Extensive Experience in the Evaluation of Medical Devices

Our expertise ranges from early device iteration, optimization, and mechanistic studies aimed at driving differentiation in the marketplace, to large-scale GLP safety assessments for regulatory submissions.

State-of-the-art medical device testing

We profile the safety and efficacy of implanted devices and combination products, and develop novel testing and assessment procedures with multiple regulatory compliances.

• Open paradigm of collaboration as a non-profit (501(c)(3)) institute
• Operational compliance and accreditation - GLP, OLAW, AAALAC
• Animal sciences expertise - full-time ACLAM-certified DVMs
• Experts in safety - full-time boarded DACVPs
• Full histology suite for all phases of embedding, sectioning, staining and imaging
• Customizable mechanical testing of both biomaterials and biological tissues
• Leaders in computational modeling of combination drug and energy delivery devices

Fully-equipped operating suites

We enable complex surgical procedures in our state-of-the-art facilities.

• Extensive surgical expertise in small and large animal models
• Multiple, fully-equipped ORs with anesthesia machines, ventilators, hemodynamic and airway gas monitoring systems
• Multiple surgery tables and hospital-grade fluoroscopy systems, including dedicated prep and recovery rooms for each suite
• Catheterization lab
• Adjoining conference facilities with 2-way video and audio

GLP-compliant imaging modalities

• Laparoscopic/Endoscopic Olympus towers
• OEC® Digital Fluoroscopy
• GE Innova System/3-D Angiography
• Computed Tomography (CT) and Optical Coherence Tomography (OCT)
• EP Mapping and Electrophysiology
• Ultrasound in a wide range of clinical applications, including Intravascular (IVUS), Transthoracic (TTE), Trans-esophageal (TEE), and Intra-cardiac (ICE) procedures
• Faxitron: Bench-top x-ray enables high resolution imaging of specimens and devices ex vivo
• Scanning Electron Microscopy (SEM)

Therapeutic areas and technical acumen

• Interventional cardiology
• Cardiovascular surgery
• Structural heart therapies
• Dermal
• Electrophysiology
• Gastrointestinal / bariatric
• Plastic & reconstructive surgery
• Laparoscopic / endoscopic procedures
• Neurological
• Oncology
• Opthalmology
• Orthopedic
• Otology
• Regenerative medicine
• Respiratory
• Urogenital
• Women’s health
• Wound healing
• Hemostasis
• Hernia repair
• Tendon repair
• General surgery / surgical wounds
• Adhesion models