Technologies term index
Related glossaries include
Cell
& tissue technologies,
Drug
delivery & formulation
Labels, signaling &
detection Metabolic profiling
Microscopy, Nanoscience & 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.
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm
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 http://www.technologyreview.com/featuredstory/513716/additive-manufacturing/
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
https://en.wikipedia.org/wiki/Biocomposite
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:
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
http://bioeng.berkeley.edu/about-us/what-is-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
http://www.mdpi.com/journal/bioengineering/about
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. 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 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, prosthetics, biopharmaceuticals,
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 http://en.wikipedia.org/wiki/Biological_engineering
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
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
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
https://www.journals.elsevier.com/biomaterials/
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:
Biochemistry Relating to or denoting synthetic methods which mimic biochemical
processes. Oxford English Dictionary
https://en.oxforddictionaries.com/definition/biomimetic
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
https://en.wikipedia.org/wiki/Biomimetics
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:
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 environment, agriculture, energy, industry, food
production, biotechnology and
medicine.
Wikipedia accessed 2018 Oct 18 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
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; sonar, radar,
and medical ultrasound imaging
imitating animal
echolocation. In the field of computer
science, the study of bionics has produced artificial
neurons, artificial
neural networks,[3] and swarm
intelligence. Evolutionary
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
https://en.wikipedia.org/wiki/Bionics
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
biopolymers:
Macromolecules (including proteins, nucleic acids
and polysaccharides) formed by living organisms. IUPAC Compendium 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
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.
http://www.fda.gov/Training/CDRHLearn/default.htm
combination products:
Regulatory
databases medical device approvals FDA:
https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htm
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 http://www.wired.co.uk/news/archive/2013-05/28/electroceuticals
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
http://pittsburghplastics.com/assets/files/What%20Are%20Hydrogels.pdf
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
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202502.htm
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: 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
https://www.fda.gov/forpatients/approvals/devices/ucm405378.htm
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
https://en.wikipedia.org/wiki/Medical_device_reporting
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
https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/medicaldevicetracking/default.htm
Medical Device User
Fee and Modernization Act MDUFA:
https://www.fda.gov/forindustry/userfees/medicaldeviceuserfee/ucm454046.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/
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
https://en.wikipedia.org/wiki/Medical_Devices_Directive
molecular self-assembly:
Wikipedia
https://en.wikipedia.org/wiki/Molecular_self-assembly
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
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
https://en.wikipedia.org/wiki/Neuromodulation_(medicine)
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
https://en.wikipedia.org/wiki/Neurostimulation
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.
http://www.ncbi.nlm.nih.gov/pubmed/23372076
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
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/ucm259555.htm#IOS
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? https://whatis.ciowhitepapersreview.com/definition/patient-monitoring/
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
https://www.degruyter.com/view/j/ci.2005.27.issue-5/ci.2005.27.5.21a/ci.2005.27.5.21a.xml
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
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.
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
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
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
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
https://www.fda.gov/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/default.htm
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.
https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program
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.
https://www.ncbi.nlm.nih.gov/pubmed/24280635
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 https://www.investopedia.com/terms/w/wearable-technology.asp
wearables: 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. https://www.triconference.com/Digital-Health
Biomaterials & Medical Devices resources
Emergo Group, Glossary of Medical Device Terms
https://www.emergogroup.com/resources/glossary-medical-device-industry-terms
FDA , Data Standards and Terminology Standards for Information Submitted to
CDRH https://www.fda.gov/medicaldevices/deviceregulationandguidance/datastandardsmedicaldevices/default.htm
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
https://www.iupac.org/publications/pac/pdf/2012/pdf/8402x0377.pdf
Medical Device & Diagnostics Industry MDDI Qmed
directory https://directory.qmed.com/ 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
6. Williams DF (Ed.). Definitions in Biomaterials, Proceedings of a
Consensus Conference of the European Society for Biomaterials, Elsevier,
Amsterdam (2004).
https://books.google.com/books/about/The_Williams_Dictionary_of_Biomaterials.html?id=Hv45B7P5N3gC
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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