Biomedical Devices Overview

Biomedical technology broadly refers to the application of engineering and technology principles to the domain of living or biological systems. Usually, the inclusion of the term biomedical denotes a principal emphasis on problems related to human health and diseases, whereas terms like “biotechnology” can be medical, environmental, or agricultural in the application. But most terms in this general realm still lack clear boundaries. Biomedical engineering and Biotechnology alike are often loosely called Biomedical Technology or Bioengineering. The Biomedical technology field is currently growing at a rapid pace. Required jobs for the industry expect to grow 23% by 2024.

Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life,
  • control of conception,
  • disinfection of medical devices
  • providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

Monitoring of Tacrolimus in Oral Fluids

INVENTORS • Fatemeh Akhlaghi, Mwlod Ghareeb


This is a novel, highly reproducible method for the measurement of tacrolimus in oral fluid samples. The technology uses validated liquid chromatography-tandem mass spectrometry methods (LC-MS/MS), and can potentially provide improved patient safety and allograft survival rates.


Tacrolimus is a widely prescribed immunosuppressive agent to prevent allograft loss for the solid organ transplantation market. Ongoing therapeutic monitoring of tacrolimus, when prescribed to organ transplant patients, is crucial to prevent organ rejection. Maintenance of optimal therapeutic concentrations will improve allograft survival rates and reduce nephrotoxicity. Oral fluid concentrations provide the added benefit of monitoring free or pharmacologically active forms of tacrolimus (see schematic diagram below).


• Less invasive than current methods – Patient self-sampling with saliva eliminates need
for blood samples.
• Eliminates need for healthcare provider to administer test.
• Less costly –specialized collection facilities no longer needed.
• Improves transplant patient safety and survival
• Non-invasive estimate of total exposure (area under concentration-time curve (AUC)
• Simple method for estimating pharmacologically active tacrolimus
Technology is available for licensing.
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Integrated Finite Element and Circulatory Model for Predicting Hemodynamic Effects of Left Ventricular Impairment, Resynchronization, and Remodeling

INVENTORS • Ying Sun, Frederick J. Vetter, Rumei Dong, Salvatore A. Chiaramida


This invention and the associated software provide a useful platform for modeling and simulation that assists the development and operation of a variety of medical devices pertaining to cardiovascular diseases. The computational model determines the dynamics of a left ventricle continuously over consecutive cardiac cycles by integrating finite element model of the left ventricular wall with a complex electrical analog circulatory model. It allows prediction of hemodynamic outcome of a regional left ventricular impairment.


• Ventricular restoration surgery
• Surgical treatment of heart failure
• Cardiac resynchronization therapy using biventricular pacing
• Cardiovascular medical devices
• Pharmaceutical research


• Dynamic and efficient integration of complex
electrical circulatory model with finite element model.
• Effective for both transient and steady states of cardiovascular dynamics.
• Predicts hemodynamic effects of action potential propogation.
• Many cardiac cycles can be processed continuously to reveal transient phase quickly.
• Model generates realistic hemodynamic waveforms in response to physiological variables.
• The model can assess outcomes of
– left ventricle infarction
– cardiac resynchronization therapy
– ventricular restoration surgery
US #8295907
Technology is available for licensing.
URI# 04-1115
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