JACKSON MEDICAL
Successfully Guiding Medical Innovation
GCMI is proud to work in over 11 therapeutic areas and a wide array of medical products (Class I, II and III) including drugs and biologics. Below are some of the projects that we have had the pleasure to be a part of and further information on what roles we played in its development and to what result.
Please contact us today if you have any questions or are a physician innovator or engineer with an idea for a new device.
GloShield™ - Jackson Medical
The Unmet Need
Overheating lighting instruments coupled with human error are a leading cause of intra-operative fires and patient burns. The healthcare system refers to these as “never events.” Sadly, data indicates that they occur more than twice a day.
The Process
Jackson Medical Co-founders James Rains and Kamil Makhnejia were joined by Dr. Spencer Kozinn, a local Atlanta urologist, to create GloShield.™ In 2017, the GCMI Phase Zero Program paved a pathway for Jackson Medical to further develop the innovative technology that reduces dangerous thermal conditions in the operating room.
“GCMI helped to characterize our use need and the thermal environment, then prototyped solutions that met the more refined specifications,” says Rains. “We knew that we had an innovative concept and that there is nothing like GloShield currently on the market, but needed to ensure that we were taking the correct steps that would help us reach commercialization in a timely and cost-efficient manner.”
For Jackson Medical, GCMI’s Phase Zero program developed intellectual properties and a functioning prototype as well as guidance on next steps in the pathway from concept to commercialization.
The Results
GloShield is a reliable solution that reduces the risk of fires and burns in the operating room attributed to fiber-optic light cables. With seamless implementation onto existing cables, GloShield limits “never events” and prevents thermal injury.
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SALDANA RESEARCH GROUP & GEORGIA TECH
PPE Face Shields
PPE Face Shields - Saldana Research Group & Georgia Tech
Unmet Need
In early 2020, U.S. frontline healthcare workers were in desperate need of personal protective equipment (PPE) as Covid-19 began to ravage the country and its healthcare system.
By March 13, Christopher Saldana, Ph.D., associate professor of manufacturing at Georgia Tech and his mechanical engineering students and colleagues were already working on challenges and solutions for PPE for frontline healthcare workers.
Chris’ team needed a scalable, final design capable of transitioning to large scale manufacturing to meet the end users’ urgent needs for PPE face shields.
Our Process
Thanks to the close knit medtech innovation ecosystem in Georgia, Sherry Farrugia and Joanna Newton, MD, connected Christopher and his team with GCMI.
The GCMI / Saldana Research Group / Georgia Tech team went into ‘all hands on deck’ startup mode to rapidly design, prototype and iterate. Chris’ team used their fabrication facility to produce the face shield prototypes. GCMI documented clinical feedback, functionality and traceable document specificity. GCMI helped the team understand the use case in the hospital setting as well as requirements for large scale manufacturing. We helped guide Saldana’s team’s prototyping because manufacturers need specific details on manufacturing allowances and tolerances to deliver the product the frontline clinicians need.
Results
The collaboration produced the final designs including documentation and regulation considerations to enable manufacturing partners to produce the face shields and begin distribution to the front line providers and hospitals.
To date, more than 2 million PPE face shields have been delivered to front line healthcare workers across the country. The team made the designs freely available to all, so others like KIA have been manufacturing face shields using the Saldana design and GCMI specifications for use under EUA. The project earned a Georgia Bio 2021 Golden Helix Award for Innovation.
Face Shield Prototype – Rigid
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NFANT LABS
NeoNatal Feeding System
ProgenaMatrix™ - Cell Constructs
The Problem
In the United States, up to 70% of infants born prematurely and 10% of infants born full term have trouble transitioning to breast or bottle feeding on their own; infant feeding complications are one of the leading causes of delay in discharge from the NICU. Furthermore, infants that don’t reach feeding independence are at risk for returning to the NICU.
The Solution
NFANT Labs has created a device that tracks infant progress in feeding. nfant® Feeding Solution is a system that provides data to help clinicians guide premature infants to a safe and healthy transition to independent feeding. The sensor, which connects to standard nipples and bottles, feeds data instantly to the clinician’s tablet, allowing them to see the impact of their therapies and tailor care for each infant.
It all started in a 10 x 10 cubicle at GCMI. ”The decision to move into GCMI’s space provided instant access to the right people and right services for the right price at the right time,” NFANT CEO Lou Malice said.
The Results
Ideation to FDA submission in 10 months. “If we worked with another design and development firm, we wouldn’t have had the flexibility to do what we needed to do in the time frame we set,” Malice said. “The GCMI team always delivered and their sensitivity to time and budget allowed us to take our device from ideation to FDA submission in 10 months.”
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DR. SCOTT HOLLISTER, CHILDRENS HEALTHCARE OF ATLANTA
First 3D Printed Pediatric Tracheal Implant
ProgenaMatrix™ - Cell Constructs
The Problem
A 7-month-old boy battling congenital heart disease and tracheo-bronchomalacia, a condition that causes severe life-threatening airway obstruction. During his six-month inpatient stay in the Pediatric Intensive Care Unit, he experienced frequent episodes of airway collapse that could not be corrected by typical surgery protocols. The clinical team proposed surgically inserting an experimental 3D-printed tracheal splint to open his airways and expand the trachea and bronchus.
The Solution
Scott Hollister, Ph.D., who holds the Patsy and Alan Dorris Endowed Chair in Pediatric Technology, a joint initiative supported by Georgia Tech and Children’s Healthcare of Atlanta, developed the process for creating the tracheal splint using 3D printing technology at University of Michigan C.S. Mott Children’s Hospital prior to joining Georgia Tech. The Children’s procedure was the 15th time a 3D-printed tracheal splint was placed in a pediatric patient.
GCMI provided the business, administrative and quality support necessary to move Dr. Hollister’s technology from research to the clinic. There are always challenges in moving new technology in the lab into products in the market where it can benefit society. Our collaborative approach helps bring diverse groups of stakeholders together towards a common purpose – to help improve the lives of others.
The Results
In a complex 10-hour surgery, Children’s cross-functional team of surgeons successfully placed three 3D-printed splints around the patient’s trachea on the morning of August 17, 2018. The splints will eventually be absorbed into the body, allowing for expansion of the trachea and bronchus.
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EMORY CHILDREN’S PEDIATRIC RESEARCH CENTER / GEORGIA TECH BME
Re-expressing Pacemaking Cells for Cardiac Arrhythmia in Pediatric Patients
SIRA™ RFA Electrosurgical Device - Innoblative
The Problem
Children, especially newborns’ and infants’, heart rates are much faster than adults because their physiological needs are much higher. When a pacemaker is needed, the battery drains much faster. For congenital heart disease, patients require two to three high risk surgeries to replace the device to survive. Additionally, pacemaker wires can come off and break in small children who move around a great deal.
The Solution
By delivering a single gene, Dr. Cho’s technology can convert heart muscle into autonomously functioning pacemaker cells like the precious few ones we are born with that do not regenerate on their own. The research team have developed the technology to regenerate the pacemaking tissue with a single injection of a key gene.
The Results
“Our confidence in the data generated by our in vivo studies with T3 Labs cannot be greater,” Dr. Cho said. “The quality of the data leaves no uncertainty and a painstaking review of the 30–day continuous ECG data by two cardiologists has revealed no dangerous arrhythmias or safety concerns in the subject animals. The quality control and confidence in the data cannot be greater because those cardiologists reviewed the data bit by bit. It took seven months.”
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GEORGIA TECH BME FALL 2021 CAPSTONE: TEAM FIVE OF HEARTS
A Safer Way to Conduct Pericardiocentesis
SIRA™ RFA Electrosurgical Device - Innoblative
The Problem
Heart disease, Viral infections, autoimmune diseases, and cancer can all cause excess fluid to fill the pericardial sac. Physicians frequently perform “pericardiocentesis” by inserting a large 18-gauge needle through the patient’s chest and into the pericardial space to drain this fluid. Unfortunately, the needle can unintentionally perforate the vascular heart in up to 50% of these procedures, and 1 in 4 people die due to this complication.
The Solution
Team Five of Hearts devised the SafeCentesis, a device with a novel, half-coiled tip for parallel entry into the pericardium intending to allow physicians to more safely access and drain the pericardial space by entering the pericardium by no more than 1cm.
The Results
“In our tests supported by GCMI and T3 Labs, we found our device reduces pericardial entry depth by over three times less compared to currently available technologies including the 18 gauge needles on the market,” Lauren said. “This allows significantly more control over the depth of entry into the pericardial sac.”
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