JOY HSU

• Specialized in experimental planning, verification, and validation (V&V) testing for high risk medical devices.
• Hands-on expertise in risk management (ISO 14971), biocompatibility and degradation studies (ISO 10993 series), and usability engineering (IEC 62366)
• Research background in colorectal cancer molecular mechanisms using Digital Spatial Profiling; identified CEACAM6 as a potential biomarker.
• Cross-disciplinary experience linking clinical diagnostics, R&D, and regulatory science, enabling translation of technical findings into regulatory and academic contexts.
• Strong interest in advancing biomedical engineering research device safety evaluation and biomaterial's degradation modeling.

Identification of early events in serrated pathway colorectal tumorigenesis by using digital spatial profiling

https://pubmed.ncbi.nlm.nih.gov/38830348/ 

Su, M. C., Hsu, C. H., Chen, K. C., Lin, J. R., Li, H. Y., Fang, Y. T., Huang, R. Y., & Jeng, Y. M. (2024). Identification of Early Events in Serrated Pathway Colorectal Tumorigenesis by Using Digital Spatial Profiling. Pathobiology : journal of immunopathology, molecular and cellular biology, 91(6), 393–410. https://doi.org/10.1159/000539612

Medical Technologist

• Support regulatory submissions (FDA 510(k), TFDA) for class II/III implantable medical devices, including risk management and biological evaluation reports.
• Established Design History File (DHF) and contributed to design changes and post-market surveillance (PMS) for IVD diagnostic kits.

My academic and professional journey has evolved from clinical science to regulatory innovation. I learned my bachelor's degree in Medical Laboratory Science and Biotechnology from China Medical University, where I  built a strong foundation in clinical diagnostics, molecular biology, and quality control. This period trained me to approach problems with analytical precision and a rigorous scientific mindsets.

To deepen my understanding of disease mechanisms, I pursued a Master's degree in Pathology at National Taiwan University (NTU). My thesis focused  on the serrated pathway of colorectal cancer, using Digital Spatial Profiling (DSP) and the Cancer Transcriptome Atlas (CTA) to explore gene expression in serrated lesions such as sessile serrated lesions (SSLs) and traditional traditional serrated adenomas (TSAs). I identified key genes- includes CEACAM6, LCN2, KRT19, and Lysozyme- and revealed CEACAM6's critical role in tumor proliferation, migration, and invasion. This project enhanced my experimental design and data interpretation abilities while fostering a deeper appreciation for translational medicine and biomarker discovery.

After completing my graduate studies, I transitioned from academic research to the medical device industry, joining Catcher Technology Co., Ltd. as a Regulatory Affairs Specialist. My work centers on high risk medical device, particularly PLGA-based bioabsorbable fasteners and electrosurgical systems. Through this role, I have gained extensive experience in FDA 510(k) submissions, EU MDR techinical documentation, and TFDA regulatory reviews. I also collaborate closely with R&D teams to develop risk management files (ISO 14971), biological evaluation (ISO 10993 series), and design validation plans that ensure both product safety and regulatory compliance.

These combined experiences- from molecular pathology to regulatory science- have shaped my interdisciplinary perspective. They also inspired my long-term goal: integrating data-driven modeling technologies with regulatory decision-making to make the approval of innovative medical devices more scientific, transparent, and efficient. 

Working at the intersection of regulation and innovation, I have observed the growing challenge regulators face in evaluating advanced medical technologies such as AI-assist systems and personalized implants. Traditional preclinical and clinical testing frameworks are often time-consuming, costly, and limited in their ability to predict device behavior under diverse real-world conditions. This realization motivated me to explore how Digital Twin (DT) technology- which creates virtual replicas of physical devices- could be harnessed to transform medical device evaluation.

My proposed PhD. research, titled ''Regulatory Evaluation and Risk Prediction Model for Medical Devices Based on Digital Twin Technology,'' aims to establish a new scientific framework for regulatory assessment. The research will:

• Analyze global regulatory frameworks (FDA, EU, MDR, TFDA) for their applicability to Digital Twin applications.
• Develop a Digital Twin-based risk evaluation model that integrates AI and big data to simulate device performance across patient-specific and environmental variables.
• Demonstrate how virtual simulations can support pre-market testing, enhance post-market surveillance, and reduce dependence on extensive human trials.
• Propose strategies for improving the regulatory acceptance and validation pathways of Digital Twain models.

This topic aligns closely with NTU's research strength in medical imaging, computational modeling, and device innovation, and represents an intersection of my academic and professional experiences. 

My long-term aspiration is to contribute to the emerging field of regulatory science for digital health technologies. Through doctoral research, I aim to develop methodologies that support data-driven, predictive regulatory evaluation for high-risk medical devices.

In addition, I plan to participate in an international internship program within a medical device company for a period of six months to one year during my Ph.D. studies. This experience would allow me to gain first-hand understanding of global regulatory practices strategies in major markets such as the U.S. or European Union. I believe that this international exposure will strength my ability to bridge Taiwan's regulatory framework with global innovation standards.

After completing the Ph.D. program, I plan to:

• Join a company specializing in Digital Twin or smart healthcare technologies to apply my interdisciplinary expertise in regulatory science and digital innovation'
• Collaborates with regulatory agencies and industry partners to established validation guidelines for AI and simulation-based testing, and
• Support the development of Taiwan's digital regulatory ecosystem, aligning it with global standards while fostering innovation.

Ultimately, I aspire to bridge the gap between biomedical research, device engineering, and regulatory policy, contributing to a future where medical device regulation keeps pace with technological advancement while maintaining patient safety and scientific integrity.

The Ph.D. program at the Graduate Institute of Medical Device and Imaging, National Taiwan University, provides the idea platform for me to merge my background in pathology, biomedical science, and regulatory affairs with advanced digital technology research. I am confident that my interdisciplinary training, combined with NTU's world-class academic environment, will enable me to make meaningful contributions to the development of next-generation regulatory science, where innovation and safety coexist through the power of Digital Twin technology.