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Biomaterials & medical devices glossary & taxonomy

  Evolving terminologies for emerging technologies
Comments? Questions? Revisions?
Mary Chitty MSLS
Last revised June 24, 2019

Technologies term index  Related glossaries include Cell & tissue technologiesDrug delivery & formulation   Labels, signaling & detection   Metabolic profiling  MicroscopyNanoscience & Miniaturization

510(K)  A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process.  The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."  Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.  Legally marketed also means that the predicate cannot be one that is in violation of the Act.
Monthly listings of Premarket Notification [510(k)] 

A 510(k) application involves demonstrating that the new product is substantially equivalent to an existing product on the market. It is limited to devices and diagnostics, and by definition, applies only to "me- too" type devices. That is, it represents an incremental improvement over something that is already on the market ... Because of its similarity to a product that has already had a thorough regulatory review, it does not bring up any new issues. .. For 510(k)s, we [the FDA] have been averaging about 1,000 a year.  Joseph Hackett, in CHI Summit Pharmacogenomics Report

additive manufacturing: printing the part with lasers rather than casting and welding the metal. The technique, known as additive manufacturing (because it builds an object by adding ultrathin layers of material one by one), .. Additive manufacturing—the industrial version of 3-D printing—is already used to make some niche items, such as medical implants, and to produce plastic prototypes for engineers and designers.  10 Breakthrough Technologies 2013, MIT Technology Review,  Martin LaMonica, April 2013   See related Three dimensional printing

Bioartificial Organs: Artificial organs that are composites of biomaterials and cells. The biomaterial can act as a membrane (container) as in BIOARTIFICIAL LIVER or a scaffold as in bioartificial skin. MeSH 2001

biocompatible coated materials: Biocompatible materials usually used in dental and bone implants that enhance biologic fixation, thereby increasing the bond strength between the coated material and bone, and minimize possible biological effects that may result from the implant itself. MeSH, 1999 

biocompatible materials:  Synthetic or natural materials, other than drugs, that are used to replace or repair any body tissue or bodily function. MeSH, 1973 Related term: biomaterials Narrower term: biocompatible coated materials

biocomposite: (bio from Greek 'alive') is a composite material formed by a matrix (resin) and a reinforcement of natural fibers. These kind of materials often mimic the structure of the living materials involved in the process keeping the strengthening properties of the matrix that was used, but always providing biocompatibility. Wikipedia accessed 2018 Nov 11

biodynotics Biologically Inspired Multifunctional Dynamic Robotics: The use of biologically inspired practices, principles, multifunctional materials, sensors, and signal processing to demonstrate energy efficient and autonomous locomotion and behavior in challenging unplanned environments (e.g., rubble of different sizes, flight in wind, turbulent water). We are interested in exploring new modalities of locomotion such as climbing (trees, cliffs, cave walls), jumping, and leaping and the ability to manipulate the world with an appendage that allows grasping and digging.    Broader term: robotics

bioelectronics: the field of developing medicines that use electrical impulses to modulate the body's neural circuits. Virtually all of the body's organs and functions are regulated through circuits of neurons communicating through electrical impulses. The theory is that if you can accurately map the neural signatures of certain diseases, you could then stimulate or inhibit the malfunctioning pathways with tiny electrodes in order to restore health, without having to flood the system with molecular medicines. Electroceuticals swapping drugs for devices, Wired 28 May 2013  Related term: electroceuticals; Genomics optogenetics

bioengineering:  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, new medical imaging technology, portable disease diagnostic devices, and tissue engineered organs. Berkeley Bioengineering  

Bionics and biological cybernetics: implantology; bio–abio interfaces; Bioelectronics: wearable electronics; implantable electronics; “more than Moore” electronics; bioelectronics devices; Bioprocess and biosystems engineering and applications: bioprocess design; biocatalysis; bioseparation and bioreactors; bioinformatics; bioenergy; etc.; Biomolecular, cellular and tissue engineering and applications: tissue engineering; chromosome engineering; embryo engineering; cellular, molecular and synthetic biology; metabolic engineering; bio-nanotechnology; micro/nano technologies; genetic engineering; transgenic technology; Biomedical engineering and applications: biomechatronics; biomedical electronics; biomechanics; biomaterials; biomimetics; biomedical diagnostics; biomedical therapy; biomedical devices; sensors and circuits; biomedical imaging and medical information systems; implants and regenerative medicine; neurotechnology; clinical engineering; rehabilitation engineering; Biochemical engineering and applications: metabolic pathway engineering; modeling and simulation; Translational bioengineering  SCOPE NOTE Bioengineering MDPI  Related term: biological engineering

biofabrication: can be defined as the production of complex living and non-living biological products from raw materials such as living cells, molecules, extracellular matrices, and biomaterials. Cell and developmental biology, biomaterials science, and mechanical engineering are the main disciplines contributing to the emergence of biofabrication technology. The industrial potential of biofabrication technology is far beyond the traditional medically oriented tissue engineering and organ printing and, in the short term, it is essential for developing potentially highly predictive human cell- and tissue-based technologies for drug discovery, drug toxicity, environmental toxicology assays, and complex in vitro models of human development and diseases. In the long term, biofabrication can also contribute to the development of novel biotechnologies for sustainable energy production in the future biofuel industry and dramatically transform traditional animal-based agriculture by inventing 'animal-free' food, leather, and fur products.  Biofabrication: a 21st century manufacturing paradigm. Mironov V et al. Biofabrication. 2009 Jun;1(2):022001. doi: 10.1088/1758-5082/1/2/022001. Epub 2009 Jun 10. 

bioinks: Cell-laden hydrogels are commonly used in biofabrication and are termed "bioinks.  25th anniversary article: Engineering hydrogels for biofabrication. Malda J et al Adv Mater. 2013 Sep 25;25(36):5011-28. doi: 10.1002/adma.201302042. Epub 2013 Aug 23.

biological engineering: the application of principles of biology and the tools of engineering to create usable, tangible, economically viable products.[1] Biological engineering employs knowledge and expertise from a number of pure and applied sciences,[2] such as mass and heat transfer, kinetics, biocatalysts, biomechanics, bioinformatics, separation and purification processes, bioreactor design, surface science, fluid mechanics, thermodynamics, and polymer science. It is used in the design of medical devices, diagnostic equipment, biocompatible materials, renewable bioenergy, ecological engineering, agricultural engineering, and other areas that improve the living standards of societies. Examples of bioengineering research include bacteria engineered to produce chemicals, new medical imaging technology, portable and rapid disease diagnostic devices, prostheticsbiopharmaceuticals, and tissue-engineered organs[3]. Bioengineering is overlaps substantially with biotechnology and the biomedical sciences[4] in a way analogous to how various other forms of engineering and technology relate to various other sciences
Wikipedia accessed 2018 Oct 18   Related term: bioengineering

biological ink-jet printing For many years, ink-jet technology has been used as a helpful tool in providing a noncontact technique to print inks in a rapid manner. Recently, this technology has been applied in the medical field by using encapsulated cells as the ink (bio-ink) in order to print tissues and organs, including heterogeneous tissue and microvascular cell assembly as well as biomaterials. With help from a pressurized air-supply controlled by solenoid valves, these bioprinters deposit encapsulated cells onto the substrate Bioprinting Science or Fiction? Arif Sirinterlikci and Lauren Walk Medical Manufacturing Yearbook April 2014

biological laser printing: (BioLP) is an automated CAD based transfer process where a laser beam moves cells covered by a medium, usually within microbeads or microcapsules, onto the receiving substrate. It is capable of rapidly depositing living cells onto a variety of surfaces. Unlike other techniques such as ink-jetting printing, the process delivers a small volume of a variety of biomaterials without using an orifice, and eliminates potential clogging issues and damage to the cells. Today’s laser-assisted bioprinting technology applications include laser-based micro patterning of cells in gelatin, cell assembly, bioprinting of skin, and laser-engineered microenvironments for cell culture. -  Bioprinting Science or Fiction? Arif Sirinterlikci and Lauren Walk Medical Manufacturing Yearbook April 2014

biomaterial: Material exploited in contact with living tissues, organisms, or microorganisms. Note 1: The notion of exploitation includes utility for applications and for fundamental research to understand reciprocal perturbations as well. Note 2: The definition “non-viable material used in a medical device, intended to interact with biological systems” recommended in [6] cannot be extended to the environmental field where people mean “material of natural origin”. Note 3: This general term should not be confused with the terms biopolymer or biomacromolecule. The use of “polymeric biomaterial” is recommended when one deals with polymer or polymer device of therapeutic or biological interest.  IUPAC Terminology for Biorelated Polymers    

A biomaterial is now defined as a substance that has been engineered to take a form which, alone or as part of a complex system, is used to direct, by control of interactions with components of living systems, the course of any therapeutic or diagnostic procedure.   …The scope of the journal covers the wide range of physical, biological and chemical sciences that underpin the design of biomaterials and the clinical disciplines in which they are used. These sciences include polymer synthesis and characterization, drug and gene vector design, the biology of the host response, immunology and toxicology and self-assembly at the nanoscale. Clinical applications include the therapies of medical technology and regenerative medicine in all clinical disciplines, and diagnostic systems that reply on innovative contrast and sensing agents. The journal is relevant to areas such as cancer diagnosis and therapy, implantable devices, drug delivery systems, gene vectors, bionanotechnology and tissue engineering. Biomaterials, Elsevier Aims & Scope

Synthetic or natural materials that can replace or augment tissues, organs or body functions. Related terms: biocompatible materials, biopolymers, smart materials:

Mechanical structures of  living organisms (especially muscles and bones).  Wikipedia 

biomedical engineering: Wikipedia 

biomimetic materials: Materials fabricated by BIOMIMETICS techniques, i.e., based on natural processes found in biological systems. MeSH 2003

biomimetics:   Biochemistry Relating to or denoting synthetic methods which mimic biochemical processes. Oxford English Dictionary

An interdisciplinary field in materials science, ENGINEERING, and BIOLOGY, studying the use of biological principles for synthesis or fabrication of BIOMIMETIC MATERIALS. MeSH 2003

Biomimetics or biomimicry is the imitation of the models, systems, and elements of nature for the purpose of solving complex human problems.[1] The terms "biomimetics" and "biomimicry" derive from Ancient Greek: βίος (bios), life, and μίμησις (mīmēsis), imitation, from μιμεῖσθαι (mīmeisthai), to imitate, from μῖμος (mimos), actor. A closely related field is bionics.[2   Wikipedia accessed 2018 Oct 18

The term biomimetics was coined in 1972 in the context of artificial enzymes; it might be defined broadly as "the abstraction of good design from nature". It is a fact of everyday life that nature has managed to built materials and 'devices' with breathtaking functionality, heterogeneity and stability by using a comparatively limited number of building blocks (the whole range of synthetic materials is restricted to man- made engineering). The basic concepts of nature are often simple; it is the way in which building blocks and materials are arranged that results in functionality. Among the most simple and abundant themes of nature is self- assembly: lipids assemble in sheets to form cell membranes, proteins assemble into functional enzymes, cellular 'sensors', fibers, or virus coats, and DNA assembles in double strands to provide the very basis for live: replication. George M. Whitesides, Harvard Univ. Research: "Biomimetics"    
Related terms:
  biopolymers, molecularly imprinted polymers; Drug discovery & development molecular mimicry, peptidomimetic, Gene amplification & PCR PCR, PNA; Glycosciences  glycomimetic 

biomolecular engineering: the application of engineering principles and practices to the purposeful manipulation of molecules of biological origin. Biomolecular engineers integrate knowledge of biological processes with the core knowledge of chemical engineering in order to focus on molecular level solutions to issues and problems in the life sciences related to the environmentagricultureenergyindustryfood productionbiotechnology and medicine. Wikipedia accessed 2018 Oct 18 

biomolecular materials: An emerging discipline, materials whose properties are abstracted from biology. They share many of the characteristics of biological materials but are not necessarily of biological origin. For example, they may be inorganic materials that are organized or processed in a biomimetic fashion. A key feature of biological and biomolecular materials is their ability to undergo self- assembly. Biomolecular self- assembling materials, National Academy of Sciences 1996

biomotors: Driven by energy sources such as adenosine triphosphate (ATP) for chemical transduction and other processes. These biomotors are considered to be biomolecular and are discussed in the body of this report, but strictly speaking they do not conform to the panel's definition of self- assembly. Biomolecular self- assembling materials, National Academy of Sciences 1996 

bionics or biologically inspired engineering is the application of biological methods and systems found in nature to the study and design of engineering systems and modern technology.[1] The word bionic was coined by Jack E. Steele in 1958, possibly originating from the technical term bion (pronounced BEE-on; from Ancient Greek: βίος bíos), meaning 'unit of life' and the suffix -ic, meaning 'like' or 'in the manner of', hence 'like life'. Some dictionaries, however, explain the word as being formed as a portmanteau from biology and electronics.[2] It was popularized by the 1970s U.S. television series The Six Million Dollar Man and The Bionic Woman, both based upon the novel Cyborg by Martin Caidin, which was itself influenced by Steele's work. All feature humans given superhuman powers by electromechanical implants. ...The term "biomimetic" is preferred when reference is made to chemical reactions.[citation needed] In that domain, biomimetic chemistry refers to reactions that, in nature, involve biological macromolecules (e.g. enzymes or nucleic acids) whose chemistry can be replicated in vitro using much smaller molecules. Examples of bionics in engineering include the hulls of boats imitating the thick skin of dolphins; sonarradar, and medical ultrasound imaging imitating animal echolocation. In the field of computer science, the study of bionics has produced artificial neuronsartificial neural networks,[3] and swarm intelligenceEvolutionary computation was also motivated by bionics ideas but it took the idea further by simulating evolution in silico and producing well-optimized solutions that had never appeared in nature.  Wikipedia accessed 2018 Oct 18  

bioplastic: Biobased polymer derived from the biomass or issued from monomers derived from the biomass and which, at some stage in its processing into finished products, can be shaped by flow. Note 1: Bioplastic is generally used as the opposite of polymer derived from fossil resources. Note 2: Bioplastic is misleading because it suggests that any polymer derived from the biomass is environmentally friendly. Note 3: The use of the term “bioplastic” is discouraged. Use the expression “biobased polymer. IUPAC Terminology for Biorelated Polymers 

Macromolecules (including proteins, nucleic acids and polysaccharides) formed by living organisms. IUPAC Compendium
See also biorelated polymers, polymers biomedica

bioprinting: A material transfer technique used for assembling biological material or cells into a prescribed organization to create functional structures such as MICROCHIP ANALYTICAL DEVICES, cell microarrays, or three dimensional anatomical structures. MeSH 2013

New manufacturing technologies under the banner of rapid prototyping enable the fabrication of structures close in architecture to biological tissue. In their simplest form, these technologies allow the manufacture of scaffolds upon which cells can grow for later implantation into the body. A more exciting prospect is the printing and patterning in three dimensions of all the components that make up a tissue (cells and matrix materials) to generate structures analogous to tissues; this has been termed bioprinting.  Printing and prototyping of tissues and scaffolds. Derby B. Science. 2012 Nov 16;338(6109):921-6. doi: 10.1126/science.1226340

Recently, there has been growing interest in applying bioprinting techniques to stem cell research. Several bioprinting methods have been developed utilizing acoustics, piezoelectricity, and lasers to deposit living cells onto receiving substrates. Using these technologies, spatially defined gradients of immobilized biomolecules can be engineered to direct stem cell differentiation into multiple subpopulations of different lineages. Stem cells can also be patterned in a high-throughput manner onto flexible implementation patches for tissue regeneration or onto substrates with the goal of accessing encapsulated stem cells of interest for genomic analysis. Bioprinting for stem cell research. Tasoglu S1, Demirci U. Trends Biotechnol. 2013 Jan;31(1):10-9. doi: 10.1016/j.tibtech.2012.10.005. Epub 2012 Dec 19. 

bioprinting - organs and tissues: The most recent advances in organ and tissue bioprinting based on the thermal inkjet printing technology are described in this review. Bioprinting has no or little side effect to the printed mammalian cells and it can conveniently combine with gene transfection or drug delivery to the ejected living systems during the precise placement for tissue construction. With layer-by-layer assembly, 3D tissues with complex structures can be printed using scanned CT or MRI images. Vascular or nerve systems can be enabled simultaneously during the organ construction with digital control. Therefore, bioprinting is the only solution to solve this critical issue in thick and complex tissues fabrication with vascular system. Collectively, bioprinting based on thermal inkjet has great potential and broad applications in tissue engineering and regenerative medicine.  Thermal inkjet printing in tissue engineering and regenerative medicine. Cui X et. al. Recent Pat Drug Deliv Formul. 2012 Aug;6(2):149-55.

bioprinting technologies: Bioprinting is an emerging technology that has its origins in the rapid prototyping industry. The different printing processes can be divided into contact bioprinting(1-4) (extrusion, dip pen and soft lithography), contactless bioprinting(5-7) (laser forward transfer, ink-jet deposition) and laser based techniques such as two photon photopolymerization(8). It can be used for many applications such as tissue engineering(9-13), biosensor microfabrication(14-16) and as a tool to answer basic biological questions such as influences of co-culturing of different cell types(17). Unlike common photolithographic or soft-lithographic methods, extrusion bioprinting has the advantage that it does not require a separate mask or stamp. Using CAD software, the design of the structure can quickly be changed and adjusted according to the requirements of the operator. This makes bioprinting more flexible than lithography-based approaches..Printing thermoresponsive reverse molds for the creation of patterned two-component hydrogels for 3D cell culture. Müller M et. al. J Vis Exp. 2013 Jul 10;(77):e50632. doi: 10.3791/50632

biorelated polymers: Like most of the materials used by humans, polymeric materials are proposed in the literature and occasionally exploited clinically, as such, as devices or as part of devices, by surgeons, dentists, and pharmacists to treat traumata and diseases. Applications have in common the fact that polymers function in contact with animal and human cells, tissues, and/or organs. More recently, people have realized that polymers that are used as plastics in packaging, as colloidal suspension in paints, and under many other forms in the environment, are also in contact with living systems and raise problems related to sustainability, delivery of chemicals or pollutants, and elimination of wastes. These problems are basically comparable to those found in therapy. Last but not least, biotechnology and renewable resources are regarded as attractive sources of polymers.  IUPAC Recommendations, Terminology for Biorelated Polymers and Applications 2012  
See also biopolymers, polymers biomedical

biorobotics:  Our research focuses on the role of sensing and mechanical design in motor control, in both robots and humans. This work draws upon diverse disciplines, including biomechanics, systems analysis, and neurophysiology. The main approach is experimental, although analysis and simulation play important parts.  In conjunction with industrial partners, we are developing applications of this research in biomedical instrumentation, teleoperated robots, and intelligent sensors. Harvard Biorobotics Laboratory, 2004. 

bone substitutes: Synthetic or natural materials for the replacement of bones or bone tissue. They include hard tissue replacement polymers, natural coral, hydroxyapatite, beta- tricalcium phosphate, and various other biomaterials. The bone substitutes as inert materials can be incorporated into surrounding tissue or gradually replaced by original tissue. MeSH, 1995

CDRH Center for Devices and Radiologic Health: CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. Part of FDA.

combination products: Regulatory

databases medical device approvals FDA:

Monthly listings of Premarket Notification [510(k)] and Premarket Approval (PMA) decisions ·         Information on Humanitarian Device Exemption (HDE) approvals ·         Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.

electroceuticals: The first logical step towards electroceuticals is to better map the neural circuits associated with disease and treatment.  This needs to happen on two levels.  On the anatomical level researchers need to map disease-associated nerves and brain areas and identify the best points for intervention. On the signalling level, the neural language at these intervention points must be decoded to develop a "dictionary" of patterns associated with health and disease states -- a project synergistic with international drives to map the human brain. Research teams across the globe have realised that by targeting individual nerve fibres or specific brain circuits they may soon be able to treat a wide range of conditions that have formerly relied on drug-based interventions. This could include inflammatory diseases such as rheumatoid arthritis, respiratory diseases such as asthma and diabetes. In the long run you could also control neuro-psychiatric disorders like Parkinson's and epilepsy. It wouldn't be possible to treat infectious diseases, since the bacteria and viruses that cause them aren't directly connected to the nervous system, nor would you be able to treat cancer directly in this way. However, in both cases you could stimulate the relevant nerves to boost aspects of the immune system. Electroceuticals swapping drugs for devices, Wired 28 May 2013   Related terms: bioelectronics, Genomics: optogenetics

hydrogels: Gelatin powder, such as Kraft Foods’ Jell-O, is a solid. Empty a packet of Jell-O into a mixing bowl and add boiling water. Stir until dissolved and then chill. Now the material in the bowl is neither solid nor liquid nor gas; it’s a hydrogel. Like a solid, hydrogels do not flow. Like a liquid, small molecules diffuse through a hydrogel. So what is a hydrogel? In 1926, Dorothy Jordan Lloyd stated that “the colloidal condition, the gel, is one which is easier to recognize than to define”. Hydrogels are currently viewed as water insoluble, cross-linked, three-dimensional networks of polymer chains plus water that fills the voids between polymer chains. Crosslinking facilitates insolubility in water and provides required mechanical strength and physical integrity. Hydrogel is mostly water (the mass fraction of water is much greater than that of polymer). The ability of a hydrogel to hold significant amount of water implies that the polymer chains must have at least moderate hydrophilic character. Classification [of hydrogels] may be based on physical structure of the polymer chain: amorphous (random, noncrystalline), semi-crystalline (regions of partially ordered structure) or hydrogen-bonded (network held together by hydrogen bonds). Another way to classify hydrogels is by the method of preparation: homopolymer (made from one type of monomer), copolymer (made from more than one type of monomer), multipolymer (more than one type of polymer) or interpenetrating polymer (a second polymer network is polymerized around and within a first polymer network, and there are no covalent linkages between the two networks). Hydrogels may also be categorized based on ionic charges as follows: neutral (no charge) such as dextran; anionic (negative charge) such as carrageenan; cationic (positive charge) such as chitosan; and ampholytic (capable of behaving either positively or negatively) such as collagen. What are hydrogels? Pittsburgh Plastics 

implant: Medical device made from one or more biomaterials that is intentionally placed within the body, either totally or partially buried beneath an epithelial surface [6]. Note: There are also other devices implanted that are not medical devices, e.g., for cosmetic, cultural, or aesthetic purposes. IUPAC Terminology for Biorelated Polymers 

infusion pump glossary 

MatML Materials Markup Language: An extensible markup language (XML) developed especially for the interchange of materials information.  

materials science: Science of  ceramics, glass, metals, plastics, semiconductors.

medical device: Instrument, apparatus, implement, machine, contrivance, in vitro reagent, or other similar or related article, including any component, part of accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man [6]. IUPAC Terminology for Biorelated Polymers 

Medical Device Development: Medical device development follows a well-established path. Many of these steps overlap with each other as scientists invent, refine, and test the devices. Typically, the development process begins when researchers see an unmet medical need. Then, they create a concept or an idea for a new device. From there, researchers build a “proof of concept,” a document that outlines the steps needed to determine whether or not the concept is workable. Many times, concepts are not practical. The concepts that do show promise move to the later stages of development. FDA Device Discovery and Concept

Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled Wikipedia accessed 2019 Jan 16

Medical device tracking: Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the Food and Drug Administration (FDA) to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.  FDA, Medical Device Tracking

Medical Device User Fee and Modernization Act MDUFA: 

medical devices: Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers.
Device Advice

Medical Devices Directive  (Council Directive 93/42/EEC of 14 June 1993[1] concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union.   Wikipedia accessed 2019 Jan 16

molecular self-assembly:  Wikipedia

molecularly imprinted polymers MIPs: A new class of materials that have artificially created receptor structures. Since their discovery in 1972, MIPs have attracted considerable interest from scientists and 3engineers involved with the development of chromatographic absorbents, membranes, sensors and enzyme and receptor mimics. S. Piletsky et. al. "Molecular imprinting: at the edge of the third millennium" Trends in Biotechnology 19 (1): 9- 12, Jan. 2001

nanobiomaterials: a field at the interface of biomaterials and nanotechnologies, when applied to tissue engineering applications, are usually perceived to resemble the cell microenvironment components or as a material strategy to instruct cells and alter cell behaviors. Therefore, they provide a clear understanding of the relationship between nanotechnologies and resulting cellular responses.  Advanced nanobiomaterial strategies for the development of organized tissue engineering constructs. An J et. al, Nanomedicine (Lond). 2013 Apr;8(4):591-602. doi: 10.2217/nnm.13.46.

National Institute of Biomedical Imaging and Bioengineering: Molecular  Imaging 

neuromodulation:  "the alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body". It is carried out to normalize – or modulate – nervous tissue function. Neuromodulation is an evolving therapy that can involve a range of electromagnetic stimuli such as a magnetic field (rTMS), an electric current, or a drug instilled directly in the subdural space (intrathecal drug delivery). Emerging applications involve targeted introduction of genes or gene regulators and light (optogenetics), and by 2014, these had been at minimum demonstrated in mammalian models, or first-in-human data had been acquired.[1] The most clinical experience has been with electrical stimulation. Wikipedia Accessed 2018 Nov 21   Related terms electroceuticals, neurostimulation

neurostimulation: the purposeful modulation of the nervous system's activity using invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcranial alternating current stimulation, tACS). Neurostimulation usually refers to the electromagnetic approaches to neuromodulation.  Wikipedia accessed 2018 Nov 1 Related terms: electroceuticals, neuromodulation

organ printing: defined as computer-aided additive biofabrication of 3-D cellular tissue constructs, has shed light on advancing this field into a new era. Organ printing takes advantage of rapid prototyping (RP) technology to print cells, biomaterials, and cell-laden biomaterials individually or in tandem, layer by layer, directly creating 3-D tissue-like structures.  Bioprinting toward organ fabrication: challenges and future trends. Ozbolat IT1, Yu Y. IEEE Trans Biomed Eng. 2013 Mar;60(3):691-9. doi: 10.1109/TBME.2013.2243912. Epub 2013 Jan 30.

pancreas artificial device systems: Researchers and manufacturers are developing three main categories of Artificial Pancreas Delivery Systems . They differ in how the insulin pump acts on readings from the continuous glucose monitoring system. Threshold Suspend  Device System   Insulin Only System   Bi-Hormonal Control System   FDA Medical Devices Artificial Pancreas Device Systems

patient monitoring: the observation of a disease, medical condition, and other vital parameters and of a patient over a period of time. It is usually performed by continually measuring certain medical parameters with the use of a device called as medical monitor and also performing medical tests like blood tests and urine tests. A medical monitor usually consists of one or more sensors, processing components, display devices and communication links for displaying or recording the results through a monitoring network. The development of new techniques is a highly sophisticated and growing field in smart medicine, predictive medicine, integrative medicine, alternative medicine, preventive medicine that emphasizes on patient monitoring of comprehensive medical data of patients. CIO Whitepapers: What is patient monitoring?  

Patient monitoring product directory  
Top 10 remote patient monitoring companies for hospitals  

plastic: Generic term used in the case of polymeric material that may contain other substances to improve performance and/or reduce costs. Note 1: The use of this term instead of polymer is a source of confusion and thus is not recommended. Note 2: This term is used in polymer engineering for materials often compounded that can be processed by flow. IUPAC Terminology for Biorelated Polymers 

polymer: Substance composed of macromolecules [2]. Note: Applicable to substance macromolecular in nature like cross-linked systems that can be considered as one macromolecule. IUPAC Terminology for Biorelated Polymers 

polymers - biomedical:  Like most of the materials used by humans, polymers and polymeric materials have been tested and used by surgeons and pharmacists to treat trauma and diseases. Polymers are also used when studying living systems in the environment. Each domain has developed specific terminologies, which have been the source of misunderstanding, confusion, and misperception among scientists, surgeons, pharmacists, journalists, and policy makers. This project aims to define specific terms used by people active in the biomedical, pharmacological, environmental, and journalistic fields. IUPAC, Terminology for biomedical (therapeutic) polymers, 2009
Related terms; biopolymers, biorelated polymers;  Biomolecules macromolecule (polymer molecule), polymers, regenerative medicine

positional control:  Ralph Merkle, Adding positional control to molecular manufacturing, Xerox PARC, 1993

premarket approval PMA: Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k). 
Monthly listings of Premarket Approval (PMA) decisions

prosthesis: Device that replaces a limb, organ, or tissue of the body [6]. IUPAC Terminology for Biorelated Polymers 

scaffolds: A major pillar of most tissue engineering approaches is the scaffold, a biocompatible network of synthetic or natural polymers, which serves as an extracellular matrix mimic for cells. When the scaffold is seeded with cells it is supposed to provide the appropriate biomechanical and biochemical conditions for cell proliferation and eventual tissue formation. Numerous approaches have been used to fabricate scaffolds with ever-growing complexity.  Toward engineering functional organ modules by additive manufacturing. Marga F et. al, Biofabrication. 2012 Jun;4(2):022001. doi: 10.1088/1758-5082/4/2/022001. Epub 2012 Mar 12.

self-assembly: <biology>  A process in which supramolecular hierarchical organization is established without external intervention.... The approaches used can be expected to fall into two general categories. The first involves directly mimicking biological systems or processes to produce materials with enhanced properties. An example of this approach is the use of molecular genetic techniques to produce polymers with unprecedentedly uniform molecular length. The second category involves studying how nature accomplishes a task or creates a structure with unusual properties, and then applying similar techniques in a completely different context or using completely different materials. Biomolecular self- assembling materials, National Academy of Sciences 1996  Narrower terms: self- assembling biomolecular materials, self-assembling peptides

software as a medical Device: Data Science

smart materials: A smart material is defined as any material that is capable of being controlled such that its response and properties change under a stimulus. A smart structure or system is capable of reacting to stimuli or the environment in a prescribed manner.  Scope Smart Materials and Structures, IOP Science, Institute of Physics

smart polymers: Smart polymers are macromolecules capable of undergoing rapid, reversible phase transitions from a hydrophilic to a hydrophobic microstructure when triggered by small changes in their immediate environment, such as slight variations in temperature, pH or ionic strength. Smart Polymers, CRC Press 2001 Wikipedia 

Software as a medical device: As technology continues to advance all facets of health care, software has become an important part of all products, integrated widely into digital platforms that serve both medical and non-medical purposes.  Software, which on its own is a medical device – Software as a Medical Device – is one of three types of software related to medical devices. The other two types of software related to medical devices include software that is integral to a medical device (Software in a medical device) and software used in the manufacture or maintenance of a medical device. FDA Medical Devices Digital Health  2017   more on software and medical devices

software precertification digital health: The Software Precertification (Pre-Cert) Pilot Program, as outlined in the FDA's Digital Health Innovation Action Plan [PDF], will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market.

tissue constructs bioprinted: Bioprinted tissue constructs have potential in both therapeutic applications and nontherapeutic applications such as drug discovery and screening, disease modelling and basic biological studies such as in vitro tissue modelling. The mechanical properties of bioprinted in vitro tissue models play an important role in mimicking in vivo the mechanochemical microenvironment. In this study, we have constructed three-dimensional in vitro soft tissue models with varying structure and porosity based on the 3D cell-assembly technique.  Mechanical characterization of bioprinted in vitro soft tissue models. Zhang T et. al. Biofabrication. 2013 Dec;5(4):045010. doi: 10.1088/1758-5082/5/4/045010. Epub 2013 Nov 26.

Printing, Three-Dimensional: Process for making, building or constructing a physical object from a three-dimensional digital model by laying down many successive thin layers of building material. MeSH Year introduced: 2015 See related additive manufacturing

wearable technology:  a blanket term for electronics that can be worn on the body, either as an accessory or as part of material used in clothing. There are many types of wearable technology but some of the most popular devices are activity trackers and smartwatches. One of the major features of wearable technology is its ability to connect to the internet, enabling data to be exchanged between a network and the device. This ability to both send and receive data has pushed wearable technology to the forefront of the Internet of Things (IoT). Investopedia  

 Digital Biomarkers: Biosensors, Wearables, and mHealth  June 11-12, 2018 Boston, MA Program |   As the role of biosensors, wearables and mobile health in modern healthcare evolves, the potential of digital biomarkers to continually monitor patient health, rapidly diagnose disease, and accurately predict outcomes becomes increasingly apparent. Physiological data may now be collected via digital devices such as portables, wearables, and implantables. Mobile health, or “mHealth,” promises to transform not only the future of healthcare but also the process of clinical trials. 

Digital Health, Sensors, Wearable and IOT Clinical Utility and Emerging Applications in Drug Development, Diagnostics, and Healthcare MARCH 11-13, 2019, San Francisco CA   Digital Health is promising to revolutionize healthcare delivery, optimize personalized and precision medicine, and offer new tools for drug and diagnostic development. The applications of biosensors, mobile devices and wearables, Internet of Things, mobile health platforms, artificial intelligence, and digital biomarkers are quickly expanding into all areas of patient monitoring and disease management, point-of-care diagnostics, and digital endpoints in clinical trials. Cambridge Healthtech Institute’s Inaugural Digital Health: Sensors, Wearables, and IoT meeting will bring together leading experts and thought leaders in digital health to discuss the latest technologies and implementation of digital tools into drug development, diagnostics and healthcare. 

Biomaterials & Medical Devices resources
Emergo Group, Glossary of Medical Device Terms
FDA , Data Standards and Terminology Standards for Information Submitted to CDRH  
INSPEC thesaurus, 2012
IUPAC. Compendium of Chemical Terminology, 2nd ed. (the "Gold Book"). Compiled by A. D. McNaught and A. Wilkinson. Blackwell Scientific Publications, Oxford (1997). XML on-line corrected version: (2006-) created by M. Nic, J. Jirat, B. Kosata; updates compiled by A. Jenkins. ISBN 0-9678550-9-8.
IUPAC, Terminology for biorelated polymers and applications, 2012
Medical Device & Diagnostics Industry MDDI Qmed directory  

Medicines & Device Regulation: What you need to know, MHRA Medicine & Healthcare products Regulatory Agency, UK 
6. Williams DF (Ed.). Definitions in Biomaterials, Proceedings of a Consensus Conference of the  European Society for Biomaterials, Elsevier, Amsterdam (2004). 

3D Bioprinting Information Resources poster presented World Pharmaceutical Congress 2015 June  

How to look for other unfamiliar  terms

IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry.

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