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Introduction
Publications
Publications (48)
Advanced driver assistance systems (ADAS) have been developed to enhance driving safety by issuing timely warnings to drivers. However, current ADAS do not take into account the driver's cognitive state when delivering warnings, which can result in false alarms and impact the driver's trust in the system. To address this issue, we propose a Cogniti...
As autonomous vehicles (AVs) become more prevalent on public roads, they will inevitably interact with human-driven vehicles (HVs) in mixed traffic scenarios. To ensure safe interactions between AVs and HVs, it is crucial to account for the uncertain behaviors of HVs when developing control strategies for AVs. In this paper, we propose an efficient...
As autonomous vehicles (AVs) continue to be integrated into public roads, it is inevitable that they will interact with human-driven vehicles (HVs) in a mixed traffic environment. In such traffic scenarios, it is crucial to consider the reactive and uncertain behavior of HVs when developing control strategies for AVs. This paper investigates the sa...
With the rapidly increasing popularity of 5G mobile technology, the effect of radiofrequency radiation on human health has caused public concern. This study explores the effects of a simulated 3.5 GHz radiofrequency electromagnetic radiation (RF-EMF) environment on the development and microbiome of flies under intensities of 0.1 W/m², 1 W/m² and 10...
This study aimed to investigate alterations in the activity and sleep of Drosophila melanogaster under simulated microgravity, which was implemented through the random positioning machine, while different light conditions (normal photoperiod and constant dark) were set. Fruit flies of different strains and sexes were treated for 3 days, and activit...
With the rapid development of science and technology, 5G technology will be widely used, and biosafety concerns about the effects of 5G radiofrequency radiation on health have been raised. Drosophila melanogaster was selected as the model organism for our study, in which a 3.5 GHz radiofrequency radiation (RF-EMR) environment was simulated at inten...
Response surface methodology (RSM) was applied to obtain the optimal extraction yield of total protein from Caulerpa lentillifera. The effects of liquid-material ratio, crushing grinding power, crushing grinding time, and reaction temperature on the extraction yield of protein were investigated, respectively. Based on single factor tests, RSM with...
An Implantable Cardioverter Defibrillator (ICD) is a medical device used for the detection of potentially fatal cardiac arrhythmias and their treatment through the delivery of electrical shocks intended to restore normal heart rhythm. An ICD reprogramming attack seeks to alter the device's parameters to induce unnecessary therapy or prevent require...
An Implantable Cardioverter Defibrillator (ICD) is a medical device used for the detection of potentially fatal cardiac arrhythmias and their treatment through the delivery of electrical shocks intended to restore normal heart rhythm. An ICD reprogramming attack seeks to alter the device’s parameters to induce unnecessary therapy or prevent require...
The feature interaction problem occurs when two or more features interact and possibly conflict with each other in unexpected ways, resulting in undesirable system behaviors. Common approaches to resolving feature interactions are based on priorities, which are ineffective in scenarios where the set of features may evolve past the design phase, and...
Driving is a social activity which involves endless interactions with other agents on the road. Failing to locate these agents and predict their possible future actions may result in serious safety hazards. Traditionally, the responsibility for avoiding these safety hazards is solely on the drivers. With improved sensor quantity and quality, modern...
An Implantable Cardioverter Defibrillator (ICD) is a medical device used for the detection of potentially fatal cardiac arrhythmia and their treatment through the delivery of electrical shocks intended to restore normal heart rhythm. An ICD reprogramming attack seeks to alter the device's parameters to induce unnecessary shocks and, even more egreg...
In this paper we aim to answer the question, "How can modeling and simulation of physiological systems be used to evaluate life-critical implantable medical devices?" Clinical trials for medical devices are becoming increasingly inefficient as they take several years to conduct, at very high cost and suffer from high rates of failure. For example,...
In this paper we aim to answer the question, ``How can modeling and simulation of physiological systems be used to evaluate life-critical implantable medical devices?'' Clinical trials for medical devices are becoming increasingly inefficient as they take several years to conduct, at very high cost and suffer from high rates of failure. For example...
Regulatory authorities require that the safety and efficacy of a new high-risk medical device be proven in a Clinical Trial (CT), in which the effects of the device on a group of patients are compared to the effects of the current standard of care. Phase III trials can run for several years, cost millions of dollars, and expose patients to an unpro...
Autonomous medical devices such as implantable cardiac pacemakers are capable of diagnosing the patient condition and delivering therapy without human intervention. Their ability to autonomously affect the physiological state of the patient makes them safety-critical. Sufficient evidence for the safety and efficacy of the device software, which mak...
Bringing new safety-critical medical devices to market faces several major challenges, but modeling and formal methods can facilitate this process from early system requirements verification to platform-level testing to late-stage clinical trials.
Ventricular Fibrillation is a disorganized electrical excitation of the heart
that results in inadequate blood flow to the body. It usually ends in death
within seconds. The most common way to treat the symptoms of fibrillation is to
implant a medical device, known as an Implantable Cardioverter Defibrillator
(ICD), in the patient's body. Model-bas...
The design of bug-free and safe medical device software is challenging, especially in complex implantable devices. This is due to the device's closed-loop interaction with the patient's organs, which are stochastic physical environments. The life-critical nature and the lack of existing industry standards to enforce software validation make this an...
The design of bug-free and safe medical device software is challenging, especially in complex implantable devices. This is due to the device's closed-loop interaction with the patient's organs, which are stochastic physical environments. The life-critical nature and the lack of existing industry standards to enforce software validation make this an...
Medical device is a typical Cyber-Physical System and ensuring the safety and efficacy of the device requires closed-loop verification. Currently closed-loop verifications of medical devices are performed in the form of clinical trials in which the devices are tested on the patients.
Implantable cardiac pacemakers restore normal heart rhythm by delivering external electrical pacing to the heart. The pacemaker software is life-critical as the timing of the pulses determine its ability to control the heart rate. Recalls due to software issues have been on the rise with the increasing complexity of pacing algorithms. Open-loop tes...
Software-based control of life-critical embedded systems has become increasingly complex, and to a large extent has come to determine the safety of the human being. For example, implantable cardiac pacemakers have over 80,000 lines of code which are responsible for maintaining the heart within safe operating limits. As firmware-related recalls acco...
The design and implementation of software for medical devices is challenging due to the closed-loop interaction with the patient, which is a stochastic physical environment. The safety-critical nature and the lack of existing industry standards for verification make this an ideal domain for exploring applications of formal modeling and closed-loop...
Implantable cardiac pacemakers restore normal heart rhythm by delivering external electrical pacing to the heart. The pacemaker software is life-critical as the timing of the pulses determine its ability to control the heart rate. Recalls due to software issues have been on the rise with the increasing complexity of pacing algorithms. Open-loop tes...
The design and implementation of software for medical devices is challenging due to their rapidly increasing functionality and the tight coupling of computation, control, and communication. The safety-critical nature and the lack of existing industry standards for verification, make this an ideal domain for exploring applications of formal modeling...
The heart is the most important natural realtime system and its interaction with an implantable artificial pacemaker make for a perfect example of a Cyber-Physical System. The increasing complexity in implantable cardiac device software has been responsible, in part, for the surge in device recalls due to firmware problems. To ensure the safety and...
Model-Driven Design (MDD) of cyber-physical systems advocates for design procedures that start with formal modeling of the real-time system, followed by the model's verification at an early stage. The verified model must then be translated to a more detailed model for simulation-based testing and finally translated into executable code in a physica...
The design and implementation of software for medical devices is challenging due to their rapidly increasing functionality and the tight coupling of computation, control, and communication. The safety-critical nature and the lack of existing industry standards for verification, make this an ideal domain for exploring applications of formal modeling...
The design of bug-free and safe medical device software is challenging, especially in complex implantable devices that control and actuate organs in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators between 1990 and 2000 affected over 600 000 devices. Of these, 200 000 or 41% were due to firmware issue...
Implantable cardiac devices such as artificial pacemakers deliver therapies according to the timing information from the heart. Such devices work under the assumptions of perfect sensing, which are: (a) the pacemaker leads remain in place, and (b) the pacing therapy in one chamber (e.g. atrium) is insulated from the other chambers (e.g. ventricles)...
The increasing complexity of software in implantable medical devices such as cardiac pacemakers and defibrillators accounts for over 40% of device recalls. Testing remains the principal means of verification in the medical device certification regime. Traditional software test generation techniques, where the tests are generated independently of th...
The increasing complexity of software in implantable medical devices such as cardiac pacemakers and defibrillators accounts for over 40% of device recalls. Testing remains the principal means of verification in the medical device certification regime. Traditional software test generation techniques, where the tests are generated independently of th...
We present the design of an integrated modeling platform to investigate efficient methodologies for certifying medical device software. The outcome of this research has the potential to expedite medical device software certification for safer operation. Our specific focus in this study is on our ongoing research in artificial pacemaker software. De...
Artificial pacemakers are one of the most widely-used implantable devices today, with millions implanted worldwide. The main purpose of an artificial pacemaker is to treat bradycardia, or slow heart beats, by pacing the atrium and ventricles at a faster rate. While the basic functionality of the device is fairly simple, there are many documented ca...
Designing bug-free medical device software is dif- ficult, especially in complex implantable devices that may be used in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators due to firmware problems between 1990 and 2000 affected over 200,000 devices, comprising 41% of the devices recalled and are increas...
Designing bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. In the 20-year period from 1985 to 2005, the US Food and Drug Administration's (FDA) Maude database records almost 30,000 deaths and almost 600,000 injuries from device failures [8]. There is currently no fo...
Designing bug-free medical device software is difficult, especially in complex implantable devices used for rhythm management of the cardiac or the neurological system. There is currently no formal methodology or open experimental platform to validate the correct operation of implantable medical device software. We describe our recent work on heart...