Biomedical engineering, or bioengineering, is the application of engineering principles to the fields of biology and health care. Bioengineers work with doctors, therapists and researchers to develop systems, equipment and devices in order to solve clinical problems. Biomedical engineering is a discipline that applies engineering principles of design and analysis to biological systems and biomedical technologies. Examples of bioengineering research include bacteria engineered to produce chemicals, portable disease diagnostic devices, and tissue engineered organs.
Biotechnology is the field devoted to applying the techniques of biochemistry, cellular biology, biophysics, and molecular biology to addressing practical issues related to human beings, agriculture, and the environment. Biotechnology generally involves the use of living organisms or biological processes for the purpose of developing useful agricultural, industrial, or medical products, especially by means of techniques, such as genetic engineering, that involve the modification of genes. In other words, biotechnology may be thought of as the fusion of biology and technology through the application of biological techniques to produce large molecules useful in treating and preventing disease.
CROs and Clinical Trial Sites
Pharmaceutical and medical device companies typically outsource certain product development and testing functions. CROs (contract research organizations) provide support to the pharmaceutical and medical device industries in the form of primarily research and testing services. Clinical trial sites may be free standing dedicated investigational sites, sites associated with physician practices, or sites associated with academic medical centers. Such sites conduct interventional studies for drug companies on volunteer human subjects according to strict, institutional review board approved protocols in order to assess the safety and efficacy of a given drug compound as required by the FDA approval process.
Diagnostic services include the clinical aspects of pathology and laboratory medicine, radiology, and nuclear medicine. These services function in the settings of acute care, outpatient care (including free- standing diagnostic facilities, such as imaging centers), rehabilitative care, skilled nursing facilities, and residential care.
The broad scope of digital health (also known as health informatics) includes categories such as mobile health (mHealth), health information technology, wearable and implantable “smart” devices, telehealth and telemedicine, and aspects of personalized medicine.
Facilities Based Services
Facilities based services includes a broad spectrum of services requiring an inpatient stay provided in brick and mortar health care facilities. Such facilities include acute care hospitals, physical rehabilitation hospitals, long-term acute care hospitals, skilled nursing facilities, assisted living facilities, traditional nursing homes, and residential treatment centers.
Home Health Care
Home health care refers to the medically-related services provided to patients in a home setting rather than in a medical facility, such as a hospital or a primary health care center. Home health services include medical or psychological assessment, wound care, medication education and management, pain management, disease education and management, physical therapy, speech therapy, occupational therapy, physical therapy, and skilled nursing. Home health care services focus typically on assisting patients to increase their ability to perform activities of daily living. Home health care services sometimes includes palliative or hospice care.
Logistics management, a component of supply chain management, deals with the processes that integrate the procurement of health care goods by the ultimate customer, including the handling, warehousing, transportation, and distribution of health care goods.
Managed care describes a medical delivery system that attempts to manage the quality and cost of medical services that individuals receive. Most managed care systems utilize an HMO, EPO, PPO, or POS network design, limiting, to varying degrees, the number of providers from which a patient can choose, whether the patient has to use a primary care physician, whether out-of-network care is covered under the plan, and whether the patient is subject to a formulary. Managed care also includes third-party administrators (TPA) that manage claims administration, loss control, or risk management for an insurer or self-insured employer. Some managed care plans attempt to improve health quality by emphasizing prevention of disease.
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device. Examples of medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.
Outsourced staffing provides clinical staffing and business services to hospitals and other health care providers or end consumers. The staffing function often deals with providing facilities based clinicians under contract to hospitals and other facilities. Such clinicians may include emergency department physicians, hospitalists, radiologists, anesthesiologists, pathologists, nurse practitioners, physician assistants, certified registered nurse anesthetists, registered nurses, and perfusionists and other medical technicians. Business services sometimes provided on an outsourced basis may include medical billing, medical procedure coding, insurance claims processing, and medical transcription.
Pharmaceuticals refers generally to developers and manufacturers of proprietary and generic drugs that require a prescription to purchase. More specifically, pharmaceuticals refers to the activities involved in the pharmaceutical company’s in-house drug discovery, FDA application, manufacturing, marketing, licensing, and intellectual property management processes. See also “CROs and Clinical Trial Sites” and “Biotechnology”.
Walk-in care includes facilities and offices that provide highly consumer oriented health care services without an appointment. Such facilities and offices might include urgent care centers, and clinics within retailers such as drug stores. Typically, walk-in care is limited to treating routine and low acuity medical issues.
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