November/December 2012

Pioneer

WHY DID YOU BECOME a Biomedical Engineering major? Among the variety of reasons everyone has is the desire to be in a career that has a direct impact on the world, and on the lives of the people in it. Yet, few engineers are able to witness the usage of a product that they helped develop. Chris Gemmiti, Georgia Tech and Emory Department of Biomedical Engineering Ph.D. graduate of 2006, has that envied job: he is able to see the product through from start to finish. Dr. Gemmiti works as the Product Director for the Oral Regeneration department of Organogenesis, an industry leader in the field of regenerative medicine. While he was always interested in

business, it took what Dr. Gemmiti called "a wake-up moment" to pursue it: Organogenesis went bankrupt, despite having a revenue-generating, FDA-approved product. From then on it became a personal goal − how can "a very cool, sexy, interesting tissue engineered product” become a commercially successful product as well? During his following years at Tech, D r . G e m m i t i p a r t o o k i n t h e Technological Innovation: Generating Economic Results (TI:GER) program, earned a minor in Management and received a Certificate of Engineering Entrepreneurship. Now, from his post

by Valeriya Popovaby Valeriya Popovaby Valeriya Popovaby Valeriya Popova————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

THE COULTER DEPARTMENT STUDENT PUBLICATION

Alumni Spotlight: Dr. Chris GemmitiAlumni Spotlight: Dr. Chris GemmitiAlumni Spotlight: Dr. Chris GemmitiAlumni Spotlight: Dr. Chris Gemmiti The Business Side of Biomedical EngineeringThe Business Side of Biomedical EngineeringThe Business Side of Biomedical EngineeringThe Business Side of Biomedical Engineering

How FDA regulations and

patent law influence the

development of new devices

BELIEVE IT OR NOT, this past October was American Pharmacists Month, an initiative created by the American Pharmacists Association (APhA) to educate the public about the pharmacist's role in improving medication and advancing patient care. While the common perception of pharmacists evokes an image of someone who interprets a physician's prescription at a local drug store, reality can create a different picture. Instead of the “typical” pharmacists, imagine the growing group of medication therapy managers (MTM): pharmacists who serve patients as counselors by reviewing their medication history and suggesting the best way to reduce drug-related costs. Alongside these new, proactive pharmacists, imagine a pharmacist goes on rounds with a doctor and recommends medications that meet the unique needs of a patient. Finally, imagine pharmacists in consultant positions in which they can advise healthcare facilities or insurance providers on raising the efficiency of pharmacy services. Regardless of the form, these growing breeds of

PrePrePrePre----PharmacyPharmacyPharmacyPharmacy

Dr. Chris Gemmiti at the Georgia Bio Convention (Photo: Benjamin Stewart)

by Jaemin Sungby Jaemin Sungby Jaemin Sungby Jaemin Sung————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

Path to Becoming a PharmacistPath to Becoming a PharmacistPath to Becoming a PharmacistPath to Becoming a Pharmacist

VOLUME VII ISSUE 3

NOV/DEC 2012

PIONEER.GATECH.EDU

DIVERSITY

Dr. Barabino discusses her

initiatives to improve diversity

within the academic fields

Continued on page 4444

A corner of the pre-health advising section in Clough Commons (Photo: by Alex Y. Shao)

FACULTY SPOTLIGHT

One of our newest faculty members from

Imperial College, Dr. Ethier talks about his

journey towards Biomedical research

INNOVATION

Continued on page 10101010

PioneerPioneerPioneerPioneer Established 2007

From the Editor in Chief

BME ANSWERSBME ANSWERSBME ANSWERSBME ANSWERS …………………………………………….………….……...….………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….………….……...….………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….………….……...….………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….………….……...….………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..…………………………………………………………………..…………………………………………………………………..…………………………………………………………………..3333 Your Questions Answered by AEMB, the Secret Honor Society of BME

INNOVATION IN THE BIINNOVATION IN THE BIINNOVATION IN THE BIINNOVATION IN THE BIOMEDICAL FIELDOMEDICAL FIELDOMEDICAL FIELDOMEDICAL FIELD ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……4444 FDA Regulations and Patent Law Revealed

RECENT PUBLICATIONSRECENT PUBLICATIONSRECENT PUBLICATIONSRECENT PUBLICATIONS ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………………………………… .………………….........………………….........………………….........…………………........6666

GRADUATE SPOTLIGHT: GRADUATE SPOTLIGHT: GRADUATE SPOTLIGHT: GRADUATE SPOTLIGHT: IAN CAMPBELLIAN CAMPBELLIAN CAMPBELLIAN CAMPBELL ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………7777 Ambassador Between the Liberal Arts and the Sciences

DR.BARBINOS MINORITY INITIATIVESDR.BARBINOS MINORITY INITIATIVESDR.BARBINOS MINORITY INITIATIVESDR.BARBINOS MINORITY INITIATIVES ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....................………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....................………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....................………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....................8888 The Importance of Diversity in Academia

FACULTY SPOTLIGHT: DFACULTY SPOTLIGHT: DFACULTY SPOTLIGHT: DFACULTY SPOTLIGHT: DR.ROSS ETHIERR.ROSS ETHIERR.ROSS ETHIERR.ROSS ETHIER ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………….………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………….………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………….………………………..…………….…………………....………………………..…………….…………………....………………………..…………….……………….9999 World Renown Researcher from Imperial College

UNDERGRADUATE SPOTLIUNDERGRADUATE SPOTLIUNDERGRADUATE SPOTLIUNDERGRADUATE SPOTLIGHT: GHT: GHT: GHT: PATRICK STRANEPATRICK STRANEPATRICK STRANEPATRICK STRANE ………………………..…………….…………………....……………………….………………………..…………….…………………....……………………….………………………..…………….…………………....……………………….………………………..…………….…………………....……………………….10101010 Engineering Inside and Outside of the Classrooms

2013 IDEAS TO SERVE COMPETITION2013 IDEAS TO SERVE COMPETITION2013 IDEAS TO SERVE COMPETITION2013 IDEAS TO SERVE COMPETITION ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………….......………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………….......………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………….......………………………..…………….…………………....………………………..…………….…………………....………………………..…………….………………….......11111111 Developing Solutions for Real wOrld Problems

DESIGN TOOL BOXDESIGN TOOL BOXDESIGN TOOL BOXDESIGN TOOL BOX ………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..……………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………….…………………....………………………..…………………………………….…………………....………………………..………….…………………....………………………..………….…………………....………………………..………….…………………....………………………..…………12121212 A Guide to the Design and Market of Medical Devices

INSIDE:PIONEER

Hello and welcome to another issue of Pioneer!

Innovation: The proverbial Holy Grail of Biomedical Engineering, whether it be the development of new life-saving devices, the discovery of life-changing cures, or the implementation of new life-improving procedures. We hear this word used often and find ourselves striving towards it. As much as the courses offered to us at the Wallace H. Coulter Department of Biomedical Engineering give us valuable insight into the fundamentals and principles of innovation, we still do not have the opportunity to witness the real world process towards innovation until our later years here. Therefore for this issue of Pioneer, we bring a look into the overarching process of turning ideas into feasible solutions which save lives through new methods and devices constantly being developed in the biotechnology community. We start with our feature on one of our newest additions to the faculty, Dr. Ethier, a leading researcher in the study of glaucoma, arterial disease, and osteoarthritis who hopes to one day find a cure for each. Next, we take you through the process which ensures that the end products meet the users’ safety needs through our coverage on design development and FDA regulations. However, even if a device is FDA approved, not all devices become successful in the market. Our interview with one of our alumnus, Dr. Gemmiti, currently the Product Director at Organogenesis, gives great insight into what it takes to build the market up for a biomedical device. Innovation never stops at devices and treatments, constantly extending to people. A strong leader in the community and newly elected president of the Biomedical Engineering Society (BMES), Dr. Barabino harnesses new strategies to provide outreach and mentorship to minorities currently underrepresented science technology, engineering, and mathematics (STEM) fields. With these initiatives, Barabino strives to build the diversity of these communities for a wider array of solutions in the future. Of course, there is much more offered in this issue and we hope you enjoy all the content! It has been a fun and exciting semester, and we look forward to continue bringing new and exciting coverage both in print and online. For more updates on the happenings of the biotechnology community, feel free to like our page on Facebook: facebook.com/gtpioneerfacebook.com/gtpioneerfacebook.com/gtpioneerfacebook.com/gtpioneer and/or follow us on Twitter: twitter.com/pioneergttwitter.com/pioneergttwitter.com/pioneergttwitter.com/pioneergt. And, as always, feel free to contact us for any comments or concerns at [email protected]@[email protected]@gatech.edu. With warm regards, Virginia Lin Editor-in-Chief Pioneer

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Virginia LinVirginia LinVirginia LinVirginia Lin

Wendy Newstetter, Ph.D.

Timothy LinTimothy LinTimothy LinTimothy Lin

Saranya KarthikeyanSaranya KarthikeyanSaranya KarthikeyanSaranya Karthikeyan

Guergana TerzievaGuergana TerzievaGuergana TerzievaGuergana Terzieva

Jaemin SungJaemin SungJaemin SungJaemin Sung

Sara KhalekSara KhalekSara KhalekSara Khalek

Elizabeth Walker

Felis (Doyeon) Koo

Jaheda Khanam

Jimmy Nguyen

Taufiq Dhana

Subhendu DeSubhendu DeSubhendu DeSubhendu De

Rachel Stewart Rachel Stewart Rachel Stewart Rachel Stewart

Abigail Riddle

Amrita Banerjee

Arun Kumar

Belane Gizaw

Guergana Terzieva

Harish Srinimukesh

Hifza Sakhi

Iva Zivojinovic

Nina Mohebbi

Nithya Paranthaman

Prateek Neil Viswanathan

Sarah Gonzales

Steven Touchton Jr

Valeriya Popova

Yeonghoon Joung (Robert)

Harish Srinimukesh Harish Srinimukesh Harish Srinimukesh Harish Srinimukesh

Arun Kumar

Fatiesa Sulejmani

Jackson Hair

Kristen Weirich

Steven Touchton Jr

Kevin Lam Kevin Lam Kevin Lam Kevin Lam

Alexandra Low

Marisa Casola

Summer Lee

Xurong Liu

William SessionsWilliam SessionsWilliam SessionsWilliam Sessions

Alex Shao

Benjamin Stewart

David Van

Henry Mei

Hyunjun Fred Woo

Jacob Khouri

Rachel Moore

Sheridan Carroll

Shriya Raje

Karen Adams

Paul Fincannon

Sally Gerrish

Marty C. Jacobson

Jennifer Kimble

Megan McDevitt

Mark P. McJunkin

Colleen Mitchell

Adrianne Proeller

Shannon Sullivan

EDITOR IN CHIEF

FACULTY SPONSOR

OPERATIONS

SECRETARY

TREASURER

PUBLIC RELATIONS

WEBMASTERS

STAFF WRITERS

EDITORS

LAYOUT EDITORS

PHOTOGRAPHERS

COLLABORATORS

3

BME FRACTURES

When one day you're doing def. bod's,

another mass balances, and another

I wonder how

many five hour

nights would

take me to

increase my

grade in2210

Because Even the Best Major Ever Needs to Vent

I wish I could write

something witty. But I

guess that's why I'm at

Georgia Tech.

Part of your grade

always depends on

how much people

screw you over.

Is it wrong to think of your genetic make up every

time I see you? And what our kids would look like?

That's the sound of my GPA sinking.

MEs struggle with Dynamics and Def Bods; BMEs

struggle with Biomechanics!

How do I find out about internships?How do I find out about internships?How do I find out about internships?How do I find out about internships? Visit Georgia Techs Department of Professional Practice or contact the BME intern/co-op advisor Rob Rogers for more Information! What clubs should I join to help build What clubs should I join to help build What clubs should I join to help build What clubs should I join to help build my resume?my resume?my resume?my resume? BMES is a great way to meet many BME students and become involved. Don’t forget that the BME honor society, AEMB, is a great resume builder with excellent leadership opportunities. You can also look into clubs outside of BME such as Medlife, Engineering World Health (EWH), FIMRC, and for the premeds out there the Student Hospital Connection (SHC) is an excellent way of getting shadowing experience. How do I go about finding a research How do I go about finding a research How do I go about finding a research How do I go about finding a research position?position?position?position? There isn’t a set way for doing this. The best way to start though is to go onto the BME website and find a lab that l o o k s i n t e r e s t i n g ( h t t p : / /w ww . bm e . ga t e c h . ed u /re s e a r c h /labs.shtml). From there, you can contact the professor via email. Let them know you’re interested in working in the lab, and ask if there are any available spots. If the professor doesn’t reply, you may want to try contacting the graduate students in the lab! Also, check out the Biomedical Research Opportunity Society (BROS). It is a great resource and club designed to help you get involved in research.

What are the hardest classes?What are the hardest classes?What are the hardest classes?What are the hardest classes? There is no single class that can be heralded as the hardest. Being a student at Georgia Tech you will unavoidably be tested with difficult coursework. For a mentor to help with coursework join the BMES Mentor Mentee program! When should I take my Depth and When should I take my Depth and When should I take my Depth and When should I take my Depth and Breadth Electives?Breadth Electives?Breadth Electives?Breadth Electives? Save these classes for your later years at Georgia Tech when you have a better idea of the direction you wish to take whether it be Pre-Med, Research or a Minor. It is also wise to cater your depth electives toward your future. For instance, are you thinking about being a neurologist? You should take neuroscience and neuroengineering. The depth is highly customizable. Pick them wisely, and don’t just pick the classes that might be easy. These are the classes that are great to talk about with future employers. Q:Q:Q:Q: Is it a good idea to take summer Is it a good idea to take summer Is it a good idea to take summer Is it a good idea to take summer classes even though classes even though classes even though classes even though the pace is the pace is the pace is the pace is faster?faster?faster?faster? Summer classes can be a great way to get some time consuming classes out of the way. In general, students are less busy in the summer and have more time to devote to class. Just be careful not to take too many hours, since the classes are squeezed into a shorter semester.

BME AnswersBME AnswersBME AnswersBME Answers

By AEMB, Bme’s Secret Honor Society By AEMB, Bme’s Secret Honor Society By AEMB, Bme’s Secret Honor Society By AEMB, Bme’s Secret Honor Society

Your Questions AnsweredYour Questions AnsweredYour Questions AnsweredYour Questions Answered

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pharmacists demonstrate that the pharmaceutical industry is not simply filled with pill counters; like everywhere else in the biomedical field, it is exploding with innovation and fresh new challenges. Since the H1N1 virus outbreak in 2009, all 50 states have granted pharmacists the right to give flu shots. Some states have even allowed pharmacists to administer vaccines. As evidenced in these expanding roles of pharmacists in healthcare, what pharmacists do now affects the public health more than ever. With this in mind, more and more college students head to pharmacy schools to pursue careers in the pharmaceutical industry. What does it take to get into pharmacy school? The application process is similar to the one required for medical schools. The American Association of Colleges of Pharmacy (AACP) is a great hub of resources for learning about the pharmacy school admission process. First, the combination of a good overall GPA and PCAT (Pharmacy College Admission Test) score will always help an applicant stand out from the pool. The course requirements differ from school to school; for instance, the University Of Georgia College Of Pharmacy requires applicants to take a 3 credit-hour speech class. Besides academics, any experience in relation to pharmaceuticals or general medicine will bolster their applications. Though it may not seem like it as first glance, opportunities are plentiful, including volunteering at the Stamps Health Services Pharmacy or shadowing a local pharmacist. Just like any professional track, the journey to becoming a pharmacist is a long and arduous process that results in a worthwhile experience at the end. For entry-level positions, aspiring pharmacists are required to hold Doctor of Pharmacy (Pharm. D.) professional degrees. Pharmacy schools take four years to complete and prepare students for the technical, scientific, and patient-care aspects of the profession. The Pharm. D. education encompasses a variety of subjects, such as pathophysiology, toxicology, and biopharmaceuticals, and

has clinical training integrated into the curriculum. Upon graduation from pharmacy school, graduates often pursue additional training through residencies or fellowships for one to two years. The goal of the post-graduate training is to allow pharmacists to gain direct, patient-care experience in community pharmacies, hospitals, and other healthcare facilities. Fellowships, though, provide more specialized training in biomedical research to further innovation in the pharmaceutical industry. Lastly, the graduates must pass the North American Pharmacists Licensure Examination in order to distribute medicine in the United States. While the job market for pharmacists has been sluggish due to the downturn of the economy, experts say an aging population and increasingly complex medicines will keep industry growth healthy for years to come. In fact, the Bureau of Labor Statistics projects a 25.4% employment growth for pharmacists between 2010 and 2020, and he earnings are expected to remain relatively high. According to the Labor Department, the median annual salary for pharmacists was $111,570 in 2010. The best-paid 10 percent made approximately $138,620 a year, while the lowest-paid made approximately $82,090. These statistics explain why the pharmacist profession is ranked third in the Best Jobs of 2012 by U.S. News and World Report. With the continuous development in healthcare information technology, the role of pharmacists becomes wider and more complex. More sophisticated skill sets and intelligent minds are needed in the pharmaceutical industry, and the students here at Georgia Tech certainly have potential to fill these needs. For more information regarding how to prepare for pharmacy school, learn of the admission process, and learn of the career choices in pharmacy, contact Jennifer Jennifer Jennifer Jennifer Kimble Kimble Kimble Kimble at [email protected]. For more information about AACP please visit www.aacp.orgwww.aacp.orgwww.aacp.orgwww.aacp.org

Continued from page 1Continued from page 1Continued from page 1Continued from page 1

PrePrePrePre----PharmacyPharmacyPharmacyPharmacy

Innovation in the Biomedical FieldInnovation in the Biomedical FieldInnovation in the Biomedical FieldInnovation in the Biomedical Field

By Neil ViswanathanBy Neil ViswanathanBy Neil ViswanathanBy Neil Viswanathan————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department FDA Regulations and Patent Law Revealed FDA Regulations and Patent Law Revealed FDA Regulations and Patent Law Revealed FDA Regulations and Patent Law Revealed

NEW REGULATIONS AND LEGISLATION have changed the biomedical industry by increasing the costs and regulatory hurdles that must be cleared before a product can come to market. As stated in “The State of Innovation in the Biomedical Field”, inventors and businesses face a more competitive regulatory environment for their products in the United States of America (U.S). Without adapting successfully to an overhaul of the existing patent law and the series of proposed changes by the Food and Drug Administration (FDA), they will not be able to achieve the same level of success as in years past. America’s patent law had undergone several changes since its inception in 1793, by Thomas Jefferson, but the passage of the Smith-Leahy America Invents Act of 2011 (AIA) has flipped our patent law on its head by introducing a “first-to-file system” and new legal proceedings. In addition, after thirty years of stability, the FDA has proposed over 60 new changes to its regulatory procedures to increase costumer

safety and administrative oversight. So why should all innovators watch these changes closely? Innovation cannot thrive if companies and inventors cannot sell their products at profit, and that cannot happen without patents and FDA clearance. Assume that you have already invested heavily, on the order of millions of dollars, in designing a new drug or device that you believe is profitable. You, understandably, do not want a rival company to see your design and then start to produce your product while circumventing the cost of research. If the shareholders and investors who keep your company afloat realize that a rival could generate greater profits faster, they would sell your shares and invest their money in your rivals, putting an end to your funding, despite the hard work you have invested in your product. To protect yourself from such a scenario, you would need to protect your idea and your profit by patenting your product. A patent is a grant from the government that gives someone

5

exclusive rights to an invention. The two main classes of patents are utility patents, which focus on the function of the device, and design patents, which focus on the appearance of the device. Both classes of patents last for 20 years. Regardless of the type of patent, two parties are involved: The assigners, who are the inventors, and the assignees, who are companies or other products that the assigners are giving the patent to. The assigners grant written permission to the assignees only to exclude others from making, selling, or importing that invention, though the assignee himself or herself will not be able to do any of those things if the invention would violate existing laws. For instance, just because someone has received a patent to manufacture a new type of automatic weapon, they cannot manufacture it in Georgia if such weapons were already banned. Applying for a patent is a long and costly process. After conceiving the idea and establishing credible documentation, the first step is to draft and file a provisional application. This costs $200 if done alone, but can reach up to $2,000 with competent patent lawyers. The United States Patent and Trade Office (USPTO) review the application, some 18 to 36 months after it is filed, and will return the patent application with objections. Each redrafting costs approximately $10,000 with a suitable lawyer, and once the USPTO approves the provisional application, they grant a year-long grace period to file an official application. Most patents can cost from between $25,000 to $150,000, and take between four to eight years to complete. Even after the patent is completed, it is still vulnerable to other companies, who can file requests for review, or even file declaratory judgment suits to allege that the patent infringes on their earlier patent. Under current law, the U.S operates a unique “First to Invent” (FTI) system that gives priority to earlier inventors. If an applicant does not agree with the system, it would file a rare “interference proceeding” and challenge the earlier inventorship. In addition, the FTI system granted a grace period of a year during which inventors could disclose their inventions to potential investors and still be eligible for a patent. After March 16th, 2013, when the AIA takes effect, the U.S will switch to a “First to File” system and eliminate the early interference proceedings, replacing them with a new Post Grant Review, which is easier to initiate. The AIA will also eliminate the one-year grace period, meaning that if at any point the inventors disclose their ideas to potential investors, they cannot apply for a patent. This new law will impact innovation by increasing costs and time, but small businesses and start-ups will bear a disproportionate share of the burden. Without the one-year grace period, inventors will have to enter the costly patent application process without any assurance in finding interested investors. Inventors will have less time to develop ideas and be pushed to file more attempts earlier to ensure priority and a patent. After the AIA takes effect, other companies can individually file for Post Grant Reviews against the patent, tying the patent application up in more costly legal proceedings that could prevent production for several years. After receiving a patent, medical companies still must gain FDA approval in order to bring their products to market. Gaining FDA approval requires conducting expensive clinical trials that can cost above $50,000. However, for the past three decades, the FDA had maintained a shortcut, via the 510(k) process. It would grant clearance, not approval, to a medical device if the manufacturers could prove that this device was substantially similar to previous devices that had already been approved through the clinical process-even if the

previous devices were later recalled from the market for poor performance or low safety. While this lowers costs between $2,000 and $5,000 for manufacturers, many policy makers and patients remain concerned about the 501(k)’s effectiveness in protecting consumers, and have now started calling for changes to this process. If these proposals pass, medical devices will take more time to get to market, and the resulting costs to companies from clinical trials will reduce their ability and incentive to invest in research and development (R & D). In order to circumvent such costs, companies will design and manufacture their products in America, but will first sell them in overseas markets with fewer regulations. This allows U.S based companies to offset the costs of regulation and generate safety data for a fraction of what it would cost at home. The market for biomedical devices is becoming more expensive to enter, even for those innovators and companies that can withstand the heavy costs of R&D. Before bringing a product to market, many companies have to wrestle with expensive and time-consuming legal patent battles, while simultaneously incurring costs for FDA approval or clearance. While companies can, with some effort, adapt to costlier FDA regulations by testing and marketing their products overseas, no likewise solutions exist to lower patent costs. However, companies and inventors face even more serious constraints in investing in new products, because new legislation and economics have constricted their budgets. Stay tuned, because those new factors will be in the next Pioneer Issue.

Recent Publications Compiled by Yeonghoon Joung

Journal Article Title Authors

Academic Radiology Grand rounds and a visiting professorship program in a Tridandapani S, Mullins ME, Meltzer CC.

ACS Nano Piezo-phototronic Effect Enhanced Visible and Ultraviolet Photodetection Using a ZnO-CdS Core-Shell Micro/nanowire.

Zhang F, Ding Y, Zhang Y, Zhang X, Wang ZL.

Annals of Biomedical Engineering Spatiotemporal Mechanical Variation Reveals Critical Role for Rho Kinase During Primitive Streak Morphogenesis.

Henkels J, Oh J, Xu W, Owen D, Sulchek T, Zamir E.

Biochemical and Biophysical Research Communications

Piperlongumine inhibits atherosclerotic plaque formation and vascular smooth muscle cell proliferation by suppressing PDGF receptor signaling.

Son DJ, Kim SY, Han SS, Kim CW, Kumar S, Park BS, Lee SE, Yun YP, Jo H, Park YH.

Biomaterials Effect of modulating macrophage phenotype on peripheral nerve repair.

Mokarram N, Merchant A, Mukhatyar V, Patel G, Bellamkonda RV.

Biomedical Microdevices Hollow microneedles for intradermal injection fabricated by sacrificial micromolding and selective electrodeposition.

Norman JJ, Choi SO, Tong NT, Aiyar AR, Patel SR, Prausnitz MR, Allen MG.

Biophysical Journal A Modular Fibrinogen Model that Captures the Stress-Strain Behavior of Fibrin Fibers.

Averett RD, Menn B, Lee EH, Helms CC, Barker T, Guthold M.

Environmental Science & Technology

Contribution of Water-Soluble and Insoluble Components and Their Hydrophobic/Hydrophilic Subfractions to the Reactive Oxygen Species-Generating Potential of Fine Ambient Aerosols.

Verma V, Rico-Martinez R, Kotra N, King L, Liu J, Snell TW, Weber RJ.

Integrative and Comparative Biology Swimming in the Intermediate Reynolds Range: Kinematics of the Pteropod Limacina helicina.

Chang Y, Yen J.

Intergrative and Comparative Biology Using Computational and Mechanical Models to Study Animal Locomotion.

Miller LA, Goldman DI, Hedrick TL, Tytell ED, Wang ZJ, Yen J, Alben S.

International Journal of Computational Biology and Drug Design

Integrating image analysis algorithms in a web interface for the quantification of microtubule dynamics.

Kong KY, Marcus AI, Giannakakou P, Wang MD.

International Journal forNumerical Methods in Biomedical Engineering

Review and perspective: neuromechanical considerations for predicting muscle activation patterns for movement.

Ting LH, Chvatal SA, Safavynia SA, Lucas McKay J.

Journal of the Acoustical Society of America

Acoustoelastic Lamb wave propagation in biaxially stressed plates.

Gandhi N, Michaels JE, Lee SJ.

Journal of the American Academy of Orthopaedic Surgeons

Sex differences in osteoarthritis of the knee. Boyan BD, Tosi L, Coutts R, Enoka R, Hart DA, Nicolella DP, Berkley K, Sluka K, Kwoh K, O'Connor MI, Kohrt W.

Journal of Visualized Experiments. Probing and mapping electrode surfaces in solid oxide fuel cells.

Blinn KS, Li X, Liu M, Bottomley LA, Liu M.

Medical Physics MR⁄PET quantification tools: Registration, segmentation,

classification, and MR-based attenuation correction. Fei B, Yang X, Nye JA, Aarsvold JN, Raghunath N, Cervo M, Stark R, Meltzer CC, Votaw JR.

Neural Computation A Common Network Architecture Efficiently Implements a Variety of Sparsity-Based Inference Problems.

Charles AS, Garrigues P, Rozell CJ.

Nucleic Acids Research Chromatin signature discovery via histone modification profile alignments.

Wang J, Lunyak VV, Jordan IK.

Physical Review E: Statistical, Nonlinear, and Soft Matter Physics.

Phase response theory extended to nonoscillatory network components.

Sieling FH, Archila S, Hooper R, Canavier CC, Prinz AA.

Public Library of Science One (PLoS One)

Cell stiffness is a biomarker of the metastatic potential of ovarian cancer cells.

Xu W, Mezencev R, Kim B, Wang L, McDonald J, Sulchek T.

Small Hierarchical Rutile TiO(2) Flower Cluster-Based High Efficiency Dye-Sensitized Solar Cells via Direct Hydrothermal Growth on Conducting Substrates.

Ye M, Liu HY, Lin C, Lin Z.

The Journal of Pathology Physical and chemical microenvironmental cues orthogonally control the degree and duration of fibrosis-associated epithelial to mesenchymal transition.

Brown AC, Fiore VF, Sulchek TA, Barker TH.

Vaccine Measles vaccination using a microneedle patch. Edens C, Collins ML, Ayers J, Rota PA, Prausnitz MR.

6

7

Graduate Spotlight: Ian CampbellGraduate Spotlight: Ian CampbellGraduate Spotlight: Ian CampbellGraduate Spotlight: Ian Campbell

JOSEPH E.STIGLITZ ONCE SAID

Indeed, few students at technical colleges are as much concerned with the breadth of knowledge as they are with its depth. Ian C. Campbell, a Ph.D. student in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, seems to have done just that with a balance between science and the humanities. As Institute of Electrical and Electronics Engineers (IEEE)-USA's 2012 Engineering Mass Media Fellow, Campbell has found his niche in research by serving as an ambassador of science to the general public. Campbell’s undergraduate and graduate educations thus far have certainly shaped his research and career prospects. For his undergraduate studies, Campbell attended St. Olaf College, a private liberal arts school in Minnesota where he

worked with a glaciologist each summer studying climate change. After double majoring in physics and math, he entered the joint Biomedical Engineering (BME) program between Georgia Tech and Emory. “My parents are both science-minded people,” said Campbell, “I think it was sort of inevitable that I would end up in graduate school.” Having a botany professor as a father and a nurse as a mother gave Campbell a better idea of what field he wanted to go into. Campbell has completed most of his course work at Tech, and currently works in two labs at Emory. Campbell’s current research at Emory involves the phenomenon of plaque erosion. In the past, it was believed that heart attacks only occurred as a result of plaque rupture—where an atherosclerotic plaque bursts. Plaque erosion, however, occurs when the clot does not actually rupture. Campbell is currently working with a data set from coronary arteries to explore why plaque erosion happens in some patients. Ultimately, the goal is to discover what makes some people susceptible to plaque erosion and identify those high risk patients. Upon graduation, Campbell has a postdoctoral lined up in the BME Program at Georgia Tech working with Dr. Ross Ethier, a recently recruited faculty from Imperial College in London. Aside from this, Campbell has developed an interest in a science-writing career to compliment his work in the lab. After completing the Mass Media Fellows Program, a ten week session writing for The Oregonian, a newspaper in Portland, Oregon, Campbell has developed a desire to get a science-writing career going on the side. “I’m trying to figure out how to get my writing up and going again—whether it’s freelancing or just writing a personal blog,” said Campbell. Campbell advises all undergraduate students in the field to “Write, write, write. Writing skills take you so far.” He recommends composing abstracts for conferences, taking an elective that makes you put pen to paper, keeping a diary, or having a blog. Aside from academics, Campbell brews his own beer and enjoys the social atmosphere Atlanta has to offer. He frequently attends concerts at the music venue near his apartment complex, and he relishes the restaurant and bar scene around Atlanta. Campbell was also involved with a community service organization called Roots & Shoots, a program that goes into third grade classrooms for one hour each week and cultivates a love for science in young students. With outreach, research, and writing on his plate, Campbell knows the true value of balance. He has success-fully found equilibrium between his liberal arts undergradu-ate and his technical graduate school education. “I’m a big fan of knowledge for the sake of knowledge, but there is also a lot to be said for knowing technical skills. It’s important to learn how to learn, but it’s also important to know something at the end,” said Campbell. With his past accomplishments and intense passion for his field of study, Ian Campbell is sure to go on to conduct sophisticated research and act as a representative of science and technology to the general public. His work continues to prove that science and the humanities should go hand-in-hand.

by Abigail Riddleby Abigail Riddleby Abigail Riddleby Abigail Riddle————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

Ambassador Between the Liberal Arts and the SciencesAmbassador Between the Liberal Arts and the SciencesAmbassador Between the Liberal Arts and the SciencesAmbassador Between the Liberal Arts and the Sciences

Ian Campbell, a Ph.D. student in Biomedical Engineering at Georgia Tech and Emory University, has been selected to be the IEEE-USA's

2012 Engineering Mass Media Fellow aimed to make science and engineering more relatable to the average person.

(Photo: Rachel Moore)

“The no�on that every well educated

person would have a mastery of at least

the basic elements of the humani�es, sciences,

and social sciences is a far cry

from the specialized educa�on that most

students today receive, par�cularly in the

8

DR. GILDA BARABINO, Professor and Associate Chair for Graduate Studies in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Tech and Emory University, is engaged in many initiatives that aid in the recruitment and retention of minorities in the academic setting. She is an avid supporter of leveling the playing field to provide an inclusive and welcoming environment for all students regardless of their skin color or gender. She has performed services through many ways, such as through actively recruiting students by building relationships with the community, providing active mentorship, giving lectures and keynotes at various institutions and conferences like the Annual Biomedical Research Conference for Minority Students (ABRCMS), serving on advisory boards, as well as conducting research on factors that affect the inclusion and retention of minorities in higher education. Notably, Dr. Barabino provides leadership and takes on diversity initiatives over and above her roles as a teacher, administrator and researcher. To begin with, Dr. Barabino is actively involved in recruiting minority students. She believes that the best way to accomplish this endeavor is through building sound relationships with the community. It’s imperative that relationships are built not only with the

interested students, but also with the programs where the students are coming from. This establishes a much greater bond and trust between the recruiter and the community, and in turn attracts more minority students to enter programs in which they will be successful. Likewise, Dr. Barabino does extensive mentoring of minority students, who reach out to her from all over the country. She provides assistance on all topics ranging from the myriad of academic careers to the particulars of their current studies. She gives students advice on which classes they should take and provides guidance on how to navigate through different career paths to get into the fields of their interests, be it research, academia, professional school, or industry. Similarly, she directs students to online and other resources specifical-ly designed for underrepresented minorities by various agencies, organizations and institutions. This helps the students to network effectively by establishing and sustaining key contacts which will be extremely important in their future careers. But, her effort of supporting underrepresented minorities does not stop with the students. She also focuses extensively on the professional development and retention of women

and minority faculty. The Minority Faculty Development Workshop, organized by Dr. Barabino and supported by the National Science Foundation (NSF), helps to bring together the best and brightest minds from top universities like Harvard, Stanford, North Carolina A&T State University, and Massachusetts Institute of Technology (MIT). “Researchers who attended the most recent 2012 workshop gained key insights, resources, and knowledge on activities that support innovation, entrepreneurial endeavors and ultimately, the economic status of our nation” says Dr. Barabino. Similarly, the workshop for minority female faculty is a cross-disciplinary initiative focusing on professional development and mentorship oppor-tunity for participants. She greatly believes in the importance of such programs, because of two main reasons. First, minority students and faculty often do not have access to as many o p p o rt u n it ie s fo r p r o fe s s io n a l development, and her initiatives thus aid in filling this gap. Likewise, “research has shown that there is a link between the representation of minority faculty and minority students,” says Dr. Barabino. “A similar link is also found between female faculty and female students.” Hence establishing such initiatives not only provides minority and female faculty with the support they need, but is also an investment in the future of minority students. This is because minority students look up to authority figures as role models and naturally gravitate towards mentors and faculty members with a similar background as them. Hence, these initiatives for minority faculty will in turn also attract more minority students to enter the academic setting. Alongside these initiatives, Dr. Barabino also conducts research on factors impacting career paths for minorities, both students and faculty. She pursues this endeavor in collabora-tion with Psychology professors and social scientists. Using the frameworks from psychology and social science, she and her team of collaborators try to understand the experiences of minority students and faculty. Her team goes beyond the pure statistics on the

Dr. Barabino’s Minority InitiativesDr. Barabino’s Minority InitiativesDr. Barabino’s Minority InitiativesDr. Barabino’s Minority Initiatives

by Hifza Sakhiby Hifza Sakhiby Hifza Sakhiby Hifza Sakhi ————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

The Importance of Diversity in AcademiaThe Importance of Diversity in AcademiaThe Importance of Diversity in AcademiaThe Importance of Diversity in Academia

Dr. Barabino, currently the president of the National BMES chapter, is a strong supporter of minority recruitment in academia.

(Photo: Henry Mei)

9

THE NEWEST ADDITION to the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University is Dr. Ross Ethier, Ph.D., leading researcher in the study of glaucoma, arterial disease, and osteoarthritis. He is a Georgia Research Alliance Lawrence L. Gellerstedt Jr. Eminent Scholar in Bioengineering, and he comes to Tech from Imperial College London, where he was a professor and the Chair of the Department of Bioengineering. Although now quite renowned in his field, Ethier originally had no desire to go into a biology-related field. His decision changed when a friend was injured in an accident and became a quadriplegic. At that time, Ethier had the opportunity to become involved in a

senior capstone project focusing on the treatment of quadriplegia and physical treatment modalities. Although he originally chose the project because of his friend, Ethier found the application of engineering to living systems to be both stimulating and enjoyable and decided to study BME in graduate school at the Massachusetts Institute of Technology. Ethier began researching ocular problems in graduate school and his ultimate goal in that field is to find a cure for glaucoma, which is currently the second most common cause of blindness. “This field is in a really exciting place right now, on the cusp of something really big,” says Ethier. Since glaucoma affects over 70 million people,“the possibility of a cure is going

to have a large impact.” Ethier is also interested in trying to understand the relationship between mechanics and arterial disease. “There’s a big link there, between blood f low and the development of atherosclerosis and endothelial mechanotransduction.” His lab is “trying to understand some of the f u n d a m e n t a l d e t e r m i n a n t s o f endothelial mechanotransduction set points in a system.” Ethier explains the importance of his third area of research, osteoarthritis, by emphasizing the force placed on a person’s joints every day. “If you have a body of mass of 80 kg and you bend down to pick something up, the force in your knee could be equivalent to a mass of almost 1000 kg. Because they work at a mechanical disadvantage, your knees and all your other joints really get beaten up and wear out.” Ethier’s entrance into this field was “totally unplanned, beginning with a phone call from a colleague needing someone with a background in biomechanics.” Today, his lab is trying to develop new osteochondral (bone and cartilage) constructs that will help to explain some of the mechanobiologybehind osteoarthritis. Ethier’s decision to come here was motivated by Tech’s great reputation for smart, dedicated students, a strong h i s t o r y o f b i o m e c h a n i c s a n d m e c h a n o b io l o g y , a n d a g r e a t environment for research. Although it took Ethier a while to realize that he was interested in an academic career, he r eal l y l ik es th e acad em ic environment where he can be around bright students and faculty who keep him on his toes.

C. Ross Ethier, Ph.D., is a new faculty member of the Wallace H. Coulter BME department and GRA Lawrence L. Gellerstedt, Jr. Eminent Scholar in Bioengineering.

(Photo: Jacob Khouri)

Faculty Spotlight: Dr. Ross EthierFaculty Spotlight: Dr. Ross EthierFaculty Spotlight: Dr. Ross EthierFaculty Spotlight: Dr. Ross Ethier

by Amrita Banerjeeby Amrita Banerjeeby Amrita Banerjeeby Amrita Banerjee————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

World Renown Researcher from Imperial CollegeWorld Renown Researcher from Imperial CollegeWorld Renown Researcher from Imperial CollegeWorld Renown Researcher from Imperial College

number of students entering universi-ties and academia and instead specifically looks at the role of identity formation in career paths, and how the external environment influences the way an individual perceive themselves and in turn the career paths they pursue. Hence, all of these initiatives stem from Dr. Barabino’s core beliefs about the scholarship of research, the scholarship of teaching, and the

scholarship of service. She believes that it is imperative for our society to have a paradigm shift, and instead of just letting individuals bear the responsibil-ity for diversity, institutions and the environment as a whole should be based on the notion of inclusion and acceptance for all. Drawing on diverse backgrounds and analytical abilities will make it easier to solve today’s most pressing and challenging problems. By looking at a problem through their own

lens, individuals bring unique strengths to the table, and providing an accommo-dating environment for all such individuals will in turn allow us all to reap the benefits of a more diverse, sustainable, and robust society, and ultimately a healthy economy. Hence, Dr. Barabino paves the way for the recruitment and retention of minorities in the academic setting and is truly a role model for minorities all over the country.

10 10

as Product Director, he makes the connections between the Research and Development, clinical trials, FDA approval, and finally, sales and marketing as the product goes through its development. For Gemmiti, the cross-functional strategic position is a "perfect match." The Organogenesis latest medical break-through, Gintuit™, recently approved by the FDA, has been seven years in the making, from clinical development to commercialization. Gintuit™ is a product in the dental surgery market, and is manufactured using allogeneic keratinocytes and fibroblasts in a bovine collagen matrix. It is used for the treatment of mucogingival conditions, aiding to replenish the keratinized gum tissue. For the purposes of commercialization and cost efficacy, Dr. Gemmiti says that the product "really only made sense for Organogenesis to do," as the company used the same platform, a collagen matrix, keratinocytes and fibroblasts to create their pioneering bi-layer cell technology, Apligraf®, which is implemented in chronic wounds. This pragmatic approach to the new market demand greatly leveraged the company’s clinical understanding and manufacturing infrastructure, which Dr. Gemmiti views as one of the biggest advantages.

The other key to success in biomedical manufacturing lies in proving the safety and efficacy of your product, and this is where the FDA approval plays a massive role. While the entire development of Gintuit™ may have taken over half a dozen years, FDA approval can be an intense process of mere months. Dr. Gemmiti points out that the whole process was "as exciting as it was traumatic," about which he is only partly joking, since stress levels are high. Apligraf® was the very first allogeneic cell-based product to be approved by the US FDA, and Gintuit marks the first living cellular FDA approved product to be used in the dental market. Dr. Gemmiti notes that the "enormity of it," both the time and the money that goes into the generation of one product, from concept to commercialization, is tremendous. In addition, Dr. Gemmiti serves as the Head of the Industry Committee for the journal Tissue Engineering. He hopes that exposing the academic community more to the industry side of regenerative medicine and being able to "share the lessons" learned by others will stimulate the development that is vital to the industry. He also encourages students to "not be afraid of trying a different avenue of your career. The engineering discipline is one that builds transferrable skills, such as quantitative and analytical skills, which you can apply to a lot of different areas."

FROM A YOUNG AGE, Patrick Strane, a senior undergraduate student in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, loved tinkering with motors and machines and wanted to become a mechanical engineer. As he continued his studies, however, he found that he also loved biology and decided to combine the two into his interest in medical devices. After coming to Tech, Strane earned a position in the Matrix Biology and Engineering Lab headed by Dr. Thomas Barker, Associate Professor in the Coulter Department. He has worked in the Matrix Biology and Engineering Lab for the past three years, first as a volunteer and then as a research assistant. Strane’s research focused on focal adhesion and cell migration and he was involved with a paper called Identification of Fibroblast Subpopulations in Living Lung Tissue, published by Dr. Barker’s lab. Strane’s main role was harvesting tissue from mouse lungs, which demonstrate high concentrations of fibroblast cells. From his experiences, Strane recommends that BME students find a lab to work in, and, “[stick] with that lab long enough to really get into a routine in order to see what it is really going be like to have one topic of focus for a long time.” For his extensive work in the Matrix Biology and Engineering Lab, Strane has been awarded the President’s Undergraduate Research Award (PURA). Strane was one of 19 students to be

chosen as part of the 2012 class of Petit Undergraduate Research Scholars. As part of the program, graduate and undergraduate applicants, are accepted separately into the program and then matched with a mentor or mentee whose interests align with theirs. Strane was matched with graduate student Vince Fiore. Strane says that it is a great program for students who want to,

“put a whole year into research, especially if [they have] been in a lab for a while and [want] to continue the research.” Addition-ally, The Petit Research Program provides a great avenue for determined undergradu-ates to pursue a high level of academic research with one-on-one mentoring from talented graduate students. Besides research, Strane has been heavily involved with the machine shop guild (BME Guild) for the past two years. As a member, Strane is involved with training new students to use the machines in the shop. Strane recommends that students be involved with the machine shop because it helps students “understand the manufac-turing side of engineering,” which allows them to come up with more feasible ideas. As the shop recently received some new machines, Strane has been helping to set them up and learning how to use them in order to instruct others on their use. As a BME student at Georgia tech, it can be difficult to manage time effectively, but Strane has been successful in balancing his time between school and hobbies. Outside of school, Strane plays the guitar regularly

Undergraduate Spotlight: Patrick StraneUndergraduate Spotlight: Patrick StraneUndergraduate Spotlight: Patrick StraneUndergraduate Spotlight: Patrick Strane

by Nina Mohebbi by Nina Mohebbi by Nina Mohebbi by Nina Mohebbi ————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

Engineering Inside and Outside of the ClassroomsEngineering Inside and Outside of the ClassroomsEngineering Inside and Outside of the ClassroomsEngineering Inside and Outside of the Classrooms

Patrick Strane, a well-rounded, outstanding student at Georgia Tech, majoring in

Biomedical Engineering. (Photo: Shriya Raje)

Alumni SpotlightAlumni SpotlightAlumni SpotlightAlumni Spotlight

Continued from page 1Continued from page 1Continued from page 1Continued from page 1

ARE YOU INTERESTED IN DEVELOPING A CREATIVE PRODUCT, service, or business venture concept geared towards creating a better world? If so, entering in the 2013 Ideas to Serve (I2S) com-petition, hosted by the Georgia Tech Institute for Leadership and Entrepreneurship (ILE) Program, gives you the opportunity to win cash awards and service packages to be used towards pushing your innovative ideas to the next level. The competition encour-ages a mixture of creativity, imagination and technology to solve social and environmental problems. The competition is for both current Georgia Tech students as well as recent alumni, and en-tries focus on issues such as poverty, hunger, health and well-ness, pollution, natural resources, or sustainable energy. The main goal of the competition is to push innovative ideas to real world application. I2S believes that “great ventures and or-ganizations begin with great ideas.” The hope is that these prod-ucts, services, and business ventures will “lead to sustainable organizations that are able to generate sufficient income flows to sustain their missions.” The competition promotes growth and realization of ideas focused on society, the environment, and re-turn on investment. For example, 2012 I2S winner Mekong Green Tech focused on a business concept to “clean up Asia's brickmak-ing industry through clean, efficient, culturally sensitive rice husk gasifiers.” I2S consists of two phases. In the preliminary round, each team submits an executive summary briefly describing the idea or venture and a one-minute video pitch. After submitting the sum-mary and video, the teams present a poster in the College of Man-agement Auditorium for a panel of judges, themselves social en-trepreneurs and environmental advocates. Each idea is judged based on its “potential to deliver large-scale impact in the fu-ture.” The same judging criteria are used in the final round of the competition, in which five to seven finalist teams present to a large audience including students and judges in the LeCraw Audi-torium. Besides the competition itself, there are many optional work-shops that aid teams in the process of entrepreneurial planning and developing ideas. To learn more about the competition, visit ile.gatech.edu/i2s. Applications for the competition open in Janu-ary so be on the lookout!

calendar

11

November

6 Graduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar Series Placental models from human pluripotent stem cells Balaji Rao, PhD - North Carolina State University 11am—IBB 1128

7 Graduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar Series Suhasa Kodandaramaiah - Advisor, Craig Forest, PhD James Kratzer - Advisor, Eric Gaucher, PhD 12pm—IBB 1128

13 Bioengineering Seminar SeriesBioengineering Seminar SeriesBioengineering Seminar SeriesBioengineering Seminar Series Engineering Microsystems for Studying and Diagnosing Hematologic Disorders Wilbur Lam, MD, PhD - Wallace H. Coulter Department 830am—IBB 1128

14 Graduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar Series Randy Ankeny - Advisor, Bob Nerem, PhD Jinsung Hong - Advisor, Cheng Zhu, PhD 12pm—IBB 1128

15 Bioengineering Seminar SeriesBioengineering Seminar SeriesBioengineering Seminar SeriesBioengineering Seminar Series Engineering the Innate Immune Response to Infection Scott Simon, PhD - University of California, Davis 11am—IBB 1128

28 Graduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar Series Ivan Caceres - Advisor, Hang Lu, PhD Tiffany Chen - Advisor, Charlie Kemp, PhD 12pm—IBB 1128

December

4 Stem Cell Engineering Center Seminar SeriesStem Cell Engineering Center Seminar SeriesStem Cell Engineering Center Seminar SeriesStem Cell Engineering Center Seminar Series Advanced microscale technologies for the in vitro study of stem cells Elisa Cimetta, PhD - Columbia University 11am—IBB 1128

5 Graduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar SeriesGraduate and Postdoc (GaP) Seminar Series Idy Akinsanmi - Advisor, Gilda Barabino, PhD Lisa McGinley - Advisor, Robert M. Nerem, PhD 12pm—IBB 1128

11 Breakfast Club Seminar SeriesBreakfast Club Seminar SeriesBreakfast Club Seminar SeriesBreakfast Club Seminar Series Mesenchymal Stem Cell Angiogenic Capacity in Amputated Limbs Luke Brewster, PhD - Department of Surgery Emory University 830am—IBB 1128

Bioengineering Seminar SeriesBioengineering Seminar SeriesBioengineering Seminar SeriesBioengineering Seminar Series Frontiers in Ultra High Field Magnetic Resonance Imaging: From Brain Function and Connectivity to Angiography in the Human Torso Kamil Ugurbil, PhD - University of Minnesota School of Medicine 11am—IBB 1128

13 Petit Institute Holiday PartyPetit Institute Holiday PartyPetit Institute Holiday PartyPetit Institute Holiday Party Open to all IBB faculty, staff, postdocs and graduate students 4pm—IBB Atrium (RSVP Required)

18 4th Annual Magnetic Resonance Workshop at Georgia Tech4th Annual Magnetic Resonance Workshop at Georgia Tech4th Annual Magnetic Resonance Workshop at Georgia Tech4th Annual Magnetic Resonance Workshop at Georgia Tech Open laboratory demonstrating the MRI scanner followed by a symposium presenting ongoing research in the field of Magnetic Resonance 9am—IBB Atrium (Registration)

Ideas 2 Serve Ideas 2 Serve Ideas 2 Serve Ideas 2 Serve

CompetitionCompetitionCompetitionCompetition Developing Solutions for Real World Developing Solutions for Real World Developing Solutions for Real World Developing Solutions for Real World

ProblemsProblemsProblemsProblems

by Steven Touchton, Jr.by Steven Touchton, Jr.by Steven Touchton, Jr.by Steven Touchton, Jr.————

Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

and has ongoing projects with his brother, in which they work with cars and motorcycles, sometimes even building cars for amateur races. Besides working on his own motorcycle, he and his brother have two ongoing projects – a ‘77 Porsche 911 and a ‘95 Mazda Miata. He also enjoys camping and will often block off weekends to make time to go to local camping areas such as Pine Mountain GA, and even once summited on Mount Kilimanjaro in Tanzania Africa in 2007. The key, he says, is learning to say no sometimes. Strane recommends that students actually block off some time to have to themselves every once in a while. Though difficult to do when academics, extracurricular activities, and research are piling on the work, Strane believes that students should value “free time as much as the time that is spent in academics or in your extracurricular activities.”

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Design ToolboxDesign ToolboxDesign ToolboxDesign Toolbox

by Belane Gizawby Belane Gizawby Belane Gizawby Belane Gizaw————Undergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter DepartmentUndergraduate Student in the Coulter Department

STARTING THE DESIGN PROCESS on one’s own can be difficult when attempting to gain approval for market use and trying to satisfy the users’ needs. For the approval process, the U.S. Food and Drug Administration (FDA) has created an outline for medical device designers and manufacturers that serves as a set of guidelines to follow during design planning, input, output, verification, and validation. For those new to design, the following guide provides a glimpse into stages of the design that the FDA wants to see. Design Planning 1. List the goals and objectives 2. Establish constraints such as standards and regulations 3. Identify the major tasks and the individual responsibilities 4. Establish the medium each deliverable takes 5. Identify the interfaces that provide input into the design

process Design Input or Output 1. Check the intended use of the device by checking the

needs of the client 2. Address any conflicting requirements 3. Establish production specifications such as: 4. Assembly drawings, component/material specifications 5. Quality assurance specifications, installation procedure 6. Record any results of risk analysis and biocompatibility

test results Design Verification 1. Confirm that design output meets design input

requirements 2. Check the quality of design output at each stage 3. Conduct verification activities at all stages of design

process Design Validation 1. Check that the device fit the users’ needs 2. Clinical evaluation is necessary to validate the

effectiveness and safety of the device 3. Address product packaging and labeling Design Transfer 1. Ensure that the design effectively communicates to

manufacturers the final design and meets production specifications

2. Document and validate any design changes.

Documentation is one of the main keys to a successful design process. Everything from the early ideas to the final design changes should be noted for future reference. Another main key is to keep the users’ needs in mind throughout the process while maintaining FDA regulations. Designing a medical device properly is certainly the most important component to the process, but the next important step is marketing the product. Marketing the product can be just as difficult as the design process, but following these steps may make the process more clear. Premarket Requirements 1. Labeling: Must have printed writing on immediate

container of product 2. Registration: Register the company developing the

product 3. Listing: List the type of device with the FDA Marketing Application 1. 510k Application

• Introduce device for the first time into the market

• Propose a different use for a device that is already on the market

• Modify marketed device 2. Pre-Market Approval (PMA) Application

• Complete for Class III devices Post-market Requirements 1. Quality Check

• Device manufacturing will be regularly checked to follow guidelines on design, packaging, labeling, and manufacture

2. Device Reporting

• The company must notify the FDA of any device malfunctions, fatalities, or other incidents involving their product

The key to successful marketing of a medical device is to first follow all guidelines and regulations required by the FDA and maintain good relations even after marketing clearance is approved. All these steps, though, would need a large team to keep track of all aspects of device design and product marketing, so maintaining communication between all members will make the process smooth and save time. For more information, the FDA website has detailed instructions for each step under the Medical Devices tab under Device Advice: Comprehensive Regulatory Assistance.

A Guide to the Design and Market of Medical DevicesA Guide to the Design and Market of Medical DevicesA Guide to the Design and Market of Medical DevicesA Guide to the Design and Market of Medical Devices

(Photo: Hyunjun Fred Woo)