Syndigo Introduces Comprehensive Global UDI Solution for Medical Device Manufacturers via CXH
Syndigo, a leading provider of verified product content syndication services, announced the addition of Unique Device Identifier (UDI) compliant product information for medical device manufacturers, enabling syndication to healthcare systems providers through its Content Experience Hub (CXH) platform. This expansion of product content coverage for Class I through Class III medical devices complements Syndigo’s existing portfolio of over-the-counter medical supplies and foodservice content used in retail and institutional healthcare capacities.
The added content functionality is designed to meet the expanding UDI standards around the world. It is estimated that as many as ten regulatory agencies will release new and unique UDI Requirements over the next five years.
“As the healthcare market continues to grow, the need for product content and standards has also grown,” said Syndigo Chief Commercial Officer Justin Hartanov. “This aligns with our vision of enabling commerce in the sectors and markets our clients need the most. The healthcare industry can now enjoy a full spectrum of accurate, validated product content to feed their enterprise systems while complying with the necessary regulatory requirements.”
Syndigo’s global UDI capabilities for medical devices are available for FDA GUDID requirements and will soon expand to additional markets including South Korea, Turkey, Saudi Arabia, European Union and China, as countries publish their unique UDI requirements over the next 24 months.
“Medical device manufacturers often lament that there isn’t a single UDI standard that satisfies all countries’ regulatory bodies,” said Mike Lapchick, Syndigo SVP/GM of Global Healthcare. “Syndigo’s new UDI submission solution was designed to solve this challenge globally.”
About Syndigo
Syndigo enables commerce by supporting the efficient transfer of information between brands and their customers. We provide descriptive product and nutritional information, images and other digital media, powered by deep analytics to empower engaging brand experiences online and in store. Through Syndigo’s integrated platform, Content Experience Hub, clients can publish, manage, syndicate and audit their product content across the largest trading network of brands and recipients in the world. Syndigo is a GS1 Certified Identification Partner and GDSN data pool.
Syndigo serves more than 10,000 brands and 1,500 retailers globally in many important consumer industries including grocery, foodservice, hardlines, home improvement/DIY, pet, health and beauty, automotive, apparel, and healthcare products.
Healthcare Supply Chain Intelligence Challenges and the road ahead
Supply chain intelligence (SCI) is crucial in Asia – a region that is seeing dynamic growth and increasing complexities particularly in the pharma and healthcare sectors. For customers in these industries, full visibility of supply chains through big data and AI is increasingly critical. This article explores how SCI technologies can provide strategic information to decision-makers for better-quality supply chains and how logistics providers will aid compliance and cost optimisation for their healthcare customers.
Supply chains in Asia are fast evolving into smarter, technology-driven systems for a dynamic healthcare industry. In today’s digital marketplace, supply chains are becoming highly interconnected and competitive. Now more than ever, investment in supply chains is taking on a strategic priority in Asia. Supply Chain Intelligence is a key area of focus empowering pharma business operators to better track the entire supply chain, get real-time performance insights and get full visibility along the entire process so they are in a better position to tackle today’s global complexities surrounding supply chains. Supply chain investment is a priority in order to enhance intelligence in the system itself so that supply chains continue to modernise.
Role of Supply Chain Intelligence in healthcare logistics
Generally, the supply chain refers to the resources needed to deliver goods or services to a customer. Managing the supply chain in healthcare is typically a very complex and fragmented process. Due to increasing competition, rising costs, government regulations, and demand for a higher quality of service, healthcare providers are under enormous pressure.
Logistics is the gateway for pharmaceutical companies to bring their products to a global marketplace at minimal risks. Given the diversified locations, mergers, multiple information systems, changing organizational structures across the globe, supply chain leaders in healthcare and pharma need to optimize supply usage throughout the enterprise. The real value-add lies in innovation. A strong technology-backed supply chain can provide deeper, better insights into transportation including temperature control and cost optimization.
Complete Visibility and Real-time Tracking will be game changers
Products, such as vaccines, bio-pharmaceuticals and cell therapies, need to be transported under stringent environmental conditions where temperature, humidity, light exposure and other variables are tightly controlled. Tracking and monitoring the ingredients from supplier to factory, measuring temperature, time and the location to deliver reliable data and a clear line of sight at every stage is critical. This level of visibility and tracking are the top areas which can really help supply chain leaders – and therefore, healthcare and pharma providers – to identify efficiencies and gaps and then tie that to their business profitability.
Historical data can allow supply chain providers to deploy optimal packaging designs and utilize cold storage facilities during transportation, while real-time data analysis can flag specific shipments where intervention is required immediately to save a product. For instance, FedEx regulatory compliance is supported by end-to-end tracking technologies which generate extensive data and continuous visibility on bio-pharmaceutical shipments.
One example is the SenseAware service—a FedEx innovation—that monitors temperature, humidity, light exposure, shock events, and other environmental factors that can impact supply chain integrity. The combined multi-sensor device can gather, send and monitor data, enabling a comprehensive array of real-time tracking. Customers have a clear line of sight at every stage and identify and solve potential risks along a complex supply chain.
FedEx supports clinical trial projects by providing greater transparency throughout the supply chain. It will not only make the customers’ life easier but also elevate their business and help them connect to a larger network in APAC and worldwide. To add, automation will continue to improve, and automated tracking systems will help to reduce the need for manual inventory management as well as considerably reduce drug wastage due to expiration and spoilage, since facility personnel can be proactively alerted to the status of products in storage. With inventory data digitized, healthcare facilities can work faster, and with added accuracy, to better meet accreditation and government regulation requirements.
Big Data will be central to predicting and mitigating risk
Data and AI will play a key role in supply chain management and will empower business operators to conduct real-time data analysis. Modern-day Supply Chain Intelligence (SCI) is digitally driven and can better help companies slash costs and increase customer satisfaction by combining data and analytics to draw out patterns and look into the future. Broadly speaking, supply chain management (SCM) technologies will enhance operational and transactional efficiencies in manufacturing, sourcing, and distribution. SCI technologies can integrate business intelligence with data from SCM systems, providing strategic information to decision-makers. By harnessing data and innovating with technology, manufacturers and their logistics providers can further customize solutions and effectively close the shortage gaps.
Predictive analytics can enable scientists to identify patterns and gaps, and suggest efficiencies, revenue opportunities, potential problems or competitive advantages. Real-time data can be processed by manufacturers and their supply chain vendors through descriptive analytics to reveal operations patterns. Companies can forecast how their supply chain may evolve, and develop risk-mitigation strategies to fix identified weaknesses.
Logistics is the gateway for pharmaceutical companies to bring their products to a global marketplace at minimal risks.
Logistics can drive the development of healthcare industry supply chain
The future of the healthcare industry will be global and borderless. The biopharmaceutical boom in Asia is calling for the adoption of new technologies and higher quality cold chain services. With innovative solutions such as “Smart” medical inventory cabinets and sensor-based technologies, FedEx, a logistics industry leader for healthcare and other specialty shipments, continues to identify innovative ways to provide the visibility required by customers up and down the supply chain.
Accurate forecasting, faster response times, ability to recognize shipping patterns to plan for risk, saving on costs, in addition to running a low-to-zero waste operation will be key parameters for the industry to measure business efficiencies, supplemented by effective supply chain intelligence. Logistics companies must continue to enhance their solutions and remain focused on innovation to aid compliance and cost optimization for their customers in the healthcare industry.
Accurate forecasting, faster response times, ability to recognise shipping patterns to plan for risk, saving on costs, in addition to running a low-to-zero waste operation will be key parameters for the industry to measure business efficiencies, supplemented by effective supply chain intelligence. Logistics companies must continue to enhance their solutions and remain focused on innovation to aid compliance and cost optimisation for their customers in the healthcare industry.
SAM Medical Launches New SAM IO Intraosseous Access System
SAM Medical, an industry leader committed to developing and manufacturing the most innovative trauma care medical devices, announced the launch of the SAM IO Intraosseous Access System for pre-hospital and hospital healthcare providers in the civilian and military sectors. Designed to be an effective and intuitive alternative solution to intraosseous access, the SAM IO’s unique manually powered and multi-use driver offers medical professionals the ability to quickly and easily administer critical fluids and medications into a patient’s vascular system through the bone marrow during emergency situations.
“At SAM Medical, we are dedicated to bringing emergency medical professionals the most cutting-edge, innovative and easy to use trauma care devices,” said Randy Reed, President of SAM Medical. “With the launch of the SAM IO, we are excited to offer a user-friendly, cost-conscious and more reliable option for providing quick and safe access to a patient’s vascular system when an IV is not feasible.”
At its core, the SAM IO is comprised of two main components: a driver and a needle assembly. The needle assembly, including a catheter and stylet, is secured to the driver via a snap-fit design. The needle is then introduced through the soft tissue of either the proximal humerus, proximal tibia, distal tibia, or distal femur (pediatrics only). Once the needle tip is in contact with bone, the driver handle is actuated, producing rotational control of the needle assembly. The cutting flutes of the catheter drill through cortical bone until the needle assembly is introduced into the bone marrow. The driver and stylet are then removed from the catheter.
SAM IO Intraosseous Access System Overview
- SAM IO Needles: A stylet and catheter assembly secured by a snap-fit connection. 15 mm, 25 mm, and 45 mm lengths are intended to address a broad range of patient demographics and multiple application sites. Needle tip geometry has been optimized to penetrate cortical bone efficiently. Intuitive color-coding and depth indication markers adhere to industry standards.
- NeedleVISE™: Single-use sharps containment device for the stylet.
- Extension Tubing: Connects to the catheter for flexible infusion.
- SAM IO Adaptor: Attaches to the SAM IO Driver to accommodate alternative IO needles.
- SAM IO Stabilizer: Cylinder design intended to protect the catheter from dislodgement.
- SAM IO Driver: A multi-use manually operated intraosseous access driver. Drills the needle into bone without reliance on battery power.
Availability and Additional Information
The SAM IO Intraosseous Access System has received FDA clearance and is now available in the US. The SAM IO will be available to worldwide markets as registration in each country is obtained. If you have questions about availability in your country, please contact Denise Ehlert at the number or email below. To see the new SAM IO at launch, visit the SAM Medical team at EMS 2020, booth #943. Additional products available for demo include the SAM XT, SAM Splint, SAM Pelvic Sling II, SAM Chest Seal, SAM Junctional Tourniquet, ChitoSAM 100 and SAM Soft Shell.
About SAM Medical
For over 30 years, SAM Medical has developed and manufactured innovative medical products used by military, law enforcement, emergency, wilderness and sports medicine, and pre-hospital care around the world. A resounding favorite of medical professionals, SAM Medical’s lineup of products is engineered to save lives. Innovations include SAM XT Extremity Tourniquet, SAM IO Intraosseous Access System, SAM Splint, SAM Chest Seal, SAM Junctional Tourniquet, SAM Pelvic Sling, ChitoSAM, and SAM Soft Shell Splint.
TransUnion partners with VisitPay to transform patient financial experience
TransUnion has announced a partnership with VisitPay, an online patient financial engagement and revenue recovery platform. Together both the companies are creating a comprehensive solution for healthcare providers that redefines the revenue cycle category.
The partnership helps TransUnion to extend its Revenue Protection solution to government and commercial insurance into patient payment, improving the patient experience while maximising provider revenue. Together the companies will be providing an end to end patient payment experience, linking estimation with back-end billing and creating a data-driven feedback loop for providers to improve estimate accuracy, financial performance and patient satisfaction. Patients through the solution will be able to select a personalised payment option that best meets their needs.
“As we explored the patient financial experience market it became clear that VisitPay was the best partner to complement TransUnion’s comprehensive revenue protection solutions. They engage patients to make the billing process understandable and easy to navigate. With our commitment to create a positive patient experience, it’s a natural next step for both companies to expand our reach in order to support healthcare consumers in a new way and offer a comprehensive solution to providers. Further, TransUnion will provide tools to help hospitals convert earned revenue into cash at all stages of the revenue cycle, and from all payment sources,” said Dave Wojczynski, president of TransUnion Healthcare.
In addition to offering VisitPay as a standalone platform, TransUnion Healthcare will be integrating its patient access solutions with VisitPay’s. VisitPay has recently partnered with Sphere to launch Text to Pay solution for healthcare.
“We’re excited to partner with TransUnion and transform the patient financial experience from pre-service through post-service. Together our integrated technology will deliver a first of its kind financial experience for healthcare providers and patients,” said Kent Ivanoff, Co-Founder and CEO, VisitPay.
TransUnion is a global information and insights company that makes trust possible between businesses and consumers. TransUnion Healthcare, a wholly-owned subsidiary of TransUnion, makes mutual trust possible between patients, providers, and payers by helping them navigate payment uncertainty. TransUnion Healthcare touts to help over 1,850 hospitals and 550,000 physicians collectively recover more than $1.2 billion annually in revenue.
FDA clears Fresenius Medical Cares Novalung for treatment of acute respiratory and cardiopulmonary failure
Fresenius Medical Care, the world’s leading provider of dialysis products and services, announced that the U.S. FDA has cleared Novalung , a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure. Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support. The company expects Novalung to be available within the U.S. mid-year 2020.
Patients in acute respiratory or cardiopulmonary failure often struggle to get oxygen into their bloodstream or expel carbon dioxide out of their bodies, resulting in dangerously low levels of oxygen. This acute low oxygen state can result from a wide range of conditions.
The Novalung ECMO system pumps and oxygenates a patient’s blood, reducing the stress on damaged heart and lungs. Novalung offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs, and emergency departments.
The use of Novalung as an ECMO device for critical care has several benefits, including minimizing the need for invasive ventilation, the ability to provide support after multi-organ injuries, and better survival outcomes for patients in cardiac arrest.
Novalung ECMO System
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.5 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,994 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 345,096 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of related medical services in the field of Care Coordination. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).
QuestionPro Buys Healthcare CX Firm Care Experience
Dallas, TX-based Care Experience offers a patient feedback platform through which clinical staff can map the patient journey. Its data model draws on clinical data and patient feedback from multiple sources, and in partnership with IBM Watson scans, aggregates and translates patient feedback for analytics. The firm’s customer experience technology is used by around 100 hospital systems across the US.
As part of the acquisition, Care Experience clients will move onto the QuestionPro platform and technology offerings, which are used for the creation, distribution and analysis of surveys, as well as for polling, tablet-based mobile research and data visualization. Gautam Mahtani (pictured), founder of Care Experience, will become Senior Director of Patient Experience at QuestionPro, leading the company’s Dallas office; and some of Care Experience’s ten employees will joins QuestionPro’s Austin office, or work remotely.
QuestionPro CEO and founder Vivek Bhaskaran says the buy adds a healthcare-focused segment to his firm’s portfolio. ‘We look forward to supporting the Care Experience customers throughout the coming years and are excited about this revolutionary approach to the patient experience. With the combination of the QuestionPro CX and Care Experience, the voice of the patient becomes a powerful and effective tool in the delivery of quality care’, Bhaskaran adds.
Wipro Recognized as a Leader in Everest Group PEAK Matrix Healthcare IT Security Services Assessment 2020
Wipro Limited , a leading global information technology, consulting and business process services company, today announced that it has been positioned as a Leader in Everest Group PEAK Matrix Healthcare IT Security Services Assessment with Service Provider Landscape 2020.
Wipro was positioned as a leader basis its balanced portfolios in IT security segments to offer large-scale security transformation to healthcare enterprises. Wipro stays ahead of the curve through its continued investments in next-generation security solutions and industry partnerships to improve its offerings portfolio. Wipro has leveraged its strong healthcare-specific cybersecurity framework in consultative projects for improved client delivery.
The report evaluated the capabilities of 13 healthcare IT security service providers globally and mapped them on the Everest Group PEAK MatrixTM basis several vision and capability, and market impact-related parameters.
Mohd Ehteshamul Haque, Senior Vice President and Global Head – Healthcare and Services Vertical, Wipro Limited said, “Our innovative Cyber Defense Platform that integrates multiple cloud environments has assisted healthcare customers with security operations, security monitoring and risk governance in their cloud migration journey. Our partnership ecosystem has helped us co-innovate our differentiated verification and validation capabilities, and has given us the flexibility to offer outcome-based pricing models to our healthcare clients. Our rating as a ‘Leader’ underlines the success of our strategy in this segment.”
Chunky Satija, Vice President, Everest Group said, “With data breaches on the rise and patient data privacy concerns increasing, healthcare organizations have come to realize that security is not solely an IT risk, but a critical business challenge. Addressing these issues is made more difficult by siloed data, a shortage of security talent, and an inability to drive effective employee awareness to establish pervasive security controls. Wipro’s investment in internal IP, a strong consulting-led engagement construct, and talent management, coupled with its ability to deal with on-the-ground challenges, has helped it garner increasing mindshare among healthcare enterprises looking for a strategic cybersecurity services partner.”
About Wipro Limited
Wipro Limited is a leading global information technology, consulting and business process services company. We harness the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help our clients adapt to the digital world and make them successful. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 175,000 dedicated employees serving clients across six continents. Together, we discover ideas and connect the dots to build a better and a bold new future.
TransEnterix leases robotic surgery system to hospital in Japan
TransEnterix said that it has leased one of its Senhance robotic surgery systems to a hospital in Japan. The announcement comes nearly two months after the Research Triangle, N.C.-based company predicted lower earnings for the fourth quarter and full year of 2019 due to sluggish sales of the system. TransEnterix touts Senhance as a more economical option when it comes to laparoscopic and robotic systems, with haptic feedback, surgeon camera control via eye sensing and improved ergonomics.
TransEnterix leased Senhance systems to two customers in the fourth quarter of 2019, one in the United States and one in Germany. St. Marianna University School of Medicine Toyoko Hospital, a hospital in the greater Tokyo metropolitan area, has entered into the latest lease agreement for a Senhance system.
“We are pleased with our continued expansion of the Senhance system into Japan, the world’s second-largest surgical robotics market, where hospitals and laparoscopic surgeons are seeking innovative robotic solutions while also maintaining per-procedure costs similar to laparoscopy,” said TransEnterix president & CEO Anthony Fernando in a news release. “We look forward to collaborating with St. Marianna University Toyoko Hospital as they launch their Senhance digital laparoscopy program. This represents our third clinical site in Japan and the second added since the beginning of 2020.”
St. Marianna University School of Medicine Toyoko Hospital is one of five hospitals in the St. Marianna University School of Medicine system, and is a 138-bed facility that provides advanced medical care, emergency medicine and comprehensive community-based healthcare.
“Being on the forefront of new technologies and innovation in surgery, especially ones that are cost-effective, is highly important to us as we seek to improve patient care,” said Dr. Nobuyoshi Miyajima, the director of St. Marianna University Toyoko Hospital. “The Senhance surgical system with its innovative unique technology in micro-laparoscopic instrumentation, advanced visualization capabilities and foundations in laparoscopy will allow us to quickly adapt and evolve our advanced minimally invasive surgical program at Toyoko Hospital.”
The Senhance system was approved for use by the Japanese Ministry of Health, Labor and Welfare in 2019.
Alphatec Holdings Inc Announces Agreement to Acquire EOS imaging
Alphatec Holdings, Inc. , a medical device company dedicated to revolutionizing the approach to spine surgery, announced that it has entered into an agreement to acquire EOS imaging, SA, for a purchase price of up to $88 million, plus debt retirement of $33.9 million, in a combination of cash and equity.
EOS imaging is a leader in outcome-improving orthopedic medical imaging and software solutions, and is globally recognized for its rapid, low dose, biplanar full-body imaging and 3D modeling capabilities. The EOS technology informs the entire surgical process by capturing a calibrated, full-body image in a standing (weight-bearing) position, enabling precise measurement of anatomical angles and dimensions. The resulting imaging drives a more accurate understanding of patient alignment during diagnosis, elevates the likelihood of surgical goal fulfillment by integrating a fully informed plan into surgery, and enables a post-operative assessment against the original surgical plan.
“This is a monumental transaction for ATEC,” said Pat Miles, Chairman and Chief Executive Officer. “While spine’s large players are investing in enabling technologies, we are thinking differently. We created a conduit to deliver information into the operating room with AlphaInformatiX. This transaction will integrate spine imaging and anatomical modeling onto the platform to actually inform the operative experience. By pairing ATEC’s approach-based solutions with imaging founded on Nobel Prize-winning technology, we expect to significantly increase demand for ATEC hardware and EOS systems and create a formidable competitive advantage.”
“EOS is a fabulous, game-changing technology that has unquestionably improved the treatment of children, adolescents and adults with spinal deformity,” said Dr. Christopher Shaffrey, MD, Chief of Spinal Surgery and Spine Care at Duke University Medical Center.
Once closed, the transaction is expected to immediately expand ATEC’s revenue base through the addition of EOS’s revenue run rate, and create significant pull-through and cross-selling opportunities via an expanded sales network and combined customer base. The addition of EOS imaging will advance ATEC’s AlphaInformatiX platform providing capabilities in surgical planning, patient-specific implants, intraoperative alignment reconciliation, and other intraoperative functionalities resulting in a platform distinctively equipped to address the requirements of spine surgery.
The Company expects the acquisition to be accretive to revenue, revenue growth, adjusted EBITDA and free cash flow in the first full year of operations following the transaction close.
With more than 500 scientific articles published in leading journals, EOS’s technology has achieved widespread support and endorsement from the academic community and thought leaders worldwide. EOS’s installed base of over 350 imaging systems encompasses 9 of the top 10 U.S. hospitals, and 20 of the top 251. Additionally, EOS’s well-established international footprint will expedite ATEC’s future ability to enter and penetrate key markets outside of the United States.
“We are very enthusiastic about the opportunity to join the complementary strengths and know-how of EOS imaging and ATEC,” said Mike Lobinsky, Chief Executive Officer of EOS imaging. “I have no doubt that our organizations will be able to quickly create a highly differentiated end-to-end offering that will accelerate growth in the U.S. in the short term, while we continue to expand internationally, paving the way for the future global growth of the combined entity.”
The Boards of Directors of both ATEC and EOS have approved the execution of a tender offer agreement (the “Tender Offer Agreement”), through which ATEC will launch a tender offer for all of the issued and outstanding shares and convertible notes of EOS imaging for a total purchase price of up to $122 million (the “Offer”). The Offer will consist of a cash tender offer for a price of EUR 2.80 per EOS share (the “Cash Offer”), or at the option of each EOS shareholder, an exchange tender offer whereby each EOS shareholder will receive 0.50 ATEC common shares per EOS share (the “Exchange Offer”).
About EOS imaging
Based in Paris, EOS imaging develops and commercializes imaging systems (EOS and EOSedge systems) that provide a full-body evaluation of the patient in a standing position, resulting in a comprehensive understanding of how the patient is compensating in the hips, knees and ankles to maintain an upright posture. The measurements factor into a holistic approach to the development of customized surgical plans, which can then be integrated seamlessly into the operating room.
Utilizing advanced predictive analytics, EOS technology is uniquely capable of correlating preoperative and postoperative imaging to assure, from the operating room, the achievement of alignment, the most prognostic factor of long-term successful surgical outcomes. Compared to the conventional spine-imaging modalities, X-Ray and CT, the EOS systems significantly reduce radiation doses and exam times, producing unstitched, full-body, biplanar, high-quality images at lower cost.
About Alphatec Holdings, Inc.
Alphatec Holdings, Inc. (ATEC), through its wholly-owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company dedicated to revolutionizing the approach to spine surgery through clinical distinction. ATEC architects and commercializes approach-based technology that integrates seamlessly with the SafeOp Neural InformatiX System to provide real-time, objective nerve information that can enhance the safety and reproducibility of spine surgery.
About Perceptive Advisors
Founded in 1999 and based in New York, NY, Perceptive Advisors is an investment management firm with over $5 billion in assets whose activities are focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare.