Overview
The Center for Remote Health Technologies and Systems (CRHTS) enables its partners to efficiently and effectively achieve their goals with tailored approaches designed to meet specific needs such as rapid product design, sophisticated health data analytics or development of technologically advanced modes of health care delivery.
A comprehensive and rigorous validation process helps take a partner’s technology to the next level through a number of services that include software simulation, in vitro test platform and in vivo testing capabilities.
The center’s many capabilities include medical device design, modeling, prototyping, sensor and photonic design, algorithm development, device testing, health systems engineering and validation, including managing animal and human trials.
Research & Development
Innovation is often driven by breakthrough research. CRHTS has a wide range of application knowledge, including the integration of sensors, algorithms and embedded hardware design for glucose sensing, point-of-care diagnostics, patient monitoring and unregulated wearable fitness devices. What’s more, CRHTS expertise extends beyond devices to biocompatible materials such as shape memory polymers, to advanced biomechanical testing, to nanoscale through whole-body imaging, to systems engineering and systems thinking approaches, to animal studies and human population studies.
Test Services
Understanding a health system or device’s full potential is an integral part of the design cycle. CRHTS offers competitive studies for industry partners looking to test their devices against a competitive product or a gold standard in the market. In this capacity, CRHTS leverages its in vitro tissue and blood phantoms, which have the optical properties of tissue, to validate new optical designs, wearable sensors and medical devices.
• Animal and Human Testing
CRHTS in conjunction with the College of Veterinary Medicine and Texas A&M Institute for Preclinical Studies (TIPS) provides small and large animal testing that can be conducted under Good Laboratory Practices (GLP) conditions suitable for FDA reporting. In addition, these translational research studies provide unique access to expertise in all major medical and scientific disciplines including surgery, biomedical engineering, advanced imaging, pathology, radiography, interventional cardiology, neurology, animal behavior, chemistry and engineering.
CRHTS researchers have a wealth of expertise in distributed health systems and controlled human subjects studies and field studies. Working with colleagues in kinesiology, CRHTS provides human subjects studies under controlled conditions, including short-term treadmill and exercise studies and overnight studies along with a host of testing capabilities from blood draws to muscle biopsies. Working with colleagues at the Texas A&M Health Science Center and the School of Public Health, CRHTS also has the capacity to conduct field studies that include children, the elderly as well as occupational studies.
Licensing
CRHTS welcomes opportunities to work with companies in the successful translation of research to commercial products. The center actively seeks opportunities for companies to license medical device designs, diagnostic and algorithm intellectual property (IP), and engineered systems IP. CRHTS works closely with the Texas A&M University System Office of Technology Commercialization to translate IP out of the university as well as to help companies efficiently translate research ideas through the design process into commercial products.
Regulatory Advice
CRHTS provides consulting services to assist in meeting all regulatory requirements such as demonstration of substantial equivalence for a medical device; implementation of a quality management system that complies with FDA Quality System Regulation (QSR); or the obtaining of a 510(k) premarket notification clearance.