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Pharmaceutical Biomaterials & medical devices glossary & taxonomy
  Evolving terminologies for emerging technologies
Comments? Questions? Revisions? Mary Chitty mchitty@healthtech.com
Last revised December 02, 2014

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Cell & tissue technologiesDrug delivery & formulation   Labels, signaling & detection   Metabolic profiling  MicroscopyNanoscience & Miniaturization.   Biology Cell biology

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. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

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

actuators: Labels, signaling & detection

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 http://www.technologyreview.com/featuredstory/513716/additive-manufacturing/ 

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. http://www.ncbi.nlm.nih.gov/pubmed/20811099

Using cells, proteins, biomaterials and/or other bioactive elements as building blocks to fabricate advanced biological models, medical therapeutic products and non-medical biological systems. Scope note, Biofabrication, IOP Publishing http://iopscience.iop.org/1758-5090

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

biodecontamination: See Vaporized Hydrogen Peroxide VHP:

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. https://www.fbo.gov/index?s=opportunity&mode=form&id=d7ffd1531c72baebf9a9eeaa03dd8287&tab=core&_cview=0    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  http://www.wired.co.uk/news/archive/2013-05/28/electroceuticals  Related term: electroceuticals; Genomics optogenetics

bioengineering: Bioengineers are focused on advancing human health and promoting environmental sustainability, two of the greatest challenges for our world. Understanding complex living systems is at the heart of meeting these challenges. http://bioengineering.stanford.edu/

Wikipedia Biological engineering http://en.wikipedia.org/wiki/Biological_engineering 

After many years of service to the NIH Bioengineering community, the NIH Bioengineering Consortium (BECON) has completed its mission. Bioengineering has now become an important activity supported at nearly every NIH institute and center, and much of what BECON had done has now been well integrated across the NIH. Many of the bioengineering funding announcements and technical reports at the BECON website have migrated to the National Institute of Biomedical Imaging and Bioengineering - http://www.nibib.nih.gov/ .  

biofabrication: using cells, proteins, biomaterials and/or other bioactive elements as building blocks to fabricate advanced biological models, medical therapeutic products and non-medical biological systems. Scope note Biofabrication, IOP Press  http://iopscience.iop.org/1758-5090/ 

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. http://www.ncbi.nlm.nih.gov/pubmed/20811099 

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. http://www.ncbi.nlm.nih.gov/pubmed/24038336

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 http://www.sme.org/MEMagazine/Article.aspx?id=80443

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 http://www.sme.org/MEMagazine/Article.aspx?id=80443

biomaterials: In this context, biomaterials are defined as all those materials used in medical devices in which contact with the tissues of the patient is an important and guiding feature of their use and performance. They include a range of metals and alloys, glasses and ceramics, natural synthetics, polymers, biomimetics, composites and natural or tissue-derived materials, including combinations of synthetic materials and living tissue components. The journal is relevant to all applications of biomaterials including implantable medical devices, tissue engineering and drug delivery systems. Scope note: Biomaterials, Elsevier  http://www.elsevier.com/wps/find/journaldescription.cws_home/30392/description 

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

biomechanics: Mechanical structures of  living organisms (especially muscles and bones).  Wikipedia http://en.wikipedia.org/wiki/Biomechanics 

biomedical engineering: Wikipedia http://en.wikipedia.org/wiki/Biological_engineering 

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

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

There is a need to develop the next generation of restorative materials and medical implants. New avenues of scientific inquiry may enable the development of biomaterials that are safe, reliable, "smart", long- lasting, and perform ideally in their respective biological environments. ... Over the last few years biomimetics and tissue engineering have emerged as a new vision in the field of tissue and organ repair and restoration. Biomimetics and tissue engineering are interdisciplinary fields that combine information from the study of biological structures and their functions with physics, mathematics, chemistry and engineering for the generation of new materials, tissues and organs. These approaches can offer new ways of: (a) developing biological solutions for future design and synthesis of composite materials such as bone, cartilage, tendon, ligament, skin, dentin, enamel, cementum and periodontal ligament; (b) replacing and assembling functional tissues and organs; and (c) evaluating medical and dental implants. In the area of craniofacial, oral and dental principles from biomimetics and tissue engineering are applied to developing dental and facial implants, new polymers for guided tissue regeneration used in treating periodontal disease and bone and connective tissue defects, coral- based hydroxyapatite replicas for reconstruction of alveolar ridges and other osseous defects, temporomandibular joint (TMJ) and other joint prostheses, formation of bone matrix substitutes, and artificial replicas of bone, skin, and mucosa.  [National Institute of Dental Research, NIH, US, Biomimetics and Tissue Engineering in the Restoration of Orofacial Tissues, RFA: DE-98-009, June 19, 1998] http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-98-009.html

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"]  http://gmwgroup.harvard.edu/domino/html/webpage/homepage2.nsf     Related terms:  biopolymers, molecularly imprinted polymers; Drug discovery & development molecular mimicry, peptidomimetic, Gene amplification & PCR PCR, PNA; Glycosciences  glycomimetic 

biomolecular engineering: Under the umbrella of Biomolecular Engineering, many research groups within CBE are pioneering research in areas such as: Synthetic Biology, Systems Biology, Biomedical Research and Biotechnology, Biochemistry and Biophysics of Biological Systems. Much of the research conducted in these areas has direct applications in: Human disease: design and engineering of therapeutic antibodies and proteins, cell and tissue engineering, delivery of vaccines and therapeutics, discovery of cancer targets, treatment of brain tumors. Fundamental processes of living systems: artificial trees, bioseparations, cell-cell and virus-cell interactions, cellular and subcellular organization, protein biogenesis, regulation and control of networks.  Cornell University, School of Chemical and Biomolecular Engineering http://www.cheme.cornell.edu/research/area.cfm?area=187   
Wikipedia http://en.wikipedia.org/wiki/Biomolecular_engineering 

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  http://www.nas.edu/bpa/reports/bmm/bmm.html#PBMM

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  http://www.nas.edu/bpa/reports/bmm/bmm.html#PBMM 

biopolymers: Macromolecules (including proteins, nucleic acids and polysaccharides) formed by living organisms. [IUPAC Compendium] 

The addition of a biopolymer to a product may improve the function of that product and, therefore, improve its value. Improving or adding functions to a product will be the major role of most biopolymers. The ability to develop novel biopolymers may provide a company with the opportunity to improve a product's competitive position by improving its functionality.(64)  Biopolymers, Background economic study of the Canadian Biotechnology Industry, Industry Canada http://www.ic.gc.ca/eic/site/ippd-dppi.nsf/vwapj/HELLEREF.PDF/$FILE/HELLEREF.PDF 
See also biorelated polymers, polymers biomedical

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 http://www.ncbi.nlm.nih.gov/pubmed/23161993

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. http://www.ncbi.nlm.nih.gov/pubmed/23260439 

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. http://www.ncbi.nlm.nih.gov/pubmed/22436025

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 http://www.ncbi.nlm.nih.gov/pubmed/23892955

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 http://pac.iupac.org/publications/pac/84/2/0377/  
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.  http://biorobotics.harvard.edu/ 

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

bundling: Prior to MDUFA, submitting separate applications for devices that could have been bundled in a single submission, or bundling of devices that should have been submitted in separate applications, was primarily an administrative issue related to the efficiency of the review process. Under MDUFA, bundling within a single premarket submission takes on additional importance because of the fees that are now associated with premarket submissions as well as the performance goals that the agency has committed to meet. This guidance is intended to assist industry and FDA staff in understanding when bundling may be appropriate.  Center for Devices & Radiological Health, FDA, Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission, 2007 http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm

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. http://www.fda.gov/Training/CDRHLearn/default.htm

combination products: Regulatory Affairs

combinatorial materials design: Uses computing power (sometimes together with massive parallel experimentation) to screen many different materials possibilities to optimize properties for specific applications (e.g., catalysts, drugs, optical materials). Central Intelligence Agency, US The Global Technology Revolution, Chapter Two Technology Trends, Genomics, 2001 http://www.cia.gov/nic/pubs/research_supported_by_nic/rand/mr1307.ch2.html

composites: Combinations of metals, ceramics, polymers, and biological materials that allow multi- functional behavior. One common practice is reinforcing polymers or ceramics with ceramic fibers to increase strength while retaining light weight and avoiding the brittleness of the monolithic ceramic. Materials used in the body often combine biological and structural functions (e.g., the encapsulation of drugs). [Central Intelligence Agency, US The Global Technology Revolution, Chapter Two Technology Trends, Genomics, 2001]  http://www.cia.gov/nic/pubs/research_supported_by_nic/rand/mr1307.ch2.html

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 http://www.wired.co.uk/news/archive/2013-05/28/electroceuticals 
Related terms: bioelectronics, Genomics: optogenetics

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

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

Medical Device User Fee and Modernization Act MDUFA: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm   

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. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/default.htm
Device Advice
, FDA, CDRH http://www.fda.gov/cdrh/devadvice/  

microarrays and FDA - regulating: The Food and Drug Administration (FDA) must balance the interests of the public for thorough review of new products for safety and efficacy, against the interests of the industry for a low cost, expedited process of regulatory approval. But all too often the process can place a significant drain on the resources of a company, particularly smaller companies that are introducing new products or innovative technology. It is actually in the interest of all parties to meet each of these requirements. Patients also have an interest in expedited review of new drugs, devices and diagnostics. Companies welcome a regulatory regime that ensures safety and thus public confidence in their products. And it is in nobody’s interest to have a company bankrupt itself just as it is trying to bring an innovative drug or technology to market. The FDA, however, is faced with extraordinary challenges, not only in terms of increased workload of conventional products, but also in trying to re- define regulatory procedures that are appropriate for technologies that take an entirely different approach to diagnostics and treatment, including microarrays, genotyping and pharmacogenomics. How the genomic revolution affects FDA Regulation,  CHI GenomeLink 5.1 http://www.chidb.com/newsarticles/issue5-1.ASP 

microfabrication, molecular motors: Nanoscience & Miniaturization

molecular self-assembly: The spontaneous formation of molecules into covalently bonded, well- defined, stable structures - is a very important concept in biological systems and has increasingly become a focus of non- biological research. Thomson ISI, Special Topics "Molecular Self- Assembly" http://www.esi-topics.com/msa/  Related terms: Nanoscience & miniaturization

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. http://www.ncbi.nlm.nih.gov/pubmed/23560410

nastic structures:  Nastic structures will be capable of shape change because the material will be composed of miniature hydraulic actuators. Actuators are devices that perform mechanical work due to energy input. Most actuators use electricity as their form of driving energy, but nastic actuators will function due to an increase of internal osmotic pressure. Each actuator is very small, but the material will be packed with them, and the individual work of each actuator will add up to result in a wide range of movement, enabling net shape change. Nastic Structures, Univ of South Carolina http://www.che.sc.edu/centers/RCS/matthews/index.htm

National Institute of Biomedical Imaging and Bioengineering: Molecular  Imaging 

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. http://www.ncbi.nlm.nih.gov/pubmed/23372076

polymers - biomedical:  More and more therapeutic problems are relevant to the use of polymer- based therapeutic aids for a limited period of time, namely the healing time related to the outstanding capacity of living systems to self-repair, e.g. bone fracture fixation with screws and plates, of wound closure by sutures and also of drug delivery from implants or similar systems based on polymeric matrices, or on aqueous dispersions or solutions of polymers. After healing the remaining prosthetic materials or devices become foreign residues or wastes that have to be eliminated from the body. Nowadays, biocompatible polymers that can degrade in the body are developed. The degradation and the elimination of degradation by-products depend on rather complex phenomena that are presently reflected inconsistently by terms issued from the tradition because each domain has developed its own terminology almost independently. This is a source of misunderstandings, confusions and misperceptions among scientists, surgeons, pharmacists, journalists and politicians, the situation being increased by the introduction of degradable polymers in plastic waste management and environmental protection. IUPAC, Terminology for biomedical (therapeutic) polymers, current project, 2005 http://www.iupac.org/projects/2004/2004-043-1-400.html   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 http://www.zyvex.com/nanotech/CDAarticle.html

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). http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm  Related term medical device  

protein engineering: Protein technologies
regenerative medicine: Molecular Medicine

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. http://www.ncbi.nlm.nih.gov/pubmed/22406433

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]  http://www.nas.edu/bpa/reports/bmm/bmm.html#PBMM  Narrower terms: self- assembling biomolecular materials, self-assembling peptides
Wikipedia http://en.wikipedia.org/wiki/Self-assembly  

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 http://iopscience.iop.org/0964-1726/page/Scope

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 http://books.google.com/books?id=MKg9crX8eusC Wikipedia http://en.wikipedia.org/wiki/Smart_polymer 

spheroids: Spheroids in concert with other aggregated cell shapes allow for complex tissue architecture studies. 3D cell culture methods confer a high degree of clinical and biological relevance to in vitro models. This is specifically the case with the spheroid culture, where a small aggregate of cells grows free of foreign materials. In spheroid cultures, cells secrete the extracellular matrix (ECM) in which they reside, and they can interact with cells from their original microenvironment. The value of spheroid cultures is increasing quickly due to novel microfabricated platforms amenable to high-throughput screening (HTS) and advances in cell culture. Here, we review new possibilities that combine the strengths of spheroid culture with new microenvironment fabrication methods that allow for the creation of large numbers of highly reproducible, complex tissues.  Spheroid culture as a tool for creating 3D complex tissues. Fennema E et. al. Trends Biotechnol. 2013 Feb;31(2):108-15. doi: 10.1016/j.tibtech.2012.12.003. Epub 2013 Jan 18.               

stem cells: Stem cells

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.

Bibliography
Aptiv Solutions, Medical Device Glossary http://www.aptivsolutions.com/medical-device-trials/additional-resources/medical-devices-glossary/
Emergo Group, Glossary of Medical Device Terms http://www.emergogroup.com/glossary-of-terms 
INSPEC thesaurus, 2012 http://www.theiet.org/resources/inspec/about/records/ithesaurus.cfm
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: http://goldbook.iupac.org (2006-) created by M. Nic, J. Jirat, B. Kosata; updates compiled by A. Jenkins. ISBN 0-9678550-9-8.
doi:10.1351/goldbook  http://goldbook.iupac.org/B00661.html
IUPAC, Terminology for biorelated polymers and applications, 2012 http://pac.iupac.org/publications/pac/pdf/2012/pdf/8402x0377.pdf 
Medicines & Device Regulation: What you need to know, MHRA Medicine & Healthcare products Regulatory Agency, UK http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf 

Alpha glossary index

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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