Certificate in Medical Product Design and Device Development

Over the past 50 years, the practice of medicine has become increasingly driven by technological innovations. However, simply being able to design and develop a new technology is no guarantee that the technology will reach its intended audience, whether that audience be made of medical professionals or patients. To reach the goal of introducing a medical technology into the marketplace, a biomedical engineer must run the gauntlet of regulations, attitudes, and financial considerations that make up the United States health care system.

Medical devices are subject to extensive FDA regulations. Thus, biomedical engineers who design medical technologies must be proficient in the regulatory and economic components of introducing a new medical device into the US health market. Knowledge of intellectual property law is also a prerequisite for those who plan to develop novel medical technologies. Because the cost of obtaining FDA is steep, obtaining intellectual property protection for extended periods of time is necessary to recovering project costs. Along similar lines, biomedical engineers must also appreciate the role of Medicare and other insurers and their requirements for reimbursement.

This certificate program is designed to prepare biomedical engineers to understand the environment into which their innovations will be placed and the users who will interact with them. Professionals enrolled in the certificate will develop an understanding of critical regulatory, economic, and legal issues in addition to the project management skills that facilitate the development of new medical devices and positive working relationships with intellectual property lawyers, insurance companies, and the federal government.

Required Courses
BMES 509Entrepreneurship for Biomedical Engineering and Science3.0
BMES 538Biomedical Ethics and Law3.0
BMES 588Medical Device Development3.0
BMES 821Medical Instrumentation3.0
Select one of the following:3.0
Introduction to Medical Sci
Medical Instrumentation II
Total Credits15.0

Additional Information

For addition information, please contact Carolyn Riley (Professional Programs, cr63@drexel.edu) or Professor Kambiz Pourrezaei (Program Coordinator, pourrezk@drexel.edu).

Biomedical Engineering, Science and Health Systems Faculty

Fred D. Allen, PhD (University of Pennsylvania). Assistant Professor. Tissue engineering, cell engineering, orthopedics, bone remodeling, wound healing, mechanotransduction, signal transduction, adhesion, migration.
Sriram Balasubramanian, PhD (Wayne State University). Assistant Professor. Structural characteristics of the pediatric thoracic cage using CT scans and developing an age-equivalent animal model for pediatric long bones.
Kenneth A. Barbee, PhD (University of Pennsylvania). Professor. Cellular biomechanics of neural and vascular injury, mechanotransduction in the cardiovascular system, mechanical control of growth and development for wound healing and tissue engineering.
Lin Han, PhD (Massachusetts Institute of Technology). Assistant Professor. Nanoscale structure-property relationships of biological materials, genetic and molecular origins soft joint tissue diseases, biomaterials under extreme conditions, coupling between stimulus-responsiveness and geometry.
Uri Hershberg, PhD (Hebrew University of Jerusalem, Israel). Assistant Professor. Bioinformatics, immunology, neural computation, system biology, somatic selection, autoimmunity, genetic stability, germline diversity, dendritic cell, transcription elements, pathogens, computational and mathematical modeling, complex systems, cognition and inflammation.
Joshua Jacobs, PhD (University of Pennsylvania). Assistant Professor. Neuroengineering, electrocorticography (ECoG), electroencephalography (EEG), single-neuron spiking, brain oscillations, episodic memory, working memory, spatial navigation, conceptual representations.
Dov Jaron, PhD (University of Pennsylvania) Calhoun Distinguished Professor of Engineering in Medicine. Professor. Mathematical, computer and electromechanical simulations of the cardiovascular system.
Andres Kriete, PhD (University in Bremen Germany) Associate Director for Graduate Studies and Academic Operations. Systems biology, bioimaging, control theory, biology of aging, skin cancer.
Ryszard Lec, PhD (University of Warsaw Engineering College). Professor. Biomedical applications of visoelastic, acoustoptic and ultrasonic properties of liquid and solid media.
Peter Lewin, PhD (University of Denmark, Copenhagen-Lyngby) Richard B. Beard Professor, School Of Biomedical Engineering, Science & Health Systems. Professor. Biomedical ultrasonics, piezoelectric and polymer transducers and hydrophones; shock wave sensors.
Hualou Liang, PhD (Chinese Academy of Sciences). Associate Professor. Neuroengineering, neuroinformatics, cognitive and computational neuroscience, neural data analysis and computational modeling, biomedical signal processing.
Donald L. McEachron, PhD (University of California at San Diego) Associate Director. Research Professor. Animal behavior, autoradiography, biological rhythms, cerebral metabolism, evolutionary theory, image processing, neuroendocrinology.
Karen Moxon, PhD (University of Colorado). Associate Professor. Cortico-thalamic interactions; neurobiological perspectives on design of humanoid robots.
Banu Onaral, Ph.D. (University of Pennsylvania) H.H. Sun Professor / Director, School of Biomedical Engineering Science and Health Systems. Professor. Biomedical signal processing; complexity and scaling in biomedical signals and systems.
Kambiz Pourrezaei, PhD (Rensselaer Polytechnic University). Professor. Thin film technology; nanotechnology; near infrared imaging; power electronics.
Arye Rosen, PhD (Drexel University) Biomedical Engineering and Electrical Engineering. Microwave components and subsystems; utilization of RF/microwaves and lasers in therapeutic medicine.
Ahmet Sacan, PhD (Middle East Technical University). Assistant Professor. Indexing and data mining in biological databases; protein sequence and structure; similarity search; protein structure modeling; protein-protein interaction; automated cell tracking.
Joseph J. Sarver, PhD (Drexel University). Teaching Professor. Neuromuscular adaptation to changes in the myo-mechanical environment.
Rahamim Seliktar, PhD (University of Strathclyde, Glasgow) Vice Director, School of Biomedical Engineering, Science & Health Systems. Professor. Limb prostheses, biomechanics of human motion, orthopedic biomechanics.
Adrian C. Shieh, PhD (Rice University). Assistant Professor. Contribution of mechanical forces to tumor invasion and metastasis, with a particular emphasis on how biomechanical signals may drive the invasive switch, and how the biomechanical microenvironment interacts with cytokine signaling and the extracellular matrix to influence tumor and stromal cell behavior.
Wan Young Shih, PhD (Ohio State University) School of Biomedical Engineering, Science and Health Systems. Associate Professor. Piezoelectric microcantilever biosensors development, piezoelectric finger development, quantum dots development, tissue elasticity imaging, piezoelectric microcantilever force probes.
Kara Spiller, PhD (Drexel University). Assistant Professor. Cell-biomaterial interactions, biomaterial design, and international engineering education.
Aydin Tozeren, PhD (Columbia University) Distinguished Professor and Director, Center for Integrated Bioinformatics, School of Biomedical Engineering, Science & Health Systems. Professor. Breast cell adhesion and communication, signal transduction networks in cancer and epithelial cells; integrated bioinformatics, molecular profiling, 3D-tumors, bioimaging.
Margaret Wheatley, PhD (University of Toronto) School of Biomedical Engineering, Science and Health Systems, John M. Reid Professor. Ultrasound contrast agent development (tumor targeting and triggered drug delivery), controlled release technology (bioactive compounds), microencapsulated allografts (ex vivo gene therapy) for spinal cord repair.
Yinghui Zhong, PhD (Georgia Institute of Technology). Assistant Professor. Spinal cord repair, and engineering neural prosthesis/brain interface using biomaterials, drug delivery, and stem cell therapy.

Interdepartmental Faculty

Douglas L. Chute, PhD (University of Missouri) Louis and Bessie Stein Fellow. Professor. Neuropsychology and rehabilitation; technological applications for the cognitively compromised and those with acquired brain injuries.
Patricia A. Shewokis, PhD (University of Georgia). Professor. Roles of cognition and motor function during motor skill learning; role of information feedback frequency on the memory of motor skills, noninvasive neural imaging techniques of functional near infrared spectroscopy(fNIR) and electroencephalograpy (EEG) and methodology and research design.

Emeritus Faculty

William Freedman, PhD (Drexel University). Professor Emeritus. Motor control; sensory and motor systems; reflexes; eye movements; neural networks.
John M. Reid, PhD (University of Pennsylvania) Calhoun Professor Emeritus. Professor Emeritus. Diagnostic ultrasound, wave propagation and scattering in inhomogeneous media, imaging, instrumentation.
Hun H. Sun, PhD (Cornell University). Professor Emeritus. Biological control systems, physiological modeling, systems analysis.
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