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  • sam patrick posted an article
    Zeus has facilities in Aiken, Columbia, Gaston and Orangeburg, S.C. see more

    Compliments of Columbia Regional Business Report

    Orangeburg-based Zeus today said the company will invest millions to expand catheter manufacturing capacity worldwide, starting with the expansion of a plant in San Jose, Calif., where construction is already underway.

    The company’s core business is the development and precision extrusion of advanced polymeric materials.

    Zeus purchased CathX Medical in June 2021. CathX Medical provides catheter-based design, development and manufacturing services to medical device original equipment manufacturers. The expansion will extend the facility's footprint to increase catheter-based design and manufacturing capacity, the company said in a news release.

    The company did not say where other else it may invest in expanding catheter production.

    Steve Peterson, CEO and president at Zeus, said the investment is in response to growing demand from medical device OEMs.

    “Our customers depend on innovative thinking, speed, and the latest catheter design and manufacturing technologies to deliver their life-saving products,” Peterson said in the news release. “We want to solidify Zeus' position as their strategic, long-term partner.”

    The existing San Jose site will increase by 127%, extending its footprint to 32,000 square feet, the release said. The expansion also will increase the facility's ISO-certified cleanroom capacity for design, prototyping, validation and manufacturing to more than 7,000 square feet and double Zeus' braiding and coiling capacity for catheter-based minimally invasive devices.

    The expansion will create 15 new jobs this year in San Jose and 50-plus new jobs over the next two years, the company said, including project engineers, project managers, product builders and technicians.  

    Zeus’s enterprise includes advanced polymer solutions, from tubing, catheter componentry and heat shrink to bioabsorbable and implantable medical products, sutures and more. The company employs more than 2,000 people worldwide with manufacturing and sales facilities in Aiken, Columbia, Gaston and Orangeburg in South Carolina, along with Branchburg, N.J.; Chattanooga, Tenn.; San Jose; Guangzhou, China; and Letterkenny, Ireland. Zeus products and services serve companies in the medical, automotive, aerospace, fiber optics, energy and fluid management markets.

  • sam patrick posted an article
    Induction to the academy is the highest honor bestowed by Clemson see more

    Some of the most outstanding alumni from Clemson University’s largest college gathered in downtown Greenville on Thursday to welcome three of their own into the Thomas Green Clemson Academy of Engineers and Scientists and to honor three others as Outstanding Young Alumni.

    Induction to the academy is the highest honor bestowed by Clemson’s College of Engineering, Computing and Applied Scientists. The honor recognizes alumni and special friends who have made major contributions to their professions and have brought significant distinction to the college and university.


    The new members are Rebecca Copenhaver DeLegge, Craig Fallon and Robert Fjeld.

    The newest crop of Outstanding Young Alumni are Diana Chen, Adam Kirn and Mary Katherine Watson. The award goes to graduates of the college who are 40 years old or younger and whose achievements have been significant to their profession or to the welfare of society.

    Anand Gramopadhye, the college’s dean, thanked the night’s honorees and said each is leaving his or her unique mark on the world.

    “We will always cherish the fact that your Clemson education may have had a small role to play in your success,” he said. “To paraphrase the Dalai Lama, we hope we have given you wings to fly, roots to come back and reasons to give.”

    Below is a brief description of each honoree. You can also hear directly from their nominators in a series of videos that will be posted on the college’s social media channels: InstagramFacebookLinkedIn and Twitter.

    Thomas Green Clemson Academy of Engineers and Scientists

    Rebecca Copenhaver DeLegge: As the co-founder of two businesses and chief operating officer of a third, DeLegge is leading the charge to break the glass ceiling for girls and women who are interested in STEM disciplines and entrepreneurship. One of the companies she co-founded, DeLegge Medical, is among the nation’s premier medical device engineering, educational and consulting firms. Its customers have included major technology and medical companies, such as Boston Scientific, Corpak, Olympus, Covidien and Monteris Medical. DeLegge also co-founded Bella Veterinary Medical Solutions, a women-owned start up that creates top-quality veterinary equipment. In addition to co-founding two companies, DeLegge serves as COO for ArchCath, which was a finalist for a 2021 InnoVision Award in the Technology Development category.  She was also among the original founders and leaders of South Carolina's life sciences organization SCBIO.

    Craig Fallon: Fallon served in the U.S. Army with distinction. He received national recognition for his engineering and construction leadership and achievements from Alaska to Saudi Arabia, rising to operating vice president with Owens Corning. In 1987 he was part of an LBO spin off from Owens Corning forming a private company, Performance Contracting Group (PCG). PCG has since grown significantly to become one of the largest commercial and industrial mechanical insulation, interiors, cleanroom, and industrial service contractors in the nation with more than 50 offices across the United States and Ireland, having more than 8,000 employees, and an annual revenue approaching $2 billion. He is credited with ensuring the company today remains entirely employee owned, a move that secured the financial future for the company, its employees, and their families. Fallon retired as the company’s CEO and chairman in 2004.

    Robert Fjeld: As a faculty member, Fjeld founded the Nuclear Environmental Engineering and Science (NEES) educational and research program within the Department of Environmental Engineering and Earth Sciences. He received his Ph.D. in nuclear engineering from the Pennsylvania State University in 1976 and after a short period at Texas A&M, began his career at Clemson in 1980 to build the NEES program. His research focused on the environmental aspects of nuclear technologies. He did pioneering work in the area of risk assessment, and he is the lead author of a widely used textbook, “Environmental Risk Analysis for Human Health.” Fjeld held the Jerry E. and Harriett Calvert Dempsey Professorship of Waste Management from 1996 until he retired in 2009. He is now a faculty member emeritus. Fjeld endowed a professorship now held by Clemson’s Brian Powell, who studied under Fjeld as a Ph.D. student.

    Outstanding Young Alumni

    Diana Chen: Chen’s Clemson degrees include a Master of Science and a Ph.D., both in civil engineering. In 2016 she accepted a position as a founding faculty member of the Integrated Engineering Department in the Shiley-Marcos School of Engineering at the University of San Diego, where she contributed to the school’s National Science Foundation Revolutionizing Engineering Departments project entitled, “Developing Changemaking Engineers.” Her work on this has helped to create a program that focuses on the sociotechnical aspects of engineering and the impact engineers have on society.

    Adam Kirn: Kirn, a 2014 graduate of the engineering and science education Ph.D. program, currently serves as associate professor of engineering education in the Department of Electrical and Biomedical Engineering at the University of Nevada, Reno. Kirn is having a profound impact on the field of engineering education as the founding faculty member for the program in Reno and is establishing national prominence for his research in the field.

    Mary Katherine Watson: Watson holds Bachelor of Science and Master of Science degrees in biosystems engineering from Clemson. As an associate professor of civil and environmental engineering at The Citadel, she has been recognized for her teaching excellence and her prowess as a researcher, developing scholarly contributions to the field of engineering education. Supported by the National Science Foundation, Watson is building regional and national programs for supporting advancement of diverse faculty and students in STEM fields.

  • sam patrick posted an article
    Addressing high demand for accomplished leaders to spearhead the sector’s growth. see more

    Compliments of Investment Monitor

    The life sciences industry in Charleston is growing fast. As more and more businesses and professionals are drawn towards the area, there is high demand for accomplished leaders to spearhead the sector’s growth.

    Executive search consultant Joyce De Leo is doing her part to find these individuals. She spent a 25-year career researching and teaching medicine at esteemed institutions in the north-eastern US, earning a PhD in neuropharmacology, and establishing a start-up pharmaceuticals company focused on treating chronic pain. She now works for executive search company WittKieffer, where she recruits talent for high-level leadership roles in healthcare and academic medicine. Last year, De Leo relocated from Boston to Charleston after falling in love with the region and recognising its rich opportunities for market growth. Read the rest of this article by clicking here.

  • sam patrick posted an article
    SCBIO believes growing the life sciences sector will significantly transform the state’s economy. see more

    Compliments of the Community Journal...

    It was all smiles on Sept. 30 as BMW marked the 25th anniversary of the first vehicle to roll off its Spartanburg assembly line, a singular moment that dramatically transformed the economic face of South Carolina.

    A quarter-century after opening, the German manufacturer’s North American facility employs more than 11,000 workers who build 1,500 vehicles daily, a pace requiring the services of more than 40 main suppliers across the state.

    The average wage among all S.C. jobs supported by the automotive industry stood at $64,120 in 2017 compared to $40,293 across all employment categories, say findings commissioned by the South Carolina Biotechnology Industry Organization (SCBIO).

    Now three years old, SCBIO is spearheading an aggressive initiative to make South Carolina the preferred location for new or expanding companies in another highly promising industry: life sciences.  Read the entire story by clicking here.

  • sam patrick posted an article
    Improving patient care is at the heart of Rhythmlink's success see more

    Compliments of Scribble

    As Columbia, S.C.-based Rhythmlink International, LLC (RLI) prepares to turn 20 years old this year, co-founder and CEO Shawn Regan is reflective on just how far the organization has come since “the early days.”

    After spending more than a decade in the medical device and medical services fields, Shawn and his partners created Rhythmlink in 2002 to meet the needs of neurophysiologic end-users whom they discovered were underserved by both large and small medical device companies. Shawn’s passion to apply innovative engineering solutions to address customer needs while improving patient care and reducing medical costs set him—and Rhythmlink—on a growth path that today has reached over 325 employees worldwide and has landed the organization on the Inc. 5000 list of America’s Fastest-Growing Companies nine times.

    Of greater pride to Regan is the company’s ten straight years on South Carolina’s Best Places to Work list — a testament to Rhythmlink’s culture and the commitment of the organization to valuing the contributions and talents of its associates… whatever their role.

    RLI is in the business of connecting patients to machines to record or elicit physiology information. It designs, manufactures, and distributes medical devices that go on or in a patient to help monitor the brain and the nervous system to identify and prevent serious neurologic conditions such as paralysis, seizures, and strokes. Rhythmlink’s products are commonly used in operating rooms, intensive care units, and other neurological clinical settings in hospitals. The company is now recognized as a leader within its field at providing the important physical connection between patients and the diagnostic equipment to record or elicit neurophysiologic biopotentials.

    Originally founded by neurodiagnostic technicians and engineers, Rhythmlink is resolutely focused on continuous innovation and delivering superior quality in all of its products – and its advancements and improvements in technology and branding have brought national and international recognition to the former South Carolina start-up.

    Indicative of the company’s focus on innovative product development are two notable recent offerings developed and marketed by the company: its MR Conditional/CT Compatible Quick Connect Electrodes and its Guardian Needle Electrode.

    Rhythmlink was the first company in the world to achieve FDA approval for MR Conditional EEG electrodes. Rhythmlink’s FDA-cleared MR Conditional/CT Compatible Quick Connect Electrodes help eliminate the need and cost to have staff available to remove and reapply electroencephalography (EEG) electrodes each time a patient requires magnetic resonance (MR) imaging during critical care continuous EEG monitoring, long term epilepsy monitoring or in many other situations.

    Electroencephalography is the recording of brain activity (i.e., brain waves) to help identify dangerous brain activity such as seizures. Prior to Rhythmlink’s MR Conditional products, any time a patient needed to have their brain monitored and needed to get an imaging study done, caregivers had to take off the electrodes, image the patient and then re-apply the electrodes. Getting electrodes on the head is time-consuming, qualified staffing in hospitals is limited, and application and reapplication can result in skin breakdown at the site of the electrodes. Applying the electrodes once and keeping them on during a patient’s stay saves time and cost while improving patient safety.

    RLI achieved full FDA clearance on its MR Conditional EEG electrodes and the Quick Connect Electrode product line built upon the previous clearance. The product can also be used in a CT without having to take the electrodes off the head and re-apply them, furthering its potential use. 

    Rhythmlink’s Guardian Needle Electrode is a subdermal needle electrode designed to reduce accidental needle sticks and reduce the risk of exposure to cross contamination. Commonly used in the operating room for real-time monitoring and protection of a patient’s nervous system, this subdermal needle can be used for critical care environments, the ICU, Emergency Room or anywhere a needle electrode is called for. Additionally, the Guardian Needle combines to work perfectly with RLI’s EEG template for quick and accurate electrode placement. 

    The product was originally conceived of by Medical University of South Carolina (MUSC) Health clinicians, developed by the Zucker Institute of Applied Neurosciences (ZIAN) engineers and is today manufactured and sold by Rhythmlink, a testament to the power of collaboration in medical device innovation. The effort — ten years in the making — will make the operating room a safer place for health care team members the world over.

    Traditional subdermal needle electrodes are used during surgery to monitor a patient’s nervous system during dangerous cases to identify and prevent paralysis, stroke and other dangerous conditions and outcomes during surgery. The small needles can become dislodged and accidently stick health care personnel during the surgery, whereas the new Guardian needle aims to reduce or eliminate the accidental needle sticks. Following extensive talks, licensing, contribution of additional IP to the patent and obtaining FDA clearance, Rhythmlink launched the product just over one year ago.

    Twenty years of hard work and growth have come and gone quickly at Rhythmlink, yet the founders’ original passion still rings true today: improving patient care is — and always will be — at the very heart of Rhythmlink’s success.

     

  • sam patrick posted an article
    Provides Kyocera AVX with opportunities to further support flourishing tech industry, life sciences see more

    A manufacturer of advanced electronic components headquartered in Fountain Inn, Kyocera AVX, has invested in an early stage venture capital firm to complement its research and development programs and support innovation in the medical technology industry.

    Good Growth Capital (GGC), a majority women-owned venture capital firm based in Charleston with offices in Boston, Mass., typically invests in complex science and deep-tech startups. The partnership was established in August and announced in a news release on Nov. 29.

    “This investment provides Kyocera AVX with abundant opportunities to further support the flourishing tech industry both here in the Carolinas and nationwide by investing through GGC and exploring co-investments,” company CEO Johnny Sarvis said in the release.

    Kyocera AVX has more than 30 research, design, manufacturing and customer support facilities in 16 countries. It invests in research and development and submits several patent applications annually, according to its website.

    The company manufactures products for the automotive, industrial, medical, military, consumer electronics, communications and transportation markets. For the medical industry, the company creates products for devices such as pacemakers, cochlear implants and diagnostics equipment.

  • sam patrick posted an article
    Poly-Med welcomes Governor to Upstate see more

    Governor Henry McMaster visited with state leaders and the executive leadership team of Poly-Med, Inc.’s at its newest facility located just outside of Greenville, SC last week.  Governor McMaster’s visit was aimed at taking stock of the ever-growing biomedical industry and Poly-Med’s growing presence in the medical device industry right here in the Upstate.

    In 2019, Poly-Med, Inc., the leader in bioresorbable materials and medical device development, opened a state of the art development and production facility doubling their footprint in the Upstate.  The new facility greatly expands PMI’s capabilities to offer medical device development for  medical-grade electrospinningextrusion, additive manufacturing, and technical textile processes in a certified ISO Class 8 environment. 

    Governor McMaster was encouraged by the growth of the company and the technological advancements that Poly-Med has achieved in recent years of utilizing resorbable materials to expand medical device and implant functionality.  The Governor and many others at the state level are encouraging manufacturing investment in the life sciences and biomedical industries within the State. During his visit, the Governor toured Poly-Med’s facility and evaluated its innovative technologies used to produce implants that act as a natural scaffold in the body to replace damaged or diseased tissues.

    Poly-Med’s President, David Shalaby, stated “Poly-Med is a solutions’ driven organization that is working on the next class of medical devices.  The expansion of our facilities demonstrates Poly-Med’s dedication to build an infrastructure for custom medical device development within South Carolina. Our focus within the specialty resorbable material field continues our long history of designing and delivering first in class products. We look forward to growing our presence in South Carolina to support our clients in their medical device design and resorbable implant needs that improve the quality of life for patients.” 

    The expansion of Poly-Med’s facilities is an investment in the ever-growing life sciences community in the Southeast, particularly in South Carolina. South Carolina is home to a $12+ Billion industry with over 700 dedicated life science firms. To learn more about Poly-Med or the opening of the new facility, please contact Poly-Med.

     

    About Poly-Med, Inc.

    For the past 28 years, Poly-Med has developed first in class innovative medical implants that improve the quality of life for patients.  Poly-Med’s mission is to drive innovation in the biomedical industries that positively impact human health.

  • sam patrick posted an article
    Company investing, adding jobs to expand capabilities see more

    Arthrex, an orthopedic technology innovator, today announced plans to expand operations in Anderson County. The more than $100 million investment will create 500 new jobs.

    Founded in 1981, Arthrex is a global leader in orthopedic surgical device design, research, manufacturing and medical education. The company develops and releases more than 1,000 innovative products and surgical procedures each year to advance minimally invasive orthopedics worldwide.

    Located at 130 Arthrex Drive in Pendleton, Arthrex’s expansion will include adding a second manufacturing facility and an Electron-beam (E-beam) and X-ray sterilizations facility.

    The expansion is expected to be completed by mid-2023. Individuals interested in joining the Arthrex team should visit the company’s careers webpage.

     QUOTES

    “This investment will help Arthrex better support the growth and development of new and innovative products that help surgeons treat their patients better. Arthrex has been committed to manufacturing quality products in the United States, and this represents that continued commitment.” -Arthrex Vice President of Manufacturing Andy Owen

    “I congratulate Arthrex on this more than $100 million investment in our state. The 500 new jobs this expansion is generating will make a big difference in Anderson County, and we look forward to watching this great company continue to thrive here for years to come.” -Gov. Henry McMaster

    “Arthrex is on the cutting edge of orthopedic innovation and is a leader in our state’s booming life sciences sector. Today’s announcement by Arthrex not only proves that South Carolina has the business environment where life sciences companies can succeed, but that we have the talented workforce in place to handle the most innovative jobs. Team S.C. congratulates Arthrex on their continued success.” -Secretary of Commerce Harry M. Lightsey III

    “Our partnership with Arthrex is succeeding beyond anyone’s expectations. They showed a lot of faith in our community when they began their journey with us a few short years ago, and today’s announcement indicates the level of confidence they have in our workforce. These jobs will improve the lives of hundreds of Anderson County families, and I am truly thankful.” -Anderson County Councilman Brett Sanders, District 4

    FIVE FAST FACTS

    • Arthrex is expanding operations in Anderson County.
    • The more than $100 million investment will create 500 new jobs.
    • Arthrex is an orthopedic surgical device company.
    • Located at 130 Arthrex Drive in Pendleton, S.C.
    • Individuals interested in joining the Arthrex team should visit the company’s careers webpage.

  • sam patrick posted an article
    Artificial intelligence a critical factor in improving healthcare, booming life sciences industry see more

    Compliments of Columbia Business - Charleston Business - Greenville Business Magazines

    HCA Healthcare and Google Cloud are partnering to use data analytics and artificial intelligence along with patient information in a move they say will transform health care delivery and improve outcomes.

    It’s the latest step in the evolution of the fusion between health care and data.

    Prisma Health recently announced a partnership with Siemens Healthineers. And the Medical University of South Carolina has been working with Siemens Healthineers for years as well as Microsoft.

    Proponents say these arrangements benefit patients and providers alike. But they also raise concerns about the security of patient information.

    “What they’re doing is harnessing the power of big data to drive informed change and informed decision making,” said Dr. Christine Carr, an emergency physician and senior clinical advisor with the South Carolina Hospital Association.

    “Instead of a clinician on the floor saying, ‘I think this is the best way we should do our physician schedules or manage heart failure,’ we have so much data and analytic power now,” she told Integrated Media, publisher of Greenville Business Magazine, Columbia Business Monthly and Charleston Business Magazine. “It’s kind of like your iPhone, knowing where you’re going when you get in the car. We realize we have to get ahead of the disease.”

    If a patient has shortness of breath, for example, providers can use data tools to predict if he has a pulmonary embolism without doing any testing, Carr said. And if he does, other tools can help determine whether he should be admitted to the hospital or sent home on medication, she said.

    “The real power of using big data in health care is that it helps us deliver more efficient, high-quality care with fewer disparities,” adds Caroline Brown, chief of external affairs for MUSC and the Medical University Hospital Authority.

    “There is tremendous value in marrying disparate data that lives in different places to transform the way we deliver care. There are huge benefits for patients for this data to come together,” she said. “We can practice in a more preventive way than a reactive way.”

    But how accurate are these tools? Carr says they’re validated to a high degree of certainty so the clinician knows the risks.

    “They are extremely accurate,” she said, adding that doctors are still the ones making the decisions.  

    “It delivers information but you as a human have to ultimately decide what to do,” she said. “And any unique person is a unique person. Sometimes, I just override it. And sometimes I’m right. There are still humans, for now, at the end.”

    Another benefit of predictive analytics is lowering costs, Carr said.

    For instance, by analyzing a patient’s information, a doctor may determine that she only needs a mammogram every three years instead of annually, she said. And it can predict the risk of hospital readmissions too, she added, “which is a big financial driver for hospitals.”

    Carr speculates that all large health systems are getting into the predictive analytics space, adding that insurance companies have been using it for years to predict population health based on ZIP code, health history and socioeconomic factors.

    Founded in 1968, Nashville-based HCA Healthcare is a for-profit system with some 2,000 care locations - including 186 hospitals - in 20 states and the United Kingdom.

    Google Cloud, which “aims to accelerate companies’ digital transformation,” says it has business customers in more than 200 countries.

    A spokesman for HCA said the company would have no comment beyond a press release and a Google spokeswoman did not return calls.

    But in that release, HCA CEO Sam Hazen said that “next-generation care demands data science-informed decision support so we can more sharply focus on safe, efficient and effective patient care.”

    And Google Cloud CEO Thomas Kurian said, “The cloud can be an accelerant for innovation in health, particularly in driving data interoperability, which is critical in streamlining operations and providing better quality of care to improve patient outcomes.”

    Meanwhile, Adam Landau, vice president of marketing and corporate affairs for HCA’s South Atlantic Division, said in an email that it’s too early to know what the partnership will mean for its South Carolina hospitals - Colleton Medical Center in Walterboro, Grand Strand Medical Center in Myrtle Beach and Trident Health, which consists of Trident Medical Center in Charleston and Summerville Medical Center in Summerville.

    “I can tell you that we’re proud to be a part of HCA Healthcare,” he said. “In combination with significant investments in mobility to support clinical care … this partnership accelerates the work of HCA Healthcare clinicians, data scientists and developers by providing highly scalable technology from Google Cloud.”

    For example, he said, technology has been developed using predictive analytics that helps detect sepsis early, potentially saving lives. Another application uses clinical observations and ventilator-streamed data to reduce the length of stay for patients with acute respiratory distress syndrome (ARDS) and increase survival rates of Covid patients by 28 percent, he said.

    Brown said that health care is behind other consumer-driven industries in delivering on 21st century data technology.

    “One thing the … industry has been behind on is this whole consumer experience and digitalization of that over the last years,” she said. “Customers are expecting and demanding easier access to health care, they want to do so virtually from home, and in other formats that previously weren’t commonplace.”

    MUSC is using data analytics to help identify gaps in care, to map workflow so the system is more efficient, and to reduce wait times for patients, among other things, she said.

    A partnership with Medtronic uses more consistent monitoring technology in hospitalized patients to reduce the number of adverse respiratory events in patients prescribed opioids, she said. Another project aims to prevent hospitalizations by catching patients with heart failure and intervening earlier.

    MUSC also worked with Microsoft using artificial intelligence (AI) and machine learning to detect and address potentially deadly sepsis in hospitalized patients, she said.

    Prisma said its 10-year partnership with Siemens will use AI to develop algorithms to help clinicians make more informed decisions, allowing for quicker and more precise diagnoses and treatment plans.

    Some of the AI will be embedded in new imaging machines as software while other AI will be developed through the partnership. Siemens will also have health economists on site studying new technologies to see if they reduce health care costs.

    But with a growing number of entities gaining access to patient information, just how secure are arrangements like these?

    Nationwide, the number of health information data breaches affecting 500 or more people grew from 329 in 2016 to 648 in 2020, with hacking events growing from 78 to 230 and ransomware attacks soaring from 36 to 199 during that time frame, according to the U.S. Department of Health and Human Services.

    Ransomware is a multibillion-dollar industry, said James Andrew Lewis, senior vice president and director of the Strategic Technologies Program at the Center for Strategic and International Studies.

    And hospitals make good targets because attackers are purely about the money and go after what will generate the most return, he added.

    “You can hack a hospital and make $4 million or hack an individual and make $4,000,” he said. “These guys like bulk business. Not onesies or twosies.”

    Most hospitals pay because it’s not worth the hassle, Lewis said.

    Some have insurance to cover ransomware attacks. But most attackers hone in on what they think the target can afford and go for that at the hospitals that are easier to breach, he said. And if they think the hospital can pay $4 million, they’ll start out asking for $6 million, he said.

    So moving to the cloud makes sense, Lewis said, because while it’s not impossible to hack, it is much more difficult and could be more secure. A lot depends on the terms of the contract, such as where the data will be stored and how it will limit the risk to privacy, he said.

    Both Google and HCA say their arrangement will protect patient privacy and data by using “layers of security controls and processes” and complying with federal privacy requirements.

    “The partnership is founded on strict guiding principles around privacy and security,” Landau said. “Our contract prohibits Google Cloud from the use of patient identifiable information.”

    Brown said MUSC also only uses deidentified patient data for its projects. That means information like names and addresses are removed but relevant clinical data remain, subject to privacy guide rails, she said.

    “Cybersecurity is a huge issue globally across all industries, and health care is no different,” she said. “Any arrangement … has to be done with utmost scrutiny to make sure patients are kept first, and commit to making sure they are protected.”

    A lot of the push for these types of relationships comes from hospitals looking to solve complex health care problems on a large scale, said MUSC chief information security officer Aaron Heath.

    Machine learning is helping to do that with the use of lots of data, he said, but when those two intersect, there has to be a mechanism to share the least amount of data necessary.

    At the end of the day, he said, a hospital doesn’t need to put patient privacy on the hook to solve its problems.

    “If we want to solve for sepsis in the hospital - detect it often and early and respond quickly - we don’t have to share patient data,” he said. “Hospitals are … only sharing the minimum amount of data to accomplish goals.”

    Nonetheless, he said, it’s not without risk and hospitals need to have contracts with digital companies that prevent data from being used for any other purpose.

    “There are a lot of controls we can take,” he said, “because it’s really important.”

    Prisma Health said that protecting patient privacy is critical and that it has multiple systems and checks in place to safeguard it.

    “As part of our Siemens Healthineers’ intelligent insights center, we will use de-identified, blinded patient data,” spokeswoman Sandy Dees said in a statement. “Under no circumstances will specific identifiers such as names, birth dates or addresses be used.”

    When it comes to ransomware, hospitals are in a tough position because they can’t stop business for an attack, said Heath. MUSC has layers of defense designed to mitigate the ransomware threat so if one is breached, another kicks in, he said.

    “You may not get hit by ransomware, but I can assure you your system is being targeted by phishing emails,” he said. “We are monitoring systems at all times to look for and flag potential phishing emails and get them out of our system because it’s such a common (and easy) avenue of attack. We have seen phishing emails come in to us intended to ultimately trigger an attack, but have caught them.”

    A significant problem in dealing with ransomware is that most attacks come from outside the U.S. and there’s a lack of international law enforcement to allay it, Heath said.

    “It’s a real challenge to stop this activity across the globe because it can be conducted from anywhere,” he said.

    So MUSC invests “quite a bit” in new technology and the staff to support it, he said. And the system is constantly monitoring security and conducting training because cybercrime is a moving target that requires frequent adjustments, he said.

    Still, Lewis said that ransomware “is not rocket science,” and that hospitals should be able to deal with it by backing up and encrypting data and spending more on IT to keep current.

    “A big cloud provider makes you more secure. It’s their business,” he said. “Hospitals - their business is patient care, and (those) that invest proactively are better able to protect data.”

    A federal health care cybersecurity task force established by HHS produced a report in 2017 that outlined ways to improve protection of health information, among them increasing the security and resilience of medical devices and health IT like electronic medical records; ensuring that the health care workforce prioritizes cybersecurity; and enhancing health care industry readiness through improved cybersecurity awareness and education.

    “It’s sad we have to do this,” Lewis said. “But it’s the world we’re in and we have to pay more attention.”

     September 10, 2021
  • sam patrick posted an article
    Life sciences expands career opportunities for SC graduates see more

    Compliments of Lowcountry Graduate Press

    COVID caused pain and heartache and death across the world and here in the Lowcountry, but it also revealed some bright spots. One of those is the life sciences industry, which was responsible for diagnosing COVID, providing responses, and ultimately developing effective vaccines.

    Coincidentally, the life sciences industry in South Carolina is itself on a growth spurt that was accelerated by the pandemic. The number of firms in the industry had doubled in the last four years, making it the fastest-growing industry sector in the state. The Darla Moore School of Business estimated its annual economic impact at $12 billion before the most recent spike.

    Life sciences produce next-generation pharmaceuticals and vaccines; advanced medical devices, diagnostics, and testing; digital health; bioscience distribution; bio-agriculture and biomaterials; and biological solutions for advanced manufacturing.

    Life sciences also encompass two areas of focus for the Lowcountry Graduate Center – advanced manufacturing and healthcare management. While the connection with healthcare is obvious, many people don’t realize that life science research and advanced manufacturing work symbiotically. Many life science innovations, like medical devices, require advanced manufacturing to produce, while life science innovations can power the process of advanced manufacturing itself.

    Career Opportunities in Life Sciences

    That means jobs, and not just for M.D.s and Ph.D.’s, but for technical college graduates and university biology and chemistry majors as well. The average life sciences position pays $79,000, according to the official state affiliate of the U.S. Biotechnology Innovation Organization, also referred to as SCBIO, the nonprofit organization dedicated to promoting the life sciences industry in S.C. Because workforce development is the primary challenge facing the industry, SCBIO is engaged in an initiative to promote the industry as a career path for students, guidance counselors, and parents at the K-12 level and in two- and four-year college.

    Indeed, SCBIO is in the process of developing an industry-advocated life sciences curriculum for technical colleges that can prepare graduates for jobs in the field. Courses would cover manufacturing processes; safety and technical protocols like measurements and ISO standards; soft skills required for all workplaces; and the connections between the various life science components and the life-saving innovations they support.

    “We want to get to students even sooner so we’re partnering with organizations that are already in schools to add more of the ‘S’ in STEM,” said Erin Ford, interim CEO at SCBIO. “If someone takes a course at Trident Tech, they can get a job paying $50,000 or more with health insurance while working on a product that helps people live better lives.”

    The vector of life science development is different depending on the area of the state, with the Lowcountry showing strength in biotechnology, pharmaceutical, and manufacturing, says Ford.

    Life Science Companies Need Space to Grow

    Besides workforce development, the next big challenge constraining growth is space. Lab space at the new WestEdge development in downtown Charleston was fully subscribed when it opened and now developers are seeking new space. Clean labs are more complex and costly to retrofit and build than ordinary office or warehouse space.

    Nonetheless, the firms keep coming – or starting – and the state has gotten behind the industry. As a critical step, it authorized and funded SCBIO as the state’s lead life sciences industry economic development organization.

    Life science provides more than just more job growth: it provides diversification of an economy that 30 years ago relied heavily on a Navy base that packed up and left. Life sciences are more recession-resistant than automotive and aeronautics, two areas of manufacturing strength in the Lowcountry that respond to retail market demand. People never cease needing health innovations.

    Recognizing that, the Charleston Regional Development Alliance (CRDA) and South Carolina Research Authority have backed the industry. CRDA was the first development authority in the state to build map out a strategic plan to attract and retain life science businesses.

    Headwinds for Life Sciences in South Carolina

    Sam Konduros of KOR Medical, a clinical cannabis firm launched by the Charleston-based diagnostic and testing company Vikor Scientific, says South Carolina and SCBIO have created a business climate conducive to the industry, and the health care and advanced manufacturing infrastructure have added tailwinds to its development. Citing Vikor’s growth from 45 employees to 450 during COVID, he says recruiting a talented workforce has not been a significant challenge so far. He notes the usual Charleston quality-of-life benefits – weather, beaches, history, and food, in addition to the growing vibrancy of the industry – as recruiting tools have contributed to the success.

    Ford and Konduros see possible headwinds elsewhere for the industry. Roadways and other transportation infrastructure could use improvement, and housing availability and affordability are statewide issues. For example, the state’s franchise tax, now eliminated by 36 states, penalizes early-stage companies successfully raising venture capital before going to market. In an industry that often spends millions to earn FDA approval prior to commercialization, the tax is a burden, they say.

     September 02, 2021
  • sam patrick posted an article
    Life sciences booming in Spartanburg, Upstate see more

    Spartanburg County – and the entire Upstate – are welcoming a growing interest and investments from life sciences companies. The Upstate has a long-established history and infrastructure that have supported life sciences companies with raw materials, production and packaging operations, and distribution.

    Now, new research and innovation businesses are further supporting industry growth and fueling an ecosystem ripe for start-ups.

    More than 670 life sciences firms of all sizes call the Upstate home, with 13 companies announcing new locations in the area in the last few years.

    The newest of those companies in Spartanburg is Epica International, the leader in advanced, ultra-high-resolution mobile medical imaging and robotic applications for human and animal health, and industrial enterprises.

    The company announced its headquarters and operations in Spartanburg, covering its subsidiary companies Epica Human Health, Epica Animal Health and Roboticom. Epica established corporate, imaging and robotic system demos at its facility, currently located inside the Spark Center SC on the Tyger River Campus of Spartanburg Community College.

    “Epica’s investment in Spartanburg goes hand-in-hand with a diversified economic development strategy we’ve put in place countywide, targeting specifically investments from bioscience and life sciences industries,” said OneSpartanburg, Inc. Chief Economic Development Officer Katherine O’Neill. “These types of advanced, heavy-technology industries coming to our county gives us a considerable strategic advantage for future development and job growth.”

    Another life sciences company – Pall Corporation – announced its intent to invest in Spartanburg County earlier in 2021. Pall announced its Spartanburg County operations would create 425 new jobs and $30.2 million in investment.

    Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies. The company’s Spartanburg facility supports the rapid development of vaccines and therapeutics, including COVID-19 vaccines.

    "Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county,” said Pall Life Sciences President Joseph Repp at the time of the company’s announcement.

    Statewide, South Carolina has a significant presence in the medical device sector. And the manufacturing supply chain is robust when it comes to life sciences, mirroring the strength of the area’s overall manufacturing prowess.

    From 2015-2019, medical devices and equipment companies added 35% more jobs and accounted for 11.5% of the new companies coming to the Upstate. And on top of that, more than 700 clinical trials are being undertaken across the Upstate at any given time in the fields of oncology, companion diagnostics, genetics and more.

    The Upstate in particular has a network of acclaimed hospitals, technical training schools and more than 26 colleges and universities actively working with industry leaders and educators on all levels to ensure access a highly-skilled workforce for decades to come.

    “Spartanburg’s historic advantages when it comes to infrastructure, distribution capabilities and even the county’s location, make it a favorable home for continued investments from biosciences and life science industries,” said O’Neill. “That positions us well for the future as these industries continue to bring higher-wage, knowledge-based jobs to Spartanburg.”

  • sam patrick posted an article
    South Carolina-based firm names new head of pharma and medtech see more

    DUNCAN, SC - Stäubli announced today that Olivier Cremoux has been appointed Deputy Head of Pharma and Medical Device for Stäubli Robotics North America.

    Cremoux joined Stäubli Group in 2015 before transferring to Stäubli Corporation as the North American Business Development Manager for Robotics in 2018. Most recently, he became Key Account Manager – Pharma and will maintain this role throughout the transition period.  Cremoux will use his experience to help build the Medical Robotics team while focusing on the Pharma and Medical Device specific markets.

    Cremoux graduated from the National Institute of Science Applied of Lyon (France) with a bachelor degree in Electrical Engineering.

    Commenting on the announcement, North American Robotics Division Manager, Sebastien Schmitt stated, “We are pleased to announce Mr. Cremoux as Stäubli Robotics North American Deputy Head of Pharma and Medical Device. We believe Mr. Cremoux is the right leader for Pharma and Medical Device as we continue to expand our growing team.  This is an important step in setting up an organization fully dedicated to the pharmaceutical industry to build on our existing expertise in a number of high‑tech markets.”

    Olivier Cremoux: “I am honored by such an opportunity within Stäubli Robotics.  The Pharma and Medical Device is a strategic and growing market in which Stäubli has provided, for over 20 years, significant technological innovations.  High throughput screening, aseptic fill/finish, orthopedic surgery, bio-printing and cell culturing are examples of processes where Stäubli Robotics started as a pioneer and became a reference. With COVID-19 pandemic, robotics became even more essential to our customers, from drug production to Covid test manufacturing.  In North America, we will continue the development of our organization to ensure all current and future needs of our customers.”

    About Stäubli Robotics

    Stäubli Robotics is a leading global player in robotics, consistently delivering engineering as effective and reliable as our service and support. A complete solutions provider for digitally networked production, Stäubli offers a broad range of 4- and 6-axis robots including robotic arms designed specifically for sensitive environments, autonomous mobile robots, driver-less transport systems (AGVs) and cobots for human-robot collaboration.  www.Stäubli.com/robotics 

    About Stäubli North America

    Stäubli North America has more than 200 employees supporting Connectors, Robotics and Textiles customers. The company’s North American headquarters is in Duncan, South Carolina. Stäubli provides customer support through its locations in Duncan, Queretaro, Mexico, and the newest Stäubli North American facility, which opened in 2018 in Novi, Michigan. In addition to 24/7 customer support, each of these facilities offers training and has dedicated on-site technical experts who can be deployed whenever needed. Stäubli’s North American sales force is located strategically on the West and East coasts, and also serves Canada and Puerto Rico.

    Worldwide, Stäubli is a leading manufacturer of quick release couplings, robotics systems and textile machinery. With a workforce of more than 5,500 employees, Stäubli is present in 29 countries supported by a comprehensive distribution network in 50 countries worldwide.

  • sam patrick posted an article
    Agreement expands contract manufacturing services for Zeus customers see more

    Zeus Industrial Products has agreed to integrate catheter-based contract manufacturer CathX Medical into its organization.

    The financial terms of the agreement were not disclosed in yesterday’s announcement.

    San Jose, Calif.–based CathX provides catheter design engineering services, rapid prototyping, manufacturing, and full or sub-assemblies. CathX’s leadership will continue to manage the San Jose facility, services, and team members under the global leadership of Zeus CEO Steve Peterson.

    Zeus (Orangeburg, S.C.) has a core business centered on component manufacturing across medical and industrial markets. However, the integration with CathX extends Zeus’ capabilities to include contract manufacturing services for medical customers.

    “Like Zeus, CathX is very much a ‘people-first’ company,” Peterson said. “We share the same core values across excellence, people, integrity and creativity, and are delighted to welcome the entire CathX team into our Zeus family.”

  • sam patrick posted an article
    Arthrex, Clemson work to resolve workforce pipeline needs see more

    Compliments of GSA Business

    As the biomedical industry continues to expand in South Carolina, so does Arthrex’s need for a specialized workforce. 

    Arthrex, a company engaged in the research, design and manufacture of minimally invasive surgical technology, announced in 2017 plans for its new $69 million facility and the creation of 1,000 new jobs in Sandy Springs. Kevin Grieff, Arthrex senior vice president of operations, said he expects to reach 1,000 employees by 2024.

    A pair of programs with Clemson University helps bridge a divide between science and sales for the company’s future workforce.

    Students like T.J. Biondolillo are also recognizing the need for more specialized education, especially when it comes to blending science and business.

    “Both of the programs have helped my education immensely,” Biondolillo, a senior majoring in biological sciences, said in a news release. “As a biology student, who for the first two years of college had the goal of one day attending dental school, until I shadowed a neighbor who does medical device sales, I had pretty much no selling experience.”

    Soon after the expansion announcement, Arthrex approached Clemson University with an educational partnership opportunity to help students develop the interdisciplinary skills to position them for success in the fast-growing orthopedic medical device field. The result was an educational pilot program designed with the needs of the global medical device industry in mind.

    Arthrex has since expanded its partnership with Clemson, which is just 10 miles from the Sandy Springs location.

    Working with the academic leaders and the Clemson University Office of Corporate Partnerships and Strategic Initiatives, the company has created scholarships and two certificate programs. 

    “Arthrex takes great pride in its commitment to education and we are pleased to help develop the next generation of highly skilled professionals like Arthrex technology consultants who work with orthopedic surgeons to provide trustworthy technical product support,” Arthrex President and founder Reinhold Schmieding said in the release.

    The Sales Innovation Certificate Program and Orthopedic Medical Device Product Specialist certificate programs are designed to enable students from any major to explore medical device technology consulting. Through the programs, students gain knowledge of medical devices and techniques, and gain an introduction to the sales and marketing aspects of medical products. The programs are intended to create a strong pipeline to help support Arthrex’s growing needs in this area, according to the release.

    More than 10 students in the Sales Innovation Certificate Program have been hired by Arthrex in the last two years.

    “Through the strategic partnership with Arthrex, we have worked together to develop one-of-a-kind workforce development programs to support an integral partner need,” Angie Leidinger, vice president of external affairs for Clemson, said in the release. “The success of the pilot programs has showcased the talent of our faculty and students, and we’re excited about the opportunity to continue engaging with Arthrex in mutually beneficial ways that will strengthen educational outcomes while providing them with top-tier talent.”

    After learning about the certificate program, Biondolillo said he jumped at the opportunity to gain the targeted knowledge in medical device sales.

    “The Sales Innovation Program has improved my selling skills and taught me the principles of being a great salesperson and the Orthopedic Device Product Specialist Program has improved my product knowledge from materials used in devices to diagnosing issues and being able to properly convey product benefits,” he said in the release.

    The Sales Innovation Program coursework is tailored to develop students’ business acumen, selling frameworks and presentation ability in order to equip them for roles in health care and medical device sales or related positions. Through the program, students also take part in real-world challenges, foundational role-play exercises and leadership opportunities, the release said.

    The Orthopedic Medical Device Product Specialist Certificate provides students with core competencies in the orthopedic medical device industry with a focus on managing a product throughout its life cycle, including product development and performance relevant to clinical use, and communication of its commercial value.

    In addition to the certificate programs that provide students a pathway to learning about medical device sales, the Arthrex Scholars program provides scholarships to those same students, according to the release.

    Arthrex Scholars was announced in 2019 as a two-year pilot program, with the first scholarships awarded in 2020. Fifteen students pursuing medical device sales careers will receive $5,000 scholarships and a potential summer internship.

    “Under the direction of Ryan Mullins, our Sales Innovation Program has shown an ability to connect students with companies like Arthrex that can potentially lead to sales careers with those organizations,” Jennifer Siemens, department of marketing chair, said in the release. “Arthrex’s investment as an innovation partner in our Sales Innovation Program helps students financially and potentially creates a pipeline to our best and brightest as their next generation of employees.”

    Managed by the Department of Marketing and the Sales Innovation Program team, applications open during the fall semester and are awarded the following spring semester. 

    Arthrex also works with Clemson on several research projects, including a NanoScopeTM Surgical Imaging System reprocessing assessment with bioengineering associate professor Melinda Harma, according to the release.

  • sam patrick posted an article
    Producing and shipping 10,000 Rapid COVID-19 antigen test kits for King of Hammers racing event see more

    Vigilent Labs​, an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats, has completed and shipped its first major order of Alfa Scientific Instant-View COVID-19 Antigen Test Kits for use in the King of Hammers racing event. 

    ”We have worked diligently for months to progressively and proactively execute the safest off-road racing event possible, and we could not have held this event without the help of Vigilent Labs,” said Dave Cole, Lead for the King of Hammers Race and President of Hammerking Productions. "Our innovative partnership with Vigilent Labs enabled us to navigate public health requirements and deploy a comprehensive digital COVID monitoring solution for pre-screening our racing event attendees to ensure their health and safety." 

    This project marks an important milestone for Vigilent Labs and the South Carolina life science sector as the company recently announced that it is investing more than $104.6 million and will create over 400 new jobs at its state-of-the-art COVID-19 test manufacturing facility in the Charleston Navy Yard. 

    "Our Vigilent Labs Medical Systems technology platform is the first digital health credential connecting a real person to a rapid COVID test, taking health surveillance to the Next Level​,​” said John Falk, President of Vigilent Labs. “With the outstanding support from the entire FedEx organization, we were able to quickly get these important COVID-19 test kits into the hands of the King of Hammers organizers, enabling their public event to go forward in California."

    The cost-effective rapid antigen tests, which produce fast and accurate results in seven to 10 minutes, are CE-marked and pursuant to CDC guidance, useful for COVID-19 screening and surveillance. The kits will be immediately put to use by the​ ​King of Hammers Racing​ event, which is being held from January 28 to February 6, 2021, in San Bernardino County, California, to pre-screen attendees for COVID-19. This event is the first widely attended event to deploy the Vigilent Labs’ v.PASS digital credential, the company’s state-of-the-art ​health monitoring solution​, to ensure adherence to​ ​increased federal, state and local safety guidelines​. 

    “We take pride in our dependable, fast and efficient transportation mechanisms, which enabled us to help Vigilent Labs to deliver these COVID-19 antigen tests,” said Elizabeth Tonelis, FedEx Sales Executive. 

    To learn more about Vigilent Labs’ solutions for COVID-19 testing and monitoring, visit www.vigilentlabs.com​. 


    About Vigilent Labs 
    Vigilent Labs is an advanced health and medical technology company that provides solutions for the detection, identification and assessment of health and bio-threats. The company provides point-of-care (POC) medical testing devices, initially centered on the COVID-19 pandemic, paired with a comprehensive digital health and credentialing platform that offers near real-time tracking of disease. Founded in 2019, Vigilent Labs is headquartered in Charleston, South Carolina, with additional manufacturing and production facilities in Laramie, Wyoming and throughout the United States. For more information, visit ​https://vigilentlabs.com/​.