book reviews [five reviews]

5
IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JANUARY/FEBRUARY 2007 97 Measurement and Data Analysis for Engineering and Science (05 Edition) Patrick F. Dunn, McGraw-Hill Higher Education, 2004, ISBN: 0072825383, 540 pages, US$152. One of ABET’s requirements for bio- medical engineering programs is that students know how to make measure- ments on living systems. Indeed, many BME departments are teaching a course with a title like “Medical Measure- ments.” However, many of these cours- es are taught with books that don’t focus on measurements, but rather on instruments, where instrumentation books tend to teach students how spe- cific medical instruments work, not the general theory of making measurements on living systems. However, it is not just Biomedical Engineering that lacks a selection of textbooks aimed at measurement theo- ry. Dr Patrick Dunn’s new book Measurement and Data Analysis for Engineering and Science, published by McGraw Hill in 2005, attempts to fill a similar gap in mechanical engineering. While not ideal for all biomedical engi- neering measurement courses, with sup- plementation, Dunn’s book is a viable alternative for some. Dunn’s book is probably best used by junior undergraduates, or perhaps seniors. It has many excellent features that distinguish it from its peers. It is well written with clear and stated learn- ing objectives for each chapter. The author is clearly aware that not all students approach measurement the- ory with innate enthusiasm. As such, the chapters contain motivating diver- sions. Each chapter contains a cross- word puzzle review of the material covered in that section. Also, each chapter opens with a historical vignette. For example, chapter one opens with a picture of Leeuwenhoek’s microscope and an interesting three paragraphs on the history of the device, the way the device worked, and why the measure- ments it made mattered. The first two chapters of the book (introduction to experiments, units, and significant figures) cover topics that are often overlooked in engineering educa- tion. Even measurement textbooks often fail to cover these important top- ics. Many faculty teaching measure- ment theory from an instrumentation textbook are forced to supplement the text to teach these topics. The third chapter, on technical com- munication, is also an important topic. However, it is often covered elsewhere in the BME curriculum. Also, the chap- ter is too brief to be helpful, if this is the only exposure to the topic an engineer gets. For example, little more than one page is given to proper grammar and punctuation. Just a bit more is given to power point presentations. It is unlikely that a high school education devoid of grammar training can be undone with this brief treatment. Chapter four would be appropriate for those BME curricula that do not require a circuits class as a prerequisite to measurements. However, it is very challenging to cover in one chapter what many departments cover in one semester. Yet, Dunn does an admirable job. Dunn attempts to start where physics stops and continue up to the transistor. This is a large territory to cover, and will certainly leave some faculty unsatisfied. For example, in covering such a broad base, nomencla- ture becomes a problem: First is used for voltage, then V and then later, E. Nevertheless, when faced with teach- ing measurements without circuits, this chapter does expose the student to the required basics. The chapter on calibration and sys- tems comes next. With a good number of examples and a solid section on sys- tems, this chapter is typical of measure- ment texts. Chapter six begins to dramatically dif- ferentiate this book from a traditional book on instrumentation for biomedical engineers. Absent is a long list of sensors and their physical principals. Rather, Dunn elects to present a few select sen- sors. This is certainly in keeping with the focus of the book—measurements—but may leave some faculty having to sup- plement with their favorite sensor. Rather than focusing on sensors, this chapter adds concepts typically taught in circuits: passive and active analog filters. Unfortunately, chapter six ends with a section on digital filters and analog- to-digital conversion. This topic does not play a role in the immediately fol- lowing chapters and is quite different from the analog material. It would be more common to cover these two topics when digital signals are treated near the end of the book. Chapters 7, 8, 9, and 10 deal with sta- tistics and probability. These topics pose a difficult problem for a measure- ments textbook. On the one hand, they Paul H. King Book Reviews The author is clearly aware that not all students approach measurement theory with innate enthusiasm. As such, the chapters contain motivating diversions.

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Page 1: Book reviews [five reviews]

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JANUARY/FEBRUARY 2007 97

Measurement and Data Analysisfor Engineering and Science (05Edition)Patrick F. Dunn, McGraw-Hill HigherEducation, 2004, ISBN: 0072825383,540 pages, US$152.

One of ABET’s requirements for bio-medical engineering programs is thatstudents know how to make measure-ments on living systems. Indeed, manyBME departments are teaching a coursewith a title like “Medical Measure-ments.” However, many of these cours-es are taught with books that don’tfocus on measurements, but rather oninstruments, where instrumentationbooks tend to teach students how spe-cific medical instruments work, not thegeneral theory of making measurementson living systems.

However, it is not just BiomedicalEngineering that lacks a selection oftextbooks aimed at measurement theo-ry. Dr Patrick Dunn’s new bookMeasurement and Data Analysis forEngineering and Science, published byMcGraw Hill in 2005, attempts to fill asimilar gap in mechanical engineering.While not ideal for all biomedical engi-neering measurement courses, with sup-plementation, Dunn’s book is a viablealternative for some.

Dunn’s book is probably best used byjunior undergraduates, or perhapsseniors. It has many excellent featuresthat distinguish it from its peers. It iswell written with clear and stated learn-ing objectives for each chapter.

The author is clearly aware that notall students approach measurement the-ory with innate enthusiasm. As such,the chapters contain motivating diver-sions. Each chapter contains a cross-word puzzle review of the materialcovered in that section. Also, eachchapter opens with a historical vignette.For example, chapter one opens with apicture of Leeuwenhoek’s microscope

and an interesting three paragraphs onthe history of the device, the way thedevice worked, and why the measure-ments it made mattered.

The first two chapters of the book(introduction to experiments, units, andsignificant figures) cover topics that areoften overlooked in engineering educa-tion. Even measurement textbooksoften fail to cover these important top-ics. Many faculty teaching measure-ment theory from an instrumentationtextbook are forced to supplement thetext to teach these topics.

The third chapter, on technical com-munication, is also an important topic.However, it is often covered elsewherein the BME curriculum. Also, the chap-ter is too brief to be helpful, if this is theonly exposure to the topic an engineergets. For example, little more than onepage is given to proper grammar andpunctuation. Just a bit more is given topower point presentations. It is unlikelythat a high school education devoid ofgrammar training can be undone withthis brief treatment.

Chapter four would be appropriatefor those BME curricula that do not

require a circuits class as a prerequisiteto measurements. However, it is verychallenging to cover in one chapterwhat many departments cover in onesemester. Yet, Dunn does an admirablejob. Dunn attempts to start wherephysics stops and continue up to thetransistor. This is a large territory tocover, and will certainly leave somefaculty unsatisfied. For example, incovering such a broad base, nomencla-ture becomes a problem: First �� isused for voltage, then V and then later,E. Nevertheless, when faced with teach-ing measurements without circuits, thischapter does expose the student to therequired basics.

The chapter on calibration and sys-tems comes next. With a good numberof examples and a solid section on sys-tems, this chapter is typical of measure-ment texts.

Chapter six begins to dramatically dif-ferentiate this book from a traditionalbook on instrumentation for biomedicalengineers. Absent is a long list of sensorsand their physical principals. Rather,Dunn elects to present a few select sen-sors. This is certainly in keeping with thefocus of the book—measurements—butmay leave some faculty having to sup-plement with their favorite sensor.Rather than focusing on sensors, thischapter adds concepts typically taught incircuits: passive and active analog filters.

Unfortunately, chapter six ends witha section on digital filters and analog-to-digital conversion. This topic doesnot play a role in the immediately fol-lowing chapters and is quite differentfrom the analog material. It would bemore common to cover these two topicswhen digital signals are treated near theend of the book.

Chapters 7, 8, 9, and 10 deal with sta-tistics and probability. These topicspose a difficult problem for a measure-ments textbook. On the one hand, they

Paul H. King

Book Reviews

The author is clearly

aware that not all

students approach

measurement theory

with innate enthusiasm.

As such, the chapters

contain motivating

diversions.

Page 2: Book reviews [five reviews]

98 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JANUARY/FEBRUARY 2007

Book Reviews (continued)

are critically important to understandingmeasurements. On the other hand,many schools require a statistics coursein their curriculum. However, if the sta-tistics course is not a prerequisite forthe measurements course, it does littlegood for the student in this context.Dunn has decided to cover the materialin depth in his book. The advantage ofthis approach is that the critical materialis at the students’ fingertips, with a con-sistent nomenclature. If the instructorchooses, he can cover this section, skipthis section, or assign it as a reading(though it is a large fraction of the bookto assign for self-study).

The chapters on statistics andprobability cover all the basics, includ-ing probability, probability density,hypothesis testing, experimental design,uncertainty analysis, regression and cor-relation. Including the sections onexperimental design and regression isunique to most measurement books.These sections are well written, butbrief, perhaps making them a challengefor students with no other statistics intheir curriculum. For those curriculawhere statistics is a pre-requisite for themeasurements course, most faculty willelect to skip these chapters. However,as these four chapters make up close tohalf of the book, this decision mayeliminate this book from consideration.

Chapter eleven moves on to the fre-quency domain. Again, some curricularequire a transforms class as a pre-req-uisite to measurements. In that case,this chapter would also be skipped.Unfortunately, for biomedical engi-neering, this chapter is probably toobrief to be useful. For example, theconcept of phase is not treated in depthin this chapter. However, phase is socritical to the operation of the ear andeye, for example, that it is often morestrongly emphasized in a biomedicalengineering curriculum.

The final chapter of this book coversdigital signal processing. Though it isnot traditional to include time-domainprocessing in an introductory measure-ments class, now that data analysis toolssuch as MATLAB and LabView havebecome more powerful and more com-

mon, more and more biomedical engi-neering signals are treated solely, orlargely, in the time-domain. Hearingaids, for example, have largely movedaway from analog processing towarddigital processing. While the treatmentof the topic might be too light for someinstructors, the material that is present-ed is clear and easily understood. Thismaterial, along with the MATLABexercises throughout, would form a rea-sonable foundation for a biomedicalengineer in digital signal processing.

The MATLAB exercises form morethan just a set of simulations to helpteach the material in this text. MAT-LAB programming fundamentals aretaught. Using this text, students canstart with no MATLAB or program-ming background and leave this coursewith the rudiments in hand.

Among the appendices of this book isa companion lab manual. Dunn hasrealized that coordinating the laboratorycan be more time consuming thanteaching the course! Therefore, it is awelcome addition to see a well struc-tured laboratory sequence included withthis text. The labs cover the basics ofhow to operate the bench-top instru-ments as well as more advanced topicslike building small measurement sys-tems. Many, though not all, of the labscould be easily adapted to biomedicalengineering students. However, in orderto take full advantage of the lab manual,departments would have to purchaseexactly the same equipment (not just anoscilloscope, but a PM3380-A scope).

The Web site promises to be well-populated with homework problems,solutions manuals, MATLAB files andWebCT files (for those using thatcourseware).

Overall, instructors selecting thisbook will be disappointed if they areexpecting a traditional instrumentationtext. For example, the circuits and sen-sors portion of the text is just a fractionof the size of the section on probabilityand statistics. However, if the focus ofthe class is to be measurements, thisbook does an excellent job of taking astudent from basic physics up to signalprocessing. Like many books, the lack

of biomedical engineering examplesmeans that an instructor will have tosupplement the text throughout. Despitethese limitations, Dunn’s new text is awelcome addition to the possibilities forbiomedical measurements classes.

—Robert Malkin Duke University

Review of Biomedical Signal and Image ProcessingKayvan Najarian and Robert SplinterCRC/Taylor & Francis, Boca Raton,2006 ISBN 0824748034, US$99.95,448 pages.

This book presents wide variety oftopics pertaining to biomedical signaland image processing. It is a very read-able presentation at the introductorylevel. Each topic is presented with a bal-ance of introductory mathematics, exam-ples executed in MATLAB, andMATLAB based exercises. The exercis-es are detailed and lead the reader toappreciate the various steps in the phe-nomena or application being studied.The mathematics does not “get-in-the-way.” The level is meant for the noviceand one can get a good first understand-ing and a preparation for further study.In addition there is a wealth of introduc-tory information in the discussion sec-tions of each chapter. One can downloadall of the book’s figures, and script anddata used in the examples from the pub-lisher’s Web site. If one is interested insignal and image processing as a concen-tration, one could use this book as anintroduction for several different courses.

The book is divided into three sec-tions and contains 17 chapters. Becauseso many topics are briefly presented, itis easier to summarize each chapter’scontents. Section I contains sevenchapters and is designed to be a simpleconceptual introduction to signal andimage processing.➤ Many terms describing signals and

images are defined.➤ Makes an overview of Fourier

transforms (FT) and system transferfunctions, 2D FT, and filter proper-ties in frequency domain.

➤ Presents various techniques forimage enhancement such as

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IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JANUARY/FEBRUARY 2007 99

histogram equalization and thenmasking techniques, smoothing, andnoise filtering.➤ Defines a potpourri of edge detection

techniques and then discusses imagesegmentation using line detectionand luminance thresholding.

➤ Uses nonstationary signals as a ratio-nale for needing wavelets and pro-vides a cursory definition of 1 and 2D wavelets using MATLAB tools.

➤ Presents a variety of definitions butconcentrates on stochastic signalsStationarity, auto- and cross-corre-lation functions, and power spectraare defined. Interestingly, entropy andHuffman coding are also defined.

➤ Defines clusters and clustering andreviews the K-means algorithm.Then widely used classificationtechniques, such as Bayes and max-imum likelihood, and perceptronare defined.

➤ Section II deals with basics and pro-cessing of biomedical signals; itcontains five chapters.

➤ Ion transport is reviewed as a mech-anism for generating action poten-tials. Then the Hodgkin-Huxleyequations and wave propagation arepresented.

➤ A good summary of the mechanicalfunction of the heart and its con-comitant/causal electrical activity ispresented. Electrode placement formeasuring electrocardiogram (ECG)and typical normal ECG sets thestage for understanding the variouscardiac abnormalities and theirpathologic ECG patterns.

➤ A schematic of the brain and thegeneration of the electroencephalo-gram (EEG) are discussed. Themontage for measuring the EEG isshown and the various waves andtheir significance are discussed.This is followed by various braindysfunctions and how they are rep-resented in the EEG and evokedpotentials. The chapter ends with adiscussion of coherence.

The structure of skeletal muscle ispresented and then force generation inmuscles as a consequence of ionicactivity is summarized. The excitation

contraction coupling leads to the defin-ition of intramuscular and extramuscu-lar electromyograms (EMG). Thenneuromuscular pathologies and howthey affect the EMG is discussed. (Thechapters on ECG, EMG, and EEG endwith brief summaries of analysisapproaches in the time, frequency, andwavelet domains).

Several of other biomedical signals,such as blood pressure, are described.

Section III deals with the processingof biomedical images; it contains sixchapters.

This chapter contains a mathematicaltreatment of computed tomography.Source-attenuation relationships andprojection functions using parallelbeams are described.

The next several chapters, except16, present specific imaging modali-ties, starting with X-ray imaging andthe importance of dosage. Attenuationis mathematically defined and howvarious tissues attenuate energy isshown. Finally the various detectionmedia and their sensitivity to anatomicstructures are discussed. A similarapproach is used to present MRI andfMRI. Special emphasis is given tofMRI and the capability for imagingtime-varying cortical activity.

Ultrasound imaging is overviewed,including the mathematics of soundgeneration, attenuation, reflection, anddetection. The mathematics of themodalities for attenuation, time-of-flight, and reflection are presented sepa-rately. The challenges of artifacts,image reconstruction, and registrationare briefly discussed.

—Richard ShiaviVanderbilt University

Science and Technology inMedicine, An Illustrated AccountBased on Ninety-Nine LandmarkPublications From Five Centuries,by Andras GedeonSpringer Press, 2006, ISBN 0-387-27874-5, vii + 551 pages, US$89.95

This is a coffee table and teaching textthat covers some 99 well-selected scien-tific and technical discoveries over the

past five centuries that have had a signif-icant impact on the practice of medicine.The text has over 1,130 illustrations.Each chapter begins with a short biogra-phy of the inventors or discoverers of thetechnology (such as Michael Phelps), adescription of the technology (such as“Application of Annihilation Coin-cidence Detection to Transaxial Recon-struction Tomography,”) a perspective ofthe field, and a brief discussion of majormodifications since the inception of thetechnology. The topics are wide-ranging,and include the discovery of ether, theDoppler Effect, invention of the ophthal-moscope, antiseptic surgery, the modernECG recorder, etc. The chapters are wellreferenced and very well illustrated, theoriginal text or cover sheets of many arti-cles are to be found in many of the chap-ters (in their original language.) The textas a whole is a pleasure to read. Oncestarted, it is difficult to put down.

As a coffee table text, this bookbelongs in the waiting room of everyBME department chairman’s office! It isa motivator for anyone thinking about theinteraction of technology, engineering,and medicine. It is appropriate for manyother offices such as medical physics andhistory of medicine departments.

A great deal of effort has gone intothe generation of this text. I wish onlythat there were an accompanying CDwith all the illustrations on it (at least)such that one could pick and chooseillustrations for teaching purposes!

—Paul H. KingVanderbilt University

Wiley Encyclopedia of BiomedicalEngineering, Edited by Metin AkayWiley Interscience Press, 2006, ISBN0-471-24967-X, 4,037 pages. US$1,950.

Wiley, after publishing the six vol-ume Encyclopedia of Medical Devicesand Instrumentation by Webster, hasdone it again with the publication of thesix volume Encyclopedia of BiomedicalEngineering! In 3,881 pages, 350 arti-cles describe from accelerometer toxenotransplantation various engineeringtopics relevant to biomedical engineer-ing and the educational pursuit thereof.

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Book Reviews (continued)

There are so many topical articles thatthe index alone adds 156 pages! Thereare over 2,000 figures, tables, and illus-trations. The authors of the articles arebased worldwide. This is not a UnitedStates centric publication.

Generally speaking, the articles arepresented at an advanced undergraduatelevel, with some material at the graduatelevel. The coverage of material is quitebroad, though I expect that, given thediversity of our efforts, every profession-al will find some minor material lacking.I was disappointed to find little coverageof the design process per se, and botheredthat the one article on education com-pletely ignored it as a mandatory course.I was surprised that ISO 9000 was not tobe found, among other standards.

Most articles are well written andillustrated, though colored illustrationsand plates are once again missing. Mostarticles are fairly comprehensive, with afairly generic layout. Some articles havea section on the future of the device orprocess, a valuable addition. Most arti-cles have a good bibliography, some areexceptional. Some of the articles have asuggested reading list, for some this islargely a Web site listing, with its asso-ciated lifespan issues. The text could use(as per Webster’s Encyclopedia) a “seealso” section at the end of each article.Furthermore, each volume could use apages xx-xy listing on the spine. It isirritating to go from the index to eachvolume in turn to find a given page.

Wiley, as they have for Webster’stext above, also has generated a Website for the material covered in this text(see www.interscience.wiley.com/mrw/akay). This material will be updat-ed on a periodic basis. This service maybe done on an annual subscription or ona one-time basis. Browsing apparentlymay be done on many of the articles,the coverage is not spelled out.

Dr. Akay deserves a commendationfor the effort he has put into this ency-clopedia. It is a monumental work andis a contribution to the definition andmaturation of our profession.

—Paul H. KingVanderbilt University

Review for Medicine by Design;The Practice and Promise ofBiomedical Engineering:Fen Montaigne The Johns HopkinsUniversity Press; Baltimore, MD

In his book, Medicine by Design,author Fen Montaigne takes us on ajourney across the field of biomedicalengineering. This journey brings usinto American universities whereresearchers are applying biomedicalengineering solutions to medicalproblems and students are trained tobecome the new generation ofresearchers, but also into privatecompanies and hospitals letting ussee the personal stories of patientswhose lives were saved because ofbiomedical engineering advance-ments. The book presents this fieldwhere medicine and engineeringinterface, and provides us with a his-tory of the field, an overview ofapplications ranging from commonpacemakers to artificial hearts, nan-otechnology, and genetics.

The strength of this book is that itpresents stories of both people whohave devoted their lives to applyingengineering tools and methods to tack-le the greatest clinical challenges ofour time as well as people who havegreatly benefited from biomedicalengineering applications and devices.In the first group, the author includesnot only accomplished researchers butalso undergraduate and graduate stu-dents. Their profiles highlight theirbackground, their discovery of thefield and their dedication. The authortakes a class of students in BostonUniversity’s biomedical engineeringdepartment and presents the stories ofsome of the students of that cohort toshowcase the diversity of their profes-sional and personal backgrounds.These profiles allow us to explore thepopularity of the field and its ability,according to the author, to attract largenumbers of female students into engi-neering, a domain traditionally attract-ing primarily male students. Theauthor describes a course at that insti-tution aiming to instruct seniors onhow to handle their senior project and

prepare for their professional lives inthe real world. This example providesinsight into the minds and ambitionsof future researchers and developersand the dedication of their mentors. Atthe other end of the spectrum, we findinterviews with or narratives aboutestablished scientists who have sys-tematically explored and advanced thefield over the years, like Ali Rezai atthe Cleveland Clinic, one of thenation’s leading practitioners of brainpacing for Parkinson’s disease orRalph deVere White, the director ofthe University of California, Davis,Cancer Center that is investigatingways of imaging and treating tumorswith highly targeted molecular agents.The author manages to point out thebenefit of a diverse set of devices anddiscoveries focusing not on clinicaltrials or statistical description of out-comes but rather personal accounts ofindividuals who have benefited fromthe advances in biomedical engineer-ing, such as the first quadriplegicpatient to receive a network ofimplanted electrodes in his arms or apatient with ventricular fibrillationthat requires him to receive animplantable defibrillator. These casesincorporate the patient’s perspectiveand demonstrate how specific applica-tions saved people’s lives.

The book starts with a chapter onthe field and a brief history of its for-mation. The second chapter describesthe new generation of biomedicalengineers, namely undergraduate andgraduate students who are devoted tothis field and aspired to solve med-ical problems. The next few chaptersfocus on specific body parts or clini-cal conditions as application domainsfor biomedical engineering (startingwith cardiovascular condit ions,spinal cord injuries and focusing onthe brain in Chapters 6 and 7) .Chapter 8 is titled “The da Vinci”and focuses on a robotic surgical sys-tem. The focus of surgery is furtherexplored in the next chapter with areview of “haptics” advancements.Chapter 10 focuses on musculoskele-tal research, whereas Chapters 11

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Book Reviews (continued)

and 12 describe medical imagingprinciples and applications. Chapters13 and 14 describe two companies(Medtronic and Neurotech) and pro-vide insight into the business modeland plans of the private sector. Theremaining chapters provide anoverview of tissue engineering andthe future of the field, which theauthor describes as an effort tounderstand genes and explore thegenome and protein production, andan advancement of nanotechnology.

The book is well written and eventhough there are many names andexamples included of researchers, stu-dents, health care providers, and insti-tutions, it is easy to follow all thestories. The author visited severalsites throughout the country and inter-

viewed many researchers, studentsand patients and is to be commendedfor his thorough investigation.Perhaps one could argue that the solefocus on US-based academic researchand training institutions does notaccurately capture all trends anddevelopments of the field of biomed-ical engineering as it excludes cuttingedge research in other countries.

The chapters provide an overviewof the field of biomedical engineer-ing for a lay audience and as such thebook does not provide an in depthdiscussion of principles or technicalbackground behind the applicationsnor does it require any prior back-ground in engineering or knowledgeof the field. While this book wouldnot be the right choice as a textbook

of an undergraduate or graduatecourse in biomedical engineering dueto its superficial coverage of materialcustomized for a broader audience, itis an excellent resource for peoplewho want to learn more about thefield in general, but also for studentsin medicine, nursing and other healthprofessions who need an overview ofways with which technology is revolu-tionizing health care delivery. The com-pelling stories of pioneering engineers,patients and health care providers inthis book have the potential to recruitstudents into the field and inspire futureresearchers, and to increase the public’sknowledge and appreciation of biomed-ical engineering.

—George Demiris University of Washington

computerized systems in nonclinicallaboratories. The outcome of the confer-ence was a reference published by theDIA, Computerized Data Systems forNonclinical Safety Assessment: CurrentConcepts and Quality Assurance, whichis used throughout the world [10].

For the Red Apple II Conference, aselect group of international participantsfrom industry, government, and acade-mia was selected to participate on thevarious committees of the conference.The participants represented therequired mixture of skills and a crosssection of pertinent organizational affil-iations. The international conference,which was held 22–24 March 2006, hadas its objective the creation of a singleupdated book with significant insightinto current system validation processesfor preclinical instruments. The publica-tion date has been scheduled for early2007. Validations performed in clinicalenvironments may refer to this book, asmany of the concepts and illustrationsare GxP. The book may be supplement-ed by research to cover the additional

clinical details required (e.g., data pro-tection, HIPAA) [10].

ConclusionsAs baby boomers age, the demand willincrease for more drugs and betterhealth care. In turn, the demand forinstrumentation, biomedical equipment,and medical devices will increase,along with the demand for qualifiedpeople to provide validation services.Due to the nature of validation, hard-ware and software engineers can suc-cessfully expand into the end-usercompany validation niche.

References[1] “Good laboratory practice for nonclinical labo-ratory studies,” U.S. Government Printing Office,Washington DC, 21 Code of Federal RegulationsPart 58, Apr. 1, 2005.[2] “Current good manufacturing practice in manu-facturing, processing, packing, or holding of drugs,”Government Printing Office, Washington DC, U.S. 21Code of Federal Regulations Part 210, Dec. 6, 2005.[3] “Current good manufacturing practice for fin-ished pharmaceuticals,” U.S. Government PrintingOffice, Washington DC, 21 Code of FederalRegulations Part 211, Dec. 6, 2005.[4] “General principles of software validation; Finalguidance for industry and FDA staff ,” U.S.

Department of Health and Human Services, Foodand Drug Administration, Center for Devices andRadiological Health, Center for Biologics Evaluationand Research, U.S. Government Printing Office,Washington DC, Jan. 11, 2002.[5] “Guidance for industry, Part 11, electronic records;electronic signatures—Scope and application,” U.S.Government Printing Office, Washington, DC, 21 Codeof Federal Regulations Part 11, Aug. 2003. [6] Stephen H. Kan, Metrics and Models in SoftwareQuality Engineering , 2nd ed. Reading, MA:Addison-Wesley, 2003.[7] “What is ISO 9001:2000?” BSI Management SystemsWeb site, July 14, 2006 [Online]. Available: http://www.bsiamericas.com/QualityGateway/index.xalter[8] J. Ketola and K. Roberts, ISO 9000 in a Nutshell,2nd ed. Chico, CA: Paton Press, 2001.[9] D. Hoyle, ISO 9000 Quality Systems Handbook,3rd ed. Woburn, MA: Butterworth-Heinemann, 1998.[10] E. Hulihan, private communication, July 17, 2006.[11] J. Chen, private communication, “Qualification ofLaboratory Instruments” seminar, New York, July 2003.[12] L. Milum, private communication, July 29, 2006.[13] R. Temple, private communication, August 1,2006. [14] L. Ouderback, private communication, August2, 2006. [15] “Guidance for industry, FDA reviewers andcompliance on off-the-shelf software use in medicaldevices,” U.S. Department of Health and HumanServices, Food and Drug Administration, Center forDevices and Radiological Health, Center forBiologics Evaluation and Research, U.S. GovernmentPrinting Office, Washington, DC, Sept. 9, 1999.[16] “Food and Drug Administration glossary”[Online]. Available: http://www.fda.gov/ora/inspect_ref/igs/gloss.html

Regulatory Affairs (continued from page 93)