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Medical Device Manufacturing
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives. Medical device design in the United States The United States medical device industry is one of the largest markets globally, exceeding $110 billion annually. In 2012 it represented 38% of the global market and more than 6500 medical device companies exist nationwide. These companies are primarily small-scale operations with fewer than 50 employees. The most medical device companies are in the states of California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota, and Georgia. Washington, Wisconsin, and Texas also have high employment levels in the medical device industry. The industry is divided into branches: Electro-Medical Equipment, Irradiation Apparatuses, Surgical and Medical Instruments, Surgical Appliances and Supplies, and Dental Equipment and Supplies. FDA regulation and oversight Medica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, 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 drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nanofountain Probe
A nanofountain probe (NFP) is a device for 'drawing' micropatterns of liquid chemicals at extremely small resolution. An NFP contains a cantilevered micro-fluidic device terminated in a nanofountain. The embedded microfluidics facilitates rapid and continuous delivery of molecules from the on-chip reservoirs to the fountain tip. When the tip is brought into contact with the substrate, a liquid meniscus forms, providing a path for molecular transport to the substrate. By controlling the geometry of the meniscus through hold time and deposition speed, various inks and biomolecules could be patterned on a surface, with sub 100 nm resolution. Historical background The advent of dip-pen nanolithography (DPN) in recent years represented a revolution in nanoscale patterning technology. With sub-100-nanometer resolution and an architecture conducive to massive parallelization, DPN is capable of producing large arrays of nanoscale features. As such, conventional DPN and other pro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Insulin Pump
An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous Subcutaneous tissue, subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes: * the pump (including controls, processing module, and batteries) * a disposable reservoir for insulin (inside the pump) * a disposable infusion set, including a cannula for subcutaneous insertion (under the skin) and a tubing system to connect the insulin reservoir to the cannula. Other configurations are possible. More recent models may include disposable or semi-disposable designs for the pumping mechanism and may eliminate tubing from the infusion set. An insulin pump is an alternative to multiple daily injections of insulin by syringe#Standard U-100 insulin syringes, insulin syringes or an insulin pen and allows for flexible insulin therapy when used in conjunction with blood glucose monitoring and ca ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pacemaker
A pacemaker, also known as an artificial cardiac pacemaker, is an implanted medical device that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart. Each pulse causes the targeted chamber(s) to contract and pump blood, thus regulating the function of the electrical conduction system of the heart. The primary purpose of a pacemaker is to maintain an even heart rate, either because the heart's natural cardiac pacemaker provides an inadequate or irregular heartbeat, or because there is a block in the heart's electrical conduction system. Modern pacemakers are externally programmable and allow a cardiologist to select the optimal pacing modes for individual patients. Most pacemakers are on demand, in which the stimulation of the heart is based on the dynamic demand of the circulatory system. Others send out a fixed rate of impulses. A specific type of pacemaker, called an implantable cardioverter-defibrillator, combines pacemaker and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biocompatibility
Biocompatibility is related to the behavior of biomaterials in various contexts. The term refers to the ability of a material to perform with an appropriate host response in a specific situation. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device (such as pacemaker, hip replacement or stent). Modern medical devices and prostheses are often made of more than one material so it might not always be sufficient to talk about the biocompatibility of a specific material. Since the immune response and repair functions in the body are so complicated it is not adequate to describe the biocompatibility of a single material in relation to a single cell type or tissue. Sometimes one hears of biocompatibility testing that is a large battery of in vitro test that is used in accordance with ISO 10993 (or other similar standards) ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Additive Manufacturing
3D printing, or additive manufacturing, is the construction of a three-dimensional object from a CAD model or a digital 3D model. It can be done in a variety of processes in which material is deposited, joined or solidified under computer control, with the material being added together (such as plastics, liquids or powder grains being fused), typically layer by layer. In the 1980s, 3D printing techniques were considered suitable only for the production of functional or aesthetic prototypes, and a more appropriate term for it at the time was rapid prototyping. , the precision, repeatability, and material range of 3D printing have increased to the point that some 3D printing processes are considered viable as an industrial-production technology; in this context, the term ''additive manufacturing'' can be used synonymously with ''3D printing''. One of the key advantages of 3D printing is the ability to produce very complex shapes or geometries that would be otherwise infeasibl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directed Assembly Of Micro- And Nano-Structures
Direct may refer to: Mathematics * Directed set, in order theory * Direct limit of (pre), sheaves * Direct sum of modules, a construction in abstract algebra which combines several vector spaces Computing * Direct access (other), a method of accessing data in a database * Direct connect (other), various methods of telecommunications and computer networking * Direct memory access, access to memory by hardware subsystems independently of the CPU Entertainment * Direct (Tower of Power album), ''Direct'' (Tower of Power album) * Direct (Vangelis album), ''Direct'' (Vangelis album) * Direct (EP), ''Direct'' (EP), by The 77s Other uses * Direct (music symbol), a music symbol used in music notation that is similar to a catchword in literature * Nintendo Direct, an online presentation frequently held by Nintendo * Mars Direct, a proposal for a crewed mission to Mars * DIRECT, a proposed space shuttle-derived launch vehicle * DirectX, a proprietary dynamic medi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety, safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford (chemist), Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Photolithography
Photolithography (also known as optical lithography) is a process used in the manufacturing of integrated circuits. It involves using light to transfer a pattern onto a substrate, typically a silicon wafer. The process begins with a photosensitive material, called a photoresist, being applied to the substrate. A photomask that contains the desired pattern is then placed over the photoresist. Light is shone through the photomask, exposing the photoresist in certain areas. The exposed areas undergo a chemical change, making them either soluble or insoluble in a developer solution. After development, the pattern is transferred onto the substrate through etching, chemical vapor deposition, or ion implantation processes. Ultraviolet, Ultraviolet (UV) light is typically used. Photolithography processes can be classified according to the type of light used, including ultraviolet lithography, deep ultraviolet lithography, extreme ultraviolet lithography, extreme ultraviolet lithography ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nanolithography
Nanolithography (NL) is a growing field of techniques within nanotechnology dealing with the engineering (patterning e.g. etching, depositing, writing, printing etc) of Nanometre, nanometer-scale structures on various materials. The modern term reflects on a design of structures built in range of 10−9 to 10−6 meters, i.e. nanometer scale. Essentially, the field is a derivative of lithography, only covering very small structures. All NL methods can be categorized into four groups: photolithography, photo lithography, scanning lithography, soft lithography and other miscellaneous techniques. History Nanolithography has evolved from the need to increase the number of sub-micrometer features (e.g. transistors, capacitors etc.) in an integrated circuit in order to keep up with Moore's law, Moore's Law. While Lithography, lithographic techniques have been around since the late 18th century, none were applied to nanoscale structures until the mid-1950s. With evolution of the semico ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
