Universitat Internacional de Catalunya
Medtech and Digital Product Development
Other languages of instruction: English, Spanish,
Teaching staff
In-person or online tutorials are available upon prior request to the teaching staff. Additionally, the case-based learning activities include 2 hours of mentoring to support the development and follow-up of the group project.
Introduction
The course covers the development process of healthcare technology products (Medtech and Digital Health), from solution conceptualization through clinical validation, regulatory certification, commercialization, and adoption within the healthcare system. It examines the specific challenges of medical technologies (devices, software, digital platforms, and artificial intelligence tools) and their transformative role in healthcare delivery.
The course promotes an ethical, sustainable, patient-centered approach aligned with Sustainable Development Goals (SDGs) 3, 4, 5, 8, 9, and 12.
SDGs to which the course contributes:
SDG 3 (Good Health and Well-being)
SDG 4 (Quality Education)
SDG 5 (Gender Equality)
SDG 8 (Decent Work and Economic Growth)
SDG 9 (Industry, Innovation and Infrastructure)
SDG 12 (Responsible Consumption and Production)
Pre-course requirements
It is recommended that students have completed Introduction to Biomedical Business (2nd year) and Entrepreneurship and Innovation (3rd year).
Objectives
The teaching staff aims to:
- Explain the life cycle and key principles of Medtech product and Digital Health solution development, from ideation to market launch.
- Analyze the regulatory, quality, intellectual property, and reimbursement aspects specific to medical devices and healthcare software.
- Describe the technical and clinical validation phases, as well as certification processes (MDR and medical software regulations).
- Identify business models, funding pathways, and scaling strategies in the digital healthcare environment.
- Foster an innovative and collaborative mindset focused on solving real healthcare problems through an ethical, inclusive, and sustainable approach.
Competences/Learning outcomes of the degree programme
- CN14 - Identify the principles of biomedical sciences related to health, as well as the basic concepts and tools that have an impact on Biomedical Sciences and allow them to work in any of its fields (biomedical companies, bioinformatics labs, research laboratories, clinical analysis companies, etc.).
- CP05 - Apply biological foundations in the search for practical solutions to health problems, following ethical standards and scientific rigour and respecting fundamental equal rights between men and women, and the promotion of human rights and the values inherent in a peaceful society of democratic values that includes inclusive, non-discriminatory language without stereotypes.
Learning outcomes of the subject
By the end of the course, students should be able to:
- Understand the complete development cycle of a medical or digital product, from ideation to commercialization.
- Analyze the design, technical validation, and clinical validation stages in the development of medical technologies and digital solutions.
- Evaluate applicable regulatory frameworks (MDR, IVDR, software as a medical device) and their impact on development and commercialization.
- Develop intellectual property, quality certification (ISO 13485), and risk management (ISO 14971) strategies.
- Design business models and market access strategies in the Medtech/Digital Health environment.
- Integrate sustainability, ethics, and gender equality perspectives into the development and use of medical technologies.
Syllabus
0. Course and group project introduction
Introduction to the teaching staff, theory and practical blocks, methodology, and assessment.
Theory: 2 h
Methodologies for identifying unmet clinical needs and generating ideas.
Theory: 2 h
Key stakeholders (patients, healthcare professionals, industry, payers, regulators) and their role in product development.
Theory: 2 h
Business models and monetization strategies in Medtech/Digital Health.
Theory: 3 h
Market access, reimbursement, and international scaling strategies.
Theory: 2 h
Product design, prototyping, technical validation, and usability validation phases.
Theory: 2 h
Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), device classification, SaMD, ISO 13485, and ISO 14971.
Theory: 2 h
Design and conduct of clinical studies for medical technologies.
Theory: 1 h
Intellectual property strategies, licensing, and collaboration agreements.
Theory: 2 h
Analysis of a real-world case to map key stakeholders and relationships within the ecosystem.
Case study: 2 h
Exercise focused on validating and presenting the group project’s value proposition.
Case study: 2 h
Development of the group project’s business model.
Case study: 2 h
Case study focused on Digital Therapeutics and mentoring on scaling strategy.
Case study (Digital Therapeutics): 2 h
Mentoring: 2 hours
Final presentation: 2 h
Teaching and learning activities
In person
Lectures (18 h)
Delivery of theoretical and applied knowledge on Medtech/Digital Health development, regulation, and business.
Case method (12 h)
- Analysis of real cases involving startups, companies, and digital technologies.
- Group development of a digital product or medical device project, with a final presentation.
Evaluation systems and criteria
In person
First assessment period:
- Class participation and attitude: 10%
- Group project: Medtech/Digital Health product development (50%)
- Design and presentation of a digital health product or application, including concept, validation, regulatory strategy, and business model.
- The project assessment will account for 50% of the final grade: 15% corresponding to an initial group submission/presentation and 35% to the final project presentation.
- Multiple-choice exam: 40%
Second and subsequent assessment periods:
- The grades for participation (10%) and the group project (50%) are retained.
- Multiple-choice exam: 40%
- Maximum achievable grade: 6/10.
General conditions and minimum requirements:
- ≥5/10 in the group project to calculate the final grade.
- ≥4/10 in the multiple-choice exam to calculate the final grade.
- Minimum overall grade to pass the course: 5/10.
- Minimum attendance: 75%.
- Multiple-choice penalty: –0.33 per incorrect answer (4 options) or –0.25 (5 options)
Bibliography and resources
- Regulation (EU) 2017/745 (MDR) on medical devices.
- Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices.
- IMDRF SaMD Guidelines (Software as a Medical Device).
- Kolchinsky, P. The Entrepreneur’s Guide to a Biotech Startup.
- Topol, E. Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again. Basic Books, 2019.
- EIT Health Reports on digital health innovation.
- EMA, AEMPS, and European Commission guidelines on the assessment and commercialization of medical technologies.
- Teaching and audiovisual resources provided during the course