Pioneering next-generation surgical solutions through rigorous innovation and clinical excellence
Our R&D portfolio spans multiple domains of women's surgical care, each addressing specific clinical challenges with innovative technological approaches.
Developing advanced surgical instrumentation and integrated energy delivery systems designed to improve precision, reduce operative time, and enhance patient safety during complex gynecologic procedures.
Creating objective measurement systems that standardize clinical assessment and provide reproducible, data-driven diagnostic capabilities for pelvic floor disorders.
Engineering precision delivery systems that enable accurate, reproducible performance of office-based and ambulatory surgical procedures with enhanced ergonomics and reduced variability.
Advancing laparoscopic and robotic-assisted surgical techniques through novel device designs that reduce tissue trauma, minimize complications, and accelerate patient recovery.
Incorporating digital health technologies and analytics platforms to support clinical decision-making, outcomes tracking, and continuous quality improvement.
Applying human factors engineering principles to create intuitive, surgeon-friendly devices that reduce learning curves and enhance procedural reproducibility across diverse clinical settings.
Our development process follows rigorous, stage-gated methodology to ensure safety, efficacy, and clinical value at every milestone.
Clinical needs assessment, voice-of-customer research, and feasibility analysis
Design verification, bench testing, and iterative refinement of device concepts
Rigorous testing protocols including mechanical, electrical, and biocompatibility studies
Human factors validation and multicenter clinical trials demonstrating safety and performance
Comprehensive regulatory submissions and quality management system compliance
Market introduction with ongoing post-market surveillance and continuous improvement
Our multidisciplinary team brings together expertise across engineering, clinical medicine, regulatory science, and manufacturing to deliver innovative solutions.
Advanced mechanism design, precision manufacturing, and materials science expertise
Energy delivery platform integration, electrical safety testing, and thermal management
Precision measurement systems, calibration methodologies, and signal processing algorithms
Embedded systems, cloud platforms, and data analytics infrastructure for connected devices
Study design, biostatistics, and evidence generation through rigorous clinical investigation
FDA submission strategies, ISO compliance, and global regulatory pathway development
Design controls, risk management per ISO 14971, and quality system implementation
Contract manufacturing relationships, process validation, and supply chain management
Direct surgeon input and patient outcome data guide every design decision
Rigorous preclinical and clinical testing validates safety and performance claims
Continuous improvement through user feedback and post-market surveillance
Comprehensive risk management and failure mode analysis throughout development
Designing solutions that can be deployed across diverse healthcare settings globally
Leveraging real-world evidence to continuously enhance device performance
We welcome collaboration with leading research institutions, clinical investigators, industry partners, and investors who share our commitment to advancing women's health.
Explore Collaboration Opportunities