A Look at Nanopath’s Efforts Towards Digital Transformation

At MDIC, we are committed to accelerating the development of safe and effective medical technologies through innovative advanced manufacturing solutions. Our collaboration with Nanopath, an early-stage molecular diagnostics company developing cutting-edge platforms for rapid, point-of-care diagnosis of pelvic and gynecologic infections, exemplifies the benefits of MDIC’s Advanced Manufacturing Clearing House (AMCH) in supporting innovative companies to enhance manufacturing efficiency, increase product quality, and optimize development processes.

This use case explores Nanopath’s application of simulation-aided design to provide a digital twin that allows for rapid optimization of their diagnostic sensor’s architecture before moving to empirical testing, saving time and resources while enhancing product performance. Nanopath’s approach delivered fast, ultra-sensitive detection of viral, bacterial, and fungal pathogens, addressing a critical need for accurate and reliable diagnostics.

With MDIC’s guidance and resources, Nanopath successfully implemented advanced manufacturing approaches to enhance their cutting-edge nanobiosensor platform. By integrating simulation-aided design early in their product lifecycle, Nanopath streamlined the design process, achieving remarkable improvements in sensitivity, efficiency, and cost-effectiveness.

Our partnership empowered Nanopath to optimize end-to-end product manufacturing within the United States prior to FDA clearance—demonstrating the potential of advanced manufacturing to accelerate regulatory pathways and improve patient access to high-quality diagnostics.

Nanopath’s Results Implementing Simulation-aided Design

• 100X Improvement in Performance: Achieving unprecedented operational efficiency through advanced manufacturing techniques.
• 25X Reduction in Manpower & Time: Streamlined processes to significantly reduce resource needs and accelerate timelines.
• ~100% Return on Investment in One Month: Immediate economic value demonstrating exceptional ROI.
• 50X Reduction in Sensor Cost at-scale: Enhanced manufacturing capabilities to drastically lower sensor production costs.
• 18X Improvement in Signal-to-Noise: Improved precision and data accuracy for higher quality diagnostics.
• Positive Impact on Employee Satisfaction: Boosting morale through enhanced processes and clear operational improvements.
• Improved Institutional Knowledge: Strengthened knowledge sharing and retention throughout the organization.

At MDIC, we are proud to support innovative companies like Nanopath in their mission to transform women’s health and IVD innovation. Through our Center for Manufacturing Innovation and Quality, we are working to expand these capabilities across the medical device industry. Learn more at mdic.org/amch.