Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market
LIFE SCIENCES, MEDICAL DEVICES

Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market

Dina is currently the Vice President of Regulatory Affairs for Terumo Medical Corporation where she oversees both US and global Regulatory Affairs. Prior to joining Terumo in 2008, Dina spent 17 years at the FDA as a reviewer and later a branch chief in the Division of Cardiovascular Devices. She also spent some time as a Sr. RA consultant prior to joining Terumo.

Dina holds a BS in Biomedical Engineering from The Catholic University of America and a Master of Business Administration from the University of Maryland.

Continue reading
Transforming Supply Chain Quality Processes in the Digital Era
LIFE SCIENCES, MEDICAL DEVICES

Transforming Supply Chain Quality Processes in the Digital Era

Aileen Barreto Rivera is a transformational global leader with extensive experience in Supply Chain and Quality within the Medical Devices and Pharmaceuticals industry. Since joining Johnson & Johnson in 1995, Aileen has held multiple roles of increasing responsibility across various business units including Orthopedics, Vision Care, Diabetes Care and Innovative Medicine with direct accountability of Manufacturing, Lean, Engineering, and Quality functions. Her professional journey spans across key locations, including Puerto Rico, Europe, and the United States.

Throughout her tenure, Aileen has successfully led numerous strategic projects, including operational readiness for key product launches, site start up strategies and significant efficiency improvements within the manufacturing landscape. Her leadership has facilitated remarkable accomplishments, during acquisitions, compliance improvements initiatives, as well as significant contributions to community initiatives, reflecting her passion for people. Aileen’s commitment to excellence is evident in her ability to drive performance and engagement while maintaining high standards of quality and customer satisfaction.

Her academic background includes a Bachelor of Science in Electrical Engineering from the University of Puerto Rico, as well as an alumni of notable leadership programs at J&J.

Continue reading
From Complaints to Patient Breakthroughs: Harnessing AI to Capture Voice of Customer and Accelerate Medical Device Innovation
LIFE SCIENCES, MEDICAL DEVICES

From Complaints to Patient Breakthroughs: Harnessing AI to Capture Voice of Customer and Accelerate Medical Device Innovation

Zillery A. Fortner is a respected professional in the life sciences industry with over 30 years of experience. She has held roles like surgical assistant, quality assurance specialist, regulatory affairs expert, and accreditation professional. Now, she is the Industry Business Development Director, SME at Honeywell, advocating for customers.

Her dedication to innovation is evident in her involvement in professional organizations and her numerous patents. Zillery’s extensive knowledge helps drive digital innovation and ensure regulatory compliance in the industry.

Continue reading
Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery
LIFE SCIENCES, MEDICAL DEVICES

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

Evaluating the effects of new regulations on the medical device sector
Providing guidance on creating and deploying efficient quality management systems
Examining the careful balance between innovation and safety mandates
Sharing approaches for conducting quality risk assessments and taking proactive measures
Charting a future course for the medical device industry with best practices and learned insights

Continue reading
Performance Management Beyond Limits: Elevating Operations Excellence Globally
LIFE SCIENCES

Performance Management Beyond Limits: Elevating Operations Excellence Globally

Chester Zelaya is the Senior Vice President of Implant Network Global Operations at Edwards Lifesciences, overseeing global facilities that support both Surgical Heart Valve and Trans-Catheter Divisions. With over 30 years of leadership experience in the biopharmaceutical and medical device industries, Chester has a proven track record of driving operational excellence across diverse, multi-plant environments. Prior to joining Edwards, he held senior roles at Shire and Baxter, where he managed large-scale plasma manufacturing operations and led significant global initiatives. Chester also serves as a board member for Heart to Heart Global Cardiac Care, helping to expand access to life-saving cardiac treatments in underserved regions. His strategic vision, technical expertise, and commitment to building high-performing teams contribute to his success as a leader in the healthcare industry.

Continue reading
How a Global MedTech Leader Operates to Unlock the Future Medical Device Manufacturing
LIFE SCIENCES, MEDICAL DEVICES

How a Global MedTech Leader Operates to Unlock the Future Medical Device Manufacturing

In his role, Viju is responsible for global operations, including manufacturing, direct procurement, regulatory affairs, quality assurance, sustainability, integrated business planning, logistics and advanced operations such as additive manufacturing technology development.

Prior to joining us, Viju served as Chief Supply Chain Officer and Senior Vice President at Verizon. Before his work at Verizon, Viju held key leadership roles at Intel in technology, supply chain and manufacturing operations.

Viju earned his doctoral degree from the University of Pennsylvania and dual graduate degrees (MBA, S.M. in electrical engineering) from the Massachusetts Institute of Technology’s Leaders for Global Operations program. He also holds a graduate degree (M.S.E. in computer science engineering) from the University of Michigan and a bachelor’s degree in engineering from the University of Kerala, India.

Continue reading
The Journey from Quality Remediation to Quality Excellence
LIFE SCIENCES, MEDICAL DEVICES

The Journey from Quality Remediation to Quality Excellence

David Kunz was appointed Senior Vice President, Global Quality and Regulatory Affairs in May 2017. He is responsible for providing strategic and operational direction to achieve Quality and Regulatory Excellence across the organization and he chairs the Company’s Quality Excellence Steering Committee. Mr. Kunz joined the Company (then Zimmer) in 2011 as Vice President, Regulatory Affairs and Quality Assurance for the Spine division. He was appointed Senior Vice President, Global Quality, Clinical and Regulatory Affairs in April 2016. Prior to joining Zimmer, he served as Vice President, Quality Assurance of Ecolab, where he led a supply chain network including nine chemical plants and two equipment plants. Previously, he spent 13 years at Guidant/Boston Scientific Corporation in a variety of leadership positions, most recently as the Director of Supplier Quality Assurance for the CRV Division. He began his career at the Naval Nuclear Propulsion Program Headquarters as a mechanical engineer. Mr. Kunz holds a Bachelor of Science and an MBA from the University of Minnesota. He is a certified Nuclear Engineer and previously was a certified Licensed Professional Mechanical Engineer.

Continue reading
Supply Chain as the Enabler to Deliver on the Zero Unserved Patients Promise
LIFE SCIENCES, MEDICAL DEVICES

Supply Chain as the Enabler to Deliver on the Zero Unserved Patients Promise

In his role as Head of Supply Chain & Operations for Philips Image Guided Therapy Devices, Cory is responsible to lead a world-class supply chain organization and to drive operational excellence in support of the business goals, which are fully focused on providing patient-focused and market-leading solutions. His passion for building a high-performing team of supply chain and operational leaders is rooted in his belief that there is always a better, more efficient way to serve our customers. Prior to entering the diagnostic / therapeutic medical devices industry, Cory spent over 20 years in development and leadership roles in the medical device and automotive industries.

Continue reading
The Data-Driven Future: Leveraging Insights to Stay Ahead in Healthcare
LIFE SCIENCES, MEDICAL DEVICES

The Data-Driven Future: Leveraging Insights to Stay Ahead in Healthcare

Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,350 U.S. hospitals and health systems and approximately  325,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, NC, Premier is passionate about transforming American healthcare.

Continue reading
Fireside Chat: Chaos to Clarity: Driving Results and Engaging Teams Through Operational Rigor
LIFE SCIENCES, MEDICAL DEVICES

Fireside Chat: Chaos to Clarity: Driving Results and Engaging Teams Through Operational Rigor

Mark MewsVice President, Global Supply Chain & Operations LeaderW. L. Gore & Associates Mark Mews leads the operations and supply chain for the Peripheral Business Group and has been at W.L. Gore and Associates, Inc. for over 16 years spending a majority of that time leading cross-functionally in various operations & supply chain leadership roles across both new product development and commercial life cycles. Mark is an advocate for continuous improvement, creating a lean culture, and focusing teams and organizations on delivering targets that improve both top and bottom-line growth.

Continue reading
Building a Quality Culture and Continuous Improvement
LIFE SCIENCES, MEDICAL DEVICES

Building a Quality Culture and Continuous Improvement

Ensuring safety, compliance and innovation – How to build a strong quality culture and implementing continuous improvement practices

Successful implementation of quality culture & continuous improvement

Overcoming challenges in building a quality culture

Embrace quality at every level of the organization and adopt continuous improvement as a core value to stay competitive, compliant, and trusted in the marketplace

Continue reading
Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?
LIFE SCIENCES, MEDICAL DEVICES

Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Innovation and R&D: Fueling our industry, R&D drives groundbreaking solutions. We will explore strategies to stay ahead in technology and product development

Manufacturing Processes and the Future: Optimizing processes for agility and sustainability is key. We adapt to innovations to lead the industry forward

Quality in the Age of AI/ML: Exploring the future of medical device manufacturing and how automation will reshape operations while maintaining quality standards and leveraging technologies for risk mitigation and improvement

Regulatory Compliance: Employing effective strategies for clearance and ongoing compliance

Supply Chain Resilience and Sustainability: Enhancing supply chain resilience and sustainability through strategies that leverage digitization and AI to bolster efficiency, traceability and fortify against unforeseen challenges

Continue reading
Renewable Raw Materials: BASF’s Exciting Sustainability Initiatives
SUSTAINABILITY, VIDEO, SUSTAINABILITY, PODCAST

Renewable Raw Materials: BASF’s Exciting Sustainability Initiatives

In the run-up to the 2025 edition of the North American Sustainability & Responsibility Summit series we spoke with Jessica Monserrate and Jordan Keller of BASF, a 150-year-old chemical company with 111,000 employees working in 230 production and R&D sites in 90 countries. BASF is committed to ambitious sustainability targets, including a 25% reduction in Scope 1 and 2 greenhouse gas emissions by 2030 and achieving net zero across all scopes by 2050. In this wide-ranging conversation, we explore how BASF is driving sustainability, which role renewable carbon plays, the importance of mass balance and agriculture, and how all of these efforts can provide significant benefits to both customers and the environment. For all this and more, give this episode a listen!

Continue reading
How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better

In the run-up to the 2025 edition of the Medical Device Manufacturing Excellence Summit series we spoke with Shawn McCarthy, Jessica Swanson, and Peggy Hansen of Regenity Biosciences about exciting developments in the Medical Device space, with a particular emphasis on both the power of collaboration and the importance of a regulatory strategy. Regenity is an industry-leading CDMO working with 120 different industry partners and offering special expertise in regenerative devices. In this wide-ranging conversation we talk about industry trends, how medical device manufacturers are evolving to continue to meet the needs of patients, and also about some of the big ideas Regenity wants to share with the executives attending MDMES25. For all this and more, give this episode a listen!

Continue reading
Unlocking Career Growth at Scale: Leveraging AI and Emerging Technologies for Hyper-Personalized Learning
LEARNING, VIDEO, LEARNING

Unlocking Career Growth at Scale: Leveraging AI and Emerging Technologies for Hyper-Personalized Learning

Ashley Walvoord is Verizon’s Chief Learning Officer, bringing a people-first approach to connecting learning and career development across the employee lifecycle. With a focus on creating a robust skills ecosystem, Ashley is committed to empowering employees at every stage of their careers, ensuring they have the tools and opportunities needed to thrive. She is passionate about leveraging innovative technologies to transform the learning landscape and align it with the rapidly evolving digital world. Under her leadership, Verizon’s talent practices in performance management, assessments, and skills development have been highlighted by leading organizations such as Forrester, Gartner, Harvard Business School, and SHRM. Verizon’s learning and development programs have earned recognition from Training Top 10 Hall of Fame, CLO Learning Elite, Brandon Hall and ATD Best.

Ashley holds a Ph.D. in Industrial-Organizational Psychology from the University of South Florida, and has published multiple articles, chapters and presentations on the science of work and talent management. Her leadership is marked by a profound commitment to inclusion, culture, and innovation and she is enthusiastic about giving back to the community, volunteering her time in business development for education, diversity, and social-emotional learning initiatives.

Continue reading
Powering the Workforce of the Future Through Learning & Development: Putting the Employee at the Center to Navigate Their Career Journey
LEARNING, VIDEO, LEARNING

Powering the Workforce of the Future Through Learning & Development: Putting the Employee at the Center to Navigate Their Career Journey

Sandra Humbles has over 30 years of experience and currently serves as Johnson & Johnson’s first Chief Learning Officer since 2021. She spearheaded the creation of a new learning and development framework for the company’s employees.

Previously, she was the Vice President of Global Education Solutions for MedTech, where she developed learning strategies and implemented Virtual Reality for surgeon education. Her work influenced educational approaches globally.

Currently, Sandra Humbles leads a global team focused on the future of learning and development at Johnson & Johnson. Her leadership aims to make learning a key component of the organization’s success. She is dedicated to fostering professional growth within the company, envisioning an integrated approach to learning and development that benefits all employees.

Her contributions have supported both individual progress and the realization of Johnson & Johnson’s goal to combine heart, science, and ingenuity for global health impact.

Continue reading
Building Learning Strategies to Drive Frontline Equity
LEARNING, VIDEO, LEARNING

Building Learning Strategies to Drive Frontline Equity

Shannon leads the Global Competence Development & Learning Organization at IKEA (Ingka Group), the leader in building sustainable life at home. Her organization is responsible for developing the global strategy for learning, competence development, skills, job architecture, and learning technology across 30 countries and 177,000 co-workers. With over 20 years in talent management, she has a strong background in supporting retail, digital, and corporate teams in talent acquisition, succession, learning, skills, and development. Shannon is passionate about delivering talent management programs that create equity for frontline employees, enhance leadership, and help teams achieve strategic goals.

Continue reading