  • Preparation of a cellular model for medium throughput screening– visit of a high throughput pharmacological screening platform (10hrs-Practical work)

Teachers:

Montpellier University

  • S. CHAUMONT
  • A. CHOQUET
  • F. COURANT
  • S. DELBECQ
  • A-D. LAJOIX
  • X. GARRIC
  • S. MARY
  • F. MACARI-FINE
  • M.A. POUL

External professionals

  • ARPEGE Platform, IGF Montpellier

Goals:

  • To develop communication skills in foreign languages
  • Specialized vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content:

  • Foreign languages (40hrs-Tutorial)
  • Communication (9hrs-Tutorial)

Teachers:

Montpellier University

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

External professionals

  • Communication consultants

SPECIFIC TU (S1): MEDICAL DEVICES : FROM DESIGN TO MARKET

Objectives:

  • Introduction to the medical device sector
  • General and transversal knowledge of the different classes of biomaterials used for the design of medical devices

Content : 40h (Lecture) and 10h (Practical work)

  • Introduction to medical devices
  • Biomaterials : definition, biocompatibility and biofunctionality
  • Prerequisite about chemical and mechanical properties
  • Prerequisite about aging / degradation
  • The different classes of biomaterials
  • Practical work and mini-projects

Intervenants:

  • H. VAN DEN BERGHE
  • J. COUDANE
  • B. NOTTELET
  • X. GARRIC

SEMESTER 2

COMMON CORE (S2)

Goals:

  • To develop communication skills in a foreign language
  • Specialised vocabulary
  • Knowledge of the companies and health matters in the countries of the target language
  • Cultural approach

Content:40hrs

  • Work on all communication skills: written and oral expression and comprehension
  • Knowledge of the professional and cultural international environment
  • Job interview simulation, oral presentation using PowerPoint, meetings simulation, writing letters and emails, debates, documents reading etc.
  • Methodological aspects (according to the groups’ needs)
  • Practice on digital platform aiming at revising and strengthening language skills

Teachers:

  • I. MAITRE-DEVALLON
  • Y. ZAMBRANO
  • G. NICKSON
  • P. WEINMANN

Goals:

  • To put into practice the skills gained during the training course
  • To achieve a concrete professional project within one’s context of activities

Content:

  • Preparation and instruction to find and complete a work placement (3hrs-Lecture)
  • 3 to 5 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • A. ESCANDE
  • E. GOMEZ
  • B. NOTTELET
  • X. GARRIC

SPECIFIC TU (S2): MEDICAL DEVICES : FROM DESIGN TO MARKET

Objectives:

  • Scientific and technical knowledge on the synthesis and characterization of biomaterials

Contenu:40h(Lecture) and 10h ( Practical work)

  • Synthesis and characterization of biomaterials
  • Mechanical and thermal properties
  • Phisico-chemical properties
  • Gel characterization
  • Practical work and mini-projects

Speakers:

  • J. COUDANE
  • B. NOTTELET
  • H. VAN DEN BERGHE
  • X. GARRIC
  • A. EL GHZAOUI

Objectives:

  • Knowledge of the criteria for the selection of biomaterials for health applications
  • Regulatory and industrial constraints linked to applications of biomaterials in Health
  • Knowledge of the different families of applications of biomaterials health products
  • Ability to develop the specifications for an application

Content:35h (Lecture) and 15h (Practical work)

  • Specifications and selection of the criteria with respect to the application
  • Overview on degradation
  • Surface modifications of medical devices
  • Sterilization of medical devices
  • Applications of biomaterials in medicine (tissue engineering, implantable medical devices …)
  • Applications of biomaterials in Pharmacy
  • Practical work and mini-projects

Speakers:

  • B. NOTTELET
  • X. GARRIC

Objectives:

  • Develop autonomy and spirit of initiative of students to design a medical device
  • Know the different stages of research and development required for the design of an innovative medical device
  • Be able to  identify a medical need and to analyze a market
  • Be able to develop specifications adapted to the final application
  • Suggest a design strategy

Content:70h (Tutorial)

Work plan :

  • Literature review, scientific monitoring and competitive environment
  • Medical and socio-economic context and issues
  • Background and scientific issues
  • Expected impact on medical, scientific and economic domains
  • Regulatory aspects

Feasibility:

  • Proposal of several design strategies based on a detailed analysis of the market and the scientific literature
  • Budget needed :Raw materials(quantity, supplier, price, quality) /Equipment(quantity, supplier, price, quality) /Human resources
  • Contact persons (Need to request information from third parties)

Practical work:

  • Proposed design strategy and implementation thereof

Speakers:

  • X. GARRIC
  • B. NOTTELET

MASTER 2 

SEMESTER 3

COMMON CORE (S3)

Goals:

Project management:

  • To understand the concepts, processes and project management methods within the frame described by the Project Management Institute
  • Operational planning: from analysing a project to the preparation of a feasible work schedule
  • To know the basic framework of innovation protection, manufacturing, the marketing and surveillance of medicines

Management control:

  • To assess and understand through an account of company’s results, the items of profitality and performance

MS Project:

  • To be able to use the MS Project software

Content:

  • Project management (12hrs- Lecture + 12hrs-Tutorial)
  • Management control and performance management (6hrs-Lecture + 6hrs-Tutorial)
  • MS Project software (12hrs-Tutorial)

Teachers:

Montpellier University

  • P. CREMADES
  • R. BARTHES

External professionals

  • Service provider

Goals:

Team management:

  • To clarify the missions, roles and function of a team manager (project)
  • To understand the influence of one’s leadership of the team’s performance
  • To identify one’s management style, one’s negotiation style
  • To be able to lead a meeting

Quality management :

  • To master quality management

Marketing:

  • To understand the market’s mechanisms
  • To be able to identify the relevant stakeholders and to analyse the influence factors
  • To know the various strategic manoeuvres (by comparison with the demand and faced with the competition)
  • To be able to define the appropriate operational modes

Content:

  • Team management (12,5hrs-Tutorial)
  • Quality management (14hrs-Lecture + 12hrs-Tutorial)
  • Marketing (12hrs-Lecture)

Teachers:

  • R. BARTHES
  • N. DE LELIGNE
  • L. KABBARA BARDINA

SPECIFIC TU: MEDICAL DEVICES : FROM DESIGN TO MARKET (S3)

Objectives:

  • An introduction to the medical device sector
  • Know the anatomical, histological, regulatory and health economic specificities of different medical disciplines that use medical devices
  • Identify the major classes of medical devices by medical
  • Understand the ways toward innovation in different medical specialities

Content:40h (Lecture) 10h (tutorial)

  • Medical devices (Definition and introduction to the medical device sector)
  • Biomaterials (Classification, Degradation, Stérilization)
  • Classification of medical devices by medical disciplines

Speakers:

  • X. GARRIC
  • B. NOTTELET
  • C. HIRTZ
  • Hospital practitioners form Montpellier University Hospital Center

Objectives:

  • Acquire all general regulatory information for the development of medical devices
  • Provide general and regulatory knowledge of the stages prior to marketing in the medico-economic evaluation plan and market access

Content:40h (Lecture) 10h (Tutorial)

  • Regulations and Standards
  • Market access
  • CNEDiMTS (National Commission for assessment of medical devices and health technologies)
  • Call for tenders in hospital
  • Mini-project

Intervenants:

University of Montpellier

  • V. RAGE-ANDRIEU

Montpellier University Hospital Center

  • C. FAURE-CHAZELLES
  • J. PERREY

External professionals

  • Institutional speakers (ANSM, LNE, SNITEM, CNEDIMTS, Public and private hospitals…)

Objectives:

  • Knowledge of the various steps and associated constraints of preclinical evaluation
  • Theoretical and practical knowledge of the progress of a clinical trial dedicated to a medical device
  • Knowledge of regulatory and administrative aspects of clinical trials

Content: 40h (Lecture) 10h (Tutorial)

  • Biocompatibility, pre-clinical evaluation of medical device and compliance with the essential requirements
  • Clinical trials of medical device
  • Visit of site of preclinical and clinical evaluation service
  • Mini-projects

Speakers:

University of Montpellier

  • X. GARRIC

Montpellier University Hospital Center

  • G. MERCIER
  • A. CASTET
  • Speakers from Medical Device Companies

Objectives:

  • Present the different activities in company
  • Explain the life cycle of the medical device in company
  • Detail the various stages of the life cycle in company
  • Understand how companies adapt regulatory aspects to design, produce and market medical devices

Content: 40h (Lecture) 10h (Tutorial)

  • The different stages of the life cycle of medical devices
  • The regulation of MDs (Objectives of demand and market analysis)
  • Answers to the essential requirements
  • Quality assurance
  • Risk Analysis
  • Manufacturing and Production
  • Marketing

Speakers:

External professionals

  • C. POMPEE (Aspide Medical)
  • D. STEFANELLI (Gettinge group)
  • A. GRANGE (Medtronic)
  • F. DUPASQUIER (Bayer)
  • M. DUMONT (Laboratoires Brothier)

SEMESTER 4

COMMON CORE –WORK EXPERIENCE PLACEMENT (S4)

Goals:

  • To carry out a concrete professional project within its context of activities

Content:

  • 2hrs Lecture: preparation and instructions to find and do a work placement
  • 4 to 6 months full-time in a public or private company

Teachers:

  • B. BAÑULS
  • B. BATAILLE
  • S. BEGU
  • A. EL GHZAOUI
  • P. RAVEL
  • M. VIVIEN
  • E. GOMEZ
  • X. GARRIC

TU SPECIFIC: MEDICAL DEVICES – FROM DESIGN TO MARKET (S4)

Objectives:

  • Know how to read or search a patent
  • Understand all intellectual property rights and applied strategies
  • Use project management during the life cycle of the medical device
  • Know the tools to manage and control the production of medical devices

Content: 40h (Lecture) 10h (Practical work)

  • Patent and intellectual Property
  • Project management applied to the Medical Device
  • Production management / Production control
  • Practical work and mini-projects
  • Industrial interventions : What is the job? What is the role in the company?

Speakers:

External speakers

  • SNITEM speakers
  • Others industrials

Objectives:

  • Develop autonomy andspirit of initiative of students for marketing a medical device
  • Be able to identify a medical need and analyze a market
  • Be able to develop specifications adapted to the application
  • Know the different stages of the MD life cycle necessary to commercialize an innovative medical device in compliance with the quality approach
  • Develop a marketing plan

Content:70h (Tutorial)

Work plan:

  • Literature review, scientific monitoring and competitive environment
  • Medical and socio-economic context and issues
  • Background and scientific issues
  • Expected impact on medical, scientific, and economic
  • Regulatory aspects

Feasibility:

  • Proposal of several design strategies based on a detailed analysis of the market and the scientific literature
  • Budget needed

Practicality:

  • Proposal of a design strategy
  • Proposal of a production strategy
  • Proposal of a marketing plan

Speakers:

University of Montpellier

  • X. GARRIC
  • B. NOTTELET
  • C. HIRTZ

Resources

Download the brochure