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Medical Device Development
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 currently 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: 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 the following branches: Electro-Medical Equipment, Irradiation Apparatuses, Surgical and Medical Instruments, Surgical Appliances and Supplies, and Dental Equipment and Supplies. FDA Regulation a ... [...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), but 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 not d ... [...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 pr ... [...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 c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of 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 wasn't until the Federal Food, Drug, and Cosmetic Act (FD& ... [...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 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 insulin syringes or an insulin pen and allows for flexible insulin therapy when used in conjunction with blood glucose monitoring and carbohydrate counting. Medical uses Insulin pumps are used to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pacemaker
An artificial cardiac pacemaker (or artificial pacemaker, so as not to be confused with the natural cardiac pacemaker) or pacemaker is a medical device that generates electrical impulses delivered by electrodes to the chambers of the heart either the upper atria, or lower ventricles to cause the targeted chambers to contract and pump blood. By doing so, the pacemaker regulates the function of the electrical conduction system of the heart. The primary purpose of a pacemaker is to maintain an adequate heart rate, either because the heart's natural pacemaker is not fast enough, or because there is a block in the heart's electrical conduction system. Modern pacemakers are externally programmable and allow a cardiologist, particularly a cardiac electrophysiologist, 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 ... [...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 c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of 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 wasn't until the Federal Food, Drug, and Cosmetic Act (FD& ... [...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) to det ... [...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 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, whereby 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 impossible to construct ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directed Assembly Of Micro- And Nano-Structures
Directed assembly of micro- and nano-structures are methods of mass-producing micro to nano devices and materials. Directed assembly allows the accurate control of assembly of micro and nano particles to form even the most intricate and highly functional devices or materials. Directed self-assembly Directed self-assembly (DSA) is a type of directed assembly which utilizes block co-polymer morphology to create lines, space and hole patterns, facilitating for a more accurate control of the feature shapes. Then it uses surface interactions as well as polymer thermodynamics to finalize the formation of the final pattern shapes. To control the surface interactions enabling sub-10 nm resolution, a team consisting of Massachusetts Institute of Technology, University of Chicago, and Argonne National Laboratory developed a way to use vapor-phase deposited polymeric top layer on the block co-polymer film in 2017. The DSA is not a standalone process, but rather is integrated with tradi ... [...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 safety of food, drugs, medical devices, and cosmetics. 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 influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Photolithography
In integrated circuit manufacturing, photolithography or optical lithography is a general term used for techniques that use light to produce minutely patterned thin films of suitable materials over a substrate, such as a silicon wafer, to protect selected areas of it during subsequent etching, deposition, or implantation operations. Typically, ultraviolet light is used to transfer a geometric design from an optical mask to a light-sensitive chemical (photoresist) coated on the substrate. The photoresist either breaks down or hardens where it is exposed to light. The patterned film is then created by removing the softer parts of the coating with appropriate solvents. Conventional photoresists typically consists of three components: resin, sensitizer, and solvent. Photolithography processes can be classified according to the type of light used, such as ultraviolet, deep ultraviolet, extreme ultraviolet, or X-ray. The wavelength of light used determines the minimum feature si ... [...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 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: photo lithography, scanning lithography, soft lithography and other miscellaneous techniques. History The NL 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. While lithographic techniques have been around since the late 18th century, none were applied to nanoscale structures until the mid-1950s. With evolution of the semiconductor industry, demand for techniques capable of producing ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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