Courses

This course introduces students to the fundamentals of computational modeling of neurons and neuronal circuits and the decoding of information from populations of spike trains. Topics include: integrate and fire neurons, Spike Response Models, Homogeneous and Inhomogeneous Poisson processes, neural circuits, Weiner (optimal), Adaptive Filters, neural networks for classification, population vector coding and decoding. Programming assignments and projects will be carried out using MATLAB. Prerequisites: BME 101/201 or equivalent. 3 units. C-L: Neuroscience 503(253).

This course presents a quantitative approach to the fundamental principles, mechanisms, and techniques of electrical stimulation required for non-damaging and effective application of electrical stimulation. Consent of instructor required. Instructor: Grill. 3 units.

Design of biomedical devices for cardiac application based on a review of theoretical and experimental results from cardiac electrophysiology. Evaluation of the underlying cardiac events using computer simulations. Examination of electrodes, amplifiers, pacemakers, and related computer apparatus. Construction of selected examples. Prerequisites: Biomedical Engineering 253L(153L) or equivalents. Instructor: Wolf. 3 units.

Advanced topics on the electrophysiological behavior of nerve and striated muscle. Source-field models for single-fiber and fiber bundles lying in a volume conductor. Forward and inverse models for EMG and ENG. Bidomain model. Model and simulation for stimulation of single-fiber and fiber bundle. Laboratory exercises based on computer simulation, with emphasis on quantitative behavior and design. Readings from original literature. Prerequisite: Biomedical Engineering 301L(201L) or equivalent. Instructor: Barr or Neu. 4 units. C-L: Neuroscience 511(241)

Electrophysiological behavior of cardiac muscle. Emphasis on quantitative study of cardiac tissue with respect to propagation and the evaluation of sources. Effect of junctions, inhomogeneities, anisotropy, and presence of unbounded extracellular space. Bidomain models. Study of models of arrhythmia, fibrillation, and defibrillation. Electrocardiographic models and forward simulations. Laboratory exercises based on computer simulation, with emphasis on quantitative behavior and design. Readings from original literature. Prerequisite: Biomedical Engineering 301L(201L) or equivalent. Instructor: Barr. 4 units.

Electrophysiological behavior of excitable membranes and nerve fibers examined with methods of nonlinear dynamics. Phase-plane analysis of excitable membranes. Limit cycles and the oscillatory behavior of membranes. Phase resetting by external stimuli. Critical point theory and its applications to the induction of rotors in the heart. Theory of control of chaotic systems and stabilizing irregular cardiac rhythms. Initiation of propagation of waves and theory of traveling waves in a nerve fiber. Laboratory exercises based on computer simulations, with emphasis on quantitative behavior and design. Readings from original literature. Prerequisite: Mathematics 216(107) or equivalent. Instructor: Neu. 4 units.

This course will cover several systems that use electrical stimulation or recording of the nervous system to restore function following disease or injury. For each system the course will cover the underlying biophysical basis for the treatment, the technology underlying the treatment, and the associated clinical applications and challenges. Systems to be covered include cochlear implants, spinal cord stimulation of pain, vagus nerve stimulation for epilepsy, deep brain stim. for movement disorders, sacral root stimulation for bladder dysfunction, and neuromuscular electrical stim. for restoration of movement. Prerequisites: Biomedical Engineering 253L(153L), and consent of instructor. Instructor: Grill. 3 units.

Linear elasticity will be emphasized including concepts of stress and strain as second order tensors, equilibrium at the boundary and within the body, and compatibility of strains. Generalized solutions to two and three dimensional problems will be derived and applied to classical problems including torsion of noncircular sections, bending of curved beams, stress concentrations and contact problems. Applications of elasticity solutions to contemporary problem in civil and biomedical engineering will be discussed. Prerequisites: Engineering 201L(75L); Mathematics 353(108). Instructor: Laursen. 3 units. C-L: Civil Engineering 521(206).

This course examines the mechanical properties of cells and forces exerted by cells in biological processes of clinical and technological importance and the processes by which mechanical forces are converted into biochemical signals and activate gene expression. Topics covered include measurement of mechanical properties of cells, cytoskeleton mechanics, models of cell mechanical properties, cell adhesion, effects of physical forces on cell function, and mechanotransduction. Students will critically evaluate current literature and analyze models of cell mechanics and mechanotransduction. Prerequisites: Engineering 201L(75) and Biomedical Engineering 307(207) or equivalent, knowledge of cell biology and instructor consent. Instructors: Hoffman and Truskey. 3 units.

Methods and applications of fluid mechanics in biological and biomedical systems including: Governing equations and methods of solutions (e.g. conservation of mass flow and momentum), the nature of biological fluids (e.g. non-Newtonian rheological behavior), basic problems with broad relevance (e.g. flow in pipes, lubrication theory), applications to cells and organs in different physiological systems (e.g. cardiovascular, gastrointestinal, respiratory, reproductive and musculoskeletal systems), applications to diagnosis and therapy (e.g., drug delivery and devices). Prerequisite: Biomedical Engineering 307(207). Instructor: Katz. 3 units.

3 units. C-L: see Mechanical Engineering and Materials Science 514(211)

Introduction to the mechanical behaviors of biological solids and fluids with application to tissues, cells and molecules of the musculoskeletal and cardiovascular systems. Topics to be covered include static force analysis and optimization theory, biomechanics of linearly elastic solids and fluids, anisotropic behaviors of bone and fibrous tissues, blood vessel mechanics, cell mechanics and behaviors of single molecules. Emphasis will be placed on modeling stress-strain relations in these tissues, and experimental devices used to measure stress and strain. Student seminars on topics in applied biomechanics will be included. Prerequisites: Engineering 201L(75L); Mathematics 353(108). Instructor: Myers. 3 units.

Propagation, reflection, refraction, and diffraction of acoustic waves in biologic media. Topics include geometric optics, physical optics, attenuation, and image quality parameters such as signal-to-noise ratio, dynamic range, and resolution. Emphasis is placed on the design and analysis of medical ultrasound imaging systems. Prerequisites: Mathematics 216(107) and Physics 152L(62L). Instructor: von Ramm. 3 units.

Hands-on experience using and developing advanced technology platforms for genomics and proteomics research. Experiments may include nucleic acid amplification and quantification, lab-on-chip, bimolecular separation and detection, DNA sequencing, SNP genotyping, microarrays, and synthetic biology techniques. Laboratory exercises and designing projects are combined with lectures and literature reviews. Prior knowledge in molecular biology and biochemistry is required. Instructor consent required. Instructor: Tian. Variable credit. C-L: Computational Biology and Bioinformatics 542(222)

Quality Management Systems (QMS) form the backbone of medical device companies, from specification through development to regulatory submission and commercial launch, medical device designers must be comfortable working with and producing a broad spectrum of supporting documentation.

Using projects from the Design in Health Care courses as the active vehicle, this course introduces students to the workings of industry quality management systems and standards adherence.

Students generate QMS documentation to support development, risk management, design controls and regulatory submissions.

The course is taught by an American Society of Quality-certified Quality Manager and Quality Auditor and equips students with up-to-date practices designed to make the transition into a regulated industry seamless.

Engineering biological systems emphasizing synthetic biology and the application of biological/chemical principles to the design of new biomolecules and cellular pathways. Review of primary scientific literature, highlighting contemporary research in this area, including artificial amino and nucleic acids, gene regulatory systems, directed molecular evolution, recombinant antibodies, novel biosynthesis pathways, cell communication, and the design of minimal organisms. Topics are presented with applications such as drug design, discovery, productions, regenerative medicine, and bioremediation. Prerequisite: Biomedical Engineering 244L. Organic chemistry or biochemistry suggested. Instructor consent required. Instructor: Gersbach. 3 units.

Application of transport theory to analyze processes of HIV migration to target cells in the mucosa of the lower female reproductive tract. Analysis of the introduction, transport and bioactivity of molecules that inhibit these HIV infection processes, including those acting topically (microbicides) and those introduced in a variety of drug delivery vehicles: semi-solid materials (gels, films) and solid materials (intravaginal rings). A succession of mathematical models will describe elements of the fundamental biology of this system and analyze the performance of specific products that act prophylactically against HIV infection. Prerequisite: BME 307 or instructor consent. Instructor: Katz. 3 units.

3 units. C-L: see Civil Engineering 661L(239L)

Biosensors are defined as the use of biospecific recognition mechanisms in the detection of analyte concentration. The basic principles of protein binding with specific reference to enzyme-substrate, lectin-sugar, antibody-antigen, and receptor-transmitting binding. Simple surface diffusion and absorption physics at surfaces with particular attention paid to surface binding phenomena. Optical, electrochemical, gravimetric, and thermal transduction mechanisms which form the basis of the sensor design. Prerequisites: Biomedical Engineering 260L(100L) or equivalent and consent of instructor. Instructor: Vo-Dinh. 3 units.

Structure of biological macromolecules, recombinant DNA techniques, principles of and techniques to study protein structure-function. Discussion of biomolecular design and engineering from the research literature. Linked laboratory assignments to alter protein structure at the genetic level. Expression, purification, and ligand-binding studies of protein function. Consent of instructor is required. Instructor: Chilkoti. 3 units.

This course discusses modeling and engineering gene circuits, such as prokaryotic gene expression, cell signaling dynamics, cell-cell communication, pattern formation, stochastic dynamics in cellular networks and its control by feedback or feedforward regulation, and cellular information processing. The theme is the application of modeling to explore “design principles” of cellular networks, and strategies to engineer such networks. Students need to define an appropriate modeling project. At the end of the course, they’re required to write up their results and interpretation in a research-paper style report and give an oral presentation. Prerequisites: Biomedical Engineering 260L(100L) or consent of instructor. Instructor: You. 3 units.

Introduction to drug delivery in solid tumors and normal organs (for example, reproductive organs, kidney, skin, eyes). Emphasis on quantitative analysis of drug transport. Specific topics include: physiologically-based pharmacokinetic analysis, microcirculation, network analysis of oxygen transport, transvascular transport, interstitial transport, transport across cell membrane, specific issues in the delivery of cells and genes, drug delivery systems, and targeted drug delivery. Prerequisite: Biomedical Engineering 307(207) and Engineering 110L(53). Instructor: Yuan. 3 units.

This course will serve as an overview of selected topics and problems in the emerging field of tissue engineering. General topics include cell sourcing and maintenance of differentiated state, culture scaffolds, cell-biomaterials interactions, bioreactor design, and surgical implantation considerations. Specific tissue types to be reviewed include cartilage, skin equivalents, blood vessels, myocardium and heart valves, and bioartificial livers. Prerequisites: Mathematics 353(108) or consent of instructor. Instructor: Bursac. 3 units.

Medical physics is the application of the concepts and methods of physics and engineering to the diagnosis and treatment of human disease. This course consists of weekly lectures covering broad topics in medical physics including diagnostic imaging, radiation oncology, radiation safety, and nuclear medicine. Lectures will be given by invited speakers drawn from many university and medical center departments including Biomedical Engineering, radiology, physics, radiation safety, and radiation oncology. Prerequisites: background in engineering or physics. 1 CC (0.5 ES/0.5 ED). Consent of instructor is required. Instructor: Lo and Samei. 1 unit.

A survey of topics in modern research management techniques that will cover proven successful principles and their application in the areas of research lab organization, resource management, organization of technical projects, team leadership, financial accountability, and professional ethics. Instructor: Staff. 1 unit.

Interdisciplinary teams of students from engineering, medical science, business, and medicine work together to understand and evaluate the commercial potential of Duke faculty research innovations and develop a comprehensive research translation and business plan for one chosen opportunity. Learning includes understanding technology, product development, marketing, finance, regulatory requirements, and reimbursement. In addition to weekly lectures, students are mentored in this real world experience by a team including technology transfer experts, venture capitalists, researchers, physicians, and entrepreneurs. Prerequisites: none. Consent of instructor is required. Instructor: Myers. 3 units.

This course is designed to bring the practical application of academic engineering to medical design, while developing design skills that can be immediately transferred to industry projects—making students attractive prospects to industry recruiters. The skills course establishes a mindset and set of practical skills that form a foundation for the Design Health sequences. Students also start to build a portfolio design projects that showcase their design thinking. Through a series of modules, the skills course introduces Design for Manufacture and important concepts around production cost and the interplay between design choices, manufacturing processes and cost. Medical image reconstruction and the design of an implanted device takes students inside the body, designing for specific anatomy and bio-compatibility. The Duke skills course is supported by industry leader Protolabs, and the program is hugely grateful for their input and assistance in readying students for careers in design and development. Instructors: Fearis and Richardson. 3 Units.

This course will make students aware of the design process and considerations associated with electronics and software functionality in medical devices. Electronic hardware topics will include microcontrollers, data communication protocols (e.g., SPI, I2C, Bluetooth, WiFi, Zigbee), power supplies, analog and digital signal management, UI/UX for input/output, electronic signal transduction, heat management, PCB layout and fabrication, and cabling and connectors.

Software topics will include firmware, server/client communications, Restful APIs, HIPAA, data privacy, cybersecurity, encryption, software development process, continuous integration/deployment, version control systems, and AI-assisted algorithms. The Verification & Validation process for hardware and software will be reviewed, along with relevant industry standards (eg, IEC60601, IEC62304).

1—Discover

This course concentrates upon the identification of medical device innovation opportunities through the detailed identification and analysis of unmet, underserved and unarticulated stakeholder needs. Students work closely with clinical staff from Duke Health and other clinical experts to identify needs through primary qualitative research including first-hand observation, stakeholder interviews and other secondary processes.

Utilizing industry best-practice techniques captured in the Insight Informed Innovation process students take a broad area of focus and work with clinicians, engineering and business faculty to focus, identify and specify impactful opportunities that will become the basis of design projects take forward in the Design in Healthcare 2–Design course.

Students define their projects, considering clinical impact, regulatory and reimbursement strategy, technical feasibility and interest with an eye to the generation of intellectual property, licensing and/or startup opportunities.

2—Design

In this course, teams take a validated problem from Design in Healthcare 1—Discovery, and then generate broad ranges of solutions, iterate, and mature toward proof of principle and proof of (market) concept prototypes.

Students work in multidisciplinary teams, representative of industry team make-up, including clinical, engineering and business functions to develop engineering solutions, business plans and supporting regulatory documentation as would be required in industry.

Design in Healthcare 2 draws heavily upon the Skills and Quality courses, training students to consider product development as a holistic process where decisions are complex and interrelated.

The course is taught by industry veterans who maintain active industry roles and projects in order to stay current and relevant.

3—Deploy

This course progresses a group of active projects from Design in Health Care 2—Design, and other sources, to a level of maturity appropriate for the consideration of licensing and/or startup opportunities.

Largely self-guided, student teams apply risk management and other practices to eliminate unknowns, and generate supporting performance and usability data and investor pitches.

Interaction with Duke Engineering Entrepreneurship (EngEn) and Duke’s licensing and venture functions brings a sharp focus to projects—exposing students to the realities of the medical device business today.

Viscoelasticity of hard and soft tissue solids and composite structures. Linear and nonlinear one-dimensional viscoelastic behavior, internal damping, and three-dimensional viscoelasticity. Approximation techniques for determination of viscoelastic constitutive equations from experimental data. Mathematical formulations for the characterization of the dynamic behavior of biologic structures. Consent of instructor is required. Instructor: Myers. 3 units.

This course provides students with a mathematical basis of ultrasonic imaging methods. Topics include K-space, descriptions of ultrasonic imaging, ultrasonic beam-former design, tissue motion and blood flow imaging methods, and novel ultrasonic imaging methods. Students conduct extensive simulations of ultrasonic imaging methods. Prerequisite: BME 303(233). Instructor: Trahey. 3 units.

Designed to complement BME 233 Modern Diagnostic Imaging Systems. Review and real-life exercises on principles of modern medical imaging systems with emphasis on the engineering aspects of image acquisition, reconstruction and visualization, observations of imaging procedures in near clinical settings, and hands-on experience with the instruments. Modalities covered include ultrasound, CT, MRI, nuclear medicine and optical imaging. Prerequisite: BME 303(233) or equivalent. Instructor: Trahey. 3 units. C-L: Medical Physics 738(338)

The main goal of this course is to provide an overview of various photonics techniques and their applications. The purpose is to enhance the student’s breadth of understanding and knowledge of advanced techniques and introduce them to the wide variety of applications in photonics, the science and technology associated with interactions of light with matter. Examples of topics include: High-resolution Luminescence Techniques, Raman Techniques, Optical Coherence Techniques, Ultrafast Laser-base Techniques, Near-Filed and Confocal Optical Techniques, Remote Sensing Techniques, Advanced Light Measurement Techniques, Optical Biosensors, Nano Micro Electrooptics Systems, High throughput Assays using Optical Detection, Photonics Meta Materials and Applications, Optics in Telecommunications, and Nanophotonics. The lectures will be presented by faculty members who are leaders in their areas of research in photonics. Instructor: Vo-Dinh. 3 units. C-L: Chemistry 630(335).

• CBB 520 Genome Tools and Technologies
• MGM 732 Human Genetics
• CELLBIO 730 Stem Cell Course
• CMB 797 Modern Techniques in Molecular Biology
• MGM 701 Foundations of Molecular Genetics and Microbiology
• CELLBIO 761-763 Cellular Signaling Module I to III
• BIOCHEM 536 Bioorganic Chemistry
• BIOCHEM 622 Structure of Biological Macromolecules
• BIOCHEM 681 Biophysical Methods
• BME 790 Physiology for Engineers
• BME 790 Quantitative Pathophysiology
• EVANTH 530 Human Functional Anatomy
• MEDPHY 505 Anatomy and Physiology for Medical Physicists
• NEUROBIO 719 – Concepts in Neuroscience I (PhD only)
• NEUROBIO 720 Concepts in Neuroscience II (PhD only)
• NEUROBIO 759S Principles of Cognitive Neuroscience I
• NEUROBIO 760S Principles of Cognitive Neuroscience II
• IMM 544 Principles of Immunology
• IMM 800 Comprehensive Immunology

• BME 671 Signal Processing and Applied Mathematics
• BME 790L Computational Linear Algebra in Biomedical Engineering
• MATH 721 Linear Algebra and Applications
• MATH 753 Ordinary and Partial Differential Equations
• CEE 530/ME 524 Introduction to the Finite Element Method
• CEE 630 Nonlinear Finite Element Analysis
• COMPSCI 520/MATH 565 Numerical Analysis
• MATH 561 Numerical Linear Algebra, Optimization, and Monte Carlo Simulation
• MATH 563 Applied Computational Analysis
• MATH 660 Numerical Partial Differential Equations
• MATH 551 Applied Partial Differential Equations and Complex Variables
• MATH 577 Mathematical Modeling
• MATH 721 Linear Algebra and Applications
• MATH 753 Ordinary and Partial Differential Equations
• PHYSICS 760 Mathematical Methods in Physics
• CBB 540 Statistical Methods for Computational Biology
• MATH 545 Introduction to Stochastic Calculus
• STA 601 Bayesian and Modern Statistical Data Analysis
• STA 621/MATH 541 Applied Stochastic Processes
• STA 611 Introduction to Mathematical Statistics

MENG 540: Management in High-Tech Industries

This course addresses critical qualities of leadership, management skills, and decision-making in complex environments.

Essential topics include:

• Leadership and communication principles
• Strategic decision-making where outcomes depend on high technology
• Management of project-based and team-based organizational structures
• Role of the manager in expertise-driven organizations

MENG 590: Business Fundamentals in MedTech

After an introduction to the broader landscape of healthcare innovation (including BioTech, MedTech, and Pharma), the course provides a high-level introduction to the key non-technical areas to consider when bringing forward a medical device—including regulatory, reimbursement, business model, funding, sales, and marketing.

The focus is not only on a basic understanding of each area but also on the interplay between and among each. The course concludes with an exploration of finance-related topics where students learn the importance and application of financial statements to medical device innovation, as well as various methods of how a MedTech company is ultimately valued at acquisition.