Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to induce an electric current at a specific area of the brain through electromagnetic induction. An electric pulse generator, or stimulator, is connected to a magnetic coil connected to the scalp. The stimulator generates a changing electric current within the coil which creates a varying magnetic field, inducing a current within a region in the brain itself.
Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity
An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. For example, an implant may be a rod, used to strengthen weak bones. Medical implants are human-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone, or apatite depending on what is the most functional. In 2018, for example, American Elements developed a nickel alloy powder for 3D printing robust, long-lasting, and biocompatible medical implants. In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery.
The Feinberg School of Medicine is the medical school of Northwestern University and is located in the Streeterville neighborhood of Chicago, Illinois. Founded in 1859, Feinberg offers a full-time Doctor of Medicine degree program, multiple dual degree programs, graduate medical education, and continuing medical education.
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.
Sousan S. Altaie is Scientific Policy Advisor for the Office of In Vitro Diagnostic Devices in the United States. She joined the Food and Drug Administration in the Center for Drug Evaluation and Research in the Division of Anti-infective Drug Products as a primary reviewer in 1995. Six years later she joined the FDA's Center for Devices and Radiological Health as the Chief of Immunology and Molecular Diagnostics Branch. She is actively working as a member of the Global Harmonization Task Force (GHTF) and International Organization for Standardization (ISO) working groups. She was appointed the CDRH Critical Path Coordinator in 2004 and is actively involved in the Agency's Critical Path initiative. She has served as an observer, advisor and full member of various committees and subcommittees of the Clinical and Laboratory Standards Institute (CLSI).
Abass Alavi is an Iranian-American physician-scientist specializing in the field of molecular imaging, most notably in the imaging modality of positron emission tomography (PET). In August 1976, he was part of the team that performed the first human PET studies of the brain and whole body using the radiotracer [18F]Fluorodeoxyglucose (FDG). Alavi holds the position of Professor of Radiology and Neurology, as well as Director of Research Education in the Department of Radiology at the University of Pennsylvania. Over a career spanning five decades, he has amassed over 2,300 publications and 60,000 citations, earning an h-index of 125 and placing his publication record in the top percentile of scientists.
Total disc replacement (TDR), or artificial disc replacement (ADR), is a type of arthroplasty in which degenerated intervertebral discs in the vertebral column are replaced with artificial disc implants in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease. Disc replacement is also an alternative intervention for symptomatic disc herniation with associated arm and hand, or leg symptoms.
Mentor Worldwide LLC is an American company that supplies surgical aesthetics products to plastic surgeons. The company is based in Santa Barbara, California. It produces one of two silicone gel breast implants. Titled MemoryGel, the product was approved by the U.S. Food and Drug Administration (FDA) on November 17, 2006. The other FDA-approved products are developed by competitors Allergan and Sientra. Mentor also produces a range of lipoplasty equipment for liposuction procedures as well as a Niacin-based skincare product line called NIA 24.
Diaphragm pacing is the rhythmic application of electrical impulses to the diaphragm to provide artificial ventilatory support for respiratory failure or sleep apnea. Historically, this has been accomplished through the electrical stimulation of a phrenic nerve by an implanted receiver/electrode, though today an alternative option of attaching percutaneous wires to the diaphragm exists.
Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials. The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER).
Stephen L. Ondra is the chief medical adviser for the MITRE Corporation’s work as operator of the CMS Alliance to Modernize Healthcare federally funded research and development center. Ondra advises all HHS organizations to advance private insurance markets, Medicare and Medicaid, value-based payments, and healthcare quality. Ondra was most recently CEO of Cygnus-AI Inc., a company specializing in artificial intelligence and clinical decision support tools for diagnostic radiology. He was also founder and chief executive officer of North Star Health Care Consulting, and served on the board of directors of Triple-S Management and electroCore. A neurosurgeon and neuroscientist, Ondra has also served in senior positions in the Federal government, having a role in health reform efforts and the implementation of the Affordable Care Act. He advises corporations, provider organizations and early-stage start-ups on the transition to value-based care and health IT strategy.
Nicholas Theodore is an American neurosurgeon and researcher at Johns Hopkins University School of Medicine. He is known for his work in spinal trauma, minimally invasive surgery, robotics, and personalized medicine. He is Director of the Neurosurgical Spine Program at Johns Hopkins and Co-Director of the Carnegie Center for Surgical Innovation at Johns Hopkins.
Scott Gottlieb is an American physician, investor, and author who served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc., and a contributor to the cable financial news network CNBC and the CBS News program Face the Nation. An elected member of the National Academy of Medicine, Gottlieb is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed. His forthcoming book, The Miracle Century: Making Sense of the Cell Therapy Revolution, traces the scientific achievements that propelled progress in cell therapies.
Janet Woodcock is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
Ali R. Rezai is an Iranian-born American neurosurgeon and neuroscientist. His work and research has focused on neuromodulation treatments for patients with neurological and mental health conditions, including neuromodulation techniques such as deep brain stimulation (DBS) through brain chip implants to treat Parkinson's disease tremors, obsessive–compulsive disorder, Alzheimer's disease, traumatic brain injury, spinal cord injury, and addiction. Recent research since 2020 has focused on deep brain stimulation for addiction treatment, as well as focused ultrasound to treat tremor, addiction and Alzheimer's disease.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
