Special Interest Group Reporters - biomaterials.org · from the perspective of another, e.g., the physics of music. “Interdisciplinarity” describes the integration of discipline-specific

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Copyright© 2008 ISSN 1527-6031Society For BiomaterialsAll rights reserved

The official news magazine of the SOCIETY FOR BIOMATERIALS • Volume 30, Issue 2

Executive Editor Karen Burg, Clemson University, Department of Bioengineering501 Rhodes Engineering Research Center, Clemson, SC 29634Phone: (864) 656-6462 • Fax: (864) 656-4466E-mail: [email protected]

Managing Editor Frank Scussa, Society For Biomaterials15000 Commerce Parkway, Mt. Laurel, NJ 08054Phone: (856) 439-0500 • Fax: (856) 439-0525E-mail: [email protected]

Government News Contributing Editor

Joy Dunkers, National Institute of Standards and Technology100 Bureau Dr., Stop 8541, Gaithersburg, MD 20899-8541Phone: (301) 975-6841 • Fax: (301) 963-9143E-mail: [email protected]

Government NewsContributing Co-Editor

Christine A. Kelley, National Heart, Lung and Blood InstituteNational Institutes of Health6701 Rockledge Dr., Suite 9180, Bethesda, MD 20892-7940Phone: (301) 435-0513 • Fax: (301) 480-1336E-mail: [email protected]

Industrial News Contributing Editor

Steve T. Lin, Exactech Inc.2320 NW 66th Court, Gainesville, FL 32653Phone: (352) 377-1140 • Fax: (352) 378-2617E-mail: [email protected]

Society Business & MembershipNews Contributing Editor

Tim Topoleski, University of Maryland Baltimore CountyDepartment of Mechanical Engineering1000 Hilltop Circle, Baltimore, MD 21250Phone: (410) 455-3302 • Fax: (410) 455-1052E-mail: [email protected]

Special Interest Group NewsContributing Editor

Guigen Zhang, The University of Georgia, Faculty of Engineering501 Driftmier Engineering CenterThe University of Georgia, Athens, GA 30602Phone: (706) 583-0994 • Fax: (706) 542-8806E-mail: [email protected]

University and Research InstitutionNews Contributing Editor

Book Review Liisa Kuhn, University of Connecticut Health Center Center for Biomaterials263 Farmington Avenue, Farmington, CT 06030-1715Phone: (860) 679-3922 • Fax: (860) 679-4889E-mail: [email protected]

Biomaterials Availability & Policy Carl R. McMillin, [email protected]/Organ Therapies Jon Rowley, [email protected]

Biomaterials Education Howard Winet, [email protected] Biomaterials Trevor Snyder, [email protected]

Dental/Craniofacial Biomaterials Yunzhi Yang, [email protected] Delivery Mark E. Byrne, [email protected]

Implant Pathology Michelle A. Tucci, [email protected] Biomaterials Margaret W. Kayo, [email protected]

Orthopedic Biomaterials Rui L. Reis, [email protected] & Cells at Interfaces Christopher A. Siedlecki, [email protected]

Surface Characterization & Modification Erika Johnston, [email protected] Engineered Products Laura J. Suggs, [email protected]

Special Interest Group Reporters

Lynne C. Jones, Johns Hopkins UniversityDepartment of Orthopaedic SurgeryGood Samaritan Professional Building5601 Loch Raven Blvd, Suite 201, Baltimore, MD 21239-2905Phone: (410) 532-5906 • Fax: (410) 532-5908E-mail: [email protected]

Graphic Designer Justin Fennelly

1BIOMATERIALS FORUM • Second Quarter 2008

Second Quarter 2008 • Volume 30, Issue 2Features

2 From the Editor3 From the President3 Letter to the Editor4 Staff Update from Headquarters6 SIG Report6 Invention vs. Innovation

The Torch

Departments

10 Members in the News

Member News

7 NIST Reference Materials are “Gold Standard”for Bio-Nanotech Research

The National Institute of Standards and Technology(NIST) has issued its first reference standards fornanoscale particles targeted for the biomedical researchcommunity—literally “gold standards” for labs studying thebiological effects of nanoparticles.

11 “Intuition” and “The Sixth Cow”

Book Reviews

9 Reflecting on Our Founders

Student News

8 Encompassing a Biomaterial’s Tradition

The pursuit to develop a materials database for clinicallyapproved devices.

12 BioInk

Industry News

11 Community Calendar

Biomaterials Community

The cover photo on theprevious issue (30(1); 2008)denoted an SEM wet modeimage of bone cells and theirmineralized matrix onchitosan scaffolds after 4weeks in a rotary bioreactor.

Photo was courtesy of Dr. Joel Bumgardner of theUniversity of Memphis.

Oxygen nanosensors engulfed in mesenchymal stem cells.Photo courtesy of Erik Bland and Karen Burg of Clemson University;

the nanosensors were developed for cancer research through fundingprovided by a National Science Foundation Emerging Frontiers

in Research & Innovation grant.

2 BIOMATERIALS FORUM • Second Quarter 2008

I recently attended the American Council onEducation (ACE) Council of Fellows meeting inWashington, D.C. I love the meeting because itis an opportunity to ponder the complicatedissues and opportunities in the world of highereducation and, in my case, in researchadministration. Of interest and discussion wasthe topic of disciplinarity.

I remember as a student learning that my home department wasfounded by a multidisciplinary group of individuals in the early1960s as a Clemson University program, evolved into theDepartment of Interdisciplinary Studies, and subsequently into theDepartment of Bioengineering. This history is engrained in mymind, so it was amusing watching the ACE meeting participantswrestle with the concept of something beyond a discipline. But asthe discussion evolved, I appreciated that even we as biomaterialists,whether in industry, clinical, or academic environments, mustcarefully consider short-term and long-term potential andimplications of interdisciplinarity, particularly as we develop newtraining programs.

Terms are still being formalized (or perhaps popularized)—disciplinarity, multidisciplinarity, crossdisciplinarity,interdisciplinarity, transdisciplinarity, and postdisciplinarity.“Multidisciplinarity” implies the simple juxtaposition of disciplinesthrough, for example, the enrollment in courses of differentdisciplines. “Crossdisciplinarity” suggests the study of one disciplinefrom the perspective of another, e.g., the physics of music.“Interdisciplinarity” describes the integration of discipline-specificperspectives or ideas to form a new method or approach toward aproblem, whereas “transdisciplinarity” is perceived as the melding ofdisciplines while broad perspectives of a field (i.e., “engineering” or“humanities”) are maintained. Proposed at the ACE meeting was theconcept of postdisciplinarity—i.e., the absence of disciplines in eventhe most basic courses. We see this trend with “just-in-time” mathmodules superceding the traditional prerequisite course system(“must have calculus before biomechanics”). As I synthesize theseconcepts as a research administrator, several questions spring tomind about biomaterials education, research, and training. Should abiomaterialist be a “transdisciplinarian” or even a “post-disciplinarian,” or should a biomaterialist be a “disciplinarian” withexcellent communication skills and specific transdisciplinary skillsets? Industry colleagues frequently ask me for names of students whoare bioengineers by graduate training, but who have a classicalengineering undergraduate training. Will our ability to advance thefield be lost if we lose experts of the discipline? Will we all havetechnical breadth but no depth? Is it the logical thought patterns orthe specific facts of the discipline that are more important? Andwhen does an interdisciplinary study become a discipline in the eyesof the funding agencies that have special monies for inter-disciplinary team play? This discussion is by no means limited to theACE—in fact SFB members have an advantage in being comfortablewith the concept of complementary, integrated technical conceptsand perspectives. Will we, the SFB membership, proactively developa functional disciplinary model, i.e. the optimal combination ofmulti-, cross-, inter-, trans, or post-, for the non-biomaterialscommunity? I would suggest that we should.

Best wishes from Clemson,Karen J.L. Burg

The TorchBy Karen J.L. BurgFrom the Editor


C. William Hall had a vision where anexclusive group of scientists wouldcome together to network and learnfrom each other—a home withoutborders where everyone sharesbiomaterials as a passion. This visionbecame the Society For Biomaterials.More than 30 years later, the SFB haskept its leadership position as thepremier professional society in the

world that promotes advances in all phases of materialsresearch and development in the biomaterials field. The SFBmembership has more than tripled! Still, from generation togeneration, not only is the SFB considered the ultimateplatform for sharing, learning, and discovering the sciencebehind the building blocks of medical devices, it is a culturethat exemplifies collegiality. In 1986, Elaine Duncan, as Editorof the Torch Newsletter, clearly emphasized the role of membersand volunteers in the success of the Society: “A match canlight a torch, but will never blaze as long or as brightly.” Everyyear, the torch flame is being invigorated through thededicated commitment of members. During the past months, Ihave been amazed and delighted by the energy and leadershipskills of Council and Board members. Many activities have

been pursued by committees with the goal of increasingmembership value while fulfilling the mission of the Society. Areport card highlighting accomplishments and setting the stagefor growth and enhancement will be presented to members atthe annual business meeting and published soon thereafter. Anew look for SFB is coming!

This letter is my last as President of the SFB. And as such, Iwould like to leave office by thanking all of you for yoursupport and encouragement, and for considering the SFB yourhome. A very dear friend of mine and past-president of theSociety For Biomaterials once said: “Biomaterials became myacademic home, my passion, and my life’s accomplishments. Ihad found my true professional calling.” SFB is all aboutpassion. This is indeed contagious! Like all my predecessors, Ihave been privileged to serve you and hopefully met yourexpectations. In passing the Torch to our incoming President,Jeffrey Hubbell, I would like to leave with a charge to allyoung biomaterials scientists and engineers, to carry and sharethe Torch, lighting the path for science and discovery tobecome safe and effective clinically used technology.

Martine LaBerge, PhDPresident

The TorchBy Martine LaBergeFrom the President

I enjoyed the recent editorial(Biomaterials Forum, 29(4), 2008) onthe topic of open access. This is animportant issue for SFB, especiallyconsidering that a substantial fractionof the Society’s income derives from acontract with Wiley regarding royaltysharing. You are right to raise this issuein the Forum and sensitize themembership to this issue. I suspect that

open access will only change how we pay to publish our workbut it will not fundamentally challenge how we work.

What if the print system becomes irrelevant? The newgeneration of SFB scientists is more Internet-oriented than theprevious generation. As a result, blogs, webcasts, onlinepublications, etc. are likely to become more importantmediums of scientific communication than they are now.Print-based journals may become obsolete forms of scientificpublication. The Internet as a distribution system will replace(eventually) the publisher, especially as Google and Wikipedia(and wikis more generally—see for example,http://openwetware.org/wiki/) become more sophisticated. Ifyou want to see a vision of the future of newspapers, check outhttp://epic.makingithappen.co.uk/.

Think about the current system. The volunteer, unpaid editor,combined with volunteer reviewers, working with a for-profit

publisher, is an unstable situation. We write the articles, wereview them, and the publisher makes money because we wantto see the paper in print and they have a distribution system.University libraries are having a hard time affording printjournals and the publisher’s fees for online access.

Would we be willing to give up the aesthetically pleasingreformatting of the paper that the publisher now provides?Would we be willing to forego the editing and attention todetail (all those author queries) that the publisher pays for?Would we care if the publisher didn’t market the journal andby inference our own work or the field we are in? And whowould be responsible for maintaining the electronic archive ifnot the publisher?

But the big question is do we really need refereeing? Thephysics community apparently doesn’t. Do we? Will we evenhave a vote?

Michael SeftonInstitute of Biomaterials and Biomedical EngineeringUniversity of Toronto

Editor’s note: Royalties from John Wiley & Sons Inc. account forapproximately 20-25 percent of the Society For Biomaterials’income; subscription fees account for approximately 10-15 percentof the Society’s expenses.

The TorchBy Michael SeftonLetter to the Editor

Passing the Torch!


SFB 2008 ActivitiesThe Society For Biomaterials annual business meeting will beheld May 29, 2008, at noon at the RAI Conference Centre inAmsterdam. In addition to the 2008 World BiomaterialsCongress (May 28-June 1), the Society will be hosting a FallSymposium in Atlanta, GA, on Translational BiomaterialResearch (Sept. 11-13). The Society is also developing awebinar series to provide ongoing educational opportunitiesthroughout the year.

Committee ReportingFollowing up on the Committee reports from the last issue ofthe Forum, each of the Society’s committees are listed belowwith an update on their activities during the past quartertoward their published goals.

Awards, Ceremonies and Nominations CommitteeAward presentations and announcements concerning the 2008officer election results were made at the Society’s annualbusiness meeting during the World Biomaterials Congress inAmsterdam on May 29, 2008. The annual business meetingwas held at the RAI Conference Centre at noon and lunchwas provided for all SFB Members!

Bylaws CommitteeThe Bylaws Committee has drafted a bylaws amendment tocorrect an inconsistency with regard to the election process.The amendment, distributed to the membership in mid-March, was discussed and voted upon at the Society’s annualbusiness meeting.

Devices and Materials Committee The Devices and Materials Committee has begun negotiationswith the ASM to collaborate on the next module of theirmaterials database. They have already launched theCardiovascular Materials Database and the OrthopedicMaterials Database online. They have come to SFB for help indeveloping content on the research materials database, and itis the committee’s goal to provide this content in exchange forSFB member access to these tools. Once an agreementbetween these two organizations has been reached, thecommittee will seek Council’s approval prior to solicitingvolunteers for content development.

Education and Professional Development CommitteeThe Education and Professional Development Committee hada conference call on Feb. 8. The main item discussed was thewebinar series to be initiated in April/May. It was decided thatthis experience would be piloted with a webinar aimed at thestudent members, on a topic possibly touching career optionsafter graduation. The second webinar will be targeted to allmembers and will cover a technical topic, most likely celltherapy for cardiac regeneration. More information regardingthese webinars will be found shortly in your inbox.

Finance CommitteeThe Finance Committee is overseeing the implementation ofthe Board-approved investment and reserve policies, anddeveloping a draft policy on the solicitation of funds on theSociety’s behalf. No report has been received from thiscommittee for this period.

Liaison CommitteeThe Liaison Committee continues to interact and discusspossible joint meetings with other societies.

Long Range Planning CommitteeThe Long Range Planning Committee continues to focus itsactivities on analysis of the ranking and perception of thejournals of the Society, namely the Journal of BiomedicalMaterials Research Part A and B, relative to other peer journalsin the field of biomaterials and related disciplines.Recommendations for improvements in visibility of the journaland enhancing attraction of high visibility articles are beingformulated.

Meetings CommitteeThe members of the Meetings Committee, including MartineLaBerge, Dan Lemyre, Karen J.L. Burg, Timmie L.D. Topoleski,Antonios G. Mikos, Alan S. Litsky, and Lynne C. Jones, haveaddressed the remaining committee goals established in May2007: “the assessment of the funding and sponsorship revenueof our annual meetings and to provide recommendations for

The TorchBy Dan Lemyre, Executive DirectorStaff Update From Headquarters

Clemson University’s Department of Bioengineering is seekingapplications for the Hansjörg Wyss Endowed Chair. This prestigiousposition is supported by a $4M endowment established by The HansjörgWyss Medical Foundation and the State of South Carolina, and is anintegral part of the South Carolina Regenerative Medicine ResearchCenter of Economic Excellence. Applicants with expertise in the area oforthopaedic biomaterials, as related to trauma, spine, craniofacial, andmaxillofacial applications are sought to complement Clemson University’spioneering research and education program in biomaterials. The tenure-track appointment will be at the Associate Professor or Professor level.Candidates should have a Ph.D. in biomedical or materials engineeringor a related discipline, and a strong record of research accomplishmentsand leadership in the field, high-quality publications and presentations,extramural research funding, meaningful outreach activities, andgovernment and industry contacts. The candidate should havedemonstrated leadership skills, the ability to work across scientificdisciplines and organizations, and a commitment to teaching at theundergraduate and graduate levels. The Wyss Chair will be expected toplay a key role in the development of state-wide programs inbioengineering research and education and in the development of theClemson University - Medical University of South CarolinaBioengineering Program. Clemson University is located on Lake Hartwellin scenic upstate South Carolina, is a four hour drive from Charleston,SC, and enjoys a mild 4-season climate with a low-cost-of-living. TheMedical University of South Carolina is located in Charleston, abeautifully preserved architectural and historic city, with a rich, 300 yearheritage.

Applicants should send their CV, a statement of research and teachinginterests, and the names of at least three references to Ms. SherriMorrison, Wyss Search Committee, Department of Bioengineering, 501Rhodes Engineering Research Center, Clemson University, Clemson,SC 29634-0905. E-mail inquiries may be sent to:[email protected]. Applications will be evaluated until the positionis filled; however, to be assured full consideration, applications must bereceived by August 15, 2008. Clemson University is an AffirmativeAction/Equal Employment Opportunity employer and does notdiscriminate against any individual or group of individuals on the basisof age, color, disability, gender, national origin, race, religion, sexual

Hansjörg WyssEndowed Chair


increasing these sources of revenue to better offset meetingattendee registration costs.” The committee met throughconference calls and is now working on securing sponsorshipfor the 2008 Fall Symposium to be held in Atlanta and theassociated bash that will be held at the Georgia Aquarium.The committee is confident that its effort will lead to thedevelopment of a standard operating procedure and anincreased contact list of sponsors and exhibitors that can beused to assure the success of future annual meetings.

Membership CommitteeThe Membership Committee had conference calls in October2007 and in late-January 2008. The committee is continuingto address issues of recruiting new members into the Society aswell as a retention plan for current, active members. InOctober, Chair Ziats attended the SFB Board/Council Meetingheld in Philadelphia and gave an update on the committeeactivities. Staff from SFB headquarters managed recruitmentbooths at the Orthopedic Research Society and BiomedicalEngineering Society meetings in 2007 to explore thepossibilities of increasing our membership by reaching out to awider audience, and have begun to track how new membersare hearing about SFB. The Board felt that, in lieu of staffingan exhibit booth at other meetings, it was beneficial to partnerwith other societies for more programmatic and/or workshoptype events. New and continuing members in the Society havethe option of more than one year of renewal, that is, up tothree years. So far, this option has met with modest success,although this is the first year for this membership option. TheMembership Committee is also working with other committeesto enhance recruitment, for example, with the Education andProfessional Development Committee to increase the numberof student chapters. Some new chapters being formed includethose at Drexel University, University of Texas, RiceUniversity, and Georgia Institute of Technology. TheMembership Committee is distributing postcards to variousinstitutions as an additional method to recruit new and oldmembers. Finally, the committee had representation at theWorld Congress in May.

Presidents Advisory CommitteeThe Presidents Advisory Committee is evaluating how theSFB may interact with other professional societies in thefuture. This includes forming alliances or even mergers. Also,the committee is considering how the Annual Meeting can bemade more attractive and useful to attendees. No report hasbeen received from this committee for this period.

Program CommitteeThe Program Committee has spent considerable time in theplanning and organization of the 2008 Fall meeting focusingon “Translational Biomaterials.” The following milestoneshave been accomplished:

1. The general program for the meeting has been finalizedand consists of seven clinical application sessions (90min), four technology rapid fire sessions (60 min), twopanel discussions, and two workshops. Requests havebeen made to session chairs for abstract reviewers.

2. Dr. Nicholas L’Heureux (Cytograft) has agreed to be thefourth keynote speaker.

3. Advertisement materials with March 15 abstractdeadline date have been distributed.

4. The program planning meeting was held on Wednesday,May 14, from 9:00 am to 5:00 pm at the Grand HyattAtlanta in Buckhead.

Publications CommitteeIn addition to continuing efforts already reported, thecommittee is in the process of developing a survey of theeffectiveness and quality of all publications of the Society.The survey will be used to set future goals for our publications.Any suggestions and comments can be sent directly to theCommittee Chair, Professor Rick Gemeinhart ([email protected]).No report has been received from this committee for thisperiod.

Special Interest GroupsThe Special Interest Groups (SIGs) continue to be very activein this World Congress year. As always, the SIGs are veryinvolved in the programs of both the World Congress and theupcoming SFB Fall Symposium, which is focused ontranslational biomaterials research. The SIGs have taken amajor role in identifying topics and developing content for thissymposium. We are continuing to make inroads to improvedcommunication throughout the SIGs. This task is beingaccomplished through more frequent conference calls,newsletters, reports to the Biomaterials Forum, emails, and theSIG Web sites. A task force has been formed to work with theBylaws Committee to revise the bylaws with respect to theSIG structure and operation. The SIGs are working with theMembership Committee in the development of a postcardcampaign to recruit lapsed members back to the Society. If you are interested in knowing more about a particular issue,policy, or committee activity, or if you have any suggestions forimproved membership services, please contact me directly atthe SFB headquarters office.

Sincerely,

Dan Lemyre, CAEExecutive Director

Society For Biomaterials15000 Commerce Parkway, Suite CMount Laurel, NJ 08054Phone: 856-439-0826Fax: 856-439-0525E-mail: [email protected]


From the time that SIGs were first formed, we havecontinuously asked, “What can SIGs do for the Society ForBiomaterials?” In the past few issues of the Biomaterials Forumwe have described the impact of the SIGs on the education of,communication with, and networking between the SFBmembers. The SIGs have experienced a resurgence of activitythrough the efforts of a resourceful leadership and they areempowered to accomplish more than they ever have before.

It is now time to ask, “What can the Society For Biomaterialsdo for the SIGs?” Of course, the first response that comes tomind is to support the SIGs. But what does this actually mean?I have a few suggestions for where to begin.

First, choose dates to hold the Annual Meeting and symposiathat are not in conflict with the members’ other professionalsociety meetings. The SIGs will provide a list of the dates ofthe major meetings for their areas of focus. Second, provide

the SIGs with opportunities for networking. The schedule forthe Annual Meeting is so tight the SIGs have had to holdtheir meetings before the day’s events (at 7:00 am) or duringlunch. One suggestion is for one evening to be set aside forSIGs to hold meetings and/or networking events. Networkingevents may include guest speakers. Third, empower the SIGsto have a bigger role in the program of the Annual Meeting.Through the years, the SIGs have mostly been reactiveregarding the program content, whether it is the review andselection processes concerning the abstracts or the submissionof ideas for workshops, symposia, tutorials, or panel discussions.Allow the SIG leaders to be more proactive. They shouldidentify the current issues facing their members and encouragethem to recruit scientists who can present cutting-edgeresearch to the Society. And last, the most importantsuggestion, encourage the SIG leaders and members to thinkoutside the box. There is so much more that they can do, youneed only ask.

The TorchBy Lynne Jones, SIG Committee ChairSIG Report

I used to equate invention with innovation. Every chance Ihad, I would use these two words synonymously to show off myvocabulary. In case you are wondering if there is indeed anydifference between them, I just looked them up for you: toinvent is to create a novel object, process, or technique; toinnovate is to introduce something new. Confused? That ishow we usually define these words.

Lately, I tend to look at these words more in the terms of PeterDrucker. While invention is the act of creating somethingnew, innovation is the act of converting something new (anew form of thing or knowledge) or something old (an existingnatural material or knowledge) into a new wealth-producingresource, a resource with economic and social value. So,innovation puts more emphasis on the social and economicvalue of the act of creating something new, and it does notnecessarily have to be based on a high-tech invention. InDrucker’s words, innovation is “an economic and social ratherthan a technical term.” To innovate, you must “use both theright and left sides of your brain” to first work out thetechnical aspects of your creation and then go out to “look atpotential users to study their expectations, their values, andtheir needs.” Once your creation meets their expectations,values, and needs, you can have an innovation—a wealth-producing resource that helps push societies forward.

Seeing the difference between these two words may helpsharpen our objective in re-engineering engineering education.It urges us to prepare future engineers as knowledge workerswith technical competence and humanistic consciousness sothey will not just create something new for the sake ofnewness, but something new with economic and social valueand responsibility.

If you are still in doubt of such an engineering educationapproach, let me make another point. General GeorgeMarshall once complained that he did not receive a goodeducation at Virginia Military Institute because there was notraining in history. He knew that to be a leader one must havea sense of history, for history is the human story. The same canbe said for an engineer: to be able to innovate, the engineermust have a sense of humanistic appreciation of our society, forinnovation is not just a technical endeavor, but a human one.

The TorchBy Guigen Zhang, Education EditorInvention vs. Innovation

S e e i n g t h e d i f f e r e n ce

b e t w e e n t h e s e t w o w o r d s

m a y h e l p s h a r p e n o u r

o b j e c t i v e i n r e - e n g i n e e r i n g

e n g i n e e r i n g e d u c a t i o n .

”

“

The National Institute of Standards andTechnology (NIST) has issued its firstreference standards for nanoscale particlestargeted for the biomedical researchcommunity—literally “gold standards” forlabs studying the biological effects ofnanoparticles. The three new materials,gold spheres nominally 10, 30, and 60nanometers in diameter, were developed incooperation with the National CancerInstitute’s NanotechnologyCharacterization Laboratory (NCL).Nanosized particles are the subject of agreat deal of biological research, in partbecause of concerns that in addition tohaving unique physical properties due totheir size, they also may have uniquebiological properties. On the negative side,nanoparticles may have special toxicityissues. On the positive side, they also arebeing studied as vehicles for targeted drugdelivery that has the potential torevolutionize cancer treatments. Researchin the field has suffered from a lack ofreliable nanoscale measurement standards,both to ensure consistency of data from onelab to the next and to verify theperformance of measurement instrumentsand analytic techniques.

The new NIST reference materials arecitrate-stabilized nanosized gold particles ina colloidal suspension in water. They havebeen extensively analyzed by NIST scientists to assess particlesize and size distribution by multiple techniques for dry-deposited, aerosol, and liquid-borne forms of the material.Dimensions were measured using six independent methods—including atomic force microscopy (AFM), transmissionelectron microscopy (TEM), scanning electron microscopy(SEM), differential mobility analysis (DMA), dynamic lightscattering (DLS), and small-angle X-ray scattering (SAXS). Atthe nanoscale in particular, different measurement techniquescan and will produce different types of values for the sameparticles.

In addition to average size and size distributions, the newmaterials have been chemically analyzed for theconcentrations of gold, chloride ion, sodium, and citrate, aswell as pH, electrical conductivity, and zeta potential (ameasure of the stability of the colloidal solution). They havebeen sterilized with gamma radiation and tested for sterilityand endotoxins. Details of the measurement procedures anddata are included in a report of investigation accompanyingeach sample.

NCL examines candidate nanotech cancer drugs developed bybiotech firms and academic labs. NCL and the NCI’s Alliancefor Nanotechnology in Cancer sponsored the NIST work. Additional technical and ordering information for the newNIST nanoparticle reference materials is available at:

• RM 8011, Gold Nanoparticles, Nominal 10 nm Diameterhttps://srmors.nist.gov/view_detail.cfm?srm=8011



Polymers Division, National Institute of Standards and TechnologyFirst published in NIST Techbeat, January 8, 2008.

FeatureJoy Dunkers, Government News Contributing Editor

By Andras Vladar and Vincent HackleyNIST Reference Materials are “Gold Standard” for Bio-Nanotech Research


False color scanning electron micrograph (250,000 times magnification)showing the gold nanoparticles created by NIST and the National CancerInstitute’s Nanotechnology Characterization Laboratory (NCL) for use as

reference standards in biomedical research laboratories.Credit: Andras Vladar, NIST

The ability to access appropriatebiomaterials information can havesignificant utility in increasing the speedand efficiency of design of new medicaldevices. Not only will this impact theproductivity of engineers and designers,this information on specific materials andpredicate use impact numerous functionswithin the medical device industry,including preclinical, clinical, quality,regulatory, and supply chain. There havebeen previous attempts at creating abiomaterials database, without success. Ibegan to get a sense of the difficulty ofsuch an undertaking when in the early1990s NIH decided to upgrade the NIHguidelines on biomaterials testing,originally developed a decade earlier. PaulDidisheim asked Jeff Hubbell and me towrite the chapter on “Materials Selection”(Helmus, M., Hubbell, J. 1993). Thisarticle had extensive tables on biomaterialsand properties. It became clear that thecategorization of these properties in order to facilitatecomparison of different materials, particularly across differentclasses of materials, was exceptionally difficult. Stan Brown atFDA worked on developing a database and a software packagewas developed. However, this effort, as well as others, was notsuccessful due to political, proprietary, and cost reasons. A few years ago, I had the good fortune to reconnect withASM International and their effort at developing a materialsdatabase for clinically approved devices. The DatabaseCommittee, which I chair, in collaboration with ASMInternational and Granta Design Limited, the developer of thedatabase, has identified the material data—physical, chemical,and biological—that would be of need to medical devicedesigners.

This relational database is an extensive resource, containingthe engineering and biological performance of materials usedin medical devices, as well as information about compatiblecoatings and drugs, manufacturing processes, and an extensivedatabase of relevant published literature. The data iscomprehensively cross-referenced and fully traceable tooriginal sources. The database can be used for informationretrieval and selection of materials, drugs, and coatings forcombination devices. Using the polymer carrier of the Taxusdrug-eluting stent as an example, the following informationcan be extracted from the database: styrene-isobutylene-styrene triblock colpolymer, carrier for drug-eluting stent; ISO

Tests performed 3, 4, 5, 6, 10, 11; Citations - Gallocher et al.(2006), Silber (2003), Ranade et al. (2004). Figure 1 is anexample of some of the data that is contained for the styrene-isobutylene-styrene triblock colpolymer. Links to drugs usedwith the polymer, in this case Paclitaxel, are also contained inthe database.

The Cardiovascular Implant Module has more than 1,600device records that include mechanical, physical, biologicalresponse, and drug compatibility properties for the materialsand coatings used in cardiovascular device applications. Thenew Orthopaedic Module initially focuses on spinal implants.The module establishes records for nearly 1,200 devices forspinal interlaminal fixation orthosis, spinal intervertebral bodyfixation orthosis, and pedicle screw spinal systems. Records arebeing continuously extended to include information on deviceapplications and constituent materials, drugs, and coatings.Each material, drug, or coating is linked to further recordsproviding data on mechanical and engineering properties,materials producers, and specific material grades, enablingdevice designers to rapidly acquire information to supportdevice design, materials screening, and various regulatoryfilings. Future releases will extend coverage into otherorthopaedic applications.

The database encompasses the traditions of the field ofbiomaterials. The members of Database Committee

FeatureMichael Helmus, Chair, ASM International Database CommitteeEncompassing a

Biomaterial’s Tradition:The Materials for Medical Devices Database


demonstrate the depth and connections with biomaterialsand the Society For Biomaterials (see below). As thedatabase grows to encompass the full extent of medicaldevices, the participation of biomaterial and medical deviceresearchers and experts will be welcome and necessary.

ASM Medical Devices Database Committee• Michael Helmus, Committee Chair and Consultant:

Medical Devices, Biomaterials, Drug Delivery, andNanotechnology

• Kelvin Brockbank, Senior Vice President, OrganRecovery Systems

• Art Coury, Vice President of Research, GenzymeCorp.

• Lawrence Eiselstein, Principal Engineer, ExponentFailure Analysis Associates

• Howard Freese, Manager, Business Development, ATIAllvac

• Keith Foy, Assistant to the Chief Engineer, FDA,Office of Orphan Products Development

• Don Gibbons, Corporate Scientist (Retired), 3MBiosciences Laboratory

• Jennifer Hoffman, Managing Engineer, ExponentFailure Analysis Associates

• Gordon Hunter, Senior Research Project Manager,Smith & Nephew Orthopaedic

• Frederick Lisy, President, Orbital Research Inc. • Neil Morgan, Consultant • George Pins, Associate Professor of Biomedical

Engineering, Worcester Polytechnic Institute • Oludele Popoola, Manager, Zimmer Inc., Research

Lab • Charles Sturrock, Consultant • Ray Taylor, Director, Houston Biomaterials Research

Center• Karen Warden, Case Western Reserve University


Figure 1. SIBS Polymer Data from Materials for Medical Devices Database 1

1ASM International and Granta Design Limited (2007),Materials for Medical Devices Database (MMD),

http://products.asminternational.org/meddev/index.aspx

The SFB History Summit was recently organized in order tocapture the spirit and experiences of the beginning of theSociety through the personal recollections of its foundingmembers. When offering to help with the Summit I didn’tknow what to expect; as the first session began I quicklyrealized that it was going to be a very valuable experience.

With stories told about people showing off implants theytested on themselves, very heated discussions between friends,and early bashes with barrels of shrimp and beer on the lake,the Summit proved to be both entertaining and informative.These recollections of initial meetings by our founders were sonumerous they struggled to move past 1969 in the allottedamount of time. What struck me most when listening was theobvious camaraderie that existed between these men whenthey began having historic meetings in the basement of an oldcampus building. This sense of a scientific communitycontinues to exist between them today. Their original purposewas not to be credited with establishing a major professionalsociety, but to simply share their latest findings and thoughtsfor the betterment of society, and have fun while doing it.

Their enthusiasm for their work was not driven by a desire forpersonal gain. All were careful to include the names ofgraduate students, clinicians, and others that contributed totheir early work for the record. This commitment to sharingcredit and ideas, I believe, is what helped establish the field ofbiomaterials and allowed it to thrive.

As a society that has grown by leaps and bounds frombasement meetings and barrels of beer on the lake, we strive tobetter engage our members—our students, in particular. Wecan take some important lessons away from our humblebeginnings. Take advantage of meetings as a time to reallyengage with other members both professionally and socially.Reestablishing the sense of community that began the Societymay renew the enthusiasm of our members and ultimatelyimprove upon the important work that we do in our field.

Student NewsBy Sarina Kay, Bioengineering Doctoral Candidate,

Clemson UniversityReflecting on Our Founders

Congratulations to:

James Anderson, Case Western Reserve UniversityProfessor of Pathology, Macromolecular Science, andBiomedical Engineering, and Editor of JBMR, Part A, who waselected to the Association of American Physicians (AAP).The Association of American Physicians is a nonprofit,professional organization founded in 1885 by seven physiciansfor “the advancement of scientific and practical medicine.”Currently the Association is composed of about 1,000 activemembers and approximately 550 emeritus and honorarymembers from the United States, Canada, and other countries.The goals of the AAP members include the pursuit of medicalknowledge, and the advancement through experimentationand discovery of basic and clinical science, and theirapplication to clinical medicine. Each year, 55 individuals,having attained excellence in achieving these goals, arerecognized by nomination for membership by the Council ofthe Association.

Barbara Boyan, Professor of Biomedical Engineering andPrice Gilbert, Jr., Chair in Tissue Engineering at the GeorgiaInstitute of Technology, who received one of four 2008 RiceUniversity Distinguished Alumni Awards. The award ispresented to alumni who have advanced the interests andstandards of excellence of Rice University through distinctiveprofessional or volunteer careers. Dr. Boyan was cited as aninternationally recognized scientific leader of orthopaedic anddental regenerative medicine and tissue engineering.

Johnna S. Temenoff, Assistant Professor of BiomedicalEngineering at the Georgia Institute of Technology, and Antonios G. Mikos, J.W. Cox Professor of Bioengineering at Rice University, for publication of their biomaterials text, TheIntersection of Biology and Materials Science. The new book is afundamental textbook designed to cover basic principles ofbiomaterials science and engineering, address complex issuesassociated with the structure and biocompatibility of syntheticmaterials, and cite in-depth applications for new medicaldevices.

Nicholas Peppas, the Fletcher Stuckey Pratt Chair andProfessor of Chemical Engineering at the University of Texasat Austin, who was elected in the inaugural class of MaterialsResearch Society Fellows. Dr. Peppas was recognized “forseminal and pioneering contributions to the field ofbiomaterials and especially for the development of hydrogels asbiomaterials” at the 2008 MRS Spring Meeting in SanFrancisco. The title of MRS Fellow honors members who arenotable for their distinguished research accomplishments andtheir outstanding contributions to the advancement ofmaterials research worldwide.

Michael Sefton, Director of the Institute of Biomaterials andBiomedical Engineering at the University of Toronto, who isone of five Canadian scholars who will be honored with the2008 Killam Prize, Canada’s most distinguished annual awardfor outstanding career achievements in engineering, naturalsciences, humanities, social sciences, and health sciences. TheKillam Prizes were inaugurated in 1981 and financed throughfunds donated to the Canada Council by Mrs. Dorothy J.Killam, in memory of her husband, Izaak Walton Killam. ThePrizes were created to honor eminent Canadian scholars andscientists actively engaged in research, whether in industry,government agencies, or universities.

Patrick Stayton and Allan Hoffman, Professors ofBioengineering from the University of Washington, who co-founded PhaseRx Inc., a new Seattle biotechnology startupcompany focused on developing novel approaches to thedelivery of siRNA and other macromolecules.

Tim Topoleski, Professor of Mechanical Engineering at theUniversity of Maryland, Baltimore County, who was honoredwith the University of Maryland Baltimore County (UMBC)Presidential Award. Named a UMBC Presidential TeachingProfessor, Dr. Topoleski was cited as an outstanding scholarand educator whose engaging teaching has touched andinspired many students at UMBC. Because of his vision andhard work, the UMBC Department of Mechanical Engineeringreceived two prestigious Graduate Assistance in Areas ofNational Need awards from the U.S. Department ofEducation.

Member NewsContributed from Press ReleasesMembers in the News


IntuitionBy Allegra GoodmanThe Dial Press. Copyright 2006.Paperback, 344 pages. $2 used on Amazon.com.

Description and CritiqueSet in a research lab at a prestigious institute in Cambridge,MA, the story begins with a postdoctoral fellow that suddenlyhas a major breakthrough in his research. One of his fellowpostdocs suspects the unthinkable: that his findings arefraudulent. She goes public with this suspicion (to the NIH)and the ensuing controversy makes for compelling reading.How the relationships between the postdoc that performed theexperiments and the two professors mentoring him evolvethrough the initial success to the subsequent investigation bythe government is thought provoking. The relationshipbetween the two PIs may resonate with academics reading thebook. The description of lab life is astonishingly accurate. Theextreme joy of an experiment that worked correctly, thegrueling long hours, the ambition, the intense competitiveness,the relationship between a professor and postdoc, postdoc andpostdoc, scientist and their family—all are conveyed with theintimacy of reality TV. The writing is smooth and seamless anddoesn’t get in the way of the story. Maybe when you leavework, you want to leave it all behind. In that case, this is notthe book for you. Reading this book is like looking in a mirror.You may or may not like what you see!

Audience/RecommendationFor scientists of all types. For your significant other to read sothey understand your life at work. Highly recommended.

The Sixth CowBy Michael WrightiUniverse. Copyright 2007. Paperback, 253 pages. $12 on Amazon.com.

Description and CritiqueSloan is a medical researcher determined to find a cure forcancer. To be able to follow his dream involving stem cells, hestarts his own company and receives funding from a largeventure capital group that, unbeknownst to him, has secret tiesto the pharmaceutics industry and the Food and DrugAdministration. He makes a breakthrough around the sametime he learns his wife, Ally, has melanoma and is pregnantwith their first child. Ally is told she must have an abortion,followed by traditional chemotherapy and radiation in order tolive. Rather than give up their long sought after child, the twodecide Ally will be Sloan’s first patient and receive his new,yet unproven in humans, cancer therapy. Meanwhile, theventure capital group learns that Sloan has made abreakthrough and demands full disclosure, which Sloan willnot give. The greed and politics of venture firms, big Pharma,and the FDA drive the story to a crescendo and ultimateresolution.

This book is written like a cheap thriller or spy novel and isjust too unbelievable and technically unsupported to reallyconnect to it. The female characters are shallow andtheatrical. The government monitoring of animal research isnot accurately presented. For what the backcover promised, Ithought there would be more depth to this book. Moral andethical decisions are glossed over.

Audience/RecommendationNot recommended.

Book ReviewBy Liisa Kuhn


For a change of pace, the two books reviewed in this issue of the Forum are light reading about fictionalscientific research. They are not textbooks or reference books.

European Society of BiomechanicsLucerne, Switzerland July 6-9, 2008www.esb2008.org

International Fibrinogen WorkshopVenice, Italy July 10-13, 2008http://alisf1.univpm.it/XXifw/

Society For Biomaterials Fall Translational Research SymposiumAtlanta, GASeptember 11-13, 2008www.biomaterials.org

34th Annual National Society for HistotechnologySymposium/Convention Pittsburgh, PASeptember 12-18, 2008www.nsh.org

2008 Biomedical Engineering Society Annual Fall MeetingSt. Louis, MOOctober 2-4, 2008http://bme.wustl.edu/BMES2008/ and http://www.bmes.org

2008 Materials Research Society Fall Meeting Boston, MADecember 1-5, 2008 www.mrs.org

Community

Calendar

Alphatec Holdings Inc. (Carlsbad, CA), a medicaltechnology company focused on the design, development,manufacturing, and marketing of products for the surgicaltreatment of spinal disorders, announced that the companyand Progressive Spinal Technologies LP have entered intoan exclusive worldwide license agreement that providesAlphatec Spine the right to commercialize Progressive’sdynamic anterior cervical plate technologies. The technologiesincorporate a unique self-ratcheting mechanism that enablesthe dynamic anterior cervical plate to allow for axial settlingin order to increase load sharing with the graft and therebyimprove fusion rates.

B. Braun (Melsungen, Germany), an international medicaldevice manufacturer, launched its latest breakthrough inMalaysia—a drug-eluting balloon catheter, SeQuent Please.The device combines a coronary balloon with a bioabsorbable,polymer-free drug carrier matrix. The device is a potentialalternative to drug elution stents for selected heart patients.

Exactech (Gainesville, FL) announced that it has signed anexclusive license deal with the Industrial Technology ResearchInstitute and the National Taiwan University Hospital for therights to technology and patents related to the repair ofcartilage lesions. The company noted that it expects theprojects would proceed through the completion of humanclinical trials under the guidance of the Food and DrugAdministration in order to obtain pre-market approval for thedevice in the United States.

ROBODOC (Sacramento, CA), a company that develops,manufactures, and markets a fully automated surgical roboticsystem for use in orthopaedic surgery, and IBM announced thatthey have entered into a major patent cross-licensingagreement. In addition to its current surgical robotics patents,this agreement gives ROBODOC access to more than 40,000patents in IBM’s global portfolio, particularly IBM’s surgicalrobotics patents.

On February 20, the U.S. Supreme Court handed MedtronicInc. (Minneapolis, MN) a victory in a much-watched andlong-fought product liability dispute. In issuing their landmarkdecision, the justices established a new level of legal protectionfor medical devices cleared to market via the premarketapproval (PMA) path. In an 8–1 decision in the case of Riegelv. Medtronic Inc., the justices ruled that the preemptionprovision of the Medical Device Amendments of 1976 to theFederal Food, Drug, and Cosmetic Act overrides most state-law claims seeking damages for injuries caused by medicaldevices approved by FDA under the PMA process. While thedecision was widely lauded by the medical device community,many consumer advocate groups have expressed outrage overthe decision, which they view as significantly limiting the legalrecourse of patients injured by medical devices.

PhaseRx (Seattle, WA), a biotech startup company, wasformed to develop technologies for delivery of siRNA andother macromolecules. The company was formed by RobertOverell, of Foundation BioVentures, along with co-foundersProfessors Patrick Stayton and Allan Hoffman from theUniversity of Washington’s Department of Bioengineering;Professor Oliver Press of the Fred Hutchinson CancerResearch Center’s Clinical Research Division; and Dr. Paul H.Johnson, the company’s Chief Scientific Officer. PhaseRx hasexclusively licensed novel polymer technology from theUniversity of Washington that was developed by the Staytonand Hoffman laboratories, in collaboration with the Presslaboratory. This technology enables the effective intracellulardelivery of siRNA.

Regeneration Technologies Inc. (Alachua, FL) andTutogen Medical Inc. (Alachua, FL), two companiesspecialized in allograft products processing and distribution,announced that the merger of the two companies is completed.Shareholders of both Regeneration Technologies and TutogenMedical approved the merger at separate special shareholdermeetings. The total value of the transaction is about $205million. Effective immediately, the name of the newlycombined company is RTI Biologics Inc.

Industry NewsSteve T. Lin, Industrial News Contributing Editor

From Press ReleasesBioInk


Documents

Special Interest Group Reporters - biomaterials.org · from the perspective of another, e.g., the physics of music. “Interdisciplinarity” describes the integration of discipline-specific