Areas of Expertise

Gastrointestinal

Bariatric devices must prove therapeutic effectiveness in severely obese patients with altered anatomy and metabolic dysfunction. Surgical robotics face precision demands at the tissue level. Your robotic platform needs submillimeter articulation accuracy during actual procedures, and your tissue sealant must prevent anastomotic leaks under intestinal pressure.

Surgical testing facility with robotic platform and equipment for GI device validation

Our GI Device Expertise

Your tissue sealant has to prevent anastomotic leaks under intestinal pressure. Each device type requires specialized testing approaches. Our surgical suites and obesity models replicate the conditions your device will face clinically.

We have worked with surgical devices for 40 years. That means specialized infrastructure, validated disease models, and regulatory success that general facilities can't match. We understand what makes GI testing different.

Complete Gastrointestinal Capabilities

Bariatric Therapies

Here's the bariatric device challenge. Your device must prove therapeutic effectiveness in severe obesity conditions with metabolically dysfunctional environments and altered anatomy under sustained mechanical stress. We test bariatric devices using obesity models that replicate metabolic dysfunction and obesity anatomy. We assess device durability, tissue response at implant interfaces, and weight management effectiveness. Our protocols address both 510(k) and PMA pathways from adjustable gastric bands to endoscopic sleeve positioning.

Robotics

Robotic surgery promises precision, but teleoperation accuracy must translate to actual tissue manipulation during procedures. Your articulating instruments need to perform through complex motion sequences. We test instrument performance measuring force feedback accuracy, tremor filtration, jaw closure forces, and articulation precision across multiple degrees of freedom. Our surgical suites accommodate complete robotic platforms configured to match OR setups, enabling comprehensive validation per ASTM surgical device standards.

Sealants

Anastomotic leaks are serious complications. Your sealant must prevent them with adhesion strength sufficient to withstand intestinal pressure and support tissue healing without inflammation. We measure seal integrity using burst pressure protocols and assess healing quality and biocompatibility at application sites. Our GLP protocols support submissions across fibrin-based, synthetic polymer, and biological platforms following ISO 10993 and ASTM surgical sealant standards for GI applications.

Ready to Start Your Gastrointestinal Program?

Let's discuss your device and what regulatory pathway makes sense. We'll design a validation strategy that addresses your specific GI device challenges.

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