Mingfu Chen
Scientist | IVD & Device Development Leader | Driving Assay Development for Regulatory Success | FDA 510(k) Submission, Device Verification & Validation, Diagnostics
Based in San Diego
About
What if rapid, accurate blood diagnostics could transform everyday healthcare? This question has fueled my journey from early work in biomaterials to leading assay innovation in the In Vitro Diagnostic (IVD) industry. As a curious scientist captivated by the intersection of chemistry and biology, I earned a PhD in Biomedical Engineering and joined Truvian, where I developed and validated blood diagnostic devices that meet rigorous FDA standards. I have transitioned from hands-on experimentation to leading analytical studies, development and understanding of comprehensive technology standards and practices, and translating scientific innovation into real-world solutions for patient care. Some of my proudest achievements include: • Proven track record in designing and executing 19 analytical studies supporting FDA 510(k) submissions, including sensitivity, specificity, linearity, precision, and sample stability. • Developed robust protocols improving accuracy and reproducibility for 14 Clinical Chemistry assays—representing 50% of the company’s test offerings and directly enhancing patient outcomes. • Spearheaded cross-functional efforts to troubleshoot and resolve manufacturing challenges, enhancing device reliability and regulatory compliance • Authored/co-authored 15+ peer-reviewed publications and delivered 15+ presentations, advancing knowledge in IVD assay development. I am always eager to connect with scientists, clinicians, and innovators pushing diagnostics forward. If you’re interested in collaboration, sharing insights, or new opportunities in IVD and blood diagnostics, let’s start a conversation. Specialties: Assay Development, In Vitro Diagnostics, FDA 510(k) Submission, Device Verification and Validation, Blood Diagnostics, Analytical Studies, Cross-Functional Collaboration, Data Analysis, Troubleshooting, Regulatory Compliance
Looking to connect with
Medtech professionals (In Vitro Diagnostic (IVD), Medical Device)
Hobbies & interests
Hiking, Homebrewing, Pancakes
Experience
- Scientist | IVD & Device Development Leader | Driving Assay Development for Regulatory Success at Boston University
Interests & expertise
Interests: Expand network, Explore career opportunities
Functions: Engineering
Roles: Professional
Industries: BioTech, Life Science, MedTech