Industry Voices—3 ways healthcare providers can take advantage of CMS’ reduced burdens

FierceHealthcare | February 04, 2019

It goes without saying that both regulation and accreditation are crucial to ensuring that healthcare providers and facilities uphold nationwide standards in patient care. While both hold healthcare providers accountable to their patients and community, strengthen patient safety and measure quality and safety of care, federal regulations require a great deal of physicians’ time—not to mention the looming penalties they could face if they fall short. In fact, 81% of U.S. physicians in four common specialties reported that they spend more time and effort dealing with quality measures than three years ago, according to a recent report from Health Affairs. Only 27% of those surveyed said current measures represent the quality of care they provide. Ensuring that healing environments are meeting and exceeding standards of patient care should not be a burden. CMS recently launched its “Patients Over Paperwork” initiative to identify what stakeholders consider burdensome in the healthcare environment. They found “3,040 mentions of burden,” which CMS then categorized as relating to “1,146 different issues.”

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FUTURE OF HEALTHCARE

Radius XR™ Named as the CES 2023 Innovation Award Honoree for Wearable Device That Combines Therapy and Diagnostic Capabilities

Radius XR | November 17, 2022

Today at the CES Unveiled New York event, Radius XR™, a new fashion-forward wearable healthcare technology brand, was named a CES® 2023 Innovation Awards Honoree in both the Digital Health and Virtual & Augmented Reality categories. Radius was selected from among a record number of submissions to this year’s CES Innovation Awards program. The announcement was made ahead of CES 2023, the influential technology event, happening Jan. 5-8 in Las Vegas, NV. Radius XR builds on the therapeutic legacy of IrisVision, a leader in digital vision technologies and itself a 2019 CES Innovation Winner. The Radius proprietary XR assistive device brings together—for the first time—multimodal diagnostics, practice management, and patient engagement. “This is a tremendous honor for our new company. It follows on the success of our IrisVision visual assistive device, which has provided a life-changing solution for thousands of individuals living with legal blindness and low-vision conditions. Radius expands on our commitment to vision health by providing the eyecare industry with an easy-to-use wearable device capable of performing standard perimetry tests. Other exams include color vision, visual acuity, contrast sensitivity—a comprehensive suite of standard vision tests. Development of additional exams is ongoing.” Radius founder and CEO Ammad Khan Radius enables patients to quickly and easily conduct vision tests with minimal guidance or intervention by the staff. The device’s RadiusExam® software and proprietary algorithms provide diagnostic testing results equivalent to current exam gold standards. “By designing our own hardware and software, we’re able to overcome many of the challenges inherent in the off-the-shelf headsets already on the market. Matching visual field strategies, background luminance, stimulus size and dynamic range allows us to mirror the current standards, making it easy and intuitive for clinicians to transition to Radius,” said John Trefethen, Radius Chief Marketing Officer. In addition, the included Business Suite helps clinicians manage everyday aspects critical to their practice's ongoing success. Features like patient education, staff training and clinician onboarding are now possible inline with the Radius platform. Radius is the industry’s lightest wearable device and has the look and feel of a pair of stylish sunglasses. The compact, lightweight design overcomes the challenges of expensive and bulky legacy devices that force patients to sit in uncomfortable positions for testing. With Radius, exams can be conducted anywhere, even in the waiting room, eliminating the need to shuttle patients between machines, which can be challenging for individuals with mobility or vision issues. The CES Innovation Awards program, owned and produced by the Consumer Technology Association (CTA)®, is an annual competition honoring outstanding design and engineering in 27 consumer technology product categories. Those with the highest rating receive the “Best of Innovation” distinction. An elite panel of industry expert judges, including members of the media, designers, engineers and more, reviewed submissions based on innovation, engineering and functionality, aesthetics, and design. The CES 2023 Innovation Awards honorees, including product descriptions and photos, can be found at CES.tech/innovation. Radius will be on display at the Innovation Awards Showcase at CES 2023 in Las Vegas in January. About Radius XR The Radius XR platform is a portable vision diagnostic and patient engagement system that combines medical-grade diagnostics, business management, and patient education tools in a single wearable XR device. The RadiusExam® and proprietary algorithms provide diagnostic testing results equivalent to current exam gold standards, with the clinical science validated by Deming regression. As the algorithm presents stimuli to patients, it adapts to responses to maximize the algorithm's speed. The total hardware and software system helps medical professionals diagnose patients with accuracy, grow their eyecare practices, enhance patient engagement, and reduce staff workload by enabling patients to perform self-guided vision exams with minimal supervision.

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FUTURE OF HEALTHCARE,MEDICAL DEVICES

Healthcare Under Cyberattack: Unprotected Medical IoT Devices Threaten Patient Care

Capterra | November 30, 2022

The rising adoption of connected medical devices is accelerating cyberattacks, according to Capterra’s new Medical IoT Survey of healthcare IT professionals. The survey also reveals that 67% of healthcare cyberattacks impact patient data and nearly half impact patient care, an indication that rising security risks in the industry are leading to severe consequences in patient outcomes and privacy. The medical internet of things is helping to make healthcare more convenient, efficient, and patient-centric. However, connected devices with IoT sensors often have unprotected security vulnerabilities that endanger healthcare facilities, and even patients. In fact, medical practices with more than 70% of their devices connected are 24% more likely to experience a cyberattack than practices with 50% or fewer connected devices. “As a healthcare organization connects more medical devices to its network, its attack surface expands. Connected medical devices often go unmonitored for security vulnerabilities, and because they run on a wide array of software and hardware platforms, it’s difficult to monitor with a single tool. This means that many connected medical devices are left wide open to cyberattacks.” Zach Capers, senior security analyst at Capterra More than half of healthcare IT staff rate the cybersecurity threat level in the industry as high or extreme, yet many healthcare organizations are not taking the necessary steps to protect medical IoT devices. Alarmingly, 57% do not always change the default username and password for each new connected medical device that is put into use. Additionally, 82% run connected medical devices on old Windows systems. If a security vulnerability is discovered, organizations should patch the device or update its firmware as soon as possible. Unfortunately, 68% of healthcare organizations don’t always update connected devices when a patch is available. However, vulnerabilities and associated patches aren’t always well publicized, which means healthcare IT staff must stay up-to-date on emerging threats to medical IoT devices. Medical IoT security requires proactive and ongoing vigilance. Healthcare practices should conduct routine vulnerability assessments before connecting medical devices to their IT network. They should also keep an up-to-date and accurate inventory of all connected devices plus associated software and firmware, and use software to monitor these devices. Read the full report on Capterra.com to learn more about best practices for healthcare organizations to strengthen security for their medical IoT devices. About Capterra Capterra is the leading software reviews and selection platform that connects businesses to the right technology. Compare software, read and leave reviews, and access objective insights that empower business growth.

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DIGITAL HEALTHCARE, MEDICAL DEVICES

Sharps Technology Begins Manufacturing at its Hungary Facility for the Company's Innovative Syringe Products

Sharps Technology Inc | December 21, 2022

Sharps Technology, Inc. an innovative medical device and drug delivery Company offering patented, best-in-class syringe products, announces they have commenced manufacturing of their much-needed ultra-low waste smart safety syringe products in their European operation in Hungary. The plant has been producing products and will begin shipments to support the distribution and sales agreement with Nephron Pharmaceuticals by the end of the year, and customer agreements in Europe in early 2023. The production of these specialty syringe products will ramp up over the next several months to increase supply. Sharps innovative syringe designs provide a beneficial set of features and advantages for the healthcare industry. These syringe product features include a combination of ultra-low waste, passive and active safety, and reuse prevention. By combining all these features and building them into a portfolio of syringe offerings, it will create product platforms that can help drive down the cost of healthcare treatments. “This is a transformative point for our company as we move from a pre-revenue research & development start-up to a true manufacturing company that should generate revenue in the first half of 2023. Today’s healthcare providers are responsible for managing their supply chains and driving down their total cost of ownership (TCO) for medical treatments. Sharps Technology will be able to offer products that can directly support those programs. At Sharps Technology, we feel that by using better drug delivery technology, we can help create additional medical treatments at no additional cost for patients that need them." Robert Hayes, Sharps Technology CEO "We look forward to a bright future at Sharps Technology," concluded Mr. Hayes. "The recently signed distribution agreement with Nephron Pharmaceuticals accelerates the sales plan for our innovative syringe products that are currently being produced in the Sharps plant in Hungary. The ability to pull forward our sales plan for customers in the US will create a unique opportunity for early revenue at Sharps. We expect to have our first products available for sale in the US by the end of January 2023, with additional products to be added to the distribution network by mid-year of 2023." When healthcare providers use ultra-low waste syringes with multi-dose vials, it allows for the availability of up to 20% to 40% more medication for patients that need the treatment. This medication availability is created by using more efficient syringes designated as low-waste and ultra-low waste products, and not trapping medication within the syringe after the dose is given. The use of standard syringes that are not designated as low waste or ultra-low waste products typically creates a dead space area within the syringe where excess medication is trapped and cannot be used. This dead space then causes the healthcare provider to throw away the unused medication. The trapped medication in the dead space of a standard syringe can waste as much as 100 microliters of medication or more. The Pharmaceutical companies that fill their medication into vials understand this and must then overfill the vial with drug therapy to compensate for the problem. As the costs for medication and medical treatments rise, the discarded medication can cost the industry millions of dollars, or more, globally. The purchase of the European facility was finalized in the summer of 2022 and Sharps has invested in infrastructure and equipment upgrades to prepare the plant for a full manufacturing schedule. Syringe products produced by Sharps comply with all applicable FDA and ISO requirements and have been awarded the European Union’s CE Mark. The Sharps Hungary team, led by General Manager Filippo Filippi, brings together a dedicated and knowledgeable manufacturing force, with more than 20 years of experience in supplying the world with high quality, innovative syringe products. Prior to the GM position, Filippi’s career spanned years of building, managing, and supporting multiple manufacturing sites across Europe, Asia, and Africa. The Hungary plant is vertically integrated in that it has the capability to manufacture the syringe components by injection molding, assemble the devices on automated lines or by manual assembly if required, and to sterilize the products on-site through the Ethylene Oxide sterilization process. This last stage of the syringe manufacturing process is unique in the industry and gives Sharps an advantage in supporting shortened lead times as compared to the common need to utilize a third-party for sterilization. The plant has manufacturing capacity to supply more than 50 million units today and the facility could be expanded to produce 250 million units or more over the next couple of years. About Sharps Technology Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and ready to use processing. The company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US..

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MEDICAL DEVICES

Study Reveals Florence Healthcare’s Site Enablement Platforms Can Accelerate Clinical Trials by Six Weeks and Reduce Costs by Over $1M per Study

Florence Healthcare | November 18, 2022

Florence Healthcare™, a clinical research technology company headquartered in Atlanta, Georgia, announced the completion of a year-long third-party study on the impact of Site Enablement Platforms™ on clinical research timelines and costs. The study by Marketcap Consulting is the first to compare how traditional site management approaches differ from site-first Site Enablement Platforms. The study looked at the impact of traditional sponsor portals and new Site Enablement Platforms on research sponsor and Contract Research Organization study timelines and budgets. “Pharma sponsors and CROs realize the importance of enabling sites to do their best work - but only recently have they discovered that traditional site portals are more hindrance than help. Yet, these organizations weren't able to measure the true impact of switching to a Site Enablement Platform. This year-long study aimed to fix that and highlight how linking fragmented workflows accelerates the full lifecycle of clinical trials.” Ryan Jones, CEO of Florence Healthcare Site enablement is a new technology category that prioritizes the needs of the site, a major shift from past technology that only looked at the experience of the sponsor. These platforms, including Florence Healthcare’s SiteLink™, insist on ease-of-use and ease-of-setup for the site, quality support, and simplified integrations. SiteLink works in conjunction with eBinders™, an electronic Investigator Site File solution used by over 12,000 research sites in 45 countries. About the Study Marketcap Consulting conducted interviews with clinical research operations leaders harnessing SiteLink, examined timelines and study costs, and analyzed the impact across the sites in the study. On average, the team found that SiteLink accelerated study start-up by four weeks and study close-out by two weeks at every site. For a 50-site study, this six-week acceleration reduced cash burn by one million dollars. “We can see a clear positive impact on study timelines and cash burn when research sponsors and CROs implement Site Enablement Platforms,” said Joel White, founder of Marketcap Consulting. “This early study reveals that by enabling sites to do their best work, the clinical research industry unlocks value across the full research cycle.” “While the financial impact of switching to SiteLink makes investing in site enablement an easy choice for sponsors and CROs, it’s really the acceleration of studies that gets our team at Florence Healthcare excited,” said Jones. “We aim to double the output of research teams by the end of the decade, and enabling sites is the way to do it.” About Florence Healthcare Florence Healthcare’s clinical trial software helps more than 12,000 research sites in 45 countries manage their documents, data, and workflows. The Florence Healthcare™ platform also provides remote access so sponsors and Contract Research Organizations can collaborate with their sites around the world. Florence Healthcare users now perform 5.8 million remote monitoring activities each month.

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