Meet the Finalists:

Access4Kids: an assistive input device for tablet accessibility for children with motor impairments by Ayanna M. Howard, PhD, Hae Won Park, & Giancarlo Valentin of Georgia Tech was awarded $25,000

Self-Monitoring Shunt for Hydrocephaelus by Gina Helms of UGA and Marilyn Wolf, PhD of Georgia Tech was awarded $2,500

Development of a novel, continuous and contact-free infant monitoring system to predict and prevent postnatal cardiac and respiratory morbidity and mortality without the utilization of leads, cuffs, electrodes or other attachments to the body that can cause skin irritation by Robert Arkin, MA, JD of Sensiotec, Inc., Mary Ann Ingram, PhD of Georgia Tech, and Andrew Hardin of GTRI was awarded $5,000

AnemoCheck: a point-of-care, patient-operated, self-contained, disposable, diagnostic test for anemia by Erika Tyburski and Wilbur Lam, MD, PhD of Georgia Tech was awarded $50,000

CorMatrix ECM flat aortic valve that grows and remodels into native tissue by Anna Fallon, PhD and Robert Matheny, MD of CorMatrix Cardiovascular was awarded $10,000

Comparison of two vibrational cold source devices (Buzzy®) to standard care for relief of juvenile idiopathic arthritis injections by Amy Baxter, MD and Sampath Prahalad, MD of Emory Department of Pediatrics was awarded $10,000

SurTube: Insurance for Enteral Care by Kathryn Waitzman, RN of Cnicus, LLC and Brad Slaker of DesignWise Medical was awarded $25,000

smartBRACE: Compliance Monitoring Scoliosis Brace by Chris Hermann, PhD of Emory University,  Mike Schmitz, MD of Children's Healthcare of Atlanta, Russell McCrory, MSEE of GTRI,  Barbara Boyan, PhD of Georgia Tech, and Mark Holowka, MSPO, CPO of Children's Healthcare of Atlanta was awarded $25,000

The type of project sought for these awards is one where sufficient basic research has been done to indicate a technology has commercialization potential but a commitment to a commercialization path has not been made and a focused proof of concept study is required. The intent of the seed grant program is to develop a research initiative built upon strong collaborations between faculty at Georgia Tech and investigators at the GTRI.

There is no limitation on topics that can be addressed through this funding mechanism. However, successful applications must demonstrate that the problem to be studied is of significance to healthcare and that the project is translational. All applications were reviewed by TRIBES Review Committee, which was composed of clinicians, faculty, scientists and business experts.

Awards total $25,000-$40,000 direct costs per pilot project, available for one year.

2012 Competition Finalists

1. "A Sixty Minute Rapid Polymerase Chain Reaction Handheld (SMRPH)for Virus Detection in Children," PI: Craig R. Forest, PhD. Co-Investigators: Andi L. Shane, MD, MPH, MSC, and Brent Tillery, PhD.

2. "Wireless Device to Improve and Monitor Hand Sanitizer Compliance," PIs: Franklin Bost, MBA Russell McCrory, MSEE Co-Investigators: Christopher Hermann, MSME, Jana Stockwell, MD, FAAP, FCCM, and Kate Ellingson, PhD.

3. "Computational-based Optimization of Recombinant Therapeutic Uricase Production," PI: Eric Gaucher, PhD. Co-Investigators: Andrew Morris and David Landgren.

4. "Exploring Short-Range Intra-Body Communication Techniques with Very High Bandwidth for Wireless Ultrasonic Monitoring and Imaging Application," PIs: F. Levent Degertekin, PhD and Maysam Ghovanloo, PhD

With the complexity of modern medical devices, engineers from multiple disciplines (mechanical, biomedical, electrical, software, and human factors engineering, systems analysis and manufacturing) are often required to translate clinical needs into safe and effective commercial products for healthcare. The BioID master’s program will specifically address gaps in the crucial “bedside-to-bench-to-bedside” progression that identifies and connects unmet clinical needs with advances in science, biomaterials, processes and technology.

This program will prepare students from multiple undergraduate disciplines for careers in a wide range of medical specialties. Courses include: engineering design and development; FDA and ISO requirements; medical markets and clinical specialties; clinical practice/protocols, strategy and planning; finance and economics; product costing; justifications; project planning and management; ethics; socio-economic influences; and sustainability.

Georgia Tech BioID students will interact with healthcare industry experts and guest lecturers from areas such as clinical and surgical practices, engineering design and development, regulatory requirements, business planning, and commercialization. The program incorporates experience in healthcare environments, teamwork projects, and professional communications and will culminate in a master’s level clinical/medical team project.

“With an emphasis on cross-disciplinary coursework and relevant clinical experience, this program fills a distinct market demand for broadly educated professionals at the intersection of biomedical device engineering, healthcare, and business development,” said L. Franklin Bost, professor and executive director of the program. Bost’s background in both the medical device industry and biomedical design instruction brings a distinctive professional education and commercialization perspective to the program.

In 2012, U.S. News & World Report ranked Georgia Tech’s B.S. and Ph.D. biomedical engineering programs second in the nation. The BioID master’s program will build upon the strengths and global reputation of these existing programs, said Gilda Barabino, associate chair for graduate studies in the Coulter Department. “The BioID degree is a welcome and integral addition to our graduate programs. It is consistent with our collaborative and interdisciplinary culture for basic and translational research and provides specialized training for students seeking the best preparation to convert discoveries to the clinic to benefit patients,” she said.

Ideal candidates for the BioID master’s program include early-career professionals in medical device or biomedicine-related industries; engineers seeking medical device specialization; and high-performing graduates from engineering disciplines. Graduates of this intensive 12-month master’s program will be exceptionally well prepared to pursue and advance their careers in the dynamic field of biomedical device engineering, technology development and commercialization.

 For more information, please contact info@bioid.gatech.edu

To help companies evaluate baby boomers’ perceptions, use and acceptance of home health and wellness technologies, the Georgia Institute of Technology has launched HomeLab. HomeLab is a statewide network of adults 50 years of age and older recruited to evaluate the in-home usability and effectiveness of consumer products designed for the aging adult population.

HomeLab currently consists of 100 homes distributed throughout the state of Georgia; the network is expected to grow to 150 homes later this year and 550 homes by 2014.

“My wife and I are in generally good health and are interested in assisting homebound citizens by evaluating new innovations for their independent living. We want to be part of the solution for this excellent challenge,” said Ivan Cottrell. Cottrell signed up to be a HomeLab participant with his wife, Judy, who was a home health nurse in Florida and witnessed many seniors struggling to stay in their own homes.

The HomeLab infrastructure lessens the burden for companies that need to find participants 50 years of age and older for extended in-home product testing. Because Georgia Tech collects detailed information about each HomeLab participant’s health and home up front, individuals can be rapidly recruited for targeted short- and long-term product testing.

“HomeLab provides an efficient means for companies to limit the cost of extensive user testing that is required to bring a product to market,” said Brad Fain, director of HomeLab and a principal research scientist in the Georgia Tech Research Institute (GTRI). “Evaluation of a pre-market or mature technology by Georgia Tech’s HomeLab will provide a company with documented evidence for marketing, regulatory compliance and product design.”

GTRI has a history of helping companies evaluate and improve the design of consumer products and currently serves as the independent product testing organization for the U.S. Arthritis Foundation, the Arthritis Society of Canada and Arthritis Australia. If a product passes GTRI’s rigorous ease-of-use testing, the company that created the product can use the arthritis organization’s logo in its advertisements and on its packaging.

For this work, GTRI recruits users to test a variety of consumer products -- medicine bottles, beverage containers, office supplies, medical devices, vehicles and cell phones -- in its Accessibility Evaluation Facility for at most a few hours.

With the launch of HomeLab, GTRI will expand its product testing program to include extended in-home product evaluations, which will range from one month to one year in duration and involve 25 to 125 participants who are compensated for their time. HomeLab will provide companies with product design support, early product testing, and formal usability and effectiveness evaluations.

“It is important that companies obtain consumer feedback on products as early as possible in the design process and HomeLab can facilitate an early connection with target populations to evaluate design concepts or early prototypes,” noted Fain.

If your company has a health-related product it would like to test using the HomeLab network, or if you’re 50 years or older, live in the Atlanta area or surrounding communities, and are interested in participating in this program, please visit http://homelab.gtri.gatech.edu. 

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Best Oral Presentation for Translational/Basic Science Research:

Keri Stalun- Medical Student from Emory University

Amy Hutchinson’s Laboratory

Presenting “The Handy Eye Chart^TM: A New Visual Acuity Test for Children”

Best Oral Presentation for Clinical Research:

Sarah Hill- Pediatric Surgery Research Fellow at Emory University and Children’s Healthcare of Atlanta

Mark Wulkan’s Laboratory

Presenting “Cardiaplication as an Antireflux Procedure for Infants: A Proof of Concept in a Porcine Model”

Best Poster:

Rene Olivares-Navarrete - Senior Research Scientist at Georgia Institute of Technology

Barbara Boyan’s Laboratory

Presenting “Effects of Superhydrophobic Surface Modifications on Cell Response to Titanium and PTFE”

The keynote speaker, Dr. Robert M. Campbell, Jr., related his experiences in developing the Vertical Expandable Prosthetic Titanium Rib (VEPTR). Dr. Campbell emphasized the importance of patience in bringing a medical device to market, describing the different obstacles he faced during the process. He learned that the idea is often the easiest part of the development process.  

Dr. Campbell is a pediatric orthopaedic surgeon and Professor of Orthopaedic Surgery at Children’s Hospital of Philadelphia and is esteemed for his role in inventing the VEPTR. VEPTR is used to prevent and treat deformities resulting from rare diseases of the spine and chest wall, through surgical expansion of the chest and correction of spinal deformity, without inhibiting children’s growth. The titanium rib, approved by the FDA in 2004, has been introduced in more than 30 countries and is considered the gold standard for treating fragile pediatric patients with lung-restricting deformities. He has also published extensively on the thoracic and pulmonary disability of these patients and was the first to identify the disease Thoracic Insufficiency Syndrome (TIS).

The event was hosted by Barbara D. Boyan, Ph.D., Director of the Center for Pediatric Healthcare Technology Innovation and the Atlanta Pediatric Device Consortium and Associate Dean for Research and Innovation in the College of Engineering at the Georgia Institute of Technology; Mark Wulkan, M.D., Surgeon in Chief at Children’s Healthcare of Atlanta and Professor of Surgery and Pediatrics at Emory University School of Medicine; and George Raschbaum, M.D., Medical Staff President, Vice Chief of Surgical Outcomes Research and Assistant Professor at Emory University.

The 2nd Annual Pediatric Surgery and Technology Research Day was a great success. The group will continue this event, and is already planning the 3^rd Annual event to be held in June 2013.

To address this problem, a startup company based on technology developed at the Georgia Institute of Technology is creating an efficient, safe and repeatable delivery method that protects cells from death and migration from the treatment site. Using microbead technology developed in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, SpherIngenics is producing protective capsules for the delivery of cell-based therapies.

Supported by a broad range of Georgia Tech initiatives, the company recently received a two-year $730,000 Phase II Small Business Innovation Research (SBIR) grant from the U.S. Department of Defense to continue development of the technology.

“When damaged tissue is being repaired by a cell-based therapy, our microbead technology ensures that cells travel to and remain in the targeted area while maintaining continued viability,” said SpherIngenics CEO Franklin Bost, who is also a professor in the Coulter Department. “This technology has the potential to reduce the cost of treatment by eliminating the need for multiple therapeutic procedures.”

Bost and Coulter Department Professors Barbara Boyan and Zvi Schwartz founded the company in 2007. They worked with the Georgia Tech Research Corporation to license five patents from Boyan’s lab for technology originally developed in the Georgia Tech/Emory Center for the Engineering of Living Tissue (GTEC), which was funded by a grant from the National Science Foundation. Then they secured $450,000, which included a Phase I SBIR grant from the U.S. Department of Defense and grants from the Georgia Research Alliance and the Coulter Foundation.

During Phase I of the SBIR grant, the researchers confirmed that as many as 250 human adult stem cells could remain viable in culture if they were encapsulated in a 200-micron-diameter bead made of natural algae materials and that they could release factors that enhance tissue regeneration.

“For the Phase II SBIR grant, we’re going to examine whether delivering microbeads full of stem cells can enhance cartilage repair and regeneration of craniofacial defects in an animal model,” said Boyan, who is the company’s chief scientific officer. Boyan is also the associate dean for research and innovation in the Georgia Tech College of Engineering, the Price Gilbert, Jr. Chair in Tissue Engineering at Georgia Tech, and a Georgia Research Alliance Eminent Scholar.

The company will perform this research in its laboratory space located in the Advanced Technology Development Center (ATDC) biosciences incubator.

The company’s ultimate goal is to commercialize the microbead technology for use in hospitals and by cell therapy companies. To help reach this goal, a group of students wrote a business plan for SpherIngenics last year through the Georgia Tech Scheller College of Business Technological Innovation: Generating Economic Results (TI:GER) program.

The team -- which included Coulter Department doctoral student Christopher Lee, Georgia Tech MBA students Chris Palazzola and Eric Diersen, and Emory University law students Bryan Stewart and Natalie Dana -- won third place in the 2011 Georgia Tech Business Plan Competition. The competition, while largely an education experience, provided students an opportunity to develop their venture ideas and present them to a panel of highly experienced judges in the venture capital, technology transfer and legal fields.

“The TI:GER team’s business plan helped us learn about where the market for our technology is right now and where it is going in the future, which is extremely valuable knowledge as we work toward determining the most promising pathway to market,” said Bost.

Additional members of the company include Anthony Nicolini, the principal investigator on the Phase II SBIR grant, and Joseph Williams, clinical director of craniofacial plastic surgery at Children’s Healthcare of Atlanta at Scottish Rite and clinical assistant professor in the Department of Plastic and Reconstructive Surgery at Emory University.

Research reported in this publication was supported by the U.S. Army Medical Research and Materiel Command under award numbers W81XWH-07-1-0219 and W81XWH-11-C-0071. The content is solely the responsibility of the principal investigators and does not necessarily represent the official views of the U.S. Government.

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In addition, Dr. Phelps provides clinical input into safety and regulatory interactions and assists with the development of global collaborations that integrate broad medical, scientific, and commercial concepts into the program. These efforts are designed to shepherd the transition of viable ideas into useable products across and between the fields of medicine, technology and science.

“We are excited to have someone of Dr. Phelps’ broad clinical expertise as part of our leadership team” said Barbara Boyan, Executive Director of TRIBES and the Price Gilbert, Jr. Chair in Tissue Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory and Associate Dean for Research and Innovation for Georgia Tech’s College of Engineering.

In addition to his role as TRIBES Medical Director, Dr. Phelps serves as the Director of Health Systems Technology Research and Development at the Georgia Tech Research Institute where he manages and facilitates health-related technological synergies internally and externally.

Dr. Phelps retired in March 2011 from the U. S. Army with over 30 years of total active federal service. He started in the military as a Special Forces Senior Non-Commissioned Officer.  Following his commission, he completed medical school and residency and retired as a Lieutenant Colonel in the Medical Corps.  His duties included planning, supporting, and/or directing numerous Department of Defense research and development projects totaling over $150 million. 

Widely regarded as an expert on a variety of special operations/operational medicine, injury biomechanics and wilderness medicine topics, he currently focuses on research into the cause, prevention, and development of applied solutions to human injury. He is certified as both a Senior U.S. Army and U.S. Navy Flight Surgeon/Aerospace Medicine physician, and is a distinguished Fellow of the American Academy of Family Physicians.

The Translational Research Institute for Biomedical Engineering and Science (TRIBES) links biomedical research and educational activities at Georgia Tech with key medical institutions and organizations for the benefit of diagnosis and treatment of patients in the healthcare system. TRIBES provides critical capabilities to pre-commercial engineering development activities for the license and transition of technology into industry.

TRIBES is part of the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University and includes three centers directed by Boyan – the Center for Advanced Bioengineering for Soldier Survivability, the Center for Pediatric Healthcare Technology Innovation and the Atlanta Pediatric Device Consortium.

During her visit in February, Boyan met with several congressmen, urging them to reauthorize “The Pediatric Medical Device Safety and Improvement Act." The law provides grants to fund non-profit pediatric device consortia, such as the Atlanta Pediatric Device Consortium. The grants connect scientists and innovators with device manufacturers, providing them financial resources and regulatory guidance needed to advance the development of devices for children.

“The funding from the FDA has opened many doors and some of our small companies have been able to secure venture capital funding to pursue these devices,” Boyan said.

One of three FDA-sponsored consortia awarded last year, the Atlanta Pediatric Device Consortium is a partnership between Georgia Tech, Children’s Healthcare of Atlanta and Emory University.

The Atlanta Pediatric Consortium provides assistance with engineering design, prototype development, pre-clinical and clinical studies and commercialization for novel pediatric medical devices. It is currently composed of nine projects, three main projects and six pilot projects, which were incorporated from the first Pediatric Device Competition.

“This consortium has brought excitement to the Atlanta Community and strengthened our research partnerships to develop the future of pediatric medical devices,” Boyan said.

Passed in 2007, “The Pediatric Medical Device Safety and Improvement Act" includes important incentives that promote the development of medical devices for children, which currently lags five to 10 years behind those for adults. Significant barriers to pediatric device development exist, including physiological differences in pediatric patients and challenges with recruiting pediatric participants for clinical trial. The law helps to support the creation of more pediatric devices, with 107 device projects developed during the program’s first two years, according to a report by the General Accounting Office.

Boyan was accompanied to D.C. by consortium co-directors Kevin Maher, MD, a cardiologist and researcher specializing in pediatrics with appointments at the Children’s Healthcare of Atlanta Sibley Heart Center and Emory University and Wilbur Lam, MD, PhD, a pediatric hematologist/oncologist and bioengineer with appointments at Emory, the Aflac Cancer Center of Children’s Healthcare of Atlanta and Georgia Tech.

Team MAID is composed of seniors Alex Cooper, Elizabeth Flanagan, Shawna Hagen and Jacob Thompson.  Their plan and presentation won first place in the Undergraduate Competition, 1st Place in the Overall Competition, Most Commercializable Plan and the Alumni Award in the poster session for total winnings of $42,500.

Their win represents the first time a team of undergraduates has won the overall competition, which draws undergraduate and graduate students from across Georgia Tech. The Business Plan Competition is organized annually by Georgia Tech’s College of Management.

MAID is a simplified approach to intubation that utilizes magnets to guide the endotracheal tube into the airway of a patient easily and quickly, with less risk and without the need for visualization. MAID has two components: the single-use magnetic stylet and the reusable guide magnet. The external guide magnet is placed above the cricoid cartilage of the patient. When the endotracheal tube with the magnetic stylet is inserted into the patient’s mouth, it is pulled directly into the airway by the guide magnet, resulting in near effortless intubation.

Last year the team MAID also won second place in Georgia Tech’s InVenture Prize competition, winning $10,000 cash and a patent application by the Office of Technology Licensing. In summer 2011, the Translational Research Institute for Biomedical Engineering & Science awarded the team a seed grant of $25,000 to for further prototype development of the device.

The Saint Joseph Translation Research Institute has tested their functioning prototype on multiple human cadavers with considerable success. The Office of Technology Licensing filed a full non-provisional patent in March 2012. Currently, additional design work is being conducted to improve manufacturability and reliability. The MAID design concept to improve the safety and effectiveness of the intubation procedure began as a team design project in BMED 2300, Projects in Biomedical Engineering. Franklin Bost, Professor of the Practice in biomedical engineering, and Leanne West at the Georgia Tech Research Institute, continue to advise the MAID team.

Kevin Lewis, another biomedical engineering student, whose plan for “Cold Crate” came in third in the Undergraduate Track of the Business Plan competition. Graduate student Melissa Li was a finalist for her team’s CARDIAM device and the winner of a $10,000 services package for Most Innovative Technology.  The CARDIAM Team was also a co-winner in the Elevator Pitch Competition.

Written by Adrianne Proeller, Wallace H. Coulter Dept. of Biomedical Engineering.

“It was amazing,” said Re-Hand team member Daphne Vincent, who graduated in December of 2011 with a degree in biomedical engineering. “We are so excited. We now have our first investment and we will be able to get our invention into the hands of the people that really need it.”

As the winner, Re-Hand received a cash prize of $15,000, a free U.S. patent filing by Georgia Tech’s Office of Technology Licensing (valued at approximately $20,000) and automatic acceptance to the 2012 class of Flashpoint, a Georgia Tech startup accelerator program.

Vincent’s team included three other biomedical engineering majors: Alkindi Kibria, Elizabeth LeMar and Kunal Dean MacDonald.

“The competition was nerve-racking, exhilarating and thrilling,” said Vincent “We worked really hard over the last year and especially over the past two months. We have had so many crazy times and late nights, but it finally paid off.”

Matthew Stoddard, an industrial design major, and Christopher Vollo, an electrical engineering major, finished in second place with their invention Stylii, an extraordinarily precise and pressure-sensitive capacitive stylus designed for use on the iPad.

Second place also receives a free U.S. patent filing by Georgia Tech, and automatic acceptance into Flashpoint, along with a $10,000 cash prize.

“The patent will help us out so much and we’re excited about anything that will help us get this to market,” said Stoddard. “With the right connections and the right progress, it (the Stylii) will be on market by Christmas.”

CardiacTech, a chest retractor for bypass surgery, won the People’s Choice award, which comes with a $5,000 cash prize.

Mechanical engineering students Benji Hoover and Josh DeVane and biomedical engineering students Kevin Parsons, Matthew Lee and Priya Patil made up the CardiacTech team.

“Overall, we’re pretty happy with the People’s Choice Award,” said Hoover. “We would have loved to get a patent, but we are going to continue to work on getting our FDA clearance so we can get this thing into surgery.”

Therewere 15 projects presented at the event, ranging from cranial deformationrestructuring, heart valves, medicine administering kazoo to a handy eye-chart.The review committee was composed of entrepreneurs, clinicians, scientists,industry representatives who selected the eight projects that will be passed toround two. The selected projects will be submitting a 5 page proposal andhaving a one-on-one interview with the review committee. The event endedsuccessfully with over 70 in attendance and many interesting, innovativeproposals introduced.

Thepurpose of the Pediatric Device Competition is to target project ideas that canbenefit from the product development pathway of the APDC to design, to develop,and to commercialize new devices for the pediatric population in hopes ofenhancing the lives of children through the development of novel pediatricmedical devices, which are both safe and effective

Awardsfrom $25,000 to $50,000 will be made depending on the complexity of the deviceand its development stage.  APDC expectsto make 3 to 5 project awards in 2012.

APDCwas launched this September with a two-year, $1.8 million grant from the Foodand Drug Administration (FDA) to encourage the development of medical devicestailored to the needs of children, with the plan of taking the devices fromconception to commercialization.

ThePediatric Device Competition will provide a competitive opportunity for theAtlanta scientific and business community to develop a pediatric medical deviceconcept benefitting from the expertise and infrastructure of the APDC. Withinstitutions like the APDC, innovators and more, the future of pediatricmedical devices looks bright.

Round 2 Finalists:

Handy Eye Chart, Amy Hutchinson

Bedside Diagnosis of Pneumonia in Children, David Ku

Biosorb, Jack Merritt

Pediatric Ventricular Assist Device, Kevin Maher

Hand Sanitizer, Christopher Hermann

Buzzy, Amy Baxter

Wireless Signaling Device to Treat Invontinence in Children, Greg Durgin

Prosthetic Trileaflet Valve, Anna Fallon

Hostedby the Atlanta Pediatric Device Consortium (APDC), the event will give outthree to five awards ranging from $25,000 to $50,000 depending on the deviceand its stage of development. Devices should be targeted to the pediatricpopulation and will be divided into four age groups, ranging from birth to age21.

Applicantsshould email two-page proposals for their devices by Tuesday, Nov. 1, at 3 p.m.to Maribel Baker in the Department of Biomedical Engineering. Moreinformation, including submission guidelines, is available at www.tribes.gatech.edu/compete. Submissions are welcome from all faculty, entrepreneurs, clinicians,fellows, residents and students from any of the APDC institutions (consistingof Georgia Tech, Emory University, Saint Joseph Translation Research Instituteand Children’s Healthcare of Atlanta).

Those interested in attending butnot submitting entries may RSVP to the event online. The competition is free toattend, includes a complimentary breakfast and will take place at the PetitInstitute of Bioengineering and Biosciences (IBB) Building.

APDCwas launched this month with a two-year, $1.8 million grant from the Food andDrug Administration (FDA) to encourage the development of medical devicestailored to the needs of children, with the plan of taking the devices fromconception to commercialization.

 The consortium will provide assistance with engineering design, prototype development, pre-clinical and clinical studies and commercialization for novel pediatric medical devices.

Technologies are already underway to be investigated and include:

• A Smartphone attachment designed for at-home ear examinations:
• A renal dialysis device; and
• A gel designed to delay the re-fusion of a child's skull bones after surgery for craniosynostosis

Consortium Leadership

Barbara D. Boyan Ph.D., Director

Kevin Maher, a cardiologist and researcher at Children’s Healthcare of Atlanta SIbley Heart Center and Emory University will co-direct along with WIlbur Lam, pediatric hematologists/oncologist and bioengineer at Emory, the Aflac Cancer Center of Children's Healthcare of Atlanta and Georgia tech.

Additional Leadership roles by Franklin Bost, professor of the practice and director of design instruction in the Coulter Department here at Georgia Tech and David Ku, Regents professor, Georgia Tech School of Mechanical Engineering and College of Management, Emory's Department of Surgery; and Nicholas Chronos, president of SJTRI.

To read the full article on Georgia Tech Research News click here

These are exciting times for the advancement of medical technologies and devices for the  pediatric population, as well as innovative times for the Atlanta Pediatric Device Consortium, as it establishes itself in the southeastern hub of the U.S. as a one-of-a-kind facility making significant strides toward gains in pediatric care.

To read the full article featuring Chris Herman, Ph.D. by Vision Systems Design click here

Press releases related to the medical technologies and advancements of   the center can be found on various medical research websites, click on the names of the sources below to read the press release.

Futurity

GA Tech News Room

College of Engineering Georgia Tech News Room

Medical Express

Science Daily

"By developing, testing and refining medical devices specifically for children, we hope to produce safer, more effective devices that will improve their lives," said Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

The consortium will be led by Boyan, along with consortium co-directors Kevin Maher, a cardiologist and researcher specializing in pediatrics with appointments at the Children's Healthcare of Atlanta Sibley Heart Center and Emory University, and Wilbur Lam, a pediatric hematologist/oncologist and bioengineer with appointments at Emory, the Aflac Cancer Center of Children's Healthcare of Atlanta and Georgia Tech.

Historically, devices designed for adults have been used in children. However, differences in body size and immune system responses between adults and children, and the lack of appropriate models to assess how a device might function in a growing child, can result in poor device performance and responses that are less than optimal.

"There is little information as to what devices are working well for children and what complications occur," explained Boyan, who is also a Georgia Research Alliance Eminent Scholar. "In addition, the high cost of clinical trials for a small market like pediatrics has made conducting pediatric trials cost-prohibitive for many manufacturers."

The consortium will try to reduce these barriers by creating a product development pathway that will provide support for commercialization of devices for pediatric health care from initial concept to the completed product.

To do this, the consortium will build on partnerships the institutions have with the Georgia Tech Translational Research Institute for Biomedical Engineering and Science (TRIBES), which focuses on the need for engineering systems that result in commercial products; the Global Center for Medical Innovation (GCMI), which includes a prototyping design and development facility; and the Advanced Technology Development Center (ATDC) at Georgia Tech, a startup accelerator that helps Georgia technology entrepreneurs launch and build successful companies. Consortium institutions will also partner with SJTRI and the National Institutes of Health-sponsored Atlanta Clinical & Translational Science Institute (ACTSI) for pre-clinical, first-in-child testing and clinical assessments.

Additional consortium leadership will be provided by Franklin Bost, professor and director of design instruction in the Coulter Department; David Ku, a Regents professor with appointments in the Georgia Tech School of Mechanical Engineering and College of Management, and Emory's Department of Surgery; and Nicholas Chronos, president of SJTRI.

The consortium will provide assistance for pediatric medical devices from academic institutions and small businesses. The three technologies that will be investigated initially are:

• A smartphone attachment designed for at-home ear examinations;
• A renal dialysis device; and
• A gel designed to delay the re-fusion of a child’s skull bones after surgery for craniosynostosis.

The first innovation is the RemOtoscope -- a smartphone attachment designed by Lam for at-home ear examinations. Ear infections result in more than 15 million doctor office visits each year in the United States because diagnosing them requires direct observation of the child's eardrum and ear canal with a device called an otoscope. Lam envisions a physician remotely guiding placement of the device and diagnosing the condition via real-time video consultation with parents at home. The smartphone capabilities will also enable the transmission of other relevant clinical information to guide the physician in making the correct diagnosis.

The second device the consortium will bring into the pipeline is a renal dialysis device designed especially for children with kidney failure. There is currently no FDA-approved continuous bedside dialysis device for children. When critically ill children need kidney dialysis, doctors are forced to adapt adult-size dialysis equipment. These adapted adult devices can withdraw too much fluid from a pediatric patient, leading to dehydration, shock and loss of blood pressure. Matthew Paden, a pediatric critical care physician at Children's Healthcare of Atlanta and Emory realized this problem and has collaborated with Ajit Yoganathan, a Georgia Tech Regents professor and the Wallace H. Coulter Distinguished Faculty Chair in Biomedical Engineering, to develop the device.

The consortium will also investigate the development of a gel designed to delay the re-fusion of a child's skull bones after surgery for craniosynostosis. Craniosynostosis affects approximately one in every 2,500 babies in the United States and is caused by the premature closure of gaps between skull bones. The gel is being developed by Boyan; Joseph Williams, clinical director of craniofacial plastic surgery at Children's Healthcare of Atlanta and clinical assistant professor in the Department of Plastic and Reconstructive Surgery at Emory University; and Coulter Department M.D./Ph.D. student Chris Hermann, senior scientist Rene Olivares-Navarrete, visiting professor Zvi Schwartz and associate professor Niren Murthy.

Future projects will be selected through the consortium's seed grant competition, which will provide awards between $25,000 and $50,000 to inventors in the partnering institutions and the business community to develop a pediatric medical device through the consortium. Entries are due Nov. 1, 2011.

Additional devices will also be identified through technology development and commercialization programs, including the Coulter Department capstone design class, the TI:GER (Technological Innovation: Generating Economic Results) program in the Georgia Tech College of Management, Georgia Tech's comprehensive center for technology commercialization called VentureLab and the Goizeuta Business School at Emory.

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Writer: Abby Robinson

New research presented on June 16, 2011 at the annual meeting of the International Society for Stem Cell Research (ISSCR) shows that systematically controlling the local and global environments during stem cell development helps to effectively direct the process of differentiation. In the future, these findings could be used to develop manufacturing procedures for producing large quantities of stem cells for diagnostic and therapeutic applications. The research is sponsored by the National Science Foundation and the National Institutes of Health.

"Stem cells don't make any decisions in isolation; their decisions are spatially and temporally directed by biochemical and mechanical cues in their environment," said Todd McDevitt, director of the Stem Cell Engineering Center at Georgia Tech and an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. "We have designed systems that allow us to tightly control these properties during stem cell differentiation, but also give us the flexibility to introduce a new growth factor or shake the cells a little faster to see how changes like these affect the outcome."

These systems can also be used to compare the suitability of specific stem cell types for a particular use.

"We have developed several platforms that will allow us to conduct head-to-head studies with different kinds of stem cells to determine if one type of stem cell outperforms another type for a certain application," said McDevitt, who is also a Petit Faculty Fellow in the Institute for Bioengineering and Bioscience at Georgia Tech.

Many laboratory growth methods allow stem cells to aggregate in three-dimensional clumps called "embryoid bodies" during differentiation. McDevitt and biomedical engineering graduate student Andres Bratt-Leal incorporated biomaterial particles directly within these aggregates during their formation. They introduced microparticles made of gelatin, poly(lactic-co-glycolic acid) (PLGA) or agarose and tested their impact on the assembly, intercellular communication and morphogenesis of the stem cell aggregates under different conditions by varying the microsphere-to-cell ratio and the size of the microspheres.

The researchers found that the presence of the biomaterials alone modulated embryoid body differentiation, but did not adversely affect cell viability. Compared to typical delivery methods, providing differentiation factors -- retinoic acid, bone morphogenetic protein 4 (BMP4) and vascular endothelial growth factor (VEGF) -- via microparticles induced changes in the gene and protein expression patterns of the aggregates.

By including tiny magnetic particles into the embryoid bodies during formation, the researchers also found they could use a magnet to spatially control the location of an aggregate and its assembly with other aggregates. The magnetic particles remained entrapped within the aggregates for the duration of the experiments but did not adversely affect cell viability or differentiation.

"With biomaterial and magnetic microparticles, we are beginning to be able to recreate the types of complex geometric patterns seen during early development, which require multiple cues at the same time and the ability to spatially and temporally control their local presentation," noted McDevitt.

While microparticles can be used to control differentiation by regulating the local environment, other methods exist to control differentiation through the global environment. Experiments by McDevitt and biomedical engineering graduate student Melissa Kinney have demonstrated that modulating hydrodynamic conditions can dictate the morphology of cell aggregate formation and control the expression of differentiated phenotypic cell markers.

"Because bioreactors typically impose hydrodynamic forces on cells to cultivate large volumes of cells at high density, our use of hydrodynamics to control cell fate decisions represents a novel, yet simple, principle that could be used in the future for the scalable efficient production of stem cells," added McDevitt.

Technologies capable of being directly integrated into bioprocessing systems will be the best choice for manufacturing large batches of stem cells, he noted. In the future, the development of multi-scale techniques that combine different levels of control -- both local and global -- to regulate stem cell differentiation may help the translation of stem cells into viable clinical therapies.

This project is supported by the National Science Foundation (NSF) (Award No. CBET 0651739) and the National Institutes of Health (NIH) (R01GM088291). The content is solely the responsibility of the principal investigator and does not necessarily represent the official views of the NSF or NIH.

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Writer: Abby Robinson

The discussion detailed how stem cell therapies are advancingfrom research labs to clinical applications at a cautious but accelerated pace.The reason: stem cells serve as the body’s most promising treatment option asthey have the potential to develop into many different types of cells including: blood cells, nervecells and muscle cells. However, there are many facets to stem cells therapiesthat are still unclear.

Dr. McDevitt explained the importance of researching allaspects of stem cells to better understand the effects of the stem celltherapies being developed and more importantly which stem cells are best forthe job. Currently, the Department of Defense is using stem cell therapies totreat wounded soldiers and more research isbeing done to repair spinal cords and damage caused by traumatic braininjuries. He stressed that the unknowns of stem cell therapies are still being discoveredand further study is necessary to find the best stem cell treatment for eachspecific problem.

More about this news: http://mgt.gatech.edu/news_room/news/2011/articles/SpherIngenics.html

“When I was a kid, I was really skinny. To build up muscle, I would actually carry extra books in my bag,” explains Whaley, who earned his bachelor’s degree in mechanical engineering from Tech in 2010 and now leads the company Titin Tech. “So I started thinking, ‘Why couldn’t I just have clothing be weighted?’”

Titin Tech’s initial product is a weighted shirt that can be worn during workouts to build additional strength – or throughout the day for continual exercise. The shirt uses form-fitting gel pockets that keep the body cool while adding weight (six to 20 lbs).

Whaley had initially set his sights on the athletic market, but a life-threatening injury he suffered in mid-2009 expanded his vision for the product to include patients requiring physical rehabilitation. As he recovered from a gunshot wound to the chest suffered during an armed robbery, he realized that he could use the invention to aid his own healing process. “It was hard to lift my right side up after I came home from the hospital,” says Whaley, an amateur bodybuilder who lost a third of one lung from the shooting.

The patented shirt he developed recently became available for sale on the Titin Tech Website and orders are pouring in, Whaley says. Therefore, Titin Tech’s victory in the Most Fundable category might not seem so surprising. The award goes to the team deemed by judges to be most ready for the marketplace.

Intended as an educational exercise, the BPC attracts some participants who are simply interested in learning about the venture-creation process, while others know they are serious about developing real companies. Participation in the BPC is open to all Georgia Tech students and alumni of various degree programs who’ve graduated within the last five years.

In March 2010, during his last semester at Tech, Whaley won First Place and People's Choice in Georgia Tech’s InVenture Competition (an innovation contest not involving a business plan), receiving $20,000 total. The professional network and resources he’s gained through InVenture and the BPC have helped prepare him for success in the marketplace, he says.

First Place

In addition to the Most Fundable Award, the BPC also includes numerous other prizes. The Puribio team won First Place ($10,000) for its plan to market a hemodialysis machine for clinic, home and hospital treatments. Puribio also won the Most Innovative Award (a $10,000 service package).

Puribio’s technology is targeted at the growing number of people with kidney failure (more than a 100,000 cases a year). These patients typically must undergo treatment three times a week for three to five hours per session. Currently, only eight percent of dialysis is performed in patients’ homes. But Puribio could increase that percentage with its small, portable dialysis machine design. Other benefits would include less blood cell damage and the removal of more waste molecules than current technology, resulting in longer patient life.

Jane Kang, a doctoral student in mechanical engineering, has worked on this dialysis machine since starting the PhD program in 2008. To help develop a plan to market her technologies, BPC administrators helped her find MBA students Daniel Eyrich and Manish Gupta, who saw great potential in her work. Emory law student David Giannantonio, who holds bachelor's and master's degrees in biology (2006, 2008) from Tech, also joined the team.

Kang says that participation in the BPC, which includes a series of preparatory workshops leading up to the competition each spring, was of immense educational value and could help her bring the early-stage Puribio technology to market after she finishes the PhD program in a couple of years. “The feedback I received from judges was great and will help me attract potential investors.”

The Second Place winner ($3,000) was Boss Medical, which plans to market a new device to improve spinal fusion procedures. Third Place went to SpherIgenics ($2,000), which specializes in the delivery of biological therapies through the process of micro-encapsulation. In addition to Titin Tech, other finalists (who received $500 each) included Roadside Technologies, a system designed to warm roadside personnel of impending vehicular collisions; and Kiddie Collar, a drool-catching collar for babies that replaces a bib to prevent rashes and keep clothes dry. For a full list of winners, visit the Business Plan Competition site.

Thirty teams made it to the BPC semifinals. Judges for the different stages of the competition included numerous leaders in the corporate, venture capital, technology transfer, legal, and academic communities.

Sponsors included Georgia Tech College of Management, the Institute for Leadership and Entrepreneurship, MaRC Sustainable Design & Manufacturing, Tedd Munchak Chair in Entrepreneurship, Brook Byers Institute for Sustainable Systems, GREENGUARD Environmental Institute, Advanced Technology Development Center, Nelson Mullins Riley & Scarborough LLP, AuditMyBooks, Troutman Sanders, Gray Ghost Ventures, Delaney, HLB Gross Collins PC, Executive Entrepreneurs Society, and Bondurant Mixson & Elmore LLP.

Apica Cardiovascular has licensed the Georgia Tech/Emory technology and will further develop the system, which will make the transapical access and closure procedure required for delivering therapeutic devices to the heart more routine for all surgeons. The goal is to expand the use of surgery techniques that are less invasive and do not require stopping the heart.

"Our company has leveraged the expertise in cardiovascular technology at Georgia Tech and the clinical experience of surgeons at Emory University to develop a technology that has the potential to revolutionize the delivery of different types of medical devices to the heart, including aortic and mitral valves," said the company's CEO James Greene.

With research and development support from the Coulter Foundation Translational Research Program and the Georgia Research Alliance VentureLab program, the company has already completed a series of pre-clinical studies to test the functionality of the device and its biocompatibility.

The improved heart surgery system consists of a conduit with proprietary technology inside that allows the conduit to be securely attached to the beating heart. Surgeons can then deliver therapeutic devices, such as heart valves or left ventricular assist devices, into the beating heart without loss of blood or exposure to air. Once a therapeutic device has been delivered and surgery is complete, the company's system closes and seals the access site with a biocompatible implant. The closure site can be reopened if necessary.

"By minimizing the incision size to gain access to the beating heart and eliminating the need for conventional sutures, our system improves safety, decreases procedure time and reduces the technical challenges associated with these new minimally invasive procedures," explained Vinod Thourani, an associate professor of surgery and associate director of the Structural Heart Center in Emory University's Division of Cardiothoracic Surgery.

With the new investment from Ireland-based Seroba Kernel Life Sciences and Israel-based TriVentures, the company will continue to conduct research and pre-clinical trials in Atlanta, ultimately leading up to regulatory approval. These efforts will be led by Jorge H. Jimenez, the chief technology officer of the company, which is in the VentureLab process at ATDC, Georgia Tech’s startup company accelerator.

"Our goal is to accelerate and expand the adoption of less-invasive therapeutic procedures to a greater number of surgeons and as a result, many underserved patients will receive needed treatment for valve disease and end-stage heart failure," said Ajit Yoganathan, Regents professor and Wallace H. Coulter Distinguished Faculty Chair in Biomedical Engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

The startup will also have an office in Ireland, which will benefit from the strong research collaborations between Georgia Tech, Georgia Tech Ireland and the National University of Ireland, Galway.

"We seek to contribute to and benefit from a global innovation ecosystem in ways that accelerate research results to the market while enhancing economic development opportunities here in Georgia," said Stephen E. Cross, Georgia Tech's executive vice president for research. "Apica Cardiovascular is a perfect example of the synergy between our leading edge work in Atlanta, our Irish translational unit GT Ireland, and our partnership with the National University of Ireland, Galway."

Apica Cardiovascular was founded in 2009 based on technology invented by Jimenez, Thourani, Yoganathan and Thomas Vassiliades, who was an associate professor of cardiothoracic surgery at Emory University at the time. The company was named Emory University's Startup Company of 2010.

About ATDC:
The Advanced Technology Development Center (ATDC) is a startup accelerator that helps technology entrepreneurs in Georgia launch and build successful companies. Founded in 1980, ATDC has graduated more than 120 companies, which together have raised more than a billion dollars in outside financing. In 2010, ATDC was named to Forbes Magazine’s list of the “10 technology incubators that are changing the world.”

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Media Relations Contacts: Abby Robinson (abby@innovate.gatech.edu; 404-385-3364) or John Toon (jtoon@gatech.edu; 404-894-6986)

Writer: Abby Robinson

Maybe they could regrow the tissue: Grow the cartilage, grow the blood vessels, grow the nerves and even grow the bone.

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Ajit Yoganathan's Fontan Research Featured in Reuters Article:

Researchers at the Georgia Institute of Technology, collaborating with pediatric cardiologists and surgeons at The Children's Hospital of Philadelphia, have developed a tool for virtual surgery that allows heart surgeons to view the predicted effects of different surgical approaches. By manipulating three-dimensional cardiac magnetic resonance images of a patient's specific anatomy, physicians can compare how alternative approaches affect blood flow and expected outcomes, and can select the best approach for each patient before entering the operating room. "This tool helps us to get the best result for each patient," said co-author Mark A. Fogel, M.D., an associate professor of cardiology and radiology, and director of Cardiac MRI at The Children's Hospital of Philadelphia. "The team can assess the different surgical options to achieve the best blood flow and the optimum mixture of blood, so we can maximize the heart's energy efficiency."

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Organizers of the recently established Georgia Tech Center for Advanced Bioengineering for Soldier Survivability want to change that.

"The goal of the center is to rapidly move new technologies from the laboratory to patients so that we can improve the quality of life for our veterans as they return from the wars the United States is fighting," said center director Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

The center will leverage the expertise of Georgia Tech researchers in musculoskeletal biology and regenerative medicine to quickly move tools that are clinically valuable, safe and effective from laboratories to use in trauma centers. To reduce the amount of time from invention to clinical use, engineers and scientists in the center work in teams that include a clinician with experience in combat medical care and a medical device industry partner.

Support for the center is provided by the Armed Forces Institute of Regenerative Medicine, the U.S. Army Institute of Surgical Research's Orthopedic Trauma Research Program, the U.S. Department of Defense and industry.

Researchers in the center will initially focus on ways to improve the healing of wounds, segmental bone defects and massive soft tissue defects. Traumatic injuries that affect the arms, legs, head and neck require technologies for treatment at the time of injury and in the ensuing days and months.

"These combat injuries are complicated to treat because they are large and typically infected, so even determining when a soldier should be treated for optimal recovery is a challenge," said Boyan, who is also the associate dean for research in Georgia Tech's College of Engineering and a Georgia Research Alliance Eminent Scholar. "It is not known whether a regenerative therapy will be most effective if used immediately following injury or at some later time after scar tissue has been established at the wound site."

By developing models that accurately reflect the complex aspects of injuries sustained by soldiers in combat, the researchers will be able to test assumptions about when to employ specific strategies and how to ensure their effectiveness. The models must also allow them to examine the use of technologies on both male and female patients, and on complex tissues that consist of nerves, a blood supply and multiple cell types.

"Since the processes of bone, vascular and neural formation are naturally linked during normal tissue development, growth and repair, our approach is to harness this knowledge by developing delivery strategies that present the right biologic cues in the right place at the right time to promote functional regeneration of multiple integrated tissues," said associate director of the center Robert Guldberg, a professor in Georgia Tech's Woodruff School of Mechanical Engineering.

To enhance tissue repair and regeneration following a traumatic injury, the researchers are focusing their efforts on stem cells. Even though stem cells have tremendous potential for repairing such defects, effective methods do not yet exist for delivering them to an injury site and of ensuring that they survive and remain at that site long enough to impact the regeneration process.

"Clinicians currently inject stem cells into a vein and hope that the cells will migrate to sites of injury and remain at those sites long enough to participate in the repair process. While some cells certainly do migrate to injury sites, the actual percentage is very small and those that arrive at the site do not remain to engraft with the host tissue," explained Boyan.

This limited effect may be the result of the injection process, according to Boyan, so researchers in the center are developing ways to protect the cells from damaging forces they might encounter when inserted into the body.

"Studies in our laboratory have shown that when stem cells are encapsulated in microbeads, they can be injected by needle without loss of cell viability and they remain at the injury site for at least two months," said Boyan.

Protecting the cells during insertion is just the first step toward improved tissue repair. The researchers must also examine whether the stem cells will turn into cells typical of the implanted tissue and if they produce or should be paired with molecules that can enhance the healing of the implanted tissues.

Center researchers are also investigating whether bone marrow-derived stem cells can be used in the body to heal large defects in bone and cartilage if they are inserted in fiber mesh scaffolds and silk sponges during a surgical procedure.

Additional projects in the center include assessing tissue viability, preventing the growth of bone in the soft tissues of the body and improving pre-hospital care of orthopedic injuries. Since effective treatment of traumatic injuries is an important goal for the general public as well as the military population, the researchers also hope to adapt their technologies for use in hospitals.

Other researchers in the center include Ravi Bellamkonda, a professor in the Coulter Department; Andres Garcia, the Woodruff Faculty Fellow in the Woodruff School of Mechanical Engineering; Robert Taylor, a professor in the Coulter Department and Emory's Division of Cardiology; Zvi Schwartz, a visiting professor in the Coulter Department; and U.S. Army surgical medicine consultants Michael Yaszemski and David Cohen.

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Writer: Abby Vogel