Development and Production of Medical Devices

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. 

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.  

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

Electronics design, project management

Requirements: 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.  Additional possibilities: The midterm can be retaken once during the semester. 

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