Prior Art
Senior Design Course
City College, Fall 2007
Senior Design
Main steps in Design Process
 1. Determine design specifications /
requirements, understand the problem.
 2. Prepare a project proposal.
 3. Prepare an initial timeline for the project.
 4. Consider existing/alternative solutions,
prior art search.
 5. Generate multiple (alternative) solutions
Main steps in Design Process
 6. Evaluate alternatives by comparing them to design
requirements and to each other. Steps 5-6 are iterative and
can be conducted using:
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a) Brain-storming, block-diagram, paper design
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b) Engineering/quantitative analysis (e.g. computer
modeling/simulation)
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c) Prototyping, components and different levels of abstraction
 7. Decide on applicable solution
 8. Communicate results
 The entire design process must be carefully documented.
Prior Art
 Generally, an invention is
something that is found by
reaching out into the
unknown.
 Since an invention cannot be
defined by describing
something that is still
unknown, the only
alternative is to state what is
not an invention.
 This is done by defining
what is in the prior art.
Prior Art
 Prior art may be defined very
broadly as the entire body of
knowledge from the
beginning of time to the
present.
 In most patent laws, prior
art or state of the art is all
information that has been
disclosed to the public in any
form before a given date.
Prior Art
 However, under United States patent
law, secret prior art, such as secret
sales, qualifies as prior art in certain
circumstances.
 In Europe, prior art does not include
information kept secret, whether from
trade secrecy or just a simple lack of
interest in publication.
Prior Art
 In most patent laws, prior art is expected to
provide a description sufficient to inform the
average worker in the field (or the man
skilled in the art), published in fixed form
and made available in public libraries.
Prior Art
 In most patent laws, prior art
does not include unpublished
work or mere conversations
(though according to the
Europen Patent Convention,
oral disclosures also form
prior art – see Art. 54(2)
EPC). It is disputed whether
traditional knowledge (e.g. of
medical properties of a certain
plant) constitutes prior art.
Prior Art
 The term prior art is mainly
used in the patent field.
Patents disclose to society
how an invention is
practiced, in return for the
right (during a limited term)
to exclude others from
manufacturing, selling,
offering for sale or using
the patented invention
without the patentee's
permission.
Prior Art
 Patent offices deal with prior art
searches in the context of the patent
granting procedure. To assess the
validity of a patent application,
patent offices explore the prior art
that was disclosed before the
invention occurred (in the United
States and all first-to-invent patent
systems) or before the filing date (in
Europe and all first-to-file patent
systems).
The jet engine
 Hero, an Egyptian scientist from
Alexandria, developed the first
"jet engine" about the year 100
BC. Known as the "aeolipile"
The jet engine
 Leonardo Da Vinci designed
a device called the "chimney
jack" around the year 1500
AD. The chimney jack was
used to turn a roasting
skewer. This reaction-type
turbine worked on the
principle of heat raising gases
from the roasting tire. As the
hot air rose, it passed through
fanlike blades that turned the
roast through a series of gears
The jet engine
 In 1629 an Italian engineer, Giovanni
Branca, was probably the first to invent an
actual impulse turbine. This device, a
stamping mill, was generated by a steampowered turbine. A jet nozzle directed steam
onto a horizontally mounted turbine wheel,
which then turned an arrangement of gears
that operated his mill
 In 1687 Isaac Newton attempted to put his newly
formulated laws of motion to the test with his
"steam wagon". He tried to propel the wagon by
directing steam through a nozzle pointed rearward.
Steam was produced by a boiler mounted on the
wagon. Due to lack of power from the steam, this
vehicle didn't operate
The jet engine
 In 1791 John Barber, was the
first to patent a design that used
the thermodynamic cycle of the
modem gas turbine. His design
contained the basics of the
modem gas turbine it had a
compressor, a combustion
chamber, and a turbine. The
main difference in his design
was that the turbine was
equipped with a chain-driven
reciprocating type of
compressor. He intended its use
for jet propulsion
 In January 1930 an Englishman, Frank Whittle, submitted a patent application
for a gas turbine for jet propulsion. It wasn't until the summer of 1939 that the
Air Ministry awarded Power Jets Ltd a contract to design a flight engine. In
May 1941 the Whittle W1 engine made its first flight mounted in the Gloster
Model E28/39 aircraft. This airplane would later achieve a speed of 370 MPH
in level flight with 1000 pounds of thrust.
Where?
 Scientific Journals
 Design Magazines
 Patent Offices
 Internet
 Company web sites
 Design books, texts, software, databases, etc
Scientific Journals
 BME design related journals as Anti-cancer drug
design, Artificial intelligence for engineering
design, analysis and manufacturing, Computer
aided design, Design automation for embedded
systems, Design engineering, Design management
review, Design news, Design Patents, Design
studies, Drug design and discovery, Electronic
design, Finite elements in analysis and
design, Formal methods in system design, Global
design news, Hospitality design, ID : magazine of
international design (New York, N.Y. 1984), …
Scientific Journals
 International Journal of Design Computing,
International journal of mechanics and materials in
design, Internet electronic journal of molecular
design, Journal of computer-aided materials design,
Journal of engineering design, Journal of
sustainable product design, Materials &
design, Mechanics based design of structures and
machines, Printed circuit design, Printed circuit
design & manufacture, Research in engineering
design, SBS digital design)
Design Magazines
 BME design related magazines as
http://www.medicaldesign.com/, Medical Device &
Diagnostic Industry, Medical Product
Manufacturing News, IVD Technology, MX,
European Medical Device Manufacturer, Medical
Electronics Manufacturing, Pharmaceutical &
Medical Packaging News, Medical design
technology, Medical Device & Diagnostic Industry
magazine, etc)
Medicaldesign.com
Patent and regulation Offices
 http://devicelink.com/links/regulatory.html
 Intellectual Property Sites:
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www.patentcafe.com - a good site for general inventor
info,
www.uspto.gov This is the official Web site of the
United States Patent and Trademark Office, an Agency of
the US Department of Commerce.
Patent & Standards
Organizations
 www.fda.gov/cdrh/ Food and drug administration
 Association for the Advancement of Medical
Instrumentation (AAMI) http://www.aami.org/
 American National Standards Institute (ANSI)
http://www.ansi.org/
 International Electrotechnical Commission (IEC)
http://www.iec.ch/
 CDRH Office and Division Associated with Recognized
Standards
 Processes: 510(K), PMA, PDP, IDE, HDE, GMP, DESIGN
CONTROLS
Patent and regulation Offices
 European: http://www.atlanticbridge.co.uk/page7.htm CE
Marking of Medical devices.
 National Institute of Industrial Property
(France): http://www.inpi.fr/inpi/accueil.htm
 For information about legislative requirements from the
European Union, the European Directives, and their relation
to European Standards in particular industrial sectors,
visit: http://www.newapproach.org/
Internet
 General search engines (Google, yahoo, etc);
 Scientific/medical search engines (Pub Med, ISI,
IEEE, BioOne Journals Online, JSTOR (General
Science, Mathematics and Statistics Collections),
Kluwer Online, LINK - (from Springer
Publishing Group), Oxford University Press,
Proquest Direct, ScienceDirect - (from Elsevier),
Synergy - (from Blackwell Science and
Munksgaard), Wiley Interscience
Internet
 Relevant web-based resources. Medical device
news links http://www.abledata.com;
www.bmesource.org; http://enablingdevices.com,
http://www.devicelink.com/ ,
http://www.mdtmag.com/scripts/default.asp,
www.medicaldevicesonline.com/
Relevant company web sites
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ATL
Acuson
Agilent
Colin,
Corometrics
Critikon
Criticare
Datascope
IVAC
Littman
Med-Scan
Medison
PhysioControl
Omron
Sensormedics
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Perimed
Schiller
Ash Medical
Pressurometer
American Medical
Systems
Puritan-Bennett
Dinamap
OmniTrak
Infinium
Nicolet
SPO Medical
Diasonics,
Fuji
GE,
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Hitachi,
HP,
Marquette,
Medinotes,
NEC-Mitsubishi,
Mennen
Motorola,
Nonin,
Philips,
Nihon Kohden
Siemens,
Space Labs,
Tektronix,
Toshiba,
Welch Allyn, etc.
BME design books
 King, Paul H, Fries, Richard C, Design of Biomedical Devices and
Systems, Marcel Dekker, 2002.
 Fries, Richard C. Reliable Design of Medical Devices, New York,
Marcel Dekker, 1997.
 Witkin, Karen B. Clinical Evaluation of Medical Devices: Principles
and Case Studies, Humana Press, 1997. (excellent on evaluation)
 Geddes, Leslie, Medical Device Accidents With Illustrative Cases, New
York, CRC Press, 1998. ( an interesting collection of mishaps)
 Casey, S., Set Phasers on Stun and other True Tales of Design,
Technology, and Human Error, Santa Barbara, CA, Aegean Publishing
Company, 1993. (Excellent reading on many mishaps ...)
ME/EE/Comp. Eng related
design texts
 Bock, Peter, getting it right, R&D Methods for Science and Engineering. New
York, 2001, Academic Press. (Generalist text on both R & D methodology, good
source.)
 Ulrich, K.T., Eppinger, S.D. Product Design & Development, New York, 2000,
McGraw Hill (Excellent general purpose text, useable from ME to
Management.)
 Design in the New Millennium: Advanced Engineering Environments: Phase 2,
National Academy Press. See http://www.nap.edu/books/0309071259/html/ for
an electronic copy and print order forms.
 Pahl, G., Beitz, W., Engineering Design, A Systematic Approach, London,
Springer-Verlag, 1988. (Classic, good, but hard to read)
ME/EE/Comp. Eng related
design texts
 Dieter, G.E., Engineering Design, New York, McGraw Hill, 2000. (Good
general purpose ME text)
 Suh, N. The Principles of Design New York, Oxford University Press, 1990.
(an axiomatic approach to design using information principles)
 Wilcox, A. Engineering Design For Electrical Engineers, Englewood Cliffs N.J.,
Prentice Hall, 1990. (Easy)
 Ingle, Kathryn A. Reverse Engineering, New York, McGraw-Hill Inc.,
1994. (excellent ME/EE reverse engineering examples)
 Middendorf, William H. Design of Devices and Systems, New York, Marcel
Dekker Inc., 1990. (Good overview, good coverage of Human Factors...)
ME/EE/Comp. Eng related
design texts
 Carper, Kenneth L. Forensic Engineering, New York, Elsevier,
1989.. (interesting case studies...)
 Burgess, J. Designing for Humans: The Human Factor in Engineering,
Princeton, Petrocelli Books, 1986. (Any of you needing ergonomics . . . )
 Schach, Steven R., Classical and Object-oriented Software Engineering, Irwin
Press, Chicago, 1996 (Excellent source text for software design)
 Dym, Clive L. Engineering Design, a Synthesis of Views, Cambridge University
Press, 1994 (An interesting non-denominational overview of the design process,
taxonomy, and trends)
ME/EE/Comp. Eng related
design texts
 Dieter, George E. Engineering Design, A Materials and Processing Approach,
McGraw Hill, 2000. (A Mechanical Engineering text, excellent in coverage of
the overall process of design.)
 "Curriculum Design, from an art towards a science" by S Waks (Technion U,
Israel), ISBN # 3-9804190-0-2 is recommended for planning purposes, if you are
outlining a new design or related course..
 Chaffin, DB, Andersson, GBJ, "Occupational Biomechanics", Wiley, 1991.
(some human factors use.)
 Eggert, Rudolph. "Engineering Design", Prentice Hall, 2005. (ME & aerospace
oriented, several useful chapters)
Intellectual Property/
Miscellaneous
 Sunar, D. G., The Expert Witness Handbook-a Guide for Engineers,
Belmont CA, Professional Publications, 1989. (overview of expert
witness responsibilities ...)
 Poynter, D. The Expert Witness Handbook, Tips and Techniques for the
Litigation Consultant, Para Publishing, 1987.
 Foltz, R., Penn, T. Protecting Engineering Ideas & Inventions, Cleveland
Ohio, Penn Institute, 1989. (In-depth coverage of the titled topic, of
value in your professional activities...)
 LT Kahn, JM Corrigan, MS Donaldson, To Err is Human, Building a
Safer Health System. National Academy Press, Washington,
2000. (Super statistics, proof that BMEs are needed!)
 Nahum, Alan m., Melvin, John W. “Accidental Injury, Biomechanics
and Prevention”, Springer, New York, 2002.
Quality Function Deployment
 Quality function deployment or "QFD" is a flexible and
comprehensive group decision making technique used in
product or service development, brand marketing, and
product management.
 QFD can strongly help an organization focus on the critical
characteristics of a new or existing product or service from
the separate viewpoints of the customer market segments,
company, or technology-development needs. The results of
the technique yield transparent and visible graphs and
matrices that can be reused for future product/service
developments
QFD/TRIZ Materials
 William Eureka, Nancy Ryan, The Customer-Driven Company: Managerial
Perspectives on Quality Function Deployment, ASI Press, Dearborn MI 1994
(Good QFD overview/tutorial).
 John Terninko, Step-by-Step QFD, Customer-Driven Product Design, 2nd
Edition, St Lucie Press, Boca Raton, FL, 1997 (ditto)
 Cohen, L. "Quality Function Deployment: How to Make QFD Work for You"
Addison Wesley, 1995 (good, generic coverage)
 http://www.qualisoft.com/ - for QFD information, download the demo…
 http://www.totalqualitysoftware.co.uk for qfd2000 information
 Altshuller, G.S. "Creativity as an Exact Science" Gordon & Breach Science,
1984. (translation of the original TRIZ material)
 http://www.ideationtriz.com for TRIZ materials, several publications available.
 http://www.techoptimizer.com for another TRIZ type of site, software for
invention.
Ethics
 http://www.cnn.com/HEALTH/bioethics/archive.index.html
for some of our ethical questions
 http://www.cwru.edu/med/bioethics/bioethics.html . CWRU
ethics site, comprehensive!
 http://www.nspe.org/ethics/eh1-code.asp NSPE ethics web
site, links to others
Biomaterials/Biomimetics
 Hill, D., "Design Engineering of Biomaterials for Medical
Devices", Wiley, 1998. ( A BME specific biomaterials
oriented text. 2/3 Biomaterials, 1/3 design, all very good.)
 Wise, D. L. Biomaterials and Bioengineering Handbook,
Dekker, 2000 (Very comprehensive)
 Sarikaya, M, Aksay, I. Biomimetics, Design and Processing
of Materials, AIP, 1995.
 Ratner, B., Hoffman, A., Schoen, F., Lemons, J.
Biomaterials Science: An Introduction to Materials in
Medicine, Academic Press, 1996. (Excellent coverage of a
wide variety of topics.)
Design Software
 Design, Simulation commercial products and services, etc.
Specialized packages, such as designsafe[i] – for safety
analyses of devices and processes, FMEA analysis – for
failure mode analyses, and QFD designer - for
quality/function/deployment applications are recommended
as courses become more specialized. Recommendations for
senior or graduate design aids include software such as
Working Model 2-D and 3-D modeler[ii] for motion analysis
and trajectory modeling.
[i] Design Safety Engineering, Ann Arbor MI
[ii] Knowledge Revolution, San Mateo CA
Design Software
 CAD software such as SolidWorks[iii] or Think3[iv] is
recommended for design layouts, if the students have had
introductory courses in the use of such software, or have the
time to learn it as needed. Given sufficient preparation,
prototypes from these packages can be generated and tested.
The program TechOptimizer[v] is strongly recommended for
advanced level design courses, if one can afford the license
cost. TechOptimizer will guide one through and assist in the
design process, once sufficient time is spent learning how to
use the software.
[iii] SolidWorks Corp, Concord MA
[iv] Think3, Santa Clara CA
[v] Invention Machine Corp., Boston MA
Design Software
 Options in the use of the software are routines that
guide one through product or process analysis,
evaluation of feature transfers, and generation of
similar effect listings. At a bare minimum, this
program can be used to do both a general web
search using a logical Boolean search, and to do a
similar patent search of either or both the US Patent
Office listing or the Japanese Patent Office listings.