Budapest University of Technology and Economics, Faculty of Electrical Engineering and Informatics

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    Development and Production of Medical Devices

    A tantárgy neve magyarul / Name of the subject in Hungarian: Orvostechnikai eszközök fejlesztése és gyártása

    Last updated: 2023. április 10.

    Budapest University of Technology and Economics
    Faculty of Electrical Engineering and Informatics     		Electrical Engineering MSc
    Course ID Semester Assessment Credit Tantárgyfélév
    VIEEAV18   2/2/0/v 4  
    3. Course coordinator and department Dr. Ender Ferenc,
    4. Instructors
    Dr. Tamás Pardy, research scientist, Department of Electron Devices
    Dr. Ferenc Ender, associate professor, Department of Electron Devices

    5. Required knowledge Electronics design, project management
    6. Pre-requisites
    Ajánlott:
    -
    7. Objectives, learning outcomes and obtained knowledge
    Innovative medical electronics and consumer electronics with biomonitoring functions are hallmarks of the 21st century. Connected health devices, including wearable monitors and portable diagnostics, assist in decentralizing medical diagnostics and strengthening preventive medicine, as well as chronic disease management. The majority of these complex medical devices are developed by innovative technology startups. Thus, development of these devices takes a multidisciplinary approach: besides electronics, it needs intricate knowledge in standards, quality management, regulatory requirements and approval processes, design for manufacturing. A successful medical electronics device must meet essential functional criteria, be compliant with standards and regulations and must also be optimized for production. 
    The goal of this course is to assist in specialization and prepare students for a career in the development of innovative medical electronics devices. The course teaches necessary theoretical knowledge and practical methodology through the lifecycle of an innovative, handheld, Point-of-Care diagnostic test, from development to production. Stages of this lifecycle will relate to development, regulatory approval and compliance, quality management concepts and design for manufacturing. In the lectures, the theoretical background and methodology are covered, whereas in the labs the acquired knowledge is put to practice via case studies and exercises connected to the lectures and the various stages in the product’s lifecycle. 

    8. Synopsis
    Module 1: fundamentals (week 1-4)
     Introduction and overview. The field of medical electronics, classification and definition of medical electrical devices in the EU (EN 60601-1, MDD 93/42/EEC). Definition of key concepts and terminology (e.g. medical device manufacturer, harmonized standards, essential performance etc.). Product lifecycle overview and key considerations, leading to structure of the course. Introduction to Point-of-Care Tests (POCT): overview of the field, key concepts, technology, and application areas. Examples of innovative POCT devices based on LoC technology.
     Liquid handling. Lab-on-a-Chip (LoC) and its role in innovative POCT devices. Fundamentals of microfluidics: laminar flow, mixing, flow focusing. Transport phenomena: convective and conductive mass transfer, diffusion in microflows. Droplet microfluidics: multiphase flows and their applications, contact angle and wetting. Fundamentals of flow modelling: computational fluid dynamics and applications, the role of models in device design, thermal-fluidic co-design with simulated and experimental analysis. 
     Sensors and actuators, Connected Health. Functional introduction of biosensors, key sensing modalities and working principles. Functional introduction of actuators in POCTs: mechanical, thermal and electrical. Adaptive laboratory automation, wireless communication, technical challenges. Overview of Connected Health Devices. 
     Bioanalytical assays. Introduction to In Vitro Diagnostics (IVD). Overview of biomarkers and bioanalytical assays. Qualitative and quantitative methods. Nucleic acid amplification tests, key performance indices (throughput, sensitivity, specificity, resolution). Case study: Next-generation sequencing. Sample preparation and handling. Introduction to biolabs: biosafety and test protocols.
     
    Module 2: product development (week 5-8)
     Product planning and design. Funding sources, fundamentals of intellectual property rights (publish/patent?). Patents & literature analysis, licensing (incl. open-source). Value proposition design, business modelling. Fundamentals of R&D project planning. TRL scale. Key stages in device development. Team management. Feasibility studies, iterative product design and the role of modelling. Mandatory documentation: requirement specifications, development documentation, release tests etc. System architecture design, mapping interfaces.
     Risk and quality management. Quality management systems (QMS), eQMS, ISO 13485. Risk management: risk analysis process, risk management file, risk management process, ISO 14971. Release and approval workflows, design history management (Git), document management systems. Fundamentals of data security and data management plans (DMPs).
     Medical device software development and PEMS. PEMS lifecycle (EN 60601-1). Soft/firmware lifecycle and development process, documentation (EN 62304). Software validation process (EN 62304 and FDA guidelines). Change management: version tracking, release process. Application of Agile development to medical devices. Software reuse. Security. Internal error checks (system/user).
     Standards. Overview of relevant standards (EN 60601-1, EN 62304 etc.). Key definitions (e.g. harmonized standards, essential performance, class I-III etc.). Designing for compliance: process & documentation. Patient safety (electrical and functional, EN 60601-1). Additional requirements (e.g. biocompatibility, sterilization). Functional safety and alarm systems/signals. 
     
    Module 3: compliance and regulatory approval (week 9-12)
     Usability engineering. Process and documentation (EN 62366): essentials principles of usability, design for usability. Design steps and risk management. Documentation: usability engineering file. Key considerations for user interface design (software and/or hardware). 
     Medical device regulations. CE mark (relevance to electronics, notified bodies, certification process). Detailed overview of EU regulations (93/42/EEC, 98/79/EC, 2017/746). Technical file/technical documentation. Clinical evaluation (clinical study, CROs etc.). Labelling requirements. EC declaration of conformity. International registration (FDA). 
     Compliance and certification. Key terminology for safety and testing (EN 60601-1, e.g. hazardous situations and single fault conditions). Documentation and compliance tests: electrical (EMC, ESD, EMI, electrical safety), thermal safety, mechanical safety (e.g. drop tests, expelled parts, strength), overflow/spillage (and related issues, such as cross-contamination risk). Verification of markings. Disposability and recycling.  
     Interdisciplinarity. Assay release testing: process overview, key definitions (e.g. LOD, internal control). Problem-solving in cross-disciplinary teams (engineers – biologists/chemists, engineers – QM/regulatory specialists). Tools for troubleshooting (e.g. FMEA, FDIR).

    Module 4: manufacturing and commercialization (week 13-14)
     Production planning. Product optimization: COGS analysis, mapping alternative parts and suppliers (avoiding vendor locks and supply chain issues), reducing complexity. Production optimization: lean six sigma. Quality inspection: inline inspection, random sampling, unit tests, type tests (following EN 60601-1). 
     Case studies: 1 - next generation sequencing in the IonTorrent system. 2 - SelfDiagnostics Multitest.
     Invited lecture 1. Invited lecturer shares their experience and perspective related to production, upscaling, commercialization and/or business issues.
     Invited lecture 2. Invited lecturer shares their experience and perspective related to production, upscaling, commercialization and/or business issues.
     
    Practical sessions:
    The goal of the practical sessions is to put the knowledge learned during lectures into practice. These sessions will simulate the lifecycle of an innovative medical electronics product, with each lab embodying a stage in this lifecycle. Students will form groups (“startup companies”) and define a product that complies with course criteria, then lead this product through its lifecycle, at each stage creating the necessary documentation. Topics of the labs:

    Week 1-4
     Challenge definition, forming groups (“companies”).
     Business concept development: the Business Model Canvas (BMC), creating a BMC.
     Value proposition (VP) design, creating a VP canvas.

    Week 5-10
     Product concept formulation: FTO analysis and creating a project plan.
     TD1 (technical documentation 1): Creating hardware design documentation.
     TD2: Creating software development and validation plans.
     TD3: Creating a risk assessment and mitigation plan.
     QM: Implementing a basic quality management (QM) system.

    Week 11 – Midterm test

    Week 12-15
     Certification of device: creating test plans and test reports. 
     Creating a production plan. COGS estimation, BOM optimization (with alternatives).
     Compilation of the technical file for product certification.
    9. Method of instruction
    Theoretical knowledge is disseminated via lectures (2 hours/week). Lectures will detail methodology, best practices, workflows etc., directly relevant to the practical sessions. 

    Practical sessions (2 hours/week on average) are directly related the lectures/lecture modules and guide students through the lifecycle of their chosen product. All labs are computer labs, attendance is mandatory.  

    10. Assessment

    Szorgalmi időszakban

    Exam eligibility criteria (“aláírás megszerzésének feltétele”): 

    -        Participation at all of the practical sessions, passing entry test at the start of each lab to show preparedness for the lab, regular submission of reports corresponding to practice modules

    -        Passing midterm exam on week 9 (minimum grade 2 - satisfactory)

    -        By the end of the study semester, a complete portfolio compiled from all the reports during the semester

    Vizsgaidőszakban

    Exam: 

    -        Exam can be taken if eligibility criteria are met. 

    -        The exam is verbal. 

    -        At the exam, each student presents individually, according to their assigned role in their group (“company”)

    -        At the exam, the student shall defend their portfolio and answer questions related to lecture materials and the portfolio (esp. related to potential shortcomings of the portfolio)

    Grading: The exam must be passed to receive a grade. Grades are calculated as a weighted average of the grades gained during the study semester (60% portfolio reports, 40% midterm). The final grade can be adjusted by +/- 1 grade based on the exam. 

    11. Recaps The midterm can be retaken once during the semester. 
    12. Consultations Personal consultations with lecturers are available. 
    13. References, textbooks and resources

    Digital materials in Edu.

     

    Books (available in BME library)

    -        Medical instrumentation : application and design / ed. John G. Webster and Amit J. Nimunkar. -  5. edition. - New York, N.Y. : Wiley, 2020

    -        Point-of-Care Diagnostics on a Chip [elektronikus dok.] / edited by David Issadore, Robert M. Westervelt. - Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer, 2013

    -        Micro and Nano Flow Systems for Bioanalysis [elektronikus dok.] / edited by Michael W. Collins, Carola S. Koenig. - New York, N.Y. : Springer New York : Imprint: Springer, 2013

    -        Dr. Norbert Leitgeb: Safety of Electromedical Devices Law-Risks -Opportunities 2010/ Springer-Verlag Wien

    Standards (latest available revision)

    -        EN 60601-1

    -        EN 62304

    -        ISO 13485

    EN 62366
    14. Required learning hours and assignment

    A tantárgy elvégzéséhez átlagosan szükséges tanulmányi munka

    Contact hours

    50

    Preparation for classes

    14

    Preparation for mid-term test

    16


    Preparation for the exam

    40

    Sum

    120

    15. Syllabus prepared by
    Dr. Tamás Pardy, Department of Electron Devices
    Dr. Ferenc Ender, Department of Electron Devices