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Ellen Roche is an associate professor of mechanical engineering and the associate head of the Department of Mechanical Engineering at MIT. Her research team develops new devices and therapeutic strategies for repairing the heart and other tissues. Here, she speaks with MIT President Sally Kornbluth about her work, the advantages of taking a nonlinear route to one’s chosen career, and the importance of saying "yes" to unexpected opportunities.

Links:
- Ellen Roche: https://meche.mit.edu/people/faculty/etr@mit.edu
- Therapeutic Technology Design and Development Lab: https://ttdd.mit.edu
- Video: Patient-specific, 3D-printed, soft-robotic hearts: https://youtube.com/watch?v=52qNGqBbTQA
- Dassault Systèmes: https://3ds.com/3dexperience
- Institute for Medical Engineering and Science: https://imes.mit.edu

Timestamps:
03:35 - Potential for 3D-printing hearts 
08:14 - Hydrogels
17:33 - On AI

Show notes and transcript:
https://news.mit.edu/podcast/podcast-curiosity-unbounded-episode-6-healing-ailing-heart 

Join the mailing list or send us feedback:
https://eepurl.com/ixPQPA

The Curiosity Unbounded podcast brings you behind the scenes at MIT through conversations between MIT President Sally Kornbluth and the people working in its labs and in the field. Along the way, Sally and her guests discuss pressing issues, as well as what inspires the people running at the world’s toughest challenges at one of the most innovative institutions on the planet.

Curiosity Unbounded

Curiosity Unbounded, Ep. 6: Healing the ailing heart

Medical Plastics News editor Olivia Friett is joined by Michiel van den Berg, Director of Global Pharmaceutical Packaging Development at TekniPlex to discuss methods of recycling, legislation on the subject and what companies can do to improve their recycling rates.

Recycling plastics in the medical and pharma packaging industry

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with industry leaders in medtech and healthtech and demos of some of the most innovative tech seen at CES 2024 in Las Vegas. Hannah Daniel dives into the latest developments in the intellectual property dispute between Apple and Masimo over blood oxygen sensors in the newer Apple Watch models.  
 
 Medtech Insight articles addressing topics discussed in this episode:

Dexcom COO On Stelo CGM Plans, Apple Watch Developments, And Why Non-Invasive Glucose Monitoring Still Leaves Much To Desire 
Abbott Lingo Leaders On Consumer Biowearable Outlook: ‘A Lot Of Appetite For Glucose As A Biomarker For Your Health’
CES Roundup: Holoportation, Empathic Robot, Aging Suit, Bionic Prosthetic Arm, Headband For Better Sleep 
Roundup: AI-Powered Assistive Hearing Devices Scream With Personalization; Femtech From Baby Makers To Menopause 
Apple Watches Are Back On The US Market
News We’re Watching: Apple/Masimo Patent Fight Update
Apple Drops Pulse Oximeter Features To Subvert Import Ban

Digital Health Roundup: CES Biggest Hits; Apple Versus Masimo; Insulet Recalls Diabetes App

The United States has two federal health insurance programs, Medicare and Medicaid, which cater to specific groups like the elderly, individuals with disabilities, and those in need of renal dialysis or transplantation. Compliance with minimum health and safety standards mandated by the Social Security Act is necessary for providers and suppliers to participate in these programs. CMS (Centers for Medicare & Medicaid Services) develops Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) to set standards for healthcare organizations in Medicare and Medicaid, ensuring quality and patient safety. State health agencies enforce CMS requirements, promoting a unified approach to healthcare delivery. The HTM department's role is vital in meeting CMS standards, as non-compliance could lead to financial consequences and reputational damage. Regular inspections and continuous training ensure consistent evaluations and improvements in healthcare quality. CLIA oversees laboratory testing, and preventative maintenance and AEM programs for medical devices are essential for patient safety and continuous care. State regulations are crucial in ensuring public safety and quality healthcare services in hospitals, and state departments of health collaborate with CMS to implement federal healthcare programs and monitor compliance with regulations through inspections.

202 - CMS and State Regulations

Hospital accreditation is vital to ensuring safe and high-quality care. In the U.S., the "big three" accrediting organizations are The Joint Commission, DNV, and HFAP (now part of ACHC). They conduct comprehensive surveys to assess compliance with standards. Deemed organizations are accredited by CMS-approved entities, allowing them to meet Medicare and Medicaid requirements without direct CMS surveys. The Joint Commission, formerly JCAHO, conducts voluntary surveys to evaluate compliance in various settings. The Program Specific Tracer evaluates equipment and supply management, and the Environment of Care and Emergency Management assessment assess compliance with relevant standards. DNV GL is a global quality assurance company with a healthcare arm pioneering the NIAHO® program, focusing on continuous improvement and patient safety. They offer program certifications for specialty care areas, emphasizing compliance with standards. The merger between ACHC and HFAP aims to offer complete accreditation and certification services to healthcare providers globally.

203 - Deemed Accreditation

The National Fire Protection Association (NFPA) is a nonprofit organization established in 1896, committed to promoting fire safety through comprehensive codes, standards, research, and educational programs. In healthcare, the NFPA establishes guidelines for fire protection and life safety in various settings, including hospitals. They also provide specific requirements for medical equipment electrical safety inspections, ensuring safe operation and preventing hazards. Relocatable Power Taps (RPTs) are permitted on patient care medical equipment when permanently attached, meeting UL requirements. Compliance with NFPA standards is essential for healthcare facilities to ensure patient and staff safety.

205 - NFPA and Electrical Safety

A Quality Management System (QMS) is a structured framework organizations use to manage and improve the quality of their products, services, and processes, ensuring customer satisfaction, continuous improvement, and regulatory compliance. Key elements encompass policies, procedures, risk-based approaches, documentation, resource management, monitoring, measurement, and continuous improvement. ISO 9001 and ISO 13485 are prominent QMS standards, with ISO 9001 focusing on overall organizational processes and customer satisfaction, while ISO 13485 tailors requirements for the medical device industry. ANSI/AAMI EQ56:2020 provides guidance for comprehensive medical equipment management plans, aligning with quality principles and regulatory standards, enhancing patient safety, and meeting ISO 9001 compliance requirements.

206 - Quality Management Systems

In today’s HEAL Security Dispatch Daily Digest, we highlight a major data breach at the Internet Archive, compromising the information of around 31 million users. Unauthorized individuals accessed sensitive details, including email addresses and encrypted passwords. The Internet Archive is advising all users to change their passwords immediately while investigations into further vulnerabilities continue. Additionally, Mozilla has released an emergency update for Firefox to patch a critical zero-day vulnerability that could allow hackers to execute arbitrary code on users' machines. Meanwhile, Marriott International and Starwood Hotels have reached a $52 million settlement over data breaches affecting millions of customers, with commitments to enhance their cybersecurity measures.

Shifting focus to the healthcare sector, a recent report reveals over 14,000 unsecured medical devices and databases exposed online, with nearly half located in the United States. This vulnerability stems from the decentralized nature of the U.S. healthcare system, highlighting the urgent need for stronger security practices, particularly in smaller organizations. Fidelity Investments has disclosed a breach impacting over 77,000 individuals due to an exploited system vulnerability, prompting the company to enhance its security measures. In a proactive response, the Cybersecurity and Infrastructure Security Agency (CISA) has issued new advisories to address vulnerabilities in industrial control systems and identified critical risks in Ivanti and Fortinet products, urging organizations to implement updates swiftly to protect against potential threats.
https://healsecurity.com

From Attacks to Long-Term Safeguards: Protecting Digital Assets

In this episode of the HEAL Security Dispatch Daily Digest, Richard Simmons delves into key cybersecurity developments impacting the healthcare sector. The discussion begins with an analysis of the growing threat of supply chain attacks, particularly targeting Python, npm, and open-source ecosystems. Richard highlights the American Hospital Association's concerns over new encryption requirements proposed by the Office of the National Coordinator for Health Information Technology, and the challenges posed by the aggressive timelines in the HTI-2 rule.

He then shifts focus to Juniper Networks' latest security patches, urging immediate action to address vulnerabilities that could lead to remote code execution or denial of service attacks. Richard also discusses the alarming use of OpenAI’s ChatGPT for cybercrime, with over 20 instances of AI-assisted attacks reported, as well as OpenAI’s efforts to combat this misuse in collaboration with cybersecurity partners.

A critical incident covered is the Russian cyber attack on NHS provider Synnovis, which led to widespread service disruptions in London, affecting thousands of patients. Additionally, the Trinity Ransomware group's threat to healthcare providers is explored, along with expert recommendations on safeguarding patient data using blockchain and homomorphic encryption.

The episode also covers ransomware campaigns exploiting a vulnerability in Veeam Backup & Replication software, leading to Akira and Fog ransomware distribution. Other topics include a ransomware attack on Star Health, the rise of quantum-resistant algorithms, and the rapid growth of the medical device security market, driven by the need to protect connected healthcare devices and patient data.
https://healsecurity.com

From Open-Source Vulnerabilities to AI-Assisted Cyber Attacks

In today's episode of the 'HEAL Security Dispatch Daily Digest,' Richard Simmons delves into some of the most pressing cybersecurity developments impacting the healthcare and broader digital landscape. Leading with the successful disruption of distributed denial-of-service (DDoS) attacks by Anonymous Sudan, Richard highlights the indictment of two Sudanese brothers in connection with these cyber intrusions. He also discusses critical updates from VMware, which has released patches for a high-severity SQL injection vulnerability in its HCX platform, urging users to take immediate action to safeguard sensitive data.

Additionally, Richard covers a wide range of global cybersecurity topics, from FIDO Alliance's draft protocol to simplify passkey transfers across platforms, to Intel facing allegations from Chinese cybersecurity experts about embedded backdoors. Other key updates include Singapore’s introduction of a voluntary cybersecurity labeling scheme for medical devices and a critical Kubernetes vulnerability that allows unauthorized SSH root access. Rounding off the episode is news of a partnership between Google Security Operations and Covered California, along with the latest additions to CISA's Known Exploited Vulnerabilities catalog.
https://healsecurity.com

From Healthcare Threats to Global Cybersecurity Trends: Key Updates in Today's Digital Landscape

Drawing from decades of healthcare leadership experience, Marc Buontempo presents a comprehensive strategy for building resilient healthcare systems that thrive in an evolving landscape. His vision combines operational efficiency with breakthrough medical innovations, focusing on value-based care models that prioritize patient outcomes over volume. Buontempo advocates for sustainable practices including green hospital initiatives, renewable energy adoption, and waste reduction programs. His framework emphasizes workforce development, mental health support for healthcare workers, and community engagement initiatives that create lasting positive impact while ensuring long-term economic viability and environmental responsibility.

Marc Buontempo Blueprint for Healthcare Sustainability

From Compliance to Confidence: How to Evolve Cybersecurity Beyond the Checklist

Healthcare cybersecurity stands at an inflection point. Traditional compliance frameworks are proving inadequate in the face of sophisticated threats targeting patient data, clinical operations, and connected medical devices. Robert Eikel, CISO at P-n-T Data Corp., brings unique expertise from government service, financial services, and pediatric healthcare to discuss how leading organizations are evolving beyond checklist security. We'll explore the new frontlines of healthcare cyber defense—identity, integrity, and interoperability—while examining how emerging technologies like AI and quantum computing are reshaping the threat landscape.
   • Moving from periodic compliance to continuous confidence through identity-centric, integrity-focused defense strategies
   • Protecting clinical workflows and patient safety while maintaining secure interoperability across healthcare ecosystems
   • Preparing cybersecurity programs for AI-powered threats, quantum risks, and next-generation healthcare technologies
   • Transforming cybersecurity governance from IT overhead to strategic business enabler

Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

Digital Health Talks: From Compliance to Confidence On How to Evolve Cybersecurity

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

The Daily HEAL Security Dispatch Podcast is a leading source for up-to-the-minute news and deep insights in the realm of healthcare cybersecurity and threat intelligence. 

At the heart of HEAL Security's vision is the commitment to equipping organizations and individuals with rapid, contextually rich cybersecurity updates, establishing itself as a pivotal force in unifying practice and data against the ingenious tactics of criminal and malicious entities. HEAL Security is fervently devoted to constructing a robust resource and community that champions the defense of the healthcare sector against the growing cyber threats from organized crime groups and antagonistic nation-states. Our core focus encompasses the protection of vital IT infrastructures, the security of sensitive patient and clinical information, the safeguarding of critical healthcare systems, and the assurance of continuous, undisturbed patient care services.

With 18 years in pharma sales, Marc Buontempo champions patient care, mentors students, coaches youth sports, and drives sustainability through beach clean-ups and tree planting efforts.

RADIO FOR THE HEALTHCARE INDUSTRY
Healthcare NOW Radio and Podcast Network offers discussions on the latest developments and trends impacting the industry including: health tech, health IT, healthcare innovation, healthcare policy, healthcare data security, telehealth, interoperability, biotech, med tech, value-based care, pharma, healthcare compliance, and much more. Shows are hosted by industry thought leaders. Guests are a "who's who" across the healthcare spectrum.  The listening audience is predominantly physician and hospital-based, and the healthcare industry at large.

A podcast covering the latest news and conversations in life sciences brought to you by the editors of Med-Tech Innovation News, Medical Plastics News and European Pharmaceutical Manufacturer.
Now featuring the FemTech Series!

MIT News is dedicated to bringing news from the Massachusetts Institute of Technology (MIT) to the world. We cover research, innovation, teaching, entrepreneurship, and the Institute’s distinctive and quirky culture. We find ourselves educated and amazed by our community of hands-on problem-solvers who are eager to know how things work — and inspired to make them work better. We hope you are amazed, too.

The key to building a strong HTM industry is building a strong HTM community.  We encourage you to share, interact, and network through local, regional, and national groups.  We strive to enhance academic offerings, create a pipeline for the next generation of HTM professionals, and provide opportunities for those already rooted in the industry to grow.

New tracks tagged #MedicalDevices