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
- Regenerative medicine
- Respiratory
- Urogenital
- Women’s health
- Wound healing
- Hemostasis
- Hernia repair
- Tendon repair
- General surgery / surgical wounds
- Adhesion models