Anand Navalgund

About Anand Navalgund

Directing clinical, manufacturing and R&D efforts at G-Tech Medical, our team has pioneered the GutTracker, revolutionizing GI disorder diagnostics. My role intersects leading-edge wearables technology with robust clinical operations, underpinned by a commitment to patient-centered healthcare.Our collaborations have led to an expanded FDA 510(k) indication, multiple peer-reviewed publications, and prestigious awards, reflecting a steadfast dedication to improving outcomes. With over a decade at G-Tech, I have honed a unique expertise in bridging technology with patient needs, driving innovation in healthcare systems.

Experience

1. Director, Clinical, R & d, and Manufacturing

   G-Tech Medical

   Sep 2011 — Present · Fogarty Institute for Innovation, CA

   Led the development of the innovative GutTracker device, a wireless system transforming GI disorder diagnostics from concept to the final commercial product. Generated clinical evidence, established a robust quality system, and coordinated supply chain and manufacturing operations. • Architected and submitted the premarket 510(K) submission (Class II device) for the GutTracker, coordinating with external laboratories to design and execute testing within strict timelines for compliance to relevant aspects of IEC 60601 and ISO 10993. Application was approved by the FDA in only 90 days. • Cultivated strong collaborations with leading institutions, including Mayo Clinic, Yale University, Beth Israel, Stanford Hospital, and Children’s Hospital of Philadelphia. Managed 18 clinical sites with over 1500 patients recruited. These efforts contributed to an expanded FDA 510(k) indication, five peer reviewed publications, 36 poster presentation, five podium presentations, and six awards.• Created and managed the entire design control process from start to finish, including developing requirements and specifications, leading the risk analysis process, developing and executing verification and validation testing and transferring the product to manufacturing. • Developed a tailored quality system in compliance with 21 CFR 820, successfully clearing the California Food and Drug Branch audit and obtaining and maintaining the manufacturing license.• Qualified the contract manufacturers and coordinated design to manufacturing of the GutTrackerTM device. Conducted on site manufacturing audits in Juarez, Mexico and remote audits in Taipei, Taiwan. Achieved an average yield improvement of 80%.• Built a custom Tkinter based GUI for exploratory analysis and investigations of time series data across multiple patients and sites at a cohort level. Designed the GutTracker report, built and verified the custom software to generate and provide the report to the Physician

Education

• National Institute of Technology Karnataka

  BE, Mechanical Engineering

• The Ohio State University

  MS, Mechanical Engineering

• The Ohio State University

  PhD, Biomedical Engineering

Skills

• Biostatistics
• Algorithms
• Life Sciences
• Product Development
• Biomechanics
• Project Management
• Biotechnology
• Javascript
• Statistics
• Biomedical Engineering
• C
• Lifesciences
• Signal Processing
• Pattern Recognition
• Data Analysis
• Characterization
• Grant Writing
• Testing
• Healthcare
• Ip
• Biomaterials
• Tissue Engineering
• Sensors
• Machine Learning
• Simulations
• Emg
• Python
• Physiological Signals
• Medical Imaging
• Labview
• Data Acquisition
• Experimentation
• Matlab
• Medical Devices
• Clinical Research
• Image Analysis
• R&D
• Image Processing