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Heartland Conference
We want to thank VGM Director Boone Lockard, CRT and Dave Lyman, SVP of VGM for coming by the booth this morning and trying Eclipse on for the first time here at the Heartland Conference. As a former Philips employee, this was Boone’s first opportunity to experience Eclipse, our newest magnetic mask with MagSeal. It was also his first chance to wear a mask that doesn’t leak or leave lines on his face. We appreciate you guys seeing what no headgear and no leaks can mean for comfort and compliance for your VGM members and their patients. Come on by our booth and try the latest in mask technology.
Learn moreBreathing Easy
BLEEP SLEEP CPAP masks have been a long-standing nightmare for sleep apnea patients. Many CPAP masks on the market tend to leak, are too loud and can even result in the breaking of hair and bald spots due to headgear. On this episode of clocking in, I talked to a CPAP manufacturer who — through innovation — has eliminated many of the problems that are stereotypically associated with CPAP masks. Established in 2019, CPAP manufacturer, Bleep Sleep is based out of Chapel Hill, North Carolina. Bleep Sleep was rated a Top CPAP in 2019 and 2021 by CPAPAdvice.com. The organization was awarded the 2021 NIH SBIR Grant Award for PAP Innovation by the National Institute of Health. Listen in as I speak with the Founder, Executive Chairman and Head of R&D/Product Design of Bleep Sleep, Stuart Heatherington and CEO and President of Bleep Sleep Rebecca Holland New. Stuart is the creator of Bleep’s DreamPort solution and a 30-year pioneer in the sleep industry securing approximately 15 sleep apnea product patents during the course of his career. Rebecca has served on the board of Bleep Sleep, LLC since 2019 and directs the company’s advisory board. We discuss the invention of Bleep Sleep’s Dreamport, how Stuart came up with the concept of Bleep Sleep, how Rebecca optimizes her years of expertise to take Bleep Sleep to new heights and more. LINKS NCMEPBleep Sleep ABOUT PHIL MINTZ Phil Mintz is the executive director of NC State Industry Expansion Solutions (IES) and director of the North Carolina Manufacturing Extension Partnership (NCMEP). At NCMEP, Phil drives outreach to NC manufacturers, builds relationships with federal and state leaders and coordinates efforts to drive profitable manufacturing growth in the state. He also leads the broader IES Extension Operations outreach unit of regional managers, technical specialists and business development leaders providing business engagement, assessment and improvement tools. This includes statewide peer networks, ISO 9000 quality management systems, Six Sigma, Lean manufacturing, environmental services, and health and safety solutions. STUART HEATHERINGTON Stuart Heatherington is the creator of Bleep’s DreamPort solution and a 30-year pioneer in the sleep industry securing approximately 15 sleep apnea product patents during the course of his career. As a certified sleep technician, researcher, and sleep apnea patient he has cultivated a deep domain expertise surrounding the 22 pain points that lead to poor CPAP compliance. He is a former sleep lab owner with extensive experience in sales, product development and sleep apnea treatment. Stuart has been a DME and sleep apnea patient for 18 years. He has a BA in American History from the University of North Carolina at Charlotte and is RPSGT certified. REBECCA HOLLAND NEW Rebecca Holland New carries a history of helping healthcare and life sciences companies effectively scale operations to capitalize on rapidly growing market segments. Over the course of her career, she has helped several leading companies including Thermo Fisher Scientific/Patheon, Novo Nordisk and Bristol-Myers Squibb, expand market share, execute transformational business strategies and complete several public market transactions. Rebecca has served on the board of Bleep Sleep, LLC since 2019 and directs the company’s advisory board. Rebecca received an MS in Industrial Labor Relations and a BS in Economics, Marketing, and Finance from Cornell University.
Learn moreRyan Jensen – Professional Football and Sleep Apnea
Emma is joined by Ryan Jensen, a professional football player with the Tampa Bay Buccaneers. Together they discuss: * Working as a professional athlete and not getting the good quality sleep needed for recovery from training sessions. * Ryan’s journey to diagnosis with sleep apnea and his familiarity with CPAP because his parents both used one. * Using a full face mask and struggling with leaking. * Trying DreamPorts by Bleep Sleep and finding it a better solution than the full face mask. * Becoming a role model as a professional athlete speaking publicly about living with sleep apnea. Follow Ryan on Instagram @redman7715 Follow the podcast on Instagram @sleepapneastories This episode is sponsored by: Somnomed https://somnomed.co/en/find-a-clinic/ Band Bleep Sleep Special offer for Sleep Apnea Stories podcast listeners: 20% Off Bleep Sleep DreamPorts Sleep Apnea Stories podcast listeners get 20% off when shopping with these unique links and codes: CODE FOR DREAMWAY CONNECTOR KIT IS: 20EMMADREAM THE URL TO THE DIRECT AMAZON PAGE IS: https://www.amazon.com/gp/mpc/A3988V25QUJTE4 CODE FOR DREAMPORTS IS: 20EMMAPORTS THE URL TO THE DIRECT AMAZON PAGE IS: https://www.amazon.com/gp/mpc/A3SSBN70B4BV8I Link: https://podcasts.google.com/feed/aHR0cHM6Ly9hbmNob3IuZm0vcy8yYTRiOGViMC9wb2RjYXN0L3Jzcw/episode/ZTk0ZTA2N2YtYTIyNy00NzliLWJlZjEtMjA0NDIzMDg5OTY0?hl=en-CA&ved=2ahUKEwi4jeSrnJH3AhUTlYkEHanVAcIQjrkEegQIBRAK&ep=6
Learn moreSleepTech Talk PodCast w/ guest Stuart Heatherington (Founder, Executive Chairman and Head of R&D/Product Design at Bleep Sleep)
Latest episode of SleepTech Talk is out! Meet Stuart Heatherington Founder of Bleep Sleep and the Dreamport mask. SleepTech Talk listeners will receive a discount! The code is SLEEPTALK and the link to Amazon is https://bit.ly/bleep-sleepBleep Website: https://bleepsleep.com/ Available on Apple, Spotify, Google podcast platforms or you can view on the SleepTech Talk Youtube Channel Link: https://anchor.fm/sleep-tech-talkers/episodes/SleepTech-Talk-PodCast-w-guest-Stuart-Heatherington-Founder–Executive-Chairman-and-Head-of-RDProduct-Design-at-Bleep-Sleep-e1h1f6c/a-a7o3h1n
Learn moreThe Top 25 Women Leaders in Medical Devices of 2022
The Healthcare Technology Report is pleased to announce The Top 25 Women Leaders in Medical Devices of 2022. With the medical device industry advancing at an unprecedented rate, new and exciting developments in robotics, materials science, analytics, and other technologies have accelerated the production of breakthrough devices that are improving outcomes for patients. Amid a global pandemic that has exacerbated complications in manufacturing and distribution, creative thinking has been crucial for medtech leaders as they devise proactive supply chain solutions in order to mitigate production delays and keep costs competitive. These women executives have demonstrated first-rate leadership in areas such as testing, telemedicine, orthopedics, surgery, wound care, and monitoring, among others. Everly Health’s Cindy R. Kent has marked her first months as Chief Operating Officer by helping lead the company through incredible growth: in fact, Everly Health recently announced it has enabled more than 45 million COVID-19 tests since the onset of the pandemic in addition to countless additional tests to help screen and diagnose conditions such as STIs, colon cancer, diabetes, and more. Also ringing in the new business year in a big way is Chief Commercial Officer Niamh Pellegrini of Nevro Corp, who helped her company secure UnitedHealthcare coverage for its high-frequency 10 kHz therapy—the only FDA-approved spinal cord stimulation system for treating painful diabetic neuropathy. The women on this year’s list have distinguished themselves through substantial contributions not only to their companies, but to the medical device industry as a whole. Each nominee was evaluated based on her leadership skills, professional acumen, and technology input, among other factors. Awardees were ultimately chosen using feedback submitted through the nomination entries while factoring in further research into each individual’s career achievements. Please join us in celebrating the achievements of The Top 25 Women Leaders in Medical Devices of 2022. 1. Trinh Clark, Henry ScheinTitle: Vice President of Technology Enablement, North America Distribution Group Trinh Clark is Vice President of Technology Enablement for the North America Distribution Group of Henry Schein, a Fortune 500 company and the world’s largest provider of healthcare products and services to office-based dental and medical practitioners. Clark is responsible for all aspects of the distribution group’s technology solutions to enhance customers’ effectiveness to deliver better outcomes, increase internal productivity, and to contribute towards revenue growth, margin improvement, and customer satisfaction. A seasoned veteran in health care technology, Clark has nearly 25 years of industry experience and has served in a variety of leadership roles at Henry Schein. In 2017, she was appointed co-lead of Henry Schein’s Global Digital Commerce team to champion and advance digital commerce and digital marketing initiatives, and in 2018, appointed to the Transformation Management Office, a strategic initiative designed to satisfy the evolving needs of customers and fuel future growth through the creation of engaging and personalized digital customer experiences. Prior to joining Henry Schein, Clark led the program management, customer relations, and marketing functions for eSurg, an award-winning online distributor of pharmaceutical, surgical, office, and medical supplies. In addition to her vast business contributions, Clark is a founding member of her company’s Diversity & Inclusion Council as well as Executive Sponsor of its Women’s Leadership Network and newly established Pan Asian employee resource group. She received her Bachelor of Arts in social sciences from the University of Washington. 2. Valerie Asbury, LifeScanTitle: President and Chief Executive Officer Valerie Asbury is President and Chief Executive Officer of LifeScan, a global leader in glucose monitoring and diabetes management. LifeScan is well known for its popular OneTouch brand, used by millions of consumers worldwide. Asbury has complete responsibility for LifeScan’s business and operations, which has more than 2,000 employees worldwide. Asbury has guided LifeScan’s mission to pioneer patient-centric technologies and foster cooperation and partnership within the healthcare industry. She has a depth of proven experience and expertise honed over 30 years of cross-functional leadership in guiding healthcare organizations through change in complex and challenging environments. Asbury was recently appointed as a member of both the Audit Committee and the Compliance Reimbursement Committee for Tactile Systems Technology, a company focused on developing medical devices for the treatment of patients with underserved chronic diseases at home. Prior to LifeScan, Asbury spent over 20 years with Johnson & Johnson, serving in various leadership roles of increasing responsibility across five different medical device and pharmaceutical businesses, including 10 years in the diabetes consumer medical device space, where she focused on strategic growth and talent development. A registered nurse, Asbury has a passion for volunteerism and serves on the boards of various organizations. She has a bachelor’s degree in nursing from the Vanderbilt University School of Nursing and completed executive-level business, marketing, finance, and strategic management education programs at Xavier University, Penn State, and Harvard University. 3. Cindy R. Kent, Everly HealthTitle: Chief Operating Officer Cindy R. Kent is the Chief Operating Officer of Everly Health, the digital health company at the forefront of the virtual diagnostics-driven care industry and parent company of Everlywell, Everly Health Solutions (formerly PWNHealth), EverlyDx, and Natalist. Everly Health’s subsidiaries have earned industry accolades from Forbes, Fortune, and Fierce Healthcare. Everlywell was named one of Fast Company’s Most Innovative Companies in 2019, one of Inc. Magazine’s Most Inspiring and Innovative Companies of 2020, and Best Challenger Health Brand by Adweek in 2021. Kent is a healthcare executive and corporate director widely recognized for her innovation across different sectors in healthcare. Prior to joining Everly Health, she was president of senior living operations at Brookdale Senior Living. Before that, Kent held roles of successive leadership at Eli Lilly, Medtronic, and 3M, where she consistently led strong revenue growth and margin expansion. She is a Henry Crown Fellow of The Aspen Institute, serves on the board of directors of cloud-based personalized healthcare provider Accolade, and previously served on the board of directors at Best Buy as the retailer made multi-billion dollar inroads into its consumer health strategy. Kent earned a Bachelor of Science in industrial engineering from Northwestern University as well as a Master of Divinity and Master of Business Administration from Vanderbilt University. 4. Renee Ryan, Cala HealthTitle: Chief Executive Officer Renee Ryan is the Chief Executive Officer of Cala Health, a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. Cala’s lead product, Cala Trio™, is the only non-invasive prescription therapy for essential tremor, the most prevalent movement disorder in the world. Prior to Cala, Ryan led the health technology investments for Johnson & Johnson Innovation (JJDC) on the West Coast and Asia-Pacific for 8 years. While at J&J, she made over 15 new investments, including the Series A for Cala Health, and founded seven healthtech companies. Previously, she was a healthcare investment banker at Baird, Jefferies, and Goldman Sachs. Ryan continues to advise venture funds and entrepreneurs in addition to remaining passionate about advancing human healthcare. She received her Master of Business Administration from Columbia University and her Bachelor of Arts from Georgetown University. 5. Kelly Feist, AscomTitle: Managing Director Kelly Feist serves as Managing Director for Ascom Americas and also serves on Ascom’s extended Executive Committee. As the top executive in the Americas, she is responsible for the sales performance, overall operations, and profitability of the business in the region. Feist joined Ascom from Philips Healthcare USA, where she served as the head of customer service in North America. Prior to this, she was the region’s first business leader for patient care and monitoring solutions. In both roles, Feist helped transform Philips from a capital equipment business model to a solutions-based and recurring revenue business model focusing on software, hardware, and business services. Feist has significant experience in healthcare IT solutions across several functions, including sales, marketing, product management, and customer care. She is a member and regular contributor to Forbes Technology Council. Feist earned a Master of Business Administration from Vanderbilt University and an executive certificate from the Harvard School of Public Health. 6. Niamh Pellegrini, Nevro CorpTitle: Chief Commercial Officer Niamh Pellegrini is the Chief Commercial Officer at Nevro Corporation. Nevro is a global medical device company focused on providing innovative products that improve quality of life for patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. In her role, Pellegrini is responsible for leading the global commercial success of Nevro. Most recently, the organization launched a new indication for the treatment of painful diabetic neuropathy. Nevro now provides the only SCS treatment option approved by the FDA for patients struggling with debilitating painful diabetic neuropathy and unable to find relief with currently available pharmacologic options. Prior to joining Nevro, Pellegrini served as vice president of global commercial operations at Abbott Vascular and as CEO and president at Autonomic Technologies. She has also held leadership positions in business development, strategy, sales, and marketing with Thoratec Corporation and Johnson & Johnson. Pellegrini currently serves on the board of directors of Acutus Medical. She earned a Bachelor of Science and a Master of Business Administration from Santa Clara University. 7. Karen Parkhill, MedtronicTitle: Executive Vice President and Chief Financial Officer Karen Parkhill is Executive Vice President and Chief Financial Officer of Medtronic, a global leader in healthcare technology. In addition to serving on the company’s Executive Committee, she is responsible for leading the global finance organization and key supporting functions, including treasury, controllership, tax, internal audit, investor relations, corporate strategy, and business development. In late 2020, she also assumed leadership of the IT organization. Bolstered by her deep expertise and broad-based experience, Parkhill’s unique leadership style balances sincere compassion for her colleagues and her team with a singular focus on driving meaningful outcomes. She consistently displays an unwavering commitment to Medtronic’s mission and values, and adheres to the highest standards of ethical principles. She also helped guide Medtronic through the financial challenges of the global pandemic, including impacts posed by the recent resurgence. Parkhill joined Medtronic in 2016 with a long and established career in the financial services sector. Her experience leading during the financial crisis of 2008 helped shape her approach to guiding Medtronic through the unprecedented financial and health challenges of the pandemic, and her leadership played a critical role in helping Medtronic successfully navigate these uncertain times. Parkill received a Bachelor of Business Administration and Bachelor of Science from Southern Methodist University as well as a Master of Business Administration from the University of Chicago Booth School of Business. 8. Victoria E. Carr-Brendel, Advanced Bionics at SonovaTitle: Group Vice President of Cochlear Implants, President of Advanced Bionics Victoria Carr-Brendel is the Group Vice President of Cochlear Implants and President of Advanced Bionics at Sonova, and a member of the Sonova management board. Advanced Bionics is widely recognized for developing the most advanced cochlear implant systems in the world. Under Carr-Brendel’s leadership, it has seen unprecedented growth and introduced a number of first-to-market products, including the first CI sound processors to connect to virtually any Bluetooth-enabled device and the first CI solution designed for children. Carr-Brendel has almost 30 years of medical device development experience, having served in multiple leadership roles in different medical device companies prior to joining Sonova. She was keynote speaker at Sonova’s 2019 International Women’s Day, and at MiniTec during the 2021 Medical Device & Manufacturing Expo & Conference. She was named one of the Top 25 Women Leaders in Medical Devices in 2020, a finalist for LA Times Woman of the Year in 2021, and voted one of the Top 25 Medical Device Executives of 2019. She recently joined the board of directors for the Medical Device Manufacturing Association, and has been a member of the American Institute for Medical and Biological Engineering since 2014. Carr-Brendel holds a Ph.D. in immunology/microbiology from the University of Illinois at Chicago. 9. Katie Szyman, Edwards LifesciencesTitle: Corporate Vice President and General Manager of Critical Care Katie Szyman is the Corporate Vice President and General Manager of Critical Care at Edwards Lifesciences, the global leader of patient-focused innovations for critical care and surgical monitoring as well as structural heart disease. Since joining Edwards in 2015, Szyman has brought new technologies to market that impact the lives of millions of patients each year. She initiated a shift in the business from descriptive monitoring products to predictive and AI-driven products and smart recovery technologies that aid clinicians in decision making with the goal of helping patients return home to their families faster. Before joining Edwards, Szyman spent over 20 years at Medtronic, ultimately serving as its senior vice president and president of the global diabetes business, overseeing research, development, operations, sales, and marketing for the company’s insulin infusion pumps and continuous glucose monitoring systems. She serves on the boards of Outset Medical, Inari Medical, and the Edwards Lifesciences Foundation. Szyman graduated from the University of St. Thomas with a bachelor’s degree in accounting and international business, and subsequently earned her Master of Business Administration from Harvard Business School. 10. Nancy Lurker, EyePoint PharmaceuticalsTitle: Chief Executive Officer, Board Director As President, Chief Executive Officer, and Board Director, Nancy Lurker leads EyePoint Pharmaceuticals’ mission to improve the lives of people facing serious eye disorders. With over 30 years in the pharmaceutical industry, she has driven scientific and commercial innovation across public and private companies to bring innovative therapies and solutions to patients. Prior to joining EyePoint, Lurker filled the same triple role of president, CEO, and board director for PDI, a NASDAQ-listed healthcare commercialization company now named Interpace Diagnostics Group. Before joining PDI, she was SVP and chief marketing officer at Novartis Pharmaceuticals. She also served as president and CEO of ImpactRx, a privately held healthcare information company. Prior to ImpactRx, Lurker was group VP of global primary care products for Pharmacia Corporation, and a member of its U.S. Executive Management Committee. She began her career as a senior medical representative at Bristol Myers Squibb, where she quickly rose to senior director of worldwide cardiovascular franchise management, overseeing numerous successful drug launches. Lurker has served on numerous boards across public and private companies as well as advocacy organizations. She holds a Bachelor of Science in biology from Seattle Pacific University and a Master of Business Administration from the University of Evansville. 11. Eileen Maus, RenoviaTitle: Chief Executive Officer Eileen Maus brings 20 years of healthcare experience to Renovia, a women-led company that develops digital therapeutics for women’s pelvic floor disorders. Renovia’s flagship product, the leva® Pelvic Health System, is an FDA-cleared prescription device that can help women strengthen their pelvic floor muscles effectively for the treatment of stress, mixed, and urgency urinary incontinence (UI), including overactive bladder. leva offers a non-invasive, drug-free way for women to train and strengthen their pelvic floor muscles at home in just five minutes a day, making first-line treatment accessible to the nearly 20 million with bothersome UI. leva is the first femtech product in the Digital Therapeutics Alliance product library, has multiple clinical trials and published data supporting its efficacy, and is the 2021 recipient of a Medical Device Network Sector Excellence award. Maus grew her passion for women’s health at CYTYC Corporation (now Hologic), where as vice president of commercial operations (surgical division), she was a key contributor to its rapid growth from $8 to $700 million. She also served as chief commercial officer for Constitutional Medical Investors, a portfolio company of Warburg Pincus. She received her Bachelor of Science from LaSalle University. 12. Dianne Keen-Kim, NateraTitle: Vice President of Laboratory Affairs and Quality Assurance Dr. Dianne Keen-Kim is the Vice President of Laboratory Affairs and Quality Assurance for Natera, a leader in personalized genetic testing and diagnostics transforming how critical health care decisions are made. Her responsibilities include oversight of clinical testing within Natera’s clinical laboratories, the company’s quality strategy, patient safety, and clinical trial results. Dr. Keen-Kim has more than 20 years of experience automating and scaling laboratory operations while also leading teams to produce innovative and impactful products. Her business acuity, patient-centric approach, and leadership have directly contributed to Natera’s success, and her dedication to placing patients at the core of her work is an inspiration in the field of genomic medicine. Dr. Keen-Kim is board-certified in molecular genetics, cytogenetics, and as a High Complexity Laboratory Director by the American Board of Medical Genetics and Genomics, American Board of Bioanalysis, and American Society of Clinical Pathology. She is the inventor or co-inventor on multiple U.S. issued patents, serves as an adjunct clinical professor at Stanford University School of Medicine’s Department of Pathology, volunteers in the leadership of Women In Biology (WIB) and Women of Natera, and is active in multiple industry organizations. Dr. Keen-Kim completed fellowships at University of California, Los Angeles, holds a PhD in genetics from Massachusetts Institute of Technology, and earned a Bachelor of Science in biological sciences from Carnegie Mellon University. 13. Jill Schiaparelli, Avation MedicalTitle: Chief Executive Officer and President Jill Schiaparelli is the President and Chief Executive Officer of Avation Medical, a medical technology company innovating patient-friendly wearable nerve stimulation therapies. Schiaparelli is passionate about bringing cutting-edge medical technologies to markets to help improve the lives of patients. With more than 20 years of experience in the healthcare industry, she has honed her expertise in leading innovative healthcare organizations, driving them to success with her deep knowledge of global medical device commercialization, emerging technologies, strategic marketing, healthcare consumerism, and patient care pathway modeling. Schiaparelli has held leadership roles with major healthcare companies such as Johnson & Johnson and Baxter. She has also served as an executive at high-growth, innovative companies like ApaTech (U.K.), which she helped sell to Baxter, AxoGen, where she assisted its up-list to NASDAQ, InteloMed, where she launched the CVInsight™ Monitoring and Informatics System, and Neurotechnology Innovations Translator, an incubator and investment vehicle to launch and grow companies in the neuromodulation space. Schiaparelli received a Master of Business Administration in finance and business management from the Stern School of Business at New York University and a Bachelor of Science in finance and international management from the Questrom School of Business at Boston University. 14. Erin Jacobson, Inspire Medical SystemsTitle: Zone Vice President of Sales Erin Jacobson is the West Zone Vice President of Sales for Inspire Medical Systems, a fast-growing medical device company that offers a sleep apnea treatment for those unable to use CPAP. In her current role, Jacobson has responsibility for the commercial sales strategy, execution, and market expansion in the western half of the U.S., spanning 27 states and over 125 field sales professionals. During her two-year tenure, Inspire has doubled its workforce due to robust market expansion and company growth. Before joining Inspire in 2019, Jacobson spent nearly 15 years at Boston Scientific in the cardiac rhythm management and electrophysiology division. While there, she was part of the Women’s Leadership Network, which advances diversity and inclusion initiatives. Jacobson has also served as a team captain with Inspire for the American Heart Association’s Annual Heart Walk and is an avid supporter of Heart to Home Furnishings, a nonprofit organization that was co-founded by her father. She received a bachelor’s degree in psychology from the University of St. Thomas and her Master of Science in social work from the University of Wisconsin-Madison. 15. Rosalind Beasley, Dot ComplianceTitle: Vice President of Digital Innovation Rosalind Beasley is Vice President of Digital Innovation at Dot Compliance Inc, where she leads new product introductions and serves as a life science industry and quality domain expert. In her role, Beasley runs the company’s innovation lab, which explores new and cutting-edge technologies such as artificial intelligence, process mining, RPA, and more, ultimately leading to practical inclusion in Dot Compliance products. She also serves as an industry thought leader, helping customers develop their digital transformation strategy to maximize their investment in enterprise cloud GxP solutions. Beasley is a pioneer in digital transformation and quality in the cloud. In 2011, she co-founded 123Compliance and introduced one of the first multi-tenant, cloud-based complaint management, quality management, document management, and training solutions to the life sciences industries. In the face of adversity, she did this at a time when the life sciences industry wasn’t ready to embrace the cloud for GxP solutions. 123Compliance turned the industry upside down and went on to be a success. Beasley has a Master of Business Administration from the University of Southern California Marshall School of Business. 16. Suzanne Meyer, Vein360Title: Chief Executive Officer Suzanne Meyer is the Founder and Chief Executive Officer of Vein360, a medical device company specializing in the sustainable remanufacturing of cardiovascular devices. Vein360 was founded to help vein practices recover costs and operate sustainably through single-use device reprocessing and device recovery solutions. Since its founding in 2019, Vein360 has delivered millions of dollars in savings to its customers while preventing tens of thousands of medical devices from accumulating in landfill. Meyer is a seasoned healthcare professional in the field of biomedical engineering, and has held several leadership roles in companies which develop innovative, outcome-focused product solutions for the healthcare industry. Most recently, her dual passion for engineering and the environment led her to create a world-class sustainability solution for vein clinics across the U.S. Meyer has fused her education and experience to drive down healthcare costs without compromising the quality of care for the patients and physicians she serves. She earned her master’s degree in biomedical engineering from the University of South Florida. 17. Noemi Ray, PaceMateTitle: Vice President of Product Operations Noemi Ray is a Co-Founder and the Vice President of Product Operations at PaceMate, a cardiac medical technology company. PaceMate provides an innovative digital cardiology technology—a cloud-based platform that monitors and manages implanted cardiac devices, allowing physicians to track real-time data from their patients as they go about their lives. As a leader within her company, Ray brings a wealth of experience across medical fields, including as a clinical specialist, pharmacy manager, and registered nurse, in addition to being hands-on with medical sales and marketing. She is part of the pioneering team behind PaceMate LIVE, her company’s signature customized cardiac implantable electronic device monitoring software and service. Before founding PaceMate, Ray was a clinical specialist in cardiac rhythm management for St. Jude Medical, an emergency department RN with CHRISTUS Health, and a sales/marketing manager for Ray’s Pharmacies. Her career as a medical professional began in 2005 as a sales representative with Takeda Pharmaceuticals. Now with PaceMate, Ray aims to add a unique level of compassion to the brand, setting a standard of equality in the medical workspace that shines through in the company’s customer service, mission, and core values. She received a Bachelor of Science in registered nursing from Louisiana State University-Alexandria as well as a Bachelor of Arts from Northwestern State University. 18. Laura Schulz, Ghost Productions Medical Animation and VRTitle: Chief Executive Officer Laura Schulz is the Chief Executive Officer of Ghost Productions, a medical animation studio and virtual reality developer dedicated to providing high-end medical device marketing and surgical simulation training programs for medical device manufacturers. Schulz replaced the company’s founder, Stephan Kuslich, as CEO in spring of 2020 after increasing efficiency and capacity during her tenure as Ghost’s project manager. Ghost Productions was founded in 1994, and has won several awards for its high-quality, medically accurate content, including a Gold Digital Health Award for its “COVID-19 PSA,” a Bronze Digital Health Award for “Wraith VR Surgical Simulator Demonstration,” and a Gold Aster Medical Device Marketing Award for the DePuy Trauma Animation “Heal.” Ghost Productions has clients all throughout the U.S. and Europe, including Johnson & Johnson, Zimmer Biomet, DePuy Synthes, Medtronic, Stryker, Smith and Nephew, Boston Scientific, and Integra Life Sciences. Previously, Schulz held leadership positions in the advertising photography industry. She is a certified SCRUM Master, and has a Bachelor of Arts in advertising photography from The Brooks Institute. 19. Susan Niemeier, IvenixTitle: Chief Nursing Officer Susan Niemeier is the Chief Nursing Officer of Ivenix, a medical technology company with the vision to eliminate infusion-related patient harm. Ivenix provides the Ivenix Infusion System™, which includes a next-generation large-volume infusion pump, administration sets, and software tools for patients requiring an intravenous infusion within a hospital. As a major leader within the company, Niemeier brings a wealth of experience across functional teams including clinical practice, product development, professional service operations, marketing, and sales. Prior to her current role, Niemeier was the chief nursing executive at Capsule, now part of Philips. She also served in executive and senior management roles at Radianse, a real-time location system company, and Ascension, one of the leading non-profit healthcare systems in the U.S. Niemeier has made significant contributions to medical technology development throughout her career. She is an established thought leader on innovation, and has extensive knowledge in device development, medication safety, performance improvement, and research. Her research interests center on nursing practice, nursing vitality, and emerging technologies that support safe and effective care. Niemeier received her Bachelor of Science in nursing from the University of Missouri and her Master of Healthcare Administration from Saint Louis University. 20. Kate Lee, Bigfoot BiomedicalTitle: Senior Vice President, Regulatory and Quality Affairs Kate Lee is the Senior Vice President of Regulatory and Quality Affairs for Bigfoot Biomedical, a U.S. medtech company developing innovative insulin delivery solutions for people with type-1 and type-2 diabetes. In her senior role, Lee is responsible for Bigfoot’s regulatory compliance and quality processes as well as the company’s human factors team. Amid the challenges of a global pandemic, she led the company to receive its first 510k FDA clearance in May 2021 for the Bigfoot Unity™ System, which features connected smart pen caps for disposable insulin pens that recommend doses for people relying on multiple daily injection therapy. Lee has more than 25 years of medical industry experience. Prior to joining Bigfoot Biomedical, she was an independent consultant and also served as senior director of regulatory affairs and director of catheter engineering for Hansen Medical. She has additionally held various roles with increasing responsibility in R&D, and is a co-inventor on multiple patents. Lee received her Bachelor of Science in mechanical engineering from Harvard University and a Master of Science in mechanical engineering from Stanford University. 21. Suzon Lommel, Viveve MedicalTitle: Senior Vice President, Regulatory and Quality Affairs Suzon Lommel is the Senior Vice President of Regulatory and Quality Affairs at Viveve Medical, a global women’s health care company and a leader in development of advanced medical technologies and procedures that address significant areas of unmet need in women’s health, including urinary incontinence and intimate wellness solutions. In a career that spans more than 30 years, Lommel has extensive experience in establishing and directing regulatory and quality systems in the medical device industry. She has played an instrumental lead role in the strategic planning and development of numerous innovative and disruptive technologies from early-stage development to global commercialization. Prior to joining Viveve, Lommel was global vice president of regulatory and quality affairs at Ulthera, now part of Merz Aesthetics. She has also served in executive or senior management roles at Breathe Techniques, FoxHollow Technologies, Advanced Stent Technologies, and Boston Scientific. She has coordinated regulatory strategies including IDE, PMA, and 510k submissions, and has worked closely with regulators at the FDA as well as international regulatory and licensing organizations. An avid animal lover and volunteer, Lommel has worked for years with Puppy Rescue Mission, an organization dedicated to helping military personnel bring pets home from war zones. She received her degree in physics from Moorpark College in California. 22. Karen Bannick McQuoid, BannickTitle: Chief Executive Officer Karen Bannick McQuoid is the Chief Executive Officer of Bannick, a primary device group founded in 1998 to provide clinical, medical writing, quality, regulatory, and auditing guidance to medical device companies. Building on her passion to bring safe and effective technology to patients around the world, McQuoid has practiced her unique combination of biostatistics, clinical study, and exceptional regulatory skills in the medtech industry for over 30 years. She and her expert team provide strategic guidance and development of deliverables to manufacturers, getting new medtech to the market and ensuring post-market safety. Her expertise in development of European clinical evaluations is well recognized, as is her insightful strategic guidance in clinical and regulatory matters. Before opening Bannick, McQuoid worked in the medical device industry as a biostatistician, regulatory manager, and clinical professional. She is a fellow of the Regulatory Affairs Professional Society (RAPS), regulatory affairs-certified (RAC), and served as a member of the Ethics Committee for RAPS. She is a member of Medical Alley, and helped develop clinical and regulatory groups and workshops. She is also a member of the American Medical Writers Association (AMWA), a past president of its North Central Chapter, and currently serves on the AMWA Budget & Finance committee. McQuoid is an invited speaker for RAPS, Medical Alley, and AMWA. She received a degree in biostatistics and statistics from the University of Minnesota Twin Cities, and later earned Master of Arts degrees in health and human services as well as management from Saint Mary’s University of Minnesota. 23. Karin Dahllöf, Monivent ABTitle: Chief Executive Officer Karin Dahllöf is Chief Executive Officer of Monivent AB, a young Swedish medtech company dedicated to improving the care given to newborn babies in need of respiratory support at birth. Monivent has developed a unique solution that provides continuous feedback during manual ventilation, allowing the caregiver to make necessary adjustments and thus ensuring an effective yet gentle treatment. Since joining Monivent in 2018, Dahllöf has used her broad commercial experience and leadership in the medical technology field to move the company from a startup to an established business. Dahllöf has extensive expertise in global product management, marketing, and sales of medical technology devices, with over 30 years of experience in medical technology. Prior to Monivent, she held leadership and commercial roles in international companies including HemoCue AB (a Danaher company), CellaVision AB, EKF Diagnostics, and Vidacare B.V. (acquired by Teleflex). She received her bachelor’s degree in biomedical laboratory science from Gothenburg University. 24. Laetitia Cousin, SeaSpineTitle: Vice President of Regulatory Affairs and Quality Assurance Laetitia Cousin serves as Vice President of Regulatory Affairs and Quality Assurance for SeaSpine, a medtech company focused on the design, development, and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. In her role, Cousin ensures the consistently excellent quality of the company’s comprehensive portfolio, which includes various orthobiologics and spinal implant solutions as well as its market-leading surgical navigation system. Seaspine products are marketed in the U.S. and in approximately 30 countries worldwide through a committed network of increasingly exclusive distribution partners. Before joining the SeaSpine team, Cousin spent 16 years in progressively senior positions at NuVasive, ultimately rising to fill a position similar to her current one: vice president of regulatory and clinical affairs and quality assurance. She has built up nearly two decades of medical technology experience, primarily in regulatory affairs, quality assurance, and premarket clinical studies, and has demonstrated excellence in scaling, influencing, and strategically guiding global regulatory, quality, and clinical teams in the spinal device and tissue industry. Cousin received a Bachelor of Science in biological sciences from the Florida Institute of Technology. 25. Rebecca New, BleepTitle: Chief Executive Officer Rebecca New is Chief Executive Officer of Bleep, maker of DreamPort®, the only clinically proven leak-free PAP (positive air pressure) solution on the market used to treat conditions such as obstructive sleep apnea (OSA). 30-50% of PAP users are not compliant due to headgear/mask complaints. Poor compliance is linked to hypertension, decline in mental health, motor vehicle accidents, and diabetes. As the only headgear-free solution, DreamPort® was independently rated a top CPAP in 2021, with a greater than 80% patient referral rate. In 2021, the National Institute of Health awarded Bleep a SBIR Grant Award for PAP Innovation. New has extensive experience helping healthcare companies including Thermo Fisher Scientific/Patheon, Novo Nordisk, and Bristol-Myers Squibb capitalize on rapidly growing market segments and execute transformational business strategies. Her leadership successes have been widely recognized by FiercePharma, Putnam Media, and the Triangle Business Journal, where she has been cited as a top senior executive. New volunteers with government and private groups to help leaders and influence policy, including working as a founding member of American Health Policy Institute and NC State Women in Tech. She received a Master of Science in industrial labor relations and a Bachelor of Science in economics, marketing, and finance from Cornell University.
Learn moreBleep, LLC Announces Oversight Board to support PAP Innovation funded by $1.7M NIH SBIR Grant
Chapel Hill, NC January 10, 2022 – Bleep, LLC, creators of the mask-free DreamPorts™ sleep solution, announced today the appointment of an Institutional Review Board (IRB) to oversee and monitor clinical studies and outcomes for their innovation in Positive Air Pressure (PAP) design for use in home and acute care/hospital settings. The creation of the Board is a requirement following the previously announced $1.7 million SBIR grant that was awarded from the National Institutes of Health (NIH) to Bleep for the development of Eclipse™, the company’s next-generation CPAP solution. “More than 50 million adults in the U.S. have obstructive sleep apnea (OSA) and almost half of these people are non-compliant because they do not have a product that fits properly,” said Stuart Heatherington, Bleep executive chairman and DreamPorts creator. “Our latest innovation, Eclipse, builds off of the groundbreaking DreamPort® design, which eliminates headgear and addresses many of the issues identified by traditional headgear users.” Heatherington continued, “We believe the NIH funded studies will conclude Eclipse offers ease of use, with rapid on/off application, and we expect to get the same or better results with decreased pressure, a reduction in apneas and hypopneas per hour, and improved comfort and compliance over competitive masks.” The company believes CPAP masks have not significantly changed in design in the last 30 years and believe the Eclipse will deliver greater comfort, compliance and pressure making it easier for patients to sleep and breath. The following people have been appointed to the Bleep IRB: Mary Susan Esther, MD, will serve as the Data and Safety Monitoring Board (DSMB) Chairperson. Esther has been involved in Sleep Medicine for over thirty years. She trained at Mayo Clinic in Rochester, Minnesota in Psychiatry and Sleep Medicine and was a member of the faculty at Mayo Clinic and later the University of Texas Health Sciences Center in San Antonio before moving to Charlotte. She is a diplomate of the American Board of Sleep Medicine and specialty certified in Sleep Medicine through the American Board of Psychiatry and Neurology. She has served as President of the North Carolina Academy of Sleep Medicine and was a past President of the American Academy of Sleep Medicine. “CPAP compliance has been shown to improve morbidity rate, but also A1C for type 2 diabetics, mental health, and reduce cardiovascular incidence including pressure and risk of stroke. Bleep’s Eclipse® innovation is expected to be a significant game changer for patients. Compliant patients enjoy better health and reduced overall health cost. Payers and providers also benefit through reduction in ulceration penalties, post procedure recovery time and decreased readmission rates,” stated Esther. Christopher L. Drake, PhD, Clinical Trial Specialist will lead review of trial design and outcomes. He is a graduate of the Pennsylvania State University and received his PhD in Clinical Psychology from Bowling Green State University in 2001. Drake is a licensed Clinical Psychologist with board certification in sleep medicine and behavioral sleep medicine. He was appointed Section Head of Sleep Research for Henry Ford Health System in 2014 and is a Professor in the Department of Psychiatry and Behavioral Neuroscience at Wayne State University School of Medicine. His work is funded by the National Institute of Mental Health to study the effects of insomnia treatment on the prevention of depression and by the National Institute of Nursing Research for his work on behavioral treatments for insomnia. He has been Principal investigator on more than 20 foundation, industry, and NIH grants since 2004 and has authored over 150 publications. Drake has served on the Board of Directors of the Sleep Research Society and is a former Chairman of the National Sleep Foundation. J. Wei, PhD, will serve as the lead Biostatistician. Wei is a professor of Biostatistics at Harvard University and has also served as a professor at University of Wisconsin, University of Michigan, and George Washington University. His main research interest is in the clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods which are utilized in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. He is a fellow of American Statistical Associating and Institute of Mathematical Statistics. He has more than 230 publications and served on numerous editorial and scientific advisory boards for governments and industry. He has extensive working experience in regulatory science for developing and evaluating new drugs/devices. Wei holds a PhD in Statistics from the University of Wisconsin. With this NIH grant, Bleep, LLC will optimize their Eclipse PAP technology and produce validation data necessary for successful market commercialization expected in 2022. About Bleep Sleep (bleepsleep.com) Bleep Sleep Solutions, based in Chapel Hill, NC is a sleep solution company focused on improving sleep and sleep related health outcomes. The DreamPort® is a one-size-fits-all, single SKU CPAP solution with zero headgear. It has been clinically proven not to leak, eliminates mask lines and facial irritation. It is compatible with all CPAP machines and covered by all major insurance plans. DreamPort is FDA cleared, and manufactured entirely in the United States. DreamPort provides respiratory support for patients who need continuous positive air pressure solution for the treatment of sleep apnea.
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