“The term ‘T.5’ highlights the bidirectional, interdisciplinary, and intersectoral nature of preclinical R&D, and the role that testing and optimization in this phase has on outcomes at T1 and beyond. The Tufts CTSI T.5 program brings resources and perspectives to shift the focus from translation to transformation.”

Elazer Edelman, MD, PhD, SM, SB
Director, T.5 Capacity in Medical Devices

Overview

The T.5 Capacity in Medical Devices program (T.5), located at Massachusetts Institute of Technology (MIT), addresses the challenges of bridging critical translation from preclinical development to initial human studies. We facilitate research teams at the early, pre-T1 translational stage (T.5), to efficiently turn device concepts into testable prototypes and effectively incorporate clinical insights into the full span of preliminary R&D. Successfully traversing this translational process requires specialized facilities and tools, and close collaboration between large and diverse groups of scientists, engineers, biomedical researchers, and clinical care providers. We believe that by using clinical data to fine-tune early device testing and design, promising ideas are more likely to reach medical application.

Who is eligible?

T.5 consultations are available to faculty members and trainees.
Some T.5 services are offered at no cost to faculty members and trainees at institutions affiliated with Tufts CTSI; other services are offered for a fee and are available to anyone. Submit a service request to learn more.

Resources and Services

Clinical Research Center

General

  • Experienced clinical research staff: RNs, NPs, MDs
  • Research technicians

Pre-Clinical Support

  • Proof-of-concept testing
  • Computational simulation
  • Animal models/tissue harvest

Early Human Participant Research

  • Study planning/operationalization
  • Regulatory consultation (IRB, FDA, etc.)
  • Clinical standard of care test equipment and monitors
  • Physiological monitoring (rest, exercise)
  • Metabolic/neurobehavioral monitoring
  • Specimen collection and processing

T.5 Translational R&D Laboratory

  • Translational design specifications
  • Clinical application identification
  • Device design
  • Prototyping (minimally viable prototype to clinically testable systems)
    • On-site mechanical equipment: CAD software, SLA 3D Printing, pre-clinical- and clinical-grade sterilization, precision machining tools, industrial inspection stereoscope
    • On-site electrical equipment: Sensor connectivity using a National Instrument PXI Platform with diverse monitoring and control functions (e.g., oscilloscope, multiplexers, network analyzer, wireless support)
  • Manufacturing access
  • Medical device Good Laboratory, Manufacturing & Clinical Practice training (GLP, GMP, GCP)
  • Test environments for medical sensor evaluation
  • Reconfigurable equipment (e.g., retrofit ICU bed, surgical table, at home settings)
  • User control of physical parameters (e.g., noise, light, vibration, interference)
  • Support first-in-human to clinical sites transitions
  • Regulatory consultation (IRB, FDA, etc.)

T.5 Navigators also help Tufts CTSI partners and collaborators to locate and gain access to makerspaces, fabrication facilities, imaging, and other engineering/scientific/clinical study support at MIT.

Contact

To contact us, please submit a service request.

 

Elazer Edelman, MD, PhD, SM, SB, Director, T.5 Capacity in Medical Devices

Kumaran Kolandaivelu, MD, PhD, Associate Director, T.5 Capacity in Medical Devices

Catherine Ricciardi, NP, DNP, MIT Clinical Research Center (CRC) Nursing Director