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  • 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
    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/​. 

     

  • sam patrick posted an article
    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. 

  • sam patrick posted an article
    AVX stepping up to fight COVID-19 crisis see more

    To meet the rapid increase in customer demand for critical medical equipment such as lung ventilators, mobile x-ray, CT systems, ultrasound, and patient monitors, AVX  is preparing its plants to actively support the manufacture of all required components to produce the medical equipment needed to prevent the further spread of the COVID-19 virus and treat those who have been infected.

    AVX provides a wide range of components that are critical to medical electronics in general and specifically ventilators. AVX NTCs measure gas and patient temperature. Tantalum and ceramic capacitors as well as Schottky diodes are used throughout the power supply system that powers the pumps, motors, displays, and control logic in ventilators. TransGuards are used as transient voltage protection on interfaces, keyboards, touch screens and audio alarms.

    AVX provides a wide range of components that are critical to medical electronics in general and specifically ventilators. (Credit: AVX)
     

    “All of us, at every level, function and business, feel the significance and the intensity surrounding the worldwide COVID-19 pandemic situation, both in our personal and professional lives. Teams across the company have been meeting daily to address critical employee and customer issues. What motivates AVX every day is knowing that despite the current situation, we are rising to the challenge as our manufacturing plants continue to deliver for our customers around the globe,” the company notes.

    In a recent example, AVX has committed to fast delivery of high-grade tantalum capacitors from its plant in Lanskroun, Czech Republic, directly to UK Smith Medical company in urgent need for building 10,000 ventilators for hospitals and healthcare institutions. The requirement for three TRJ series part types were processed with top urgency to deliver it in the shortest term while keeping its high-quality standard.

    According to the company, the plants continue to give their best effort to deliver all parts as soon as possible, with the shortest possible lead times with a focus on functioning effectively and efficiently to minimize all delays.

  • sam patrick posted an article
    Arthrex has completed construction on their new South Carolina manufacturing facility see more

    Brasfield & Gorrie recently completed construction on a new manufacturing facility in Anderson for Arthrex, a global orthopedic medical device company headquartered in Naples, Florida.

    The $36.1 million project includes a 250,000 square foot medical device manufacturing building and a 30,000 square foot central services building. The manufacturing building consists of 175,000 square feet of manufacturing floor space and 20,000 square feet of clean room assembly space for sterile packaging activities for all manufactured medical devices. The remainder of the building is a two-story office space for support staff.  Click here for the full story.

  • sam patrick posted an article
    Life sciences in South Carolina is big business -- and getting bigger by the day. Read why... see more

    In this article published simultaneously in Charleston Business Magazine, Columbia Business Magazine and Greenville Business Magazine, SCBIO CEO Sam Konduros paints a picture of the diversity of the rapidly-growing life sciences industry, and why the future is exceedingly bright -- and getting brighter -- as the $11.4 billion industry soars to new heights across South Carolina.

     

    Life sciences in South Carolina spans a diverse spectrum—from major pharmaceutical companies to globally known medical device companies.

    It encompasses start-ups and early stage innovation companies and embraces prestigious research universities and acclaimed health care systems employing some of America’s finest minds. It includes research and medical labs, bioscience-related distribution, even Bio-Ag tied to the state’s historical agricultural segment. Click to read complete article...

     September 05, 2018
  • sam patrick posted an article
    Clemson and Arthrex are launching a program to teach students and support the med device industry see more

    The surgical device industry is continuously growing and evolving. According to data from GlobalData, the orthopedics market is expected to grow to $66 billion by 2023 from $52.8 billion in 2017.  In South Carolina, medical devices are an anchor of the state's fast-growing and globally respected life sciences industry, according to executives with SCBIO -- the Palmetto State's life sciences industry organization and champion.

    In response to this upward trend, surgical device companies are seeking more employees with a specialized skillset, and thanks to a new partnership with Arthrex Inc., Clemson University students will be equipped to answer the call.

    A global leader in minimally invasive orthopedics, Arthrex already works with Clemson on a number of research projects. Now it’s expanding its engagement with the university through a new, two-year pilot program developed with the needs of the surgical device industry in mind and a generous gift of ten $7,500 scholarships.

    “Arthrex is one of the university’s valuable strategic partners, and this opportunity to work together to create programming unique to Clemson speaks volumes about what the company thinks of our talented faculty and students,” said Clemson President James P. Clements. “This partnership is another example of Clemson’s ongoing commitment to the state of South Carolina, and I am grateful to Arthrex for its generous gift, which will enable our students to work with a world-class company to develop skills that are vital to the surgical device industry.” 

    “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,” said Arthrex President and founder Reinhold Schmieding.

    In October 2017, Arthrex announced plans for a new $40 million facility in Sandy Springs, South Carolina. Surgical devices will be manufactured in the 290,000-square-foot facility, which is scheduled to open this summer. The new location is part of Arthrex’s efforts to expand its manufacturing base into South Carolina to create new products and jobs in America.

    The pilot program will span two years and comprise a series of courses, Arthrex internships and additional learning opportunities for rising third-year students majoring in bioengineering, marketing and health sciences departments.

    MKT 4950 Developing and Selling Medical Devices is the first course being offered in the series and will begin in fall 2019. Taught by Ryan Mullins in the College of Business, course material provides students an introduction to the health care industry with a focus on the development and marketing of surgical device innovations. Mullins was selected to develop the course as the Provost’s Inaugural Innovation Fellow, a program created to encourage faculty on campus to support corporate engagement efforts.

    “Our collaboration with Arthrex helps us create a new type of focused course,” said Mullins. “We will walk students through real case studies at Arthrex to understand how surgical devices get translated from marketable idea to surgeon or physician adoption. This helps us illustrate the challenges inherent to both the health care marketplace and marketing of new offerings, which is not taught anywhere else.”

    Students who are enrolled in the course may apply for the scholarship and additional programs offered as part of the two-year series of courses. Those who would like to participate in the entire program will take Student Affairs’ Certified Student Leader Program in the spring and an internship with Arthrex in the summer. Students outside of the participating departments can also intern with Arthrex by working with their advisers and the career center.

    This partnership was developed through Clemson’s Office of Corporate Partnerships and Strategic Initiatives. Additional details regarding the scholarship, internship and second-year courses will be available soon.

  • sam patrick posted an article
    Grant to fund creation of the South Carolina Medical Device Alliance to invent and develop products see more

    SCRA has been awarded approximately $750,000 in federal grant funding by the U.S. Economic Development Administration (EDA) as part of the 2018 Regional Innovation Strategies Competition. The grant will fund the creation of the South Carolina Medical Device Alliance to invent and develop products and bring them to market. This partnership, comprised of Clemson University, the Medical University of South Carolina and industry leaders, will form a regional innovation cluster to grow the economic impact of the medical device industry through job creation and startup formation, as well as to attract international businesses to establish a presence in South Carolina. The project total is $1,814,846, which includes the federal grant funding and matching funds.

    “We are honored to be one of forty recipients nationwide,” said Christine Dixon Thiesing, SCRA’s Director of Academic Programs. “This program will serve South Carolina’s academic institutions and clinical innovators to overcome challenges inherent in the commercialization of medical devices. Building the medical device sector will also diversify South Carolina’s economy strategically by leveraging the existing skilled workforce and fostering a broader range of job opportunities for its workers.”

    The Office of Innovation and Entrepreneurship, housed within the U.S. Department of Commerce’s Economic Development Administration, leads the Regional Innovation Strategies Program to spur innovation capacity-building activities in regions across the nation.

    “MUSC’s Foundation for Research Development (FRD) is excited to be partnering with SCRA on this project,” said Michael Rusnak, Executive Director of FRD. “This gives MUSC one more vehicle to advance medical device technologies through our company startup activities; a substantial win for local economic development and more importantly, patients.”

    To learn more about the South Carolina Medical Device Alliance, including the scope of work and key personnel click here.

    SCRA is a state-chartered organization that fuels South Carolina’s innovation economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.

  • sam patrick posted an article
    Building the business of life sciences in South Carolina has become the call to action of SCBIO... see more

    Building the business of life sciences in South Carolina has become the call to action and theme of the 2017 annual conference of the S.C. Biotechnology Organization (SCBIO).  The rapidly evolving statewide industry association is featured in this September 2017 issue of Charleston Business Magazine, and will be featured in October 2017 issues of Columbia Business and Greenville Business as well.  Click here for the full article.

     September 26, 2017