Shoulder view: Short interview with Dr Yavuz O. Uca
Today we are continuing our "Shoulder View" series, which provides insights behind the scenes at SEMDATEX. This time we are talking to Dr Yavuz O. Uca, who has been working at SEMDATEX since summer 2025. Read more about his career and what exactly he is responsible for in the following interview.
Yavuz is a Project Manager and Scrum Master in Quality Assurance. Yavuz has over ten years of experience in cutting-edge research and several years as an innovation consultant in the digital health and medtech sector. At SEMDATEX, he is responsible for the planning and implementation of complex projects, supports regulatory processes (IVDR/MDR) and promotes agile collaboration between our teams.
Yavuz, what motivated you to switch from academic research and innovation consulting to the MedTech world of SEMDATEX?
With a strong commitment to cutting-edge research and experience in medical diagnostics - albeit in academia - I was already working in the MedTech sector, focussing on medical imaging technologies. My academic career allowed me to recognise emerging trends through technology-driven innovation and witness how the field has evolved from traditional diagnostics to digital health solutions. I made a conscious decision to take a bold step and test my entrepreneurial skills by working with several start-ups and institutions. This led me to my new role as Project Manager and Scrum Master focussing on Quality Assurance in MedTech Regulatory Affairs at SEMDATEX.
What role does agility play in the development of digital medical products at SEMDATEX?
Agility is essential for the development of digital products in the MedTech sector, as it enables flexible adaptation to changing requirements or regulatory specifications and ensures the provision of innovative solutions in the form of user-validated functional increments. Using these principles as a basis, we at SEMDATEX rely on agile processes to promote collaboration between our product team - which is in continuous dialogue with users - and our development teams. This ensures a clear understanding of user needs and fast feedback loops that support continuous quality improvements and help to fulfil compliance requirements.
You have extensive experience in regulatory processes. What do you think are currently the biggest challenges in this area for digital health companies?
The complexity and unpredictability of medical device regulations, including aspects relating to data and cybersecurity, are currently among the biggest challenges in this area. Tackling compliance issues from different angles, such as EU-MDR/745, ISO 13485, IEC 62304 and ISO 27001, is an extremely demanding process that requires the highest level of operational excellence to avoid potential delays in market launches and significant financial penalties for companies. This is especially true for start-ups. In addition, patient-centred development of digital technologies must be at the heart of all processes; therefore, close collaboration between medical professionals and IT engineers is essential - which is also a major challenge.
Which project at SEMDATEX are you particularly excited about at the moment - and why?
At SEMDATEX, we are currently working on a diverse range of digital healthcare solutions, which I really appreciate in our daily business. Whilst leading the Scrum team of highly skilled developers, I am currently leading the MDR-CE certification project with the exciting goal of advancing our medical solutions. I also have the opportunity to take on cross-functional roles; as I am a TÜV-certified quality manager with audit training, I am also part of our quality management team, where I contribute these skills and expand my experience.
What motivates you personally about your work at SEMDATEX?
What I enjoy most is having the opportunity to take on cross-functional roles and make a significant contribution to the success of our day-to-day business. Working with a team of highly skilled professionals is particularly fulfilling. I have invested a lot of time growing in the MedTech industry, and working at SEMDATEX gives me the opportunity to contribute while expanding my experience beyond myself.