South Carolina's Rhythmlink acquires California-based med device manufacturer see more
COLUMBIA, SOUTH CAROLINA – Rhythmlink International, LLC is pleased to announce an exciting new investment, the acquisition of Chalgren Enterprises, a California-based medical device manufacturer that will add to their already extensive portfolio of products for brain and nervous system monitoring.
As a market leading designer and manufacturer of disposable neurodiagnostic devices and consumables, Rhythmlink has been quickly growing, even during an otherwise challenging year. Chalgren Enterprises provided another growth opportunity with a close alignment of culture, values, and product manufacturing expertise. The acquisition was completed on December 11, 2020.
“Chalgren is a good fit for our first acquisition both because of their experience in our industry and the way our cultures and missions align,” said Shawn Regan, CEO and Co-Founder of Rhythmlink. “Even with minimal changes we believe within the first year we’ll be able to take the Chalgren line of products and apply our manufacturing and sales best practices to see extensive growth.”
Chalgren Enterprises has been manufacturing electrodes for neurodiagnostics, specializing in EMG electrodes, for over 50 years. For the last 30 years Chalgren has been run by the father and son team of Richard and Michael Kaiser, who have seen the industry evolve from reusable to disposable products, product innovations, and a host of market and regulatory changes that have defined neurodiagnostic medical devices. Their reputation in the EMG market especially made them an appealing partner for Rhythmlink.
“Chalgren’s extensive experience is a good match for our innovation and steady growth,” said Regan. “Taking on their EMG products and legacy knowledge of EEG is a natural fit for our existing product lines and helps us encompass the full need of products that connect patients to machines.”
With the acquisition of Chalgren, Rhythmlink International will now offer products for epilepsy monitoring, electroencephalography, electromyography, evoked potentials, polysomnography, intraoperative monitoring and more, better serving the needs of neurologists and critical care providers through one company.
Regan concluded, “The culture we have built at Rhythmlink and our reputation in the marketplace are incredibly important to us, and Chalgren comes to us with more similarities than differences. We wanted growth that would ensure this dynamic would stay intact, and we’re excited about the future of these products and our company.”
Rhythmlink International is a medical device manufacturing company specializing in devices that help connect patients to machines to record or elicit physiologic information. Rhythmlink designs, manufactures and distributes a variety of medical devices for intraoperative neuromonitoring, electroencephalography, evoked potentials, polysomnography, long-term monitoring epilepsy and critical care units. Founded by neurodiagnostic technologists and engineers in 2002, Rhythmlink enhances patient care worldwide by transforming medical device technology that links patients to equipment. Rhythmlink also offers custom packaging, custom products, private labeling and contract manufacturing services.
Zverse steps up for South Carolina see more
John Carrington remembers the chaos from the spreading coronavirus reaching his small Columbia, S.C., company about Saturday, March 14, three days after the World Health Organization declared Covid-19 a pandemic.
It started with a phone call from a hospital executive that Saturday saying the hospital was running critically short of personal protective equipment (PPE), ventilator parts, and ventilators altogether. “What can you do?,” the hospital executive asked.
The Zverse CEO recalled that the executive “was pretty urgent,” and the gist of the message was open-ended: “We need a lot of problems solved and fast, and how can you help?”
How indeed? Carrington couldn’t offer the hospital a catalog of PPE, or a catalog of anything.
His workers were specialists in being manufacturing enablers, providing software and a cadre of experts who linked customers with ideas with manufacturing partners to convert those ideas into objects as quickly and efficiently as possible.
Within days, the company would shift into designing its own face shields for use in hospitals, later designing other models for schools or other crowded spaces.
Zverse would go from being able to make 1,000 face shields a day using 3-D printers to making the heavy investments to build molds for injection molding that allowed its production rate to climb to 120,000 units per day within about a month. That process would typically take about two or three months.
In March, Zverse had 20 employees. By September, it had 80. It expects to end the year with 100 to 120 employees — more designers, product managers, account managers, customer service and support, shipping and logistics specialists.
“It’s been a wild ride,” Carrington said.
Zverse is just one of hundreds of South Carolina businesses that were called to action by the pandemic and responded with innovations to help their customers and communities in a time of need. Several of those companies in the biotech field were highlighted in an Aug. 25 webinar by SCBIO, a not-for-profit industry association promoting the life sciences in South Carolina.
The others were:
VitaLink Research, a clinical research site network based in Greenville. VitaLink was commissioned by Moderna to conduct its Covid-19 vaccine study in South Carolina.
Vikor Scientific LLC, a Charleston testing laboratory founded in May 2018 by physician and entrepreneur Shea Harrelson and medical entrepreneur Scotty Branch. Its lab is accredited by the Centers for Medicare and Medicaid Services under its Clinical Laboratory Improvement Amendments (CLIA) certification. They have dedicated 2,000 square feet of its new 22,000-square-foot facility to Covid-19 testing. In late August it was testing about 10,000 Covid-19 swabs per day, and had the capacity to test for 20,000 per day.
Nephron Pharmaceuticals Corp., a West Columbia manufacturer of medical products and a leading producer of medical products packaged into single doses using blow-fill seal technology. It is creating space at its Lexington County plant to manufacture vaccine doses when they become available. Since the pandemic, it has created a CLIA-certified lab for Covid-19 testing, and has a mobile lab that visits the University of South Carolina and several area employers.
Modjoul Inc., founded in Clemson in 2016 by Eric Martinez, CEO, and Jen Thorson, COO. Modjoul sells a platform designed to enhance worker safety by having them wear a device called a SmartBelt that tracks their movements. Linked software identifies movements that might be dangerous — from certain bending movements to overly fast cornering with a forklift. With Covid-19, it is enabling employers to use the devices to screen body temperatures and signal workers with a vibration if they are violating social distancing. In the event of an outbreak, the data can be used for rapid contact tracing.
“When you think about it, you’re able to reduce the amount of time businesses are shut down because you know who people have been in contact with,” Thorson said. “It’s one of those happy coincidences that we’re able to use our existing device, not only for safety, but also for that illness, contact tracing and social distancing.”
Thorson said her biggest lesson from the pandemic has been “don’t be afraid to pivot quickly.”
“We have a team of really smart people, and we can figure out almost any problem,” she said.
At Nephron Pharmaceuticals in Lexington County, one of their biggest lines is generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with Covid-19.
The company has grown from 75 employees with two products in 2001 to about 80 products and about 1,100 full-time employees, in addition to 900 part-time workers, interns and apprentices. It announced an expansion this year that will expand its buildings to cover 1 million square feet by early 2021. It expects to add 380 more full-time employees by 2024, and much of the hiring is now underway.
“We want them to be trained and ready as the new buildings come online,” CEO Lou Kennedy said.
About 110,000 square feet of its expansion is for manufacturing vaccine doses, antibiotics or other chemo-therapeutic agents. Nephron Pharmaceuticals is one of seven U.S. companies identified by the federal government as key to getting a vaccine produced — once one has been developed.
“We know we’re going to need a heck of a lot of vaccines all at once if we’re going to get everybody healthy,” she said. “We are doing anything we can within our bandwidth to be patriotic Americans and help with the eradication of Covid-19.”
The New York Times first reported Jan. 8 on the emergence of a novel coronavirus in China’s Wuhan province. Two days later, China reported its first death from the virus.
The first case in the United States was confirmed Jan. 21.
On Feb. 11, the World Health Organization named the disease Covid-19.
By Feb. 26 there were 60 known cases in the United States, and Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, asked the American public to brace itself for a global pandemic.
That day President Trump said infections were “going very substantially down,” and that “we’re going to be pretty soon at only five people.”
Just two weeks later, when Covid-19 was declared a global pandemic, there were at least 1,240 people in 42 states and Washington, D.C., who had tested positive for Covid-19, and 37 had died.
Meanwhile, a wave of change was rolling toward Carrington’s 7-year-old company on Shop Road, named for its location by Columbia’s Norfolk-Southern railroad repair shops and better known for parking for UofSC football games.
His children were home from school, many offices were closing and employees were working from home — if at all.
“It was interesting,” he said. “We were not sure what this meant for us, let alone as a business, because a lot of our manufacturing customers’ factories shut down as well.”
After the weekend call from the hospital executive, Carrington tried to solve its first problem: The hospital needed fully protective face shields that could be worn in the intensive care unit, or other areas with dense aerosols.
“Literally overnight, we went from concept to prototype, rapid prototyping, multiple iterations,” Carrington said. “They were asking for 3,000 units, which was no problem. And they needed them immediately.”
The next day, Zverse got a call from a government agency that needed 10,000 face shields. And on the third day, another hospital system called needing 50,000 shields.
The second hospital system needed face shields that could be sterilized and reused because they were going through disposables at a rate of 5,000 per day for just one of its hospitals.
While 3-D printers are splendid devices for fast turnaround and multiple design changes, they are not designed for a lot of volume.
And 50,000 units is what Carrington defined as “a lot of volume.”
So, it was decision time.
More calls were coming in. “Once the word got out to a few people, we started getting direct messages from doctors, family members of nurses, who were all pleading for help, because there was no PPP at all,” Carrington said.
The mulling was not a long process. The company simply wouldn’t be able to keep up with demand using 3-D printers.
So after the call for 50,000 units, Carrington decided to move from the 3-D printing underway to injection molding, “which was a significant step, because it was a real capital investment during a time when everything was very uncertain.”
But he knew it would also allow Zverse to ramp up much more dramatically, “help a lot more people, help the company and give us a little bit more security.”
The actual injection molding would be done by outside manufacturers, but Zverse had to supply them with the molds.
According to Rex Plastics of Vancouver, Wash., an injection mold can cost $1,000 to $80,000 depending on size and complexity. A typical mold costs $12,000.
Zverse dealt with the issue by requiring its customers to pay half the cost up front. Hospitals typically pay net 30, or 30 days after invoice, but they quickly agreed. “These are different times,” Carrington said.
“We were able to get the first 5,000 units coming out of the first mold within about two weeks.”
In all, Zverse built about 24 tools for injection molding.
Carrington credited much of the company’s success to its network of manufacturers.
“We had all the right people in our ecosystem to accomplish all this.
“We sit in the middle of a lot of manufacturing capabilities. That’s what we’ve done forever,” he said. “This is the first time we took a product of our own and went to market with it.”
After injection molding was in place, Zverse spread the word that it had the capacity to make 100,000 units a day — mass manufacturing.
“We got flooded with orders from every hospital, every government agency you can imagine,” he said. “It was completely overwhelming.”
Carrington started calling his shareholders and others in his support network to solve emerging problems, like transportation logistics.
“That whole period was insane for everyone involved,” he said. “But it was super fulfilling.”
One of Zverse’s biggest contracts was for the U.S. Department of Veterans Affairs for 2 million face shields. At the time, there were reports about suppliers not being able to deliver equipment and PPE to the VA.
But Zverse supplied the order from April through June.
“That was a herculean effort to be able to deliver that on time,” he said. “The VA said we were one of the best suppliers that they had.”
In all, Zverse supplied 3 million of its health model ZShields over 75 days.
As businesses began trying to reopen in May, there was a broad need for some forms of barriers and PPE —a need that is likely to last beyond the pandemic.
Some restaurants called for the face shields Zverse was delivering to hospitals.
“I looked at them and said if I walked into a restaurant and saw someone wearing this, I wouldn’t want to eat there. That’s going to be bad for business,” he said.
Instead, Zverse designed ZShield Plex —something that would be a comfortable and effective barrier from transferring droplets from your mouth. The shield attaches at the neck and can flip down when on break or away from where needed.
“That one captured everyone’s attention,” he said.
Zverse started taking pre-orders for the shield in May from businesses, schools and others, and has since shipped millions.
Carrington said Zverse was able to make its huge pivot to meet the demands of the pandemic moment with “brute force and an incredible team.”
“The core group that’s been here since March has been averaging like 16-hour days since March, including weekends,” he said. “Everyone is driven by the fact that we’re able to produce something that is able to solve problems.
“Right now the world needs a lot of problems solved,” Carrington said.
“I don’t think there’s been a time in history when the world has needed as much innovation in one moment as it does right now.”
Over twenty experts to speak on major business issues see more
Subject matter leaders from across state, nation to cover what business needs to know to thrive despite pandemic, how to leverage state’s fastest-growing knowledge economy segment
SOUTH CAROLINA – September 2, 2020 – SCBIO will host a half-day virtual program September 23 -- Life Sciences Boot Camp: Building Your Brand & Business In a Pandemic – to inform and connect businesses, educators and professionals from across the state on leveraging opportunities, identifying trends and overcoming challenges that face organizations interested in tapping into South Carolina’s fastest-growing industry segment.
To be held completely online, the program will run from 8:15 a.m. until 12:15 p.m. on Wednesday, September 23rd. The program is delivered free to all SCBIO Members and Investors, and for a nominal fee of $50 to all non-Members. Students and media may also attend free of charge. Six sessions featuring over 20 noted presenters will precede a closing Virtual Networking Session for all attendees. Confirmed topics and speakers include:
- Search for a Cure: A National Update on the Global Pandemic – featuring a live national report from PhRMA executive Sharon Lamberton on success in battling the COVID-19 pandemic, and what lies ahead for America
- Marketing in a Pandemic: Building Your Brand & Your Topline – despite the economic turndown, some businesses are enjoying even great success – and are positioning themselves for an even better future. Learn the secrets to thriving, not surviving, during and after the pandemic from Henry Pellerin of Vantage Point, Heather Hoopes-Matthews of NP Strategy and Jessica Cokins of Thorne Research
- Best Practices in Talent Recruiting, Retention & Development – Nephron's Lou Kennedy, Arthrex's Jimmy Dascani and ERG's Matt Vaadi share how the state’s life sciences leaders are attracting, training and retaining top talent – and offer ideas your organization can deploy right now
- Partnering Effectively with Higher Education & Research Universities – tap into the wealth of resources, knowledge and experience prevalent in the state’s research universities to enhance innovation and success. Enjoy insights from Chad Hardaway of USC’s Office of Economic Engagement, Michael Rusnak of MUSC’s Foundation for Research Development, and Angela Lockman of Clemson
- Leading Virtual Teams Effectively – the pandemic has showed us that working virtually is here to stay. Find out how to make your organization collaborate seamlessly, efficiently and effectively -- wherever your colleagues are located -- from Annie McCoy of ChartSpan, Andrew Collins of Alcami and Jenni Dunlap of Parker Poe
- Pivoting with a Partner: Collaborating to Grow Your Business – learn how to successfully identify and partner with other organizations to expand and enhance product/service offerings. Hear incredible stories from the teams at Zverse/Phoenix Specialty and Rhythmlink, ZIAN and MUSC as they share their stories -- and how you can find your next great opportunity.
The program will end with a Virtual Networking session offering attendees to chat with leading economic development professionals including Stephanie Few of Womble Bond Dickinson, Tushar Chikhliker of Nexsen Pruet, and John Osborne of Good Growth Capital for conversations on Onshoring, Incentives, Accessing Capital and more.
To register or for more details, visit the Events page. Interested students and media members are invited to attend, with advance registration, at no cost.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 675 firms directly involved and 43,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. Life sciences is recognized as the fastest-growing segment of South Carolina’s knowledge economy.
For additional information on SCBIO, visit www.SCBIO.org.
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.
Rhythmlink International, LLC today announced a new patent licensing agreement... see more
Rhythmlink International, LLC today announced a new patent licensing agreement with Dignity Health that includes broad coverage for improving and expanding brain health monitoring options for caregivers and patients. Dignity Health’s US Patent Number 9,345,418 was protected and commercialized by the Dignity Health Intellectual Property Office and covers an EEG Net with Transmission Capabilities. This proprietary technology allows quick and easy collection of EEG data and distribution to medical equipment and health care personnel for analysis and intervention. This device is easy to use allowing staff the ability to monitor the brain anywhere anytime maximizing workflow efficiencies and freeing up existing EEG Neurodiagnostic staff, or other cross trained professionals, to be more productive in the patient care setting. Read full article...