In this powerful episode, we challenge the conventional wisdom around Quality Management Systems (QMS). Our guest, Etienne Nichols, Head of Industry Insights & Education at Greenlight Guru, expertly reframes the QMS from a mere regulatory burden into a foundational business asset. He delves into a human-centered approach to quality, arguing that a robust QMS is the key to both mitigating risk and proactively driving innovation. This conversation is a masterclass in seeing beyond the compliance checklist to understand how a disciplined approach to quality can fundamentally shape a company's success, valuation, and impact.

Etienne shares candid insights from the industry, revealing the costly consequences of neglecting foundational processes. He provides a roadmap for founders to move from a state of chaos to one of structured excellence, meaning this is definitely a discussion to keep you truly informed and inspired.

In this episode, hosts Kyle Kruse and Richard Meiklejohn are joined by Doug Evans, CEO of Lungpacer, to discuss innovative breakthroughs in respiratory care. Doug outlines the critical issue of mechanical ventilation, which affects 2 million patients annually in the U.S., with a 40% mortality rate among them. He provides detailed insights into how Lungpacer's FDA approved neurostimulation technology, AeroPace, aims to improve patient outcomes by maintaining diaphragm muscle function, thereby reducing time on ventilators and minimizing the need for reintubation. 

The discussion covers the rigorous research and FDA approval process, as well as the forthcoming AeroNova system, in development, designed to assist patients from the onset of mechanical ventilation. Doug also shares the company's plans for commercialization, manufacturing scale-up, and future clinical milestones. The conversation highlights the potential impact of Lungpacer’s technology on patient survival rates and healthcare costs, positioning it as a transformative solution in critical care, a story sure to leave you informed and inspired.

Join us on this episode as we delve into a "silent epidemic" affecting millions: meniscus root tears, a leading cause of knee arthritis. Our guest, Dr. Chris Anderson, founding surgeon and Chief Medical Officer of Native Orthopedics, reveals the hidden prevalence of this debilitating injury, explaining how it impacts over 800,000 Americans annually and the critical need for a new approach to knee preservation. This episode uncovers why this problem has been historically overlooked and the limitations of traditional repair methods.

Discover how Native Orthopedics is revolutionizing soft tissue repair with their FDA breakthrough-designated "Dragonfly" device. Dr. Anderson shares the ingenious, "finger trap" mechanism behind this knotless and adjustable solution, designed by a surgeon for surgeons. Learn how this innovation simplifies complex procedures, improves biomechanical repair, and is poised to introduce a new era of light-touch surgical solutions across sports medicine and beyond, promising better outcomes and faster recovery for patients. A fishing inspired tale that is sure to leave you informed and inspired.

In this episode of the MedTech Impact Podcast, Charles Gellman, CEO and Co-Founder of HiDo Health, discusses the company's mission to eliminate medication errors in the home. Gelman introduces their AI robotic caregiver, a system designed to ensure patients take the right medication at the right time. Unlike existing medication adherence solutions that rely on patient self-reporting or simple reminders, HiDo Health's technology automates the process, knows the medication name, dosage, frequency, and count, and even records consumption. This approach aims to stabilize chronic disease, reduce hospitalizations, and improve the overall quality of care.

Charles emphasizes that the device was designed with significant patient input, focusing on accountability and caregiver needs. The system uses existing pill bottles with a special cap containing an RFID chip, and incorporates face ID and video recording to confirm medication intake. This technology integrates data for both patients and providers, and early results show a substantial reduction in hospitalizations and cost savings. HiDo Health is partnering directly with payers to get the device to patients, and is focused on expanding awareness of the technology, so be sure to tune in, so you can be informed and inspired.

This episode features Yashar Seyed Vahedein, CEO and Co-founder of Coredio, a company tackling the significant problem of heart failure management. Yashar outlines the immense global and US prevalence of heart failure, the high rates of readmission due to inadequate post-discharge monitoring, and the substantial financial burden this places on hospitals and payers. He highlights the limitations of current standard care (blood pressure cuffs and scales) in providing timely and accurate cardiac insights, contrasting them with the invasiveness and cost of solutions like catheterization and implantable devices.

Coredio's innovative solution is a software platform that leverages existing wearable devices (like smartwatches and blood pressure cuffs) and patented AI and physics-based technology to extract key cardiac metrics comparable to those obtained through invasive procedures. This non-invasive approach aims to improve guideline-directed medication therapy adherence, reduce hospital readmissions and length of stay, and ultimately enhance patient outcomes by providing clinicians with timely data and enabling proactive intervention – all without requiring new devices for patients or hospitals. Tune in to learn more about this exciting startup so you can be informed and inspired.

In this episode, hosts Kyle Kruse and Richard Meiklejohn, interview Joseph ‘Yossi’ Mossel, CEO and Co-founder of Ibex Medical Analytics, about the company's innovative use of AI in cancer diagnostics. Yossi discusses the critical problem of diagnostic errors in pathology, which can reach up to 10% in some labs, and the growing shortage of pathologists worldwide. Ibex's AI technology acts as a "digital assistant" to pathologists, pre-analyzing cases and highlighting areas of concern, thereby increasing accuracy and efficiency.

Yossi emphasizes that Ibex's AI is designed to augment, not replace, pathologists, allowing them to focus on complex cases while ensuring accuracy in routine diagnoses. The conversation touches on all the incredible data and partner foundations that been developed, which has led to significant deployments in Europe and the United States. Tune in to learn more about how Ibex is re-shaping pathology so you can be informed and inspired.

In this episode, we sit down with Dr. Nicholas Nikolov, Chief Medical Officer of Cellsound Aesthetics, to discuss a revolutionary approach to aesthetic treatments. Dr. Nikolov, a plastic surgeon, shares his journey from traditional invasive procedures to pioneering non-invasive solutions using non-focused ultrasound technology. Cellsound Aesthetics aims to rejuvenate tissue, improve blood flow, and contour the body without causing trauma or downtime. Dr. Nikolov details how the technology, originally developed for wound healing, has evolved to address various aesthetic concerns, offering patients a comfortable and effective alternative to traditional methods.

Dr. Nikolov explains the science behind Cellsound, highlighting its unique ability to penetrate deep tissue layers and stimulate cellular activity without causing injury. He emphasizes the importance of patient comfort and the positive impact of the technology on their overall well-being. The conversation also delves into the company's go-to-market strategy, clinical study results, and the comprehensive training and support provided to practitioners. Dr. Nikolov's passion for the technology and its potential to transform the aesthetic industry is evident, making this episode one sure to leave you informed and inspired.

This episode features Prathamesh Prabhudasai, co-founder and CEO of SafeBVM, discussing the critical issue of ineffective manual ventilation during resuscitation. We uncover the alarming statistic that up to 50% of patients experience hypoxia due to improper bag-valve mask (BVM) use. SafeBVM addresses this problem with a novel device that works with any commercially available BVM, providing a flow-limiting valve to ensure safer and more effective breaths. Prath also emphasizes the challenges faced by healthcare providers due to infrequent BVM use and high staff turnover, and how SafeBVM's technology helps maintain competency and improve patient outcomes.

SafeBVM's approach offers a comprehensive solution that includes training coupled with their optimized manual bag for ventilation. Prath touches on the importance of federal funding in supporting clinical trials and supporting their development journey. Thanks to this foundation, the company has already seen significant success in cities like Colorado Springs and Saint Charles, with positive clinical outcomes and growing adoption. The company is now focusing on scaling, while also preparing to release exciting clinical trial data, be sure to tune in so you can be informed and inspired.

This episode features Orahn Preiss-Bloom, Chief Innovation Officer of OSSIO, discussing the company's revolutionary tech that promotes natural healing in bones. OSSIO is tackling the long-standing issues associated with metal implants in orthopedic surgery, which often lead to complications like hardware removal surgeries, patient pain, and increased healthcare costs. Orahn explains how their OSSIOfiber product, a composite material made of biocompatible mineral fibers, provides the necessary strength for bone fixation while allowing the body to naturally remodel it into bone over time, eliminating the need for future hardware removal.

The conversation delves into the challenges of bringing novel medical technologies to market, the importance of focusing on procedure-specific solutions, and the intricacies of building a successful go-to-market strategy in the orthopedic space. Orahn shines a light on how the market is shifting towards procedure ownership, where companies provide comprehensive solutions rather than just individual tools. Packed with insights into navigating the regulatory landscape, building a strong commercial team, and optimizing distribution strategies, this conversation will definitely leave you informed and inspired.

This episode features Ben Merewitz, CEO and Co-founder of Agile Devices. Ben discusses the challenges faced by interventional radiologists when navigating complex anatomy with traditional microcatheters, such as difficulties in maneuvering through tortuous vessels and achieving precise target placement. Agile Devices has developed a novel, microcatheter with active tip control, called Angler, that overcomes these limitations by allowing real-time control of the tip's shape, enabling physicians to navigate complex anatomy with greater ease and precision.

The company has received FDA clearance for the Angler and is currently conducting limited releases to gather further clinical data and demonstrate the device's effectiveness in various interventional procedures, such as embolization. Ben highlights the importance of the Boston area's vibrant medical device ecosystem in the development of this innovative technology and discusses the company's future plans, including expanding into new markets and developing new applications for their deflectable technology platform. With an ‘agile’ approach, Ben’s story is sure to keep you informed and inspired.