Parcours DMCC English

MEDICAL DEVICES – FROM DESIGN TO MARKET – MASTER 1 & 2

Informations : Xavier Garric

MDDM COURSE
MEDICAL DEVICES : FROM DESIGN TO MARKET

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

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..

PROFESSIONAL EXPERIENCES

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

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

MEDICAL DEVICES : FROM DESIGN TO MARKETING

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Exam terms and conditions :

OBJECTIVES AND CONTENTS OF THE MASTER 1 COURSE :

MASTER 1 

SEMESTER 1

COMMON CORE (S1)

TU 101 : REGULATORY AND FINANCIAL ASPECTS – QUALITY AND SAFETY

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

TU 102: DATABASES – EPIDEMIOLOGY AND ENVIRONNEMENTAL HEALTH

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

TU 103: HEALTH PRODUCTS DEVELOPMENT STRATEGY– PROJECT MANAGEMENT AND CLINICAL DEVELOPMENT

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

TU 104: BIOTECHNOLOGIES APPLIED TO HEALTH

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

TU 105: FOREIGN LANGUAGES AND COMMUNICATION

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

Intervenants extérieurs

  • Cabinet de conseil en communication

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

TU 109: BIOMATERIALS AND MEDICAL DEVICES

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)

TU 201: ENGLISH AND SECOND LANGUAGE

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

TU 202: 3 to 5 MONTH WORK PLACEMENT

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: MEDICAL DEVICES : FROM DESIGN TO MARKET (S2)

TU 215 :SYNTHESIS AND CHARACTERIZATION OF BIOMATERIALS

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

TU 216 : HEALTH APPLICATIONS OF BIOMATERIALS

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

TU 217 : LEARNING PROJECT: DESIGN AN MEDICAL DEVICE FROM BIOMATERIALS

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)

TU 301: HEALTH PRODUCTS PROJECT MANAGEMENT, MANAGEMENT CONTROL AND PERFORMANCE MANAGEMENT

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

TU 302: QUALITY MANAGEMENT, MARKETING

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)

TU 324 : OVERVIEWS AND GENERAL KNOWLEDGE ON MEDICAL DEVICES

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

TU 325 : REGULATORY ASPECTS, STANDARDS AND MARKET ACCESS

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…)

TU 326 : EVALUATION OF MEDICAL DEVICES

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

TU 327 : MEDICAL DEVICES IN COMPANY – 1

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 – STAGE (S4)

TU 401: 4 TO 6 MONTH WORK PLACEMENT

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)

TU 414 :MEDICAL DEVICES IN COMPANY – 2

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

TU 415 : LEARNING PROJECT : THE LIFE CYCLE OF DM

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