1 Bioinformatics
1
2 8 PHARMACEUTICAL ENGINEERING
2 Biomechanics
Main article: Biomechanics
See Biomechanics.
3 Biomaterial
Micromass cultures of C3H-10T1/2 cells at varied oxygen ten-
Main article: Biomaterial sions stained with Alcian blue.
5 Tissue engineering
Main article: Tissue engineering 7 Neural engineering
Tissue engineering, like genetic engineering (see below),
Neural engineering (also known as neuroengineering) is a
is a major segment of biotechnology - which overlaps sig-
discipline that uses engineering techniques to understand,
nicantly with BME.
repair, replace, or enhance neural systems. Neural engi-
One of the goals of tissue engineering is to create arti- neers are uniquely qualied to solve design problems at
cial organs (via biological material) for patients that need the interface of living neural tissue and non-living con-
organ transplants. Biomedical engineers are currently re- structs.
searching methods of creating such organs. Researchers
have grown solid jawbones[2] and tracheas[3] from hu-
man stem cells towards this end. Several articial uri-
nary bladders have been grown in laboratories and trans-
planted successfully into human patients.[4] Bioarticial 8 Pharmaceutical engineering
organs, which use both synthetic and biological compo-
nent, are also a focus area in research, such as with hep-
atic assist devices that use liver cells within an articial Pharmaceutical engineering is an interdisciplinary sci-
bioreactor construct.[5] ence that includes drug engineering, novel drug delivery
and targeting, pharmaceutical technology, unit operations
of Chemical Engineering, and Pharmaceutical Analysis.
It may be deemed as a part of pharmacy due to its focus
6 Genetic engineering on the use of technology on chemical agents in providing
better medicinal treatment. The ISPE is an international
Main article: Genetic engineering body that certies this now rapidly emerging interdisci-
plinary science.
9.1 Medical imaging 3
R1
V2 R2 R3
9.2 Implants Articial body part replacements are one of the many ap-
plications of bionics. Concerned with the intricate and
thorough study of the properties and function of human
An implant is a kind of medical device made to replace
body systems, bionics may be applied to solve some en-
and act as a missing biological structure (as compared
gineering problems. Careful study of the dierent func-
with a transplant, which indicates transplanted biomedi-
tions and processes of the eyes, ears, and other organs
cal tissue). The surface of implants that contact the body
paved the way for improved cameras, television, radio
might be made of a biomedical material such as titanium,
transmitters and receivers, and many other useful tools.
silicone or apatite depending on what is the most func-
These developments have indeed made our lives better,
tional. In some cases, implants contain electronics, e.g.
but the best contribution that bionics has made is in the
articial pacemakers and cochlear implants. Some im-
eld of biomedical engineering (the building of useful re-
plants are bioactive, such as subcutaneous drug delivery
placements for various parts of the human body). Mod-
devices in the form of implantable pills or drug-eluting
ern hospitals now have available spare parts to replace
stents.
body parts badly damaged by injury or disease [Citation
Needed]. Biomedical engineers work hand in hand with
doctors to build these articial body parts.
10 Clinical engineering
Main article: Clinical engineering
etc. Also see safety engineering for a discussion of the 12 Regulatory issues
procedures used to design safe systems.
the European Medical Device Directive". The directive form of regulation. While nations often strive for sub-
species dierent procedures according to the class of stantive harmony to facilitate cross-national distribution,
the device ranging from the simple Declaration of Con- philosophical dierences about the optimal extent of reg-
formity (Annex VII) for Class I devices to EC verica- ulation can be a hindrance; more restrictive regulations
tion (Annex IV), Production quality assurance (Annex seem appealing on an intuitive level, but critics decry the
V), Product quality assurance (Annex VI) and Full qual- tradeo cost in terms of slowing access to life-saving de-
ity assurance (Annex II). The Medical Device Directive velopments.
species detailed procedures for Certication. In gen-
eral terms, these procedures include tests and verica-
tions that are to be contained in specic deliveries such 12.1 RoHS II
as the risk management le, the technical le and the
quality system deliveries. The risk management le is Directive 2011/65/EU, better known as RoHS 2 is a re-
the rst deliverable that conditions the following design cast of legislation originally introduced in 2002. The
and manufacturing steps. Risk management stage shall original EU legislation Restrictions of Certain Haz-
drive the product so that product risks are reduced at an ardous Substances in Electrical and Electronics Devices
acceptable level with respect to the benets expected for (RoHS Directive 2002/95/EC) was replaced and super-
the patients for the use of the device. The technical le seded by 2011/65/EU published in July 2011 and com-
contains all the documentation data and records support- monly known as RoHS 2. RoHS seeks to limit the dan-
ing medical device certication. FDA technical le has gerous substances in circulation in electronics products,
similar content although organized in dierent structure. in particular toxins and heavy metals, which are subse-
The Quality System deliverables usually includes proce- quently released into the environment when such devices
dures that ensure quality throughout all product life cycle. are recycled.
The same standard (ISO EN 13485) is usually applied for The scope of RoHS 2 is widened to include products pre-
quality management systems in US and worldwide. viously excluded, such as medical devices and industrial
equipment. In addition, manufacturers are now obliged
to provide conformity risk assessments and test reports
or explain why they are lacking. For the rst time, not
only manufacturers, but also importers and distributors
share a responsibility to ensure Electrical and Electronic
Equipment within the scope of RoHS comply with the
hazardous substances limits and have a CE mark on their
products.
standard species the procedures required to maintain a Graduate education is a particularly important aspect in
wide range of medical assets in a clinical setting (e.g. BME. While many engineering elds (such as mechani-
Hospital).[11] The standards are based on the IEC 606101 cal or electrical engineering) do not need graduate-level
standards. training to obtain an entry-level job in their eld, the
The standard covers a wide range of medical equipment majority of BME positions do prefer or even require
management elements including, procurement, accep- them.[19] Since most BME-related professions involve
tance testing, maintenance (electrical safety and preven- scientic research, such as in pharmaceutical and medical
tative maintenance testing) and decommissioning. device development, graduate education is almost a re-
quirement (as undergraduate degrees typically do not in-
volve sucient research training and experience). This
can be either a Masters or Doctoral level degree; while
13 Training and certication in certain specialties a Ph.D. is notably more common
than in others, it is hardly ever the majority (except in
13.1 Education academia). In fact, the perceived need for some kind of
graduate credential is so strong that some undergradu-
Biomedical engineers require considerable knowledge of ate BME programs will actively discourage students from
both engineering and biology, and typically have a Bache- majoring in BME without an expressed intention to also
lors (B.Tech, B.S) or Masters (M.S., M.Tech, M.S.E., or obtain a masters degree or apply to medical school after-
M.Eng.) or a Doctoral (Ph.D.) degree in BME (Biomed- wards.
ical Engineering) or another branch of engineering with Graduate programs in BME, like in other scientic elds,
considerable potential for BME overlap. As interest in are highly varied, and particular programs may empha-
BME increases, many engineering colleges now have a size certain aspects within the eld. They may also
Biomedical Engineering Department or Program, with feature extensive collaborative eorts with programs in
oerings ranging from the undergraduate (B.Tech, B.S., other elds (such as the Universitys Medical School or
B.Eng or B.S.E.) to doctoral levels. Biomedical engineer- other engineering divisions), owing again to the interdis-
ing has only recently been emerging as its own discipline ciplinary nature of BME. M.S. and Ph.D. programs will
rather than a cross-disciplinary hybrid specialization of typically require applicants to have an undergraduate de-
other disciplines; and BME programs at all levels are be- gree in BME, or another engineering discipline (plus cer-
coming more widespread, including the Bachelor of Sci- tain life science coursework), or life science (plus certain
ence in Biomedical Engineering which actually includes engineering coursework).
so much biological science content that many students use
Education in BME also varies greatly around the world.
it as a "pre-med" major in preparation for medical school.
By virtue of its extensive biotechnology sector, its numer-
The number of biomedical engineers is expected to rise
ous major universities, and relatively few internal barri-
as both a cause and eect of improvements in medical
ers, the U.S. has progressed a great deal in its develop-
technology.[12]
ment of BME education and training opportunities. Eu-
In the U.S., an increasing number of undergraduate rope, which also has a large biotechnology sector and
programs are also becoming recognized by ABET as an impressive education system, has encountered trouble
accredited bioengineering/biomedical engineering pro- in creating uniform standards as the European commu-
grams. Over 65 programs are currently accredited by nity attempts to supplant some of the national jurisdic-
ABET.[13][14] tional barriers that still exist. Recently, initiatives such
In Canada and Australia, accredited graduate programs as BIOMEDEA have sprung up to develop BME-related
in Biomedical Engineering are common, for example in education and professional standards.[20] Other countries,
Universities such as McMaster University, and the rst such as Australia, are recognizing and moving to cor-
Canadian undergraduate BME program at Ryerson Uni- rect deciencies in their BME education.[21] Also, as high
versity oering a four-year B.Eng program.[15][16][17][18] technology endeavors are usually marks of developed na-
The Polytechnique in Montreal is also oering a bache- tions, some areas of the world are prone to slower devel-
lorss degree in biomedical engineering. opment in education, including in BME.
Professional Engineer (PE), but in practice such a license Kenneth R. Diller Chaired and Endowed Profes-
is not required to practice in the majority of situations sor in Engineering, University of Texas at Austin.
(due to an exception known as the private industry ex- Founded the BME department at UT Austin. Pio-
emption, which eectively applies to the vast majority neer in bioheat transfer, mass transfer, and biotrans-
of American engineers). This is notably not the case in port
many other countries, where a license is as legally neces-
sary to practice engineering as it is for law or medicine. Y. C. Fung professor emeritus at the University of
California, San Diego, considered by many to be the
Biomedical engineering is regulated in some countries, founder of modern biomechanics[25]
such as Australia, but registration is typically only rec-
ommended and not required.[22] Leslie Geddes (deceased) professor emeritus at
In the UK, mechanical engineers working in the areas of Purdue University, electrical engineer, inventor, and
Medical Engineering, Bioengineering or Biomedical en- educator of over 2000 biomedical engineers, re-
gineering can gain Chartered Engineer status through the ceived a National Medal of Technology in 2006
Institution of Mechanical Engineers. The Institution also from President George Bush[26] for his more than
runs the Engineering in Medicine and Health Division.[23] 50 years of contributions that have spawned inno-
The Institute of Physics and Engineering in Medicine vations ranging from burn treatments to miniature
(IPEM) has a panel for the accreditation of MSc courses debrillators, ligament repair to tiny blood pressure
in Biomedical Engineering and Chartered Engineering monitors for premature infants, as well as a new
status can also be sought through IPEM. method for performing cardiopulmonary resuscita-
tion (CPR).
The Fundamentals of Engineering exam the rst (and
more general) of two licensure examinations for most Willem Johan Kol (deceased) pioneer of
U.S. jurisdictionsdoes now cover biology (although hemodialysis as well as in the eld of articial or-
technically not BME). For the second exam, called the gans
Principles and Practices, Part 2, or the Professional En-
gineering exam, candidates may select a particular engi- Robert Langer Institute Professor at MIT, runs the
neering disciplines content to be tested on; there is cur- largest BME laboratory in the world, pioneer in drug
rently not an option for BME with this, meaning that any delivery and tissue engineering[27]
biomedical engineers seeking a license must prepare to
Herbert Lissner (deceased) Professor of Engineer-
take this examination in another category (which does not
ing Mechanics at Wayne State University. Initiated
aect the actual license, since most jurisdictions do not
studies on blunt head trauma and injury thresholds
recognize discipline specialties anyway). However, the
beginning in 1939 in collaboration with E.S. Gur-
Biomedical Engineering Society (BMES) is, as of 2009,
djian, a neurosurgeon at Wayne States School of
exploring the possibility of seeking to implement a BME-
Medicine. Individual for whom the American Soci-
specic version of this exam to facilitate biomedical en-
ety of Mechanical Engineers' top award in Biomed-
gineers pursuing licensure.
ical Engineering, the Herbert R. Lissner Medal, is
Beyond governmental registration, certain private-sector named.
professional/industrial organizations also oer certica-
tions with varying degrees of prominence. One such ex- John James Rickard Macleod (deceased) one of
ample is the Certied Clinical Engineer (CCE) certica- the co-discoverers of insulin at Case Western Re-
tion for Clinical engineers. serve University.
In 2012 there were about 19,400 biomedical engineers Nicholas A. Peppas Chaired Professor in
employed in the US, and the eld was predicted to grow Engineering, University of Texas at Austin, pioneer
by 27% (much faster than average) from 2012-2022.[24] in drug delivery, biomaterials, hydrogels and
Biomedical engineering has the highest percentage of nanobiotechnology.
women engineers compared to other common engineer-
ing professions. Robert Plonsey professor emeritus at Duke Uni-
versity, pioneer of electrophysiology[29]
Otto Schmitt (deceased) biophysicist with sig- [7] Couvreur, Patrick; Vauthier, Christine (2006).
nicant contributions to BME, working with Nanotechnology: Intelligent Design to Treat Com-
biomimetics plex Disease. Pharmaceutical Research. 23 (7):
14171450(34). PMID 16779701. doi:10.1007/s11095-
Ascher Shapiro (deceased) Institute Professor at 006-0284-8. Archived from the original on October 2,
MIT, contributed to the development of the BME 2007.
eld, medical devices (e.g. intra-aortic balloons)
[8] Curtis, Adam SG; Dalby, Matthew; Gadegaard,
Frederick Thurstone (deceased) professor emer- Nikolaj (2006). Cell signaling arising from nan-
itus at Duke University, pioneer of diagnostic otopography: implications for nanomedical devices.
Nanomedicine. 1 (1): 6772. ISSN 1743-5889.
ultrasound[30]
doi:10.2217/17435889.1.1.67.
John G. Webster professor emeritus at the
[9] U.S. Food and Drug Administration, Medical & Radiation
University of WisconsinMadison, a pioneer in the Emitting Device Recalls http://www.accessdata.fda.gov/
eld of instrumentation ampliers for the recording scripts/cdrh/cfdocs/cfres/res.cfm
of electrophysiological signals
[10] World Health Organization (WHO), 2003 Medical De-
U. A. Whitaker (deceased) provider of the vice Regulations Global overview and guiding princi-
Whitaker Foundation, which supported research and ples. http://www.who.int/medical_devices/publications/
education in BME by providing over $700 million en/MD_Regulations.pdf (last visit Sept 2013)
to various universities, helping to create 30 BME
programs and helping nance the construction of 13 [11] . Standards Australia. 2016-10-18 http://infostore.
saiglobal.com/store/details.aspx?ProductID=1595659.
buildings[31]
Retrieved 2016-10-18. Missing or empty |title= (help)
Seymour Ben-Zvi, ScD, CCE; - Established the Sci-
[12] U.S. Bureau of Labor Statistics - Prole for Engineers
entic and Medical Instrumentation Center (SMIC) Archived February 19, 2006, at the Wayback Machine.
at SUNY Downstate[32][33]
[13] Accredited Biomedical Engineering Programs.
Bmes.org. Archived from the original on 2011-09-28.
Retrieved 2011-09-24.
16 See also
[14] ABET List of Accredited Engineering Programs
Biomechanics Archived August 23, 2006, at the Wayback Machine.
[2] Jaw bone created from stem cells. BBC News. October [20] BIOMEDEA. September 2005. Archived from the
10, 2009. Retrieved 11 October 2009. original on May 6, 2008.
[3] Walles T. Tracheobronchial bio-engineering: biotechnol- [21] Lithgow, B. J. (October 25, 2001). Biomedical Engi-
ogy fullling unmet medical needs. Adv Drug Deliv Rev. neering Curriculum: A Comparison Between the USA,
2011; 63(4-5):367-74. Europe and Australia. Archived from the original on
May 1, 2008.
[4] Doctors grow organs from patients own cells. CNN.
April 3, 2006. [22] National Engineering Registration Board - Areas Of Prac-
tice - NPER Areas Archived January 5, 2008, at the
[5] Trial begins for rst articial liver device using human Wayback Machine.
cells, University of Chicago, February 25, 1999
[23] Medical Engineering: Homepage. Institution of Me-
[6] ""Nano": The new nemesis of cancer Hede S, Huilgol N chanical Engineers. Archived from the original on May
- J Can Res Ther. cancerjournal.net. 2, 2007.
10 19 EXTERNAL LINKS
18 Further reading
Bronzino, Joseph D. (April 2006). The Biomedical
Engineering Handbook (Third ed.). [CRC Press].
ISBN 978-0-8493-2124-5.
Villafane, Carlos (June 2009). Biomed: From
the Students Perspective (First ed.). [Technicians-
friend.com]. ISBN 978-1-61539-663-4.
19 External links
Biomedical Engineering at DMOZ
11
20.2 Images
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CC BY 2.5 Contributors: Transferred from en.wikipedia Original artist: Original uploader was en:User:Cquan at en.wikipedia
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Contributors: Available from the U.S. Armys website, http://web.archive.org/web/http://www4.army.mil/armyimages/armyimage.php?
photo=1836 Original artist: ?
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Contributors: ? Original artist: ?
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sa-3.0 Contributors: ? Original artist: ?
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Image_3684-PH.jpg License: Public domain Contributors: from NIH Here. Credit: NIADDK, 9AO4 (Connie Raab-contact); NIH.
Original artist: X-ray Image ID: 3684. Photographer: Unknown.
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tors: Transferred from en.wikipedia to Commons. Original artist: Paphrag at English Wikipedia
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cense: LGPL Contributors: Own work based on Image:Nuvola apps kcmsystem.png by Alphax originally from [1] Original artist:
MesserWoland
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nal artist: ?
12 20 TEXT AND IMAGE SOURCES, CONTRIBUTORS, AND LICENSES