Obsidian precision for the next generation of surgical cutting.
Silica Medical is developing ultra-sharp, single-use volcanic-glass blade technology for specialty surgical, research, and training applications. We are testing edge geometry and incision performance in partnership with surgeons and researchers.
Technology
Silica Medical is developing surgical blades from high-quality volcanic-glass obsidian, a material known for exceptional edge sharpness and geometry precision.
Edge Sharpness and Geometry
Obsidian naturally fractures along precise geometric planes, creating exceptionally sharp edges. We are testing whether this precision benefits specialty surgical applications, particularly in procedures requiring minimal tissue trauma and clean incision margins.
Material Characteristics
We source high-quality obsidian from controlled geological deposits and validate composition, purity, and consistency across production lots. Each blade is subject to edge-radius verification and performance testing to ensure reliability for research and evaluation use.
Product Variants (Concepts)
SilicaEdge™ (placeholder name, pending attorney clearance) is being developed in multiple variants:
• Research / Training
• Dermatology / Microsurgery
• Veterinary specialty
• Ophthalmic / Neurosurgical
These are concepts under active evaluation. No products are currently available for sale.
Quality and Safety
All blades undergo obsidian source verification, fracture control assessment, edge inspection, and sterility validation. We are developing quality systems aligned with medical-device standards to ensure safety and reliability for research and training use.
Research Evaluation Program
Silica Medical is recruiting surgeons, researchers, and surgical-training institutions to evaluate our technology and provide feedback on edge performance, handling, and potential applications.
For Surgical Skills Labs
Evaluate obsidian blades in training environments. Assess handling characteristics, edge durability, and surgeon comfort with the material compared to conventional options. Provide feedback on practice applications and breakage patterns.
For Research Teams
Collaborate on bench testing and tissue-incision analysis. Test edge geometry, cutting force, tissue response, and incision margin quality. Help us validate performance claims for research-use applications.
For Specialty Surgeons
Partner with us to explore potential use cases in dermatology, microsurgery, ophthalmology, or other specialty domains. Provide clinical observations and expert guidance on whether obsidian technology offers advantages in your field.
Evaluation Benefits
Evaluation participants receive access to our research findings, direct communication with our team, and the opportunity to shape the development of this technology. Participation is provided at no cost.
Join the Evaluation Program
If you represent a surgical-training institution, research team, or specialty surgical practice, we welcome your participation. There is no cost to evaluate our technology or provide feedback.
Apply NowRegulatory & Quality
Silica Medical is committed to responsible development. A blade used for surgery is a medical device, and regulatory compliance is foundational to our strategy.
Regulatory Strategy
We are working with regulatory counsel to determine the appropriate classification pathway for our technology. Because we are using a novel material (obsidian) in a surgical context, we are treating this as a Class II or higher device that may require predicate device analysis and clinical evidence.
Our current evaluation phase focuses on research-use and training applications, which carry different regulatory requirements than clinical-use claims. We will not make clinical efficacy claims until regulatory counsel confirms they are permitted and appropriate clinical evidence supports them.
Quality and Safety Standards
We are designing our manufacturing and quality processes to align with ISO 13485 (medical-device quality systems) and FDA regulations for manual surgical instruments. This includes:
- Obsidian source verification and material characterization
- Edge geometry and sharpness testing
- Breakage and durability assessment
- Sterile packaging validation
- Lot traceability and device history records
- Risk management and complaint handling
Claims Discipline
Silica Medical does not make claims about efficacy, safety comparisons to steel, or clinical outcomes without regulatory approval and supporting evidence. We describe our product as:
- "Developing" obsidian blade technology
- "Intended for specialty precision applications" and "research-use evaluation"
- "Testing edge geometry and incision performance"
Claims we avoid (without regulatory and clinical validation): "FDA approved," "safer," "scarless," "better healing," "replaces steel," "clinically proven," "used in human surgery."
Biocompatibility and Material Safety
Obsidian is an inert volcanic glass with no known biocompatibility concerns, but we are validating this through appropriate testing. We assess:
- Material composition and contaminant testing
- Surface characteristics after sterilization
- Tissue contact safety for research-use applications
- Particulate and breakage risk mitigation
Surgeon Advisory Program
Silica Medical is recruiting experienced surgeons and surgical educators to serve as advisors during our development phase. Advisors help us understand surgical requirements, validate concepts, and ensure our technology is developed responsibly.
What We're Looking For
We seek surgeons with expertise in microsurgery, dermatology, general surgery, ophthalmology, or other specialty domains who are interested in surgical innovation and willing to evaluate new materials and techniques.
Time Commitment
We anticipate 4–8 hours per quarter for feedback, evaluation, and strategy discussions. Advisors have input into our development priorities and regulatory strategy.
Confidentiality and IP
Advisors agree to standard confidentiality agreements. We are open to discussing IP sharing and advisory-board positions for the right partners as the company scales.
Compensation
We are currently recruiting advisors for our validation phase. Compensation will be discussed individually based on scope, time commitment, and seniority.
Become a Surgeon Advisor
If you are interested in advising Silica Medical, please reach out. We welcome conversations about how we can work together.
Contact UsGet In Touch
Interested in the evaluation program, technical information, or partnership? Send us a message and we'll get back to you.