SC invention provides a solution for reducing accidental needle sticks see more
Medical University of South Carolina neurophysiologist Jessica Barley, Ph.D., and neurologist Jonathan C. Edwards, M.D., noticed a clinical problem and decided to do something about it. The needle electrodes used to monitor a patient’s nervous system function during surgery can also pose a safety risk. Stranded uncapped needles can find their way into health care workers or even patients. Working with the Zucker Institute for Applied Neurosciences (ZIAN), an MUSC technology accelerator, and Rhythmlink International LLC, a medical device manufacturer headquartered in Columbia, South Carolina, the team created a novel safety electrode that has the potential to reduce needle sticks.
The electrode, known as the Guardian Needle, was recently approved by the U.S. Food and Drug Administration for intraoperative monitoring (IOM). The technology has been licensed to Rhythmlink, which is ramping up production for a rollout to hospitals nationwide this autumn.
“We thought it was unacceptable and unfair that the team providing the care to the patient should be put in harm's way by equipment that was meant to do the opposite and ensure patient safety,” said Barley, who runs the intraoperative neurophysiology program at MUSC Health and is co-inventor of the Guardian Needle. “This is how we first came up with the design.”
During high-risk surgical cases, the neurophysiology team uses IOM to monitor a patient’s nervous system. The process involves inserting approximately 40 needles throughout the patient’s body and connecting them with long wires to the IOM machine.
“IOM serves as a vital early warning system,” explained Barley. “It preserves neurologic function in real time.”
However, the setup increases the risk of needle dislocation. Currently available needles can become uncapped when dislodged from the patient’s skin. This results in a danger of needles sticking the staff while in the operating room (OR).
“We don't have to accept that a certain number of our staff are going to get stuck by an IOM needle,” said Edwards, chief of the Integrated Centers of Clinical Excellence in Neuroscience at MUSC Health and co-inventor of the Guardian Needle. “That's a problem, and it's our responsibility as people in the field to solve it.”
The Guardian Needle should protect the surgical team from harm because it is never uncapped. It was designed to deploy the electrode safely only when inserted in the patient. If the needle is dislodged from the skin, it automatically resheathes into its protective casing.
“The key thing is that you don't have to cap and uncap the needle, and it automatically retracts when it's not in the patient,” said Paul Asper, vice president of commercialization at ZIAN.
The design also includes adhesive bandages around the needles. The adhesives enable the team to secure needles to the patient without manually taping them, thus decreasing OR time and cost. The bandage, like the needle electrode, is sterile, which reduces the risk of infection from nonsterile tape.
“We did timed trials,” said Barley. “Just trying the full setup the very first time using the new design, we were all faster,” she said, comparing the new needles with the needles they had used before.
Not only does the Guardian Needle protect the surgical team and decrease OR time, but it also enables better patient care by reducing the risk of needle sticks to patients and helping to maintain a sterile environment.
The adhesives on the needle also secure it in place despite shifts in patient positioning. The adhesives thus ensure signal integrity as the electrodes monitor nervous system function during surgery.
The clinician-innovators were able to come up with the clever design because they were personally familiar with the clinical problem they were trying to address.
“Clinicians have great ideas all the time,” said Edwards. “But 99% of those ideas die, mostly because we don’t have time.”
Enter ZIAN, with the expertise, knowledge and resources to turn an idea into a product. In the case of the Guardian Needle, the ZIAN team developed a business plan and patent strategy, raised funding for research and development, engineered the prototype and forged a licensing agreement with a world-class medical device company, saving valuable time for the busy clinicians.
“The expertise on the ZIAN team aligns perfectly with the clinical expertise of the inventors, enabling both parties to execute on their strengths,” explained Mark Semler, CEO of ZIAN. The core mission of ZIAN is to develop and bring to market technologies that solve unmet clinical needs.
“We have that clinical perspective to create a pipeline of ideas,” said Edwards. “ZIAN provides the practical implementation of those ideas, and neither of those two would be successful without the other.”
Rhythmlink, a South Carolina-based company specializing in medical devices that record or elicit neurophysiologic biopotentials, has licensed the technology and has begun to ramp up production of the Guardian Needle. Their unique position in the industry allowed them to recognize the importance of this invention. That, combined with their contribution to the intellectual property, design enhancements for manufacturing and expertise in regulatory guidelines, helped the product become a reality.
“This is a great example of South Carolina organizations collaborating in the health care space and an illustration of South Carolina’s prowess in innovation, entrepreneurship, life sciences and manufacturing,” said Shawn Regan, co-founder and chief executive officer of Rhythmlink. “Creating a safer work environment for health care professionals absolutely aligns with our mission to improve patient care. Working with ZIAN and MUSC to develop the Guardian Needle and bring this creation to life was a no-brainer from a collaboration standpoint.”
Successful commercialization of the product and the widespread distribution that Rhythmlink can provide are key to realizing a potentially industry-changing standard of care. As the novel electrode is rolled out in hospitals across the country, researchers will collect needle-stick data to determine whether it is safer than the current standard of care. If it is safer, as its inventors believe, it would likely become the new standard of care, given federal workplace safety rules.
“Being at the forefront of an innovative and potentially industry-changing movement is exciting and exactly where we strive to be,” said Regan.
To the inventors, the Guardian Needle provided a way to make a difference not only for their MUSC Health colleagues but also for surgical team members across the globe.
“In health care, we gladly and eagerly place ourselves at risk every day when we're caring for others. But it does have an element of stress and anxiety,” said Barley. “This invention is particularly special because we're not only caring for our patients in a safer, higher-quality way, we're also protecting our colleagues and teammates. It feels like a way of giving back to them and keeping them safe.”
Edwards explained that it is this type of innovation that has enabled him to help patients and health care providers he will never meet. This he considers a benefit of practicing academic medicine.
“We always think of clinical practice, teaching and research as the three pillars of medicine,” he explained. “There's a fourth pillar, and that fourth pillar is innovation.”
Innovation has led this MUSC team to create a solution for a once-tolerated problem. They encourage other clinicians to do the same.
“Take obstacles as an opportunity to find the solution yourself,” encouraged Barley.
Blue Eye Soft launches AI-driven imaging software see more
Blue Eye Soft, an innovative IT-solutions and software development company, announced that it has received acknowledgment from the U.S. Food and Drug Administration (FDA) of its pre-submission package for its proprietary artificial intelligence (AI)-driven medical imaging software, BluedocaiTM, to assist with the medical diagnosis of diseases such as COVID-19, said a press release issued by the company.
BluedocaiTM is a clinical decision support tool that uses AI-driven deep learning algorithms to assist radiologists and other healthcare professionals with fast and accurate diagnosis of diseases, such as COVID-19. BluedocaiTM has the capability to rapidly analyze chest X-rays to detect the presence of COVID-19 with >90% accuracy and may therefore help improve the efficiency and accuracy of radiology departments in the wake of the overwhelming workload caused by the COVID-19 pandemic.1
BluedocaiTM is also under development to support the medical diagnosis of other diseases such as pneumonia, pneumothorax, tuberculosis, cancer, and stroke. BluedocaiTM has the potential to be used with a variety of medical imaging technologies across different hospital settings and locations. The pioneering technology behind BluedocaiTM is based on well-established medical image processing research of Russell C Hardie, PhD and Barath Narayanan, PhD from University of Dayton, Ohio and is currently exclusively licensed by Blue Eye Soft.
In addition, Blue Eye Soft has announced that the U.S. Department of Commerce Bureau of Industry and Security has granted the commodity classification number (ECCN ) for BluedocaiTM, clearing the pathway for Blue Eye Soft to international export. The Blue Eye Soft team believes this is an important step forward for a company rooted in South Carolina to be able to export locally developed AI-powered diagnostic technology beyond the United States with potential reach-out from around 16 countries. Srikanth Kodeboyina, CEO of Blue Eye Soft said, “Our team at Blue Eye Soft is looking forward to serving as a pivotal partner for radiology departments worldwide, helping them deliver precise and high-value patient care — even in the challenging times of this ongoing pandemic.”
Following the commodity classification of BluedocaiTM, Blue Eye Soft is awaiting FDA approval of its submission for use in clinical settings and topline readouts from ongoing BluedocaiTM pivotal trials.
There is a constant unmet need in radiology departments as imaging data continue to grow exponentially when compared with the number of available trained readers.2 AI-driven medical imaging tools have the potential to transform radiology departments in terms of enhanced productivity, increased diagnostic accuracy, more personalized treatment planning, and ultimately, improved clinical outcomes.2,3 The general principle behind AI-driven medical imaging tools is the ability to rapidly and accurately quantify and provide assessments based on the radiographic characteristics from images using deep-learning algorithms.2,3
Blue Eye Soft, a multinational corporation of South Carolina Research Authority SC Launch, U.S. Air Force Research Labs CSA cohort, and Innosphere Ventures client company, has paired its AI and computer-aided detection expertise with its fast-moving and innovative market approach to solve problems for commercial and government defense departments worldwide, the press release said.
SC life sciences news of note fro your reading pleasure is now live! see more
This edition of SCBIO's semi-monthly newsletter is chock full of great information, including next week's eagerly anticipated webinar featuring top elected officials on SC's path forward from COVID, the "Slow the Spread" PSA campaign from BCBSSC and SCHA, highlights on companies stepping up in tough times, late-breaking news and more. Read the entire thing by clicking here!
Effort to focus on life sciences, other knowledge-based industries see more
In preparation for an anticipated economic rebound once the effects of the COVID-19 health crisis subside, the Richland County Economic Development Office (RCEDO) has teamed with a group of regional partners to develop an economic development action plan for promoting the growth of knowledge-based industries within the region.
RCEDO is also collaborating on the plan’s marketing components with those partners, which include Lexington County, the City of Columbia, the University of South Carolina, Midlands Technical College, the S.C. Research Authority (SCRA) and the Central SC Alliance.
The initiative focuses on five knowledge-based industry segments: information technology/data analytics, financial services, aerospace, medical devices and the biosciences. It is designed to build on existing assets in the region and capitalize on the growing base of research, innovation and industry partnerships at the University of South Carolina.
“I am exceptionally proud that the entire economic development community in our region has united to ensure that we can more effectively compete to expand the number of knowledge-based jobs,” said Paul Livingston, chair of Richland County Council. “This initiative will have a substantial economic impact on the whole region.”
The plan also contains a robust marketing component, and RCEDO will collaborate with its regional alliances to implement key strategies. The development office will coordinate with partners to position and promote the Columbia region as a technology and innovation hub.
“South Carolina is among the most successful states in the nation in building its manufacturing base, but the state has not been as successful in generating jobs in knowledge-based industries,” said Garry Powers, who is overseeing the project for the County as a member of the Economic Development staff.
“The Columbia metro area has the highest concentration of software-related employment in the state, and bioscience-related companies are expanding rapidly in the region,” said Jeff Ruble, RCEDO director. “Therefore, once we adapt our economic development and workforce programs so that we have an improved capacity to support companies in these targeted industries, the Midlands region is well positioned to substantially increase employment, both within our existing firms and within the new firms that we will attract to the region.”
As part of this initiative, Deloitte Consulting has analyzed the region’s capacity to grow employment in the targeted industry segments. Using this information, the company developed a detailed action plan that mitigates competitive weaknesses and builds on the region’s strengths.
To assess the Midlands’ competitive position, Deloitte measured the region’s capacity to support industry expansion compared with more than two dozen other metro areas that are hotbeds of knowledge industry growth.
Further, the initiative identifies opportunities to improve the region’s competitive position in a variety of areas, including:
- Enhancing education/training programs based on an analysis of industry needs
- Expanding programs that build the talent pipeline
- Ensuring there is sufficient infrastructure (e.g., wet labs, broadband, real estate) to support the targeted industries
- Restructuring state/local education and training incentives and other state/local incentives to ensure they are competitive nationally
The SCRA is an active partner in the project because of its mandate to promote the growth of the state’s innovation economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry. Deloitte’s action plan includes provisions for growing existing small firms and attracting new, innovative small firms within the targeted industry segments. The plan will especially focus on firms capable of building university partnerships.
The project is expected to provide substantial economic development benefits statewide, and the region has established strong, project-related working relationships with several entities. These include the S.C. Department of Commerce, the State Board for Technical and Comprehensive Education, the S.C. Council on Competitiveness and SCBIO, a statewide, not-for-profit, public–private economic development organization that actively promotes, builds, supports, expands and convenes the state’s life sciences industry.
Chartspan relocating headquarters in Greenville, SC see more
A Greenville-based healthcare technology service is changing where its employees work due to unexpected consequences of COVID-19.
ChartSpan is downsizing from its 100,000-square foot headquarters at 2 N. Main St. in downtown Greenville, into a 10,000-square foot location near Liberty Bridge.
The new space will be used mostly by the company’s executives and leadership teams, as the company moves to a remote-only call center, meaning nearly 200 employees will work from home.
ChartSpan's announcement comes as the vacancy rate in Greenville's Downtown Class A vacancy rates declined to 7.06% and its Class A office property rental rates dropped to $26.16 per square foot in second quarter 2020, according to the newly released Collier International 2020 Q2 Office Greenville-Spartanburg Report.
DPX supporting higher education institutions and research facilities see more
DPX Technologies, a manufacturer of laboratory consumable products for sample preparation, has awarded over $400,000 to researchers over the last several years. This amount is a combination of product donated and money awarded for researchers to use towards travel and presentations for industry specific scientific tradeshows or publications. DPX products have been featured in scientific publications including: Journal of Analytical Toxicology, Journal of Analytical and Bioanalytical Chemistry, and Journal of Chromatography.
DPX manufactures patented sample preparation products and specializes in custom workflows for a diverse client base. The INTipTM products have attracted the attention of researchers for years. “We often get contacted by researchers that want to develop and publish new methods that use our technology. We welcome that collaboration,” says Dr. Kaylee Mastrianni.
DPX wants to take a formalized approach in supporting higher education institutions and research facilities by awarding research grants to support the use of INTip sample preparation products as tools for education or discovery. DPX now has a form on their website to apply for research grants.
Grants will be awarded based on the novelty and scientific impact of the research described in the application. Applications will be reviewed on a rolling basis throughout the year by the DPX scientific review board and recipients can be awarded up to $1000 per year. DPX Technologies will notify the winners by email and/or telephone. Multiple forms may be submitted by the same applicant, college/university or facility as long as the need demonstrated is for different applications.
Good news for investment opportunities in the Palmetto State see more
South Carolina’s General Assembly renewed the 2013 High Growth Small Business Job Creation or “Angel Investor” Act earlier this week until 2025.
The act offers tax credits of up to 35% of the investment to start-up investors, according to a recent announcement from the S.C. State Secretary Mark Hammond. Hammond’s office, which approves all businesses for the program.
“Since the High Growth Small Business Job Creation Act originally passed, nearly 300 companies have registered as qualified businesses, with over 90 registered at the end of 2019,” Hammond, said in the release. “Furthermore, these qualified businesses have reported creating over 1,200 full-time, part-time and temporary jobs. I am thrilled that our state has continued this program that promotes innovation and entrepreneurship, especially during this time of economic uncertainty.”
Qualifying businesses must be a corporation, limited liability company, general or limited partnership headquartered in South Carolina with 25 or fewer employees and a gross income of $2 million or less, according to the release.
Program preference is extended to certain types of enterprises within the manufacturing, processing, warehousing, wholesaling, software development, information technology service, research and development, and health care sectors.
Okra Medical Receives a U.S. Patent for SafeMedWaste; Product destroys addictive substances like opioidsOKRA Medical product completely destroys highly addictive substances like opioids see more
Okra Medical is pleased to announce The US Patent and Trademark Office issued a Patent for Okra’s SafeMedWaste product suite which provides a safe, environmentally friendly, and cost-effective solution to ending the lifecycle of highly-addictive controlled substances, including opioids.
“With our patent in hand, we are beyond excited to get SafeMedWaste out onto the market and offer this exciting new alternative to destroying dangerous drugs such as opioids,” said Justin Stas, Chief Technology Officer, Okra Medical.
Currently many large manufacturers of prescription drugs incinerate their waste which is a costly solution to meet the regulatory requirement for destruction. Citizens, who have leftover prescription drugs often have to wait months for special “take-back” programs to safely discard the controlled substances. Now, Okra Medical’s SafeMedWaste provides a disposal product with verified results from a DEA-licensed laboratory proving its effectiveness for regulatory destruction of more than 30 controlled substances.
SafeMedWaste is the only drug disposal product verified to completely denature a wide variety of controlled substances using high performance liquid chromatography, mass spectroscopy(HPLC-MS). HPLC-MS is the only data that the DEA considers reliable and resolute enough to meet their definition of non retrievable based on what we know currently.
“Receiving this patent has taken more than a year of hard work, but it’s worth every minute knowing SafeMedWaste will help people destroy highly addictive drugs and potentially keep them out of the hands of people who might misuse them,” said Okra Medical’s CEO Marshall Hartmann.
According to statistics from a National Survey on Drug Use and Health, 11.4 million Americans misused illegal prescription opioids in 2017. SafeMedWaste provides a critical solution through its breakthrough formula that completely destroys highly addictive controlled substances often used in hospitals, hospice, pharmacies and veterinary care clinics. Destroying unused and unwanted prescription drugs helps eliminate the threat of diversion and misuse.
Patents are only granted for new, useful and non-obvious inventions. Okra Medical also filed a Patent Cooperation Treaty (PCT) application to protect SafeMedWaste intellectual property internationally.
About Okra Medical Inc.
Okra Medical, Inc., headquartered in Johns Island, South Carolina, specializes in product development, manufacturing and strategic sourcing of controlled pharmaceutical substance disposal solutions. Founded in 2018, the Company’s mission is to improve public health. Its best-in-class suite of SafeMedWaste products use single formulas that are fully compliant with DEA regulations requiring non-retrievable destruction of controlled substances. Okra Medical is a strategic sourcing partner to hospitals, hospice facilities, law enforcement agencies, pharmaceutical manufacturers, and veterinary care clinics. Visit www.okramedical.com
ZVerse and Phoenix Specialty Manufacturing step up for South Carolina see more
Two South Carolina companies -- ZVerse and Phoenix Specialty Manufacturing -- jumped into action to meet the needs of the response to the coronavirus, manufacturing vital pieces of equipment at a time when they were urgently needed and unlikely to be easily available for import.
In doing so, they played key roles as the country rushed to provide the medical supplies needed to protect the lives of the sick and their caregivers.
In Columbia, ZVerse began March as a company that helped manufacturers by creating more effective computer files for their production processes. It had the capability to do some 3D printing but did not usually do manufacturing.
South Carolina firm's NP Collection Swab offers a highly scalable injection-molded design see more
South Carolina-based Hoowaki LLC has developed an innovative one-piece injection molded design for a COVID-19 swab to help close the gap in U.S. and global COVID-19 testing supplies. The 12-year old micro surface engineering and product solutions company has adapted its proprietary HOOWAKI MICROGRIP® surface technology to create micro-pillars used in the Hoowaki® NP Collection Swab that is shown in clinical user testing to meet existing industry-standard products for flexibility and performance. In independent laboratory testing (qPCR Assay) it has also been proven to be equivalent to the industry-standard flocked filament swabs in the collection of patient RNA that is critical for COVID-19 testing. Mass-production of its FDA registered, patent pending, Hoowaki® NP Collection Swab will begin this summer and is expected to reach at least several million units per month.
"The Hoowaki® NP Collection Swab is an important answer to the challenges posed by the global COVID-19 pandemic," said Ralph Hulseman, president of Hoowaki LLC. "Our design allows for production to be quickly scaled in communities around the world—rapidly addressing the rising demand for swabs, a critically important element of all COVID-19 testing."
A recent study by Harvard University [https://ethics.harvard.edu/files/center-for-ethics/files/roadmaptopandemicresilience_updated_4.20.20_0.pdf] cites the need for up to 20 million COVID-19 tests per day by the end of summer. The proprietary Hoowaki® NP Collection Swab is manufactured using advanced injection molding technologies that utilize existing equipment that is readily available in communities throughout the world. The swab's scalability is due to Hoowaki LLC's formulations and engineering designs working at existing injection molding facilities, which enables the swab to be produced in quantities that meet local demands anywhere in the world.
"Prisma Health collaborated with Hoowaki LLC in the testing and development of the innovative new design. The soft feel and ease of use of the Hoowaki® NP Collection Swab tip impressed my team," said Jennifer Meredith, Ph.D., clinical microbiology director at Prisma Health-Upstate.
"Prisma Health is excited to see a locally produced solution that could help ease the shortage of swabs for COVID-19 sample collection," said Meredith. "Hoowaki LLC's product has the potential to help us meet our commitment to our patients in the fight against COVID-19." Prisma Health, the largest healthcare system in South Carolina, harnessed its Rapid Innovation Task Force to help with the project.
Hulseman credits several public-private partnerships that have helped to provide start-up funding for the swab's development: "As is the case for many businesses in today's environment, Hoowaki LLC adapted quickly to meet new challenges where demand is outpacing supply so we could remain not only viable as a company, but also pursue this pioneering technology. We're grateful for the backing of the Greenville Local Development Corporation (GLDC) and SC Launch, Inc., an investment affiliate of the South Carolina Research Authority (SCRA), who have been instrumental in helping us develop the Hoowaki® NP Collection Swab."
"Hoowaki LLC is a great example of a small business that has proven to be a powerhouse of innovation during a time of incredible challenge," said David Barnett, Chairman of the Greenville Local Development Corporation. "We are proud of our continued support for Hoowaki LLC in the development of the NP Collection Swab."
Hoowaki, LLC is a micro surface engineering services and product solutions company that has developed unique micro surface pattern designs, engineering algorithms, software and manufacturing know-how to address major markets. The company's micro surface technology provides grip or slip solutions in the form of films for medical devices, packaging and other industrial and consumer products. Their team includes experienced micro surface engineers, physicists, friction experts, medical device experts, entrepreneurs, inventors and developers. Hoowaki has market deployment partnerships with Havi (packaging) and BvW Holding AG (implanted medical devices). Hoowaki has a broad patent coverage of micro surface technology.
DPX publishes new application note see more
DPX recently published a new application note “Automated Method for High-Throughput LC-MS/MS Quantitation of Testosterone from Serum: An Improved Validated Method” where a new ultra pure grade filtration tip was introduced. The method for the extraction of testosterone from serum used Low Porosity Filtration Tips- Ultra Pure (LPFT-UP) and incorporated a ZnSO4 solution in addition to acetonitrile on a Hamilton Heater Shaker (HHS) for improved recovery and precision during protein precipitation. The LPFT-UP provide a high purity filtration media for methods with very low detection limits.
Patient samples had a calculated recovery of testosterone at 99.5% with no detected matrix effects. This demonstrates that the use of ZnSO4 and acetonitrile is very efficient in extracting testosterone, and the use of ultra pure grade tips (LPFT-UP) resulted in negligible losses. The introduction of Low Porosity Filtration tips- Ultra Pure provides a new product for low detection level methods.
“We are really excited to expand our product offering for steroid testing,” said Carmen Adamson, brand manager. DPX plans to expand on the research and development to include a full panel of steroids. “Testosterone imbalance can signal a problem in both men and women. This method provides an accurate and precise tool to aid in that determination,” said Evan DiVirgilio, application scientist. DPX continues to provide methods for efficient sample processing for clinical and forensic laboratories.
DPX Technologies manufactures patented sample preparation products and specializes in custom workflows for a diverse client base including clinical, forensic, food safety, and pharmaceutical industries. Their products offer INTip™ sample preparation solutions that are compatible with semi-automated and fully automated liquid handling systems. This enables high sample throughput and high laboratory efficiency.
# # #
About DPX Technologies
DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.
Clemson targets fix for mask shortage see more
(Courtesy, Paul Alongi, Clemson College of Engineering, Computing and Applied Sciences)
Melinda Harman of Clemson University is volunteering her time to explore how hospitals could wash and sanitize medical masks without having to ship them elsewhere or buy an expensive piece of equipment.
A device that Harman designed to hold multiple N95 masks is central to her idea. It would help ensure the masks maintain their shape while being washed so that they continue to fit securely around the mouth and nose, said Harman, an associate professor of bioengineering and director of Clemson University’s Medical Device Recycling and Reprocessing program, or GreenMD.
The masks help prevent healthcare workers from inhaling the novel coronavirus that causes COVID-19 and have been in short supply since the pandemic began.
As part of her work, Harman said she has engaged three leading healthcare companies that offer expertise in detergents and decontamination. She is testing different kinds of detergents to find the best solution for cleaning mucus and proteins from the masks.
The detergents are commercially available and already used by hospitals to clean other types of medical equipment.
Harman said that her goal is “to validate a cleaning process that is compatible with existing capabilities and equipment commonly available at hospitals in South Carolina and worldwide.”
The challenge is “to avoid interfering with mask performance, while effectively cleaning the masks without degrading their filtering capacity,” she said.
Harman added, “Working with innovative industry partners is a considerable advantage, with everyone on the team willing to contribute a potential solution. They are providing reliable products that are already proven to meet routine reprocessing challenges in healthcare delivery.”
Harman said one of the advantages to her approach is that many hospitals already have the ability to clean medical equipment, even if they aren’t yet applying it to the masks. That means hospitals wouldn’t need to buy any capital equipment, she said.
Further, the masks would stay at the hospital, reducing travel time, the risk of spreading contamination outside of the hospital and the additional burden on an already-stressed logistics system, Harman said.
“The technology I’m working on is meant to be used broadly, compatible with existing reprocessing practices that are already in hospitals,” Harman said. “It’s intended for rapid deployment in health care settings, and it’s meant to be compatible with any sterilization system.”
Harman added, “Cleaning masks before sterilization enables more masks to be reused Right now, guidelines for sterilization require N95 masks to be inspected and discarded if they are ‘soiled.’ My idea is to reliably clean masks to remove both the visible and ‘invisible’ soils, making the entire reuse process safer.”
Martine LaBerge, chair of the Department of Bioengineering, said that Harman is well qualified to lead the work.
Harman has conducted extensive research into reuse and reprocessing of medical equipment. As director of GreenMD, she engages students in industry-driven research targeting healthcare needs in South Carolina and broader global health challenges. GreenMD is the nation’s only engineering-focused program for medical device design targeted for reprocessing and reuse.
“Dr. Harman has built a career on developing innovative ways to reprocess and reuse medical equipment that is normally disposable, which uniquely positions her to have a global impact,” LaBerge said. “I thank her for her service to South Carolina, the nation and the globe as we join together in the face of the unprecedented challenges posed by COVID-19.”
Harman said that if her idea works, used masks would be sent to central sterilization facilities within hospitals. The device she designed would hold the masks while they are cleaned. After cleaning, the masks would go through a separate sterilization process to get rid of any lingering microorganisms, including coronavirus.
The mask-holder that Harman designed could be 3D-printed, she said. However, she is focusing on more rapid manufacturing approaches using common acrylic materials. The technology could be readily adapted in hospitals from South Carolina to India, Harman said.
She recently disclosed the technology to the Clemson University Research Foundation, setting it on the path to commercialization and raising the potential for widespread use.
Harman said what’s been most interesting to her is that her previous work with resource-poor countries has come home to the United States, with disrupted supply chains and inadequate supplies at the point of need.
“That’s exactly the situation we’ve been working on with other countries,” Harman said. “For me that’s just been a startling change. It’s been amazing to see how many people have become interested in the topic of safe and sustainable reuse and how many unique solutions they come up with. I hope that creative energy continues, because it can solve a lot of global health problems.”
Monday Moment 5-4-2020 see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from University of South Carolina College of Pharmacy Dean Stephen Cutler saluting all those on the front lines of healthcare, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.
KIYATEC Adds Clinical and Reimbursement Experience to Board as Clinical Testing Validation ProgressesKIYATEC adds to its Board of Directors see more
KIYATEC, Inc. today announced the appointment of Bruce Nash, MD, MBA, to its Board of Directors. Dr. Nash brings over 30 years of executive-level healthcare experience in the managed care, hospital and medical group practice settings. Currently, he serves as Chief Physician Executive and Senior Vice President at Blue Cross Blue Shield of Massachusetts, one of the nation’s leading health insurance plans. During his career, Dr. Nash has held executive leadership positions in both managed care (Kaiser Permanente, Capital District Physicians’ Health Plan) and healthcare (Northern Berkshire Health System, North Adams Regional Hospital) organizations.
Dr. Nash serves on the boards of the Blue Cross Blue Shield Foundation and the Network for Excellence in Health Innovation (NEHI), while also serving on the Board of Strategic Advisors at the Excel Venture Management Fund and the Clinical Advisory Group at the Blue Venture Fund. He is a board-certified physician who completed his residency training at Duke University. Bruce earned his MBA in Health Sector Management from Duke University's Fuqua School of Business.
“We are delighted to welcome Dr. Nash to KIYATEC’s Board of Directors,” said Robert Silverman, Chairman of the Board of Directors of KIYATEC. “Bruce’s relevant experience and vision as both a clinician and an expert in managed care will provide tremendous value as KIYATEC moves forward in the development of our predictive clinical tests to improve cancer patient care and outcomes.”
The addition of Dr. Nash to the KIYATEC Board of Directors comes as the company’s evidence development efforts continue to gain momentum:
- 3D-PREDICT Study (NCT03561207) of clinical tests to predict pre-treatment drug response to drug therapies for ovarian cancer and high-grade glioma continues to add study sites and enroll patients
- Pilot study publication entitled, “Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer,” was recognized this spring by Scientific Reports (Nature Research) as being one of its Top 100 cancer papers of 2019 (of >1,000 published)
- Emerging evidence of I/O (immuno-oncology) drug response characterization to be presented via multiple posters at AACR in June
About KIYATEC, Inc.
KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types
It's Monday... start your day right with two minutes of good news, right here see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 2 minutes or less. This week, enjoy an uplifting reminder from South Carolina Hospital Association's Thornton Kirby that expresses appreciation to the SC life sciences industry, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.