Biomedical engineering can be viewed from two angles, from the medical applications side and from the engineering side. A biomedical engineer must have some view of both sides. As with many medical specialties (e. g. cardiology, neurology), some BME sub-disciplines are identified by their associations with particular systems of the human body, such as:
- Cardiovascular technology – which includes all drugs, biologics, and devices related with diagnostics and therapeutics of cardiovascular systems
- Neural technology – which includes all drugs, biologics, and devices related with diagnostics and therapeutics of the brain and nervous systems
- Orthopaedic technology – which includes all drugs, biologics, and devices related with diagnostics and therapeutics of skeletal systems.
Those examples focus on particular aspects of anatomy or physiology.
Even some complex “medical devices” (see below) can reasonably be deemed “biotechnology” depending on the degree to which such elements are central to their principle of operation. Pharmaceutical Drugs (so-called “small-molecule” or non-biologic), which are commonly designed using the principles of synthetic chemistry and traditionally discovered using high-throughput screening methods at the beginning of the development process. Pharmaceuticals are related to biotechnology in two indirect ways:
- certain major types (e. g. biologics) fall under both categories,
- together they essentially comprise the “non-medical-device” set of BME applications.
(The “Device – Bio/Chemical” spectrum is an imperfect dichotomy, but one regulators often use, at least as a starting point. ) Devices, which commonly employ mechanical and/or electrical aspects in conjunction with chemical and/or biological processing or analysis. They can range from microscopic or bench-top, and be either in vitro or in vivo. In the US, the FDA deems any medical product that is not a drug or a biologic to be a “device” by default (see “Regulation” section). Software with a medical purpose is also regarded as a device, whether stand-alone or as part of another device.
Combination Products (not to be confused with fixed-dose combination drug products or FDCs), which involve more than one of the above categories in an integrated product (for example, a microchip implant for targeted drug delivery). Tissue engineering Main article: Tissue engineering Tissue engineering, like genetic engineering (see below), is a major segment of Biotechnology – which overlaps significantly with BME. One of the goals of tissue engineering is to create artificial organs (via biological material) for patients that need organ transplants.
Biomedical engineers are currently researching methods of creating such organs. Researchers have grown solid jawbones andtracheas from human stem cells towards this end. Several artificial urinary bladders actually have been grown in laboratories and transplanted successfully into human patients.
Bioartificial organs, which use both synthetic and biological components, are also a focus area in research, such as with hepatic assist devices that use liver cells within an artificial bioreactor construct. Micromass cultures of C3H-10T1/2 cells at varied oxygen tensions stained with Alcian blue.
Genetic engineering, recombinant DNA technology, genetic modification/manipulation (GM) and gene splicing are terms that apply to the direct manipulation of an organism’s genes. Genetic engineering is different from traditional breeding, where the organism’s genes are manipulated indirectly. Genetic engineering uses the techniques of molecular cloning and transformation to alter the structure and characteristics of genes directly. Genetic engineering techniques have found success in numerous applications.
Some examples are in improving crop technology (not a medical application, but see Biological Systems Engineering), the manufacture of synthetic human insulin through the use of modified bacteria, the manufacture of erythropoietin in hamster ovary cells, and the production of new types of experimental mice such as the oncomouse (cancer mouse) for research.
Neural engineering (also known as Neuroengineering) is a discipline that uses engineering techniques to understand, repair, replace, or enhance neural systems. Neural engineers are uniquely qualified to solve design problems at the interface of living neural tissue and non-living constructs.
Pharmaceutical engineering is sometimes regarded as a branch of biomedical engineering, and sometimes a branch of chemical engineering; in practice, it is very much a hybrid sub-discipline (as many BME fields are). Aside from those pharmaceutical products directly incorporating biological agents or materials, even developing chemical drugs is considered to require substantial BME knowledge due to the physiological interactions inherent to such products’ usage.