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Pharmaceutical Biomaterials & medical devices glossary & taxonomy
  Evolving terminologies for emerging technologies
Comments? Questions? Revisions? Mary Chitty
Last revised December 30, 2013

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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.

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

BIOML Biopolymer Markup Language:  Designed by the BIOML core team at Proteometrics, LLC and Proteometrics Canada Ltd. It is to be used "for the annotation of biopolymer sequence information. BIOML allows the full specification of all experimental information known about molecular entities composed of biopolymers, for example, proteins and genes."  BIOML, XML Cover Pages, 2002

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.    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: 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.

Wikipedia 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 - .  

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 

Using biological processes to synthesize and manufacture chemicals and materials of high value to the Department of Defense. Biological processes are characterized by: low energy barriers (~10Kcal, high temperatures/pressures not required); high reaction-, regio- and stereo- specificity (protection/ deprotection wastes and catalyst poisoning avoided); spatio-temporal control of materials synthesis of defined composition and size with angstrom- level precision; and local control of the dielectric environment (largely eliminating the need for toxic solvents). Potential target materials and chemicals include composites with enhanced mechanical properties, ultra-low k dielectrics and thermoelectrics, optoelectronic materials, photonic devices (waveguides and logic elements), electronic materials (e.g., GaN, InGaN, AlGaN), elastomers, energetic materials, and adhesives. Biofabrication, DARPA 

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 

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 

biomedical engineering: Wikipedia 

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]

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: 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   

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 

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$FILE/HELLEREF.PDF 

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

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

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

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.

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

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]

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

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 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

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 

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"  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]

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

National Institute of Biomedical Imaging and Bioengineering: Molecular  Imaging 

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   Related terms;  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).  Related term medical device  

protein engineering: Protein technologies
regenerative medicine: Molecular Medicine

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

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


stem cells: Stem cells


Aptiv Solutions, Medical Device Glossary
Emergo Group, Glossary of Medical Device Terms 
INSPEC thesaurus, 2012
IUPAC, Terminology for biorelated polymers and applications, 2012 
Medicines & Device Regulation: What you need to know, MHRA Medicine & Healthcare products Regulatory Agency, UK 

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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