SurgNow

Carolina Alvarez, MD1; Zachary Riggenbach, MD1; Kristin Clark, MD1; Timothy Veit, DO1; Allison Edinger, MS2; Kalean Salcedo, BS2; Diane Goldenberg, PhD3; Tyler Young, BS3; John Kuckelman, DO1; Jason Bingham, MD1; Ross Donaldson, MD3 1Madigan Army Medical Center, Tacoma, WA; 2The Geneva Foundation, Tacoma, WA; 3Critical Innovations, Lawndale, CA

: On-demand Manufacturing Of Surgical Instruments

Objective

The SurgNow

• Addresses gaps in surgical readiness and instrument availability during forward or austere operations.

• Enables on-demand, distributed manufacturing for rapid production, inspection, and qualification of instruments directly at the point of use under Good Manufacturing Practice (GMP) and Quality Management System (QMS) standards.

  Goal

  To reduce logistical vulnerability, enhance operational autonomy, and transform surgical capability in remote, contested, or resource- constrained environments.

  Disclaimers: Funded by the Defense Health Agency, Combat Casualty Care Portfolio under Other Transactions Number W81XWH‐15‐9‐0001. Opinions, findings and conclusions, or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of the Army, the Department of War or the U.S. Government. This technology is investigational and not approved by the FDA for human use.

Technology

Self-contained production system for FDA- approved instruments integrating:

• Additive manufacturing

• In-line inspection

• Digital process monitoring and traceability

• Certified medical device quality system oversight

Designed for point-of-care production of sterile-ready surgical instruments.

Fig 1. The SurgNowTM printer developed by Critical Innovations

Preliminary Results

• Prototype platform developed and operational (Fig 1)

• Instrument prototypes undergoing performance refinement (Fig 2)

• Operates with certified medical device quality framework

• Benchtop testing and validation studies planned

User evaluation studies

• Ex-vivo models
• Live-tissue models (IACUC approved) • Cadaveric models (IRB approved)

Future Directions

• User interface refinement

• Sterilization protocol development

• Field-ready packaging

• Regulatory transition (Class 510(k)- exempt instruments)

• FDA clearance pathway for commercial distribution

• Validation under field conditions

system:

Fig 2. SurgNowTM printed instruments made from various thermoplastics