Speakers

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health.  She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.  Dr. Tarver has held various leadership positions while at FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement.  Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways.  Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health.  As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.

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.

Mark P. Brosius is senior vice president and chief manufacturing and supply chain officer at Intuitive, with responsibility for SIOP, supply chain, new product introduction, manufacturing, and logistics operations. Brosius is a leading expert in enterprise scale manufacturing and business process automation, as well as the application of big data and analytics to planning, supply chain, and manufacturing. He brings more than 30 years of experience in multinational manufacturing operations and product development.

Brosius joined Intuitive in 2012 as the founding leader of the manufacturing automation function, before leading new product introduction (NPI) engineering and ultimately all of operations. He was promoted to his current role in 2023.

Prior to joining Intuitive, he served as president and chief technology officer for Harbor Fluid Products, from 2002 to 2011.

Brosius earned a BS in mechanical engineering from Stanford University and completed graduate studies in finance at the University of California, Berkeley. He also holds an honorary degree in engineering management from California Polytechnic University at San Luis Obispo.

Peter Bennett is the Senior Vice President of Global Supply Chain for Cardinal Health. In this role, he is accountable for International Logistics, Global Trade, Global Distribution Operations, Global planning, and key customer collaborative planning, forecasting and replenishment (CPFR) teams. He supports Cardinal Health’s Global medical product brands, national brands, Presource, and AeroMed. Bennett earned a bachelor’s degree from the United States Military Academy at West Point, and a master of science from Central Michigan University. He is a member of the Association of Supply Chain Management (ASCM) and currently services as a Co-Chair of Healthcare Industry Distributor Association (HIDA) supply chain visibility council and is on the supplier advisory council of the Healthcare Industry Resilience Collaborative (HIRC).

Terry leads Beckman Coulter’s global operations team, which is focused on manufacturing, distribution, logistics, supply chain planning, and strategic sourcing across all business units.

Terry brings more than 30 years of experience in supply chain and manufacturing leadership. Before joining Beckman Coulter in 2024, Terry led global operations at SI Group and held leadership roles at Henkel, Novartis, Merck, and Johnson & Johnson. Terry brings previous Danaher experience with ChemTreat, an operating company now part of Veralto. Terry holds a Bachelor of Science in Mechanical Engineering from Rutgers University and a Master of Business Administration in International Finance from Rider University.

Rosaleen Burke, Global Quality and Regulatory, Boston Scientific, is responsible for leading all aspects of the quality and regulatory strategy for the Boston Scientific business and broad portfolio. Roz joined Boston Scientific in 1997 and has led Quality and Regulatory teams across several regions, business units, sites and quality functions in roles of increasing responsibility and scope. Roz began her current position in 2017.

She holds a B.Sc. in Microbiology and Biochemistry and a Master’s degree in Biotechnology from the University of Galway, as well as an MBA from Oxford Brookes University. Outside of her professional pursuits, she enjoys horse riding, golf, reading, and playing Scrabble.

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.

Mizanu Kebede is the Chief Quality & Regulatory Officer at Smith & Nephew and serves on the company’s Executive Leadership Team. In this role, he is responsible for leading all aspects of quality and regulatory strategy development and implementation. He is also responsible for engaging directly with global regulatory agencies on all regulatory matters impacting the company’s diverse portfolio.

With over 25 years of leadership experience across the Medical Device, Pharmaceutical, and Healthcare industries, Mizanu has held senior roles spanning R&D, Operations, Commercial, and Quality & Regulatory Affairs. Prior to joining Smith & Nephew, he held executive positions at several leading healthcare companies, including Avanos Medical, Thermo Fisher Life Technologies, STERIS Corporation, and Johnson & Johnson.

Mizanu holds a Bachelor of Science in Medical Technology and a Master of Science in Microbiology and Immunology. He is a certified Six Sigma Black Belt in Process Excellence and has authored numerous publications in scientific journals. He also holds multiple patents in the medical device space.

In addition to his professional accomplishments, Mizanu is committed to community service. He serves as an Advisory Board Member for United Way of North Fulton and is actively involved with the United Way of Greater Atlanta.

Steve C de Baca is Executive Vice President and Chief Patient Safety & Quality Officer of Royal Philips. He brings more than 35 years of quality and regulatory affairs (QRA) experience in the medical technology industry.

Prior to joining Philips in February 2023, Steve served as the EVP of QRA for Cardinal Health, supporting the $185B enterprise and was a member of the Operating Committee.

Prior to this, Steve served as VP of QRA for Orthopedics and Americas for Zimmer Biomet, where he was responsible for supporting multiple business segments as well as the Americas region for international regulatory and compliance. Earlier in his career, he served as the SVP of Quality, Regulatory & Clinical Affairs for the Danaher Diagnostic platform, which includes the four separate operating companies of Beckman Coulter Diagnostics, Leica Biosystems, Radiometer & Cepheid. Prior to that, Steve was with Boston Scientific for nearly nine years in progressively senior strategic roles, the last of which was VP of Quality, for the Cardio, Rhythm, and Vascular (CRV) and the Neuromodulation businesses.

Additionally, Steve served as an industry board member and instructor for six years for the Regulatory Affairs master’s degree program at St. Cloud State University. He earned a bachelor’s degree in engineering and industrial technology and an MBA, both at California State University Long Beach.

He lives in Minnesota and has been married to his wife Katherine for over 26 years. They are proud of their son Carson who is a graduate from Northeastern University in Boston and currently living in Chicago. Steve is an avid runner and sports enthusiast.

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.

Chuck is the Vice President and Chief Quality Officer for Johnson & Johnson MedTech, one of the world’s largest medical device companies. His work gives him the opportunity to shape the future of J&J while ensuring we deliver the highest quality products to patients and customers. He ispassionate about the remarkable technology Johnson & Johnson MedTech brings to the market, but more importantly, the people that enable that to be realized.

Chuck honored to lead an extraordinary group of dedicated, passionate, customer-focused, and innovative teams across the globe in over 100 locations. If you ask his J&J and industry colleagues about him, Chuck hopes they would describe him as a passionate leader who loves to develop and execute outcomes-based strategies. Chuck believes it’s important to have a personal motto to live into each day, and for him that is, “Work hard and always do the right thing.”

Raghu Jainapur is VP of Quality at Baxter International Inc., where he leads global quality for the $3B+ Healthcare Systems and Technologies business. With three decades of experience across the medical device, pharmaceutical and automotive sectors, he has held executive and engineering roles at Ecolab, Abbott, Roche, and Ford. He has led global teams spanning design, manufacturing, and distribution across North America, Europe, Asia, and Latin America, with a focus on FDA compliance, operational excellence, and global regulatory strategy. He also serves as an adjunct faculty member and board advisor at St. Cloud State University, contributing to the development of graduate-level quality and regulatory programs. His leadership has consistently driven successful product launches, regulatory approvals, and quality system enhancements across complex global networks. He earned his Master’s in Mechanical Engineering from the University of Toledo and MBA from Purdue University’s Krannert School of Business.

Medha serves as the Worldwide Vice President of Quality for BD’s (Becton, Dickinson and Company) Peripheral Intervention Business. BD is a leading global medical technology company headquartered in Franklin Lakes, New Jersey. Medha is a member of BD’s Quality Leadership Team and sits on the Senior Leadership Team for Peripheral Intervention Business.

She first joined BD in January 2022 as the Vice President of Quality for BD’s Medication Management Solutions business where she successfully led the Infusion platform through the design, 510(k) clearance and return-to-market of BD’s flagship Alaris Infusion Pump.

Before joining BD, Medha spent 15 years at Stryker Corporation in multiple roles of increasing responsibility in R&D, RAQA and Operations. Medha is known to build strong teams, foster collaboration, influence key stakeholders and deliver business success.

Prior to Stryker, Medha spent 5 years in multiple start-ups, designing and innovating software technologies and products.

Medha holds a B.S. in Computer Engineering from India and M.S. in Computer Science from Georgia Institute of Technology. She has completed a Global Leadership Program at Harvard Business School.

Max serves as senior vice president operational performance for BD (Becton, Dickinson and Company), a leading global medical technology company headquartered in Franklin Lakes, New Jersey. He is also a member of the BD Integrated Supply Chain Leadership Team. Max joined BD in 2021.

He first served as VP of Operational Excellence, driving continuous improvement across the end-to-end supply chain. He led the design, launch and implementation of BD Excellence; he contributed to improve operational performance focusing on savings acceleration, efficiency of critical lines and labor productivity. As part of his role, he led risk management for Integrated Supply Chain, driving progressive risk mitigation to secure business continuity of operations.

Before joining BD, Max had multiple cross-sector Executive roles in Manufacturing and Supply Chain in Fast Moving Consumer Goods, Consumer Electronics and Automotive. He served as Operational Excellence Leader in Johnson & Johnson Consumer Health and Unilever. He worked for 13 years in Automotive where he began his career at Ferrari-Maserati before continuing with Fiat Chrysler Automobiles, serving as Manufacturing Director, Global Head of Supplier Development and Lean Director.

Max holds an Executive MBA from ESCP Business School in Paris, France, a PhD in Mechanical Engineering from ‘La Sapienza’ in Rome, Italy, and a Master’s degree in Mechanical Engineering from the University of Perugia, Italy.

Prabhu Gubbi received his Ph.D. in Materials Engineering from Auburn University and has > 20 years of work experience in medical device industry (including Zimmer Biomet Dental (now known as ZimVie), Somahlution & NuVasive) and a well-recognized notified body BSI.  He has intimate knowledge of MDD 93/42/EEC, MDR 2017/745, UKCA, and related EU guidance/regulations related to medical devices with dedicated training as well as has conducted technical reviews of Class IIa, IIb and III devices under MDD, MDR & UK MDR.  Prabhu is well-conversant with design controls, risk management, pre-clinical design verification testing, design validation, usability, biological safety assessment, packaging evaluation, clinical evaluation assessment, technical documentation assessment, labelling including eIFU EU regulation, subcontractor/supplier assessment, and various device manufacturing processes/activities.  He has also demonstrated expertise in the selection of optimal materials, characterization of materials behavior, failure analysis, formal mechanical testing of materials for medical devices and other applications in addition to the development of effective osseous implant surfaces including the use of resorbable blast media, titanium plasma spray, micro and nanometer-scale hydroxyapatite depositions, and surfaces modified with acid- and laser-etching techniques. He was also instrumental in developing implantable devices, components, and associated surgical techniques.

Robert Popp is a seasoned professional with over 35 years of experience, including executive management, spanning medical devices, pharmaceuticals, and biologics. His expertise encompasses service support, sales, marketing, quality, and manufacturing. Known for his customer-centric approach, Robert leverages strong analytical skills and business acumen to drive improvements in customer experience and regulatory compliance.

Robert excels in addressing regulatory challenges and implementing lean and compliant solutions. He has a proven ability to create sustainable revenue pipelines, expand market share, and enhance product quality while maximizing operating margin and net income delivery.

As a leader, Robert focuses on team development and innovation, inspiring engaged and high-performing teams to achieve organizational goals. He drives continuous improvement initiatives and collaborates with key stakeholders to develop and deploy policies, processes, and procedures that drive sustainability, quality, and service improvements across the board.

Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.

Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year postmarket clinical study for orthopedic devices.Lowe has a bachelor’s degree in mechanical engineering from the University of Utah and an MBA from Indiana University.

Joe Goodman is the General Manager of the Americas region for Honeywell Life Sciences, where his team partners strategically with the company’s global clients and prospects, identifying the quality and manufacturing system solutions that best fits their needs. Joe is recognized as a thought leader in the fields of quality systems, regulatory compliance, and the implementation of enterprise software within the Life Sciences manufacturing industry. Before joining Honeywell, Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black Belt. He owes much of his penchant for process and solution design to his time spent in that role. Joe also speaks internationally at Compliance and Manufacturing events.

Michael brings more than 24 years of experience in the medical device industry to his role as the VP of Quality for the Orthopedics franchise at Smith+Nephew. He leads a global team responsible for the full product lifecycle from product development, through realization to post market surveillance. As a biomedical engineer with a track record of creative problem solving and leading multiple core business functions in both large and small companies, he is uniquely positioned to aid organizations in connecting strategies and processes across the business to optimize outcomes by balancing customer needs, compliance, and profitability.

Beth Crandall leads Solution Delivery at MEC with over 25 years of experience in the life sciences industry focused on the regulated medical device market. She has a successful track record of leading large quality management system programs and implementing changes to organizations, policies, procedures, and software systems. She also has direct experience conducting assessments for Quality and Regulatory organizations, including evaluation of processes, best practices, functional responsibilities, structure, and staffing. She earned a BA in Business Administration, Human Resource Management from the College of St. Thomas and has been a certified Project Manager (PMI PMP) since 2012. She has presented at several medical device conferences and published multiple articles throughout her career.

Dave brings over 28 years of experience driving transformative outcomes for MedTech companies by revolutionizing how they digitally represent and manage their products across the lifecycle. His work empowers organizations to unlock efficiency, accelerate innovation, and deliver measurable ROI through digital thread enablement.

Sajid Kunnummal is the Senior Vice President and Chief Procurement Officer (CPO) at BD (Becton, Dickinson and Company). Based in Franklin Lakes, New Jersey, Sajid joined BD in January 2025, bringing with him over two decades of global leadership experience in procurement and supply chain management, across multiple industries.

Before joining BD, Sajid served as Vice President of Supply Chain at Eaton Corporation, where he led procurement and supply chain operations for the Mobility Group. Prior to that role, Sajid was the Chief Procurement Officer at Navistar Inc., where he led a rapid transformation of the Procurement function and achieved a step-level improvement in performance & productivity. Sajid’s career also includes senior leadership roles at Johnson Controls, where he led the Global Strategic Sourcing Organization and played a key pivotal role during the merger with Tyco Fire & Security.

Known for his collaborative and pragmatic leadership style, Sajid is recognized for driving innovation, digitalization, and functional excellence in procurement and supply chain. He holds a Bachelor of Engineering in Mechanical Engineering from the National Institute of Technology, India.

Greg Smith is Executive Vice President, Global Operations and Supply Chain at Medtronic. He is responsible for the performance and integration of all aspects of the company’s operations including Manufacturing, Supply Chain, Supply Management, Operational Excellence and Transformation, Enterprise Risk and Facilities, and Operations Quality.

Before joining Medtronic in April 2021, Greg was the Executive Vice President of U.S. Supply Chain at Walmart, one of the world’s largest and most complex supply chains. Greg transformed Walmart’s supply chain to be best in class, developing and implementing a comprehensive strategy that drove sales, achieved operational excellence, reduced costs, and that created an engaging, enabling, and empowering work environment.

Greg is deeply committed to diversity, equality, and the belief that a diverse workplace where everyone feels included results in stronger teams and the highest level of service to our patients, customers, and employees. He was recognized as a 2020 Diversity Leader by Diversity Journal (opens new window).

Before joining Walmart, Greg was Senior Vice President, Global Operations at The Goodyear Tire & Rubber Company, where he was responsible for 52 manufacturing facilities across four business units around the world. He successfully led the company’s global optimization program and implemented an enterprise manufacturing operating system, a global procurement program, and an enterprise planning and logistics approach.

In his more than 35 years of supply chain and operations experience, Greg has also transformed manufacturing, procurement, and logistics programs at companies including ConAgra Foods, United Signature Foods, VDK Frozen Foods, and Quaker Oats.

Greg earned his bachelor’s degree in finance from the University of Tennessee, Knoxville, and he currently serves on the College of Business advisory board. He serves on the GS1 Management Board and is the Vice Chairman of its Board Committee for Healthcare. Additionally, he serves on the board of directors for Advance Auto Parts, Inc. He is also a member of the Gartner Supply Chain Executive Advisory Board.

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.

Paudie O’Connor is the Senior Vice President for Global Supply Chain at Boston Scientific, a position he has held since May 2022. In this role, he serves on the company’s Executive Committee and is responsible for leading the world-class Global Supply Chain team, comprised of thousands of colleagues guided by its purpose of delivering for patients. Paudie’s career in healthcare and medical technology has spanned over 26 years, serving in various roles across management, operations and engineering. Previously, Paudie served as Vice President, Planning and Customer Experience at Boston Scientific from January 2021 to April 2022 and multi-site vice president, Manufacturing from February 2015 to January of 2021. Prior roles in Boston Scientific included Vice President of the Clonmel, Ireland site from January of 2009 to February of 2015 and various engineering and operations positions in the U.S. and Ireland from 1998 to 2008. Prior, Paudie worked for Aer Lingus, PRI Automation and Integer. He is the current sponsor of the Massachusetts PRIDE employee resource group. Paudie earned a B.A. in Mechanical Engineering from Trinity College in Dublin and a master’s degree in industrial engineering from University College Dublin.

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.

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.

John Daley brings over 30 years of FDA-regulated industry experience to Compliance Architects. As Chief Quality Officer at JUUL Labs, he secured its groundbreaking ISO-13485 certification. John has led Quality at Johnson & Johnson, Boston Scientific, and IBM Watson Health, where he also oversaw Privacy and Security. With expertise in Design Controls, CAPA processes, combination products, medical devices, pharmaceuticals, and consumer goods, John offers a wealth of knowledge. He holds a BSME from the University of Rhode Island and an MBA from SUNY Albany.

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.

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.

Robert Popp is a seasoned professional with over 35 years of experience, including executive management, spanning medical devices, pharmaceuticals, and biologics. His expertise encompasses service support, sales, marketing, quality, and manufacturing. Known for his customer-centric approach, Robert leverages strong analytical skills and business acumen to drive improvements in customer experience and regulatory compliance.

Robert excels in addressing regulatory challenges and implementing lean and compliant solutions. He has a proven ability to create sustainable revenue pipelines, expand market share, and enhance product quality while maximizing operating margin and net income delivery.

As a leader, Robert focuses on team development and innovation, inspiring engaged and high-performing teams to achieve organizational goals. He drives continuous improvement initiatives and collaborates with key stakeholders to develop and deploy policies, processes, and procedures that drive sustainability, quality, and service improvements across the board.

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.

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.

Michael Ingles is Edwards Lifesciences Director of Business Excellence, orchestrating the global Operational Maturity Index (OMI) program. He leads an international team of experts assessing business areas across various manufacturing sites to ensure standardization and continuous improvement.

Michael also owns the Edwards Production System (EPS), providing plants with standardized work processes built upon proven principles, practices, and tools. His leadership is pivotal in maintaining world-class standards across the company’s global operations, including facilities in Singapore, Ireland, the Dominican Republic, Puerto Rico, Costa Rica, Utah, Irvine, California, and upcoming plants.

Mike joined Edwards Lifesciences in 2006, working in various roles in finance, project management, and strategy.

Mario Barquero is a manufacturing leader with over 20 years of experience in leadership roles within the medical device industry. As a Manufacturing Leader at Philips, Mario oversees operations across multiple manufacturing sites in Costa Rica and the United States, ensuring world-class quality, compliance, and patient-focused outcomes.

With a proven track record in strategic planning, operational excellence, and fostering high-performance cultures, Mario is passionate about aligning organizational strategies with patient impact. His leadership style emphasizes collaboration, innovation, and empowering teams to continuously improve processes and deliver solutions that enhance patient lives globally.

Throughout his career, Mario has successfully led cross-functional teams, driven sustainable practices, and championed a culture of accountability and empathy. His expertise spans lean manufacturing, quality systems, talent development, and leadership strategies to cultivate a patient-first mindset.

LINNETTE TORRES is the chief quality officer at Integra LifeSciences and is responsible for leading Integra’s quality assurance organization. She oversees critical quality programs such as the development and implementation of the enterprise-wide compliance master plan, quality operations, post-market surveillance activities, design assurance, complaint handling, and validation.

Linnette is a seasoned senior leader with extensive global experience in quality and operations and a record of accomplishments in the medical device industry. Prior to joining Integra, Linnette was at Edwards Lifesciences for more than two decades, most recently serving as senior vice president of quality in the Critical Care division. While at Edwards Lifesciences, she also founded the Hispanic employee resource group and created chapters worldwide.

Linnette completed her undergraduate degree in industrial engineering and postgraduate studies in quality management and productivity at the Instituto Tecnológico de Santo Domingo in the Dominican Republic. She holds an MBA from Pontificia Universidad Católica Madrey Maestra. Linnette is a certified ISO 13485 lead auditor and Six Sigma Green & Black Belt.

Peggy Hansen serves as General Manager of the Contract Development & Manufacturing Business at Regenity Biosciences and Senior Vice President of Quality, Regulatory & Clinical Affairs. Peggy has more than 25 years of experience in regulatory affairs, clinical research, and quality assurance of implantable medical devices and over 14 years in business development and marketing for Regenity. Before joining Regenity, Peggy was the Manager of Regulatory Affairs at SurModics, Inc., a company specializing in surface modification of medical devices, where she was responsible for the company’s regulatory affairs and quality compliance. Prior to working at SurModics, Peggy was at 3M Health Care, Medical Products Division and Cardiovascular Systems Division where she was responsible for U.S. and global regulatory filings with respect to the company’s class I, II, and III medical devices and combination products. She is a certified Regulatory Affairs Professional.

Jessica Swanson serves as Vice President of Marketing at Regenity Biosciences and is dedicated to improving lives globally through the development, commercialization, and impact of innovative healthcare devices. Prior to Regenity, Jessica served as Vice President of Global Marketing for the Breast and Skeletal Health Division at Hologic, Inc., leading a dynamic team focused on product management, integrated brand marketing, medical education, and sales training. During her tenure, she launched several new breast imaging, software, and surgery products, produced multiple award-winning marketing campaigns, and pioneered a groundbreaking health equity program. Prior to Hologic, Jessica spent several years with Medtronic, managing upstream marketing and partnering with R&D to develop numerous innovative products, including a novel endoscopic stapler with preloaded tissue reinforcement. She also led downstream commercialization for the US-based surgical devices business.

An accomplished Global Operations and Manufacturing leader with a proven track record of leading culture transformation and complex product development projects and teams for global operations. Deep background developing high-performing teams to deliver effective product solutions that improve business growth and brand reputation in competitive industries. History of driving success, working with complex multi-tiered private and Fortune 500 companies, advancing my career from product development engineering to senior leadership, overseeing complex product innovations, teams, corporate standardization and improvements.

Kim Kaplan is a Senior Product Manager at ISACA and has been a key collaborator on the Case for Quality Voluntary Improvement Program (VIP) since the development of its pilot in 2017. She is a certified CMMI Associate and Appraisal Team Member for VIP, and now sits as a standing advisor on the VIP Governing Committee. Kim led ISACA’s 2022 launch of the VIP Portal, a data management tool to help program stakeholders track individual continuous improvement journeys as well as identify broader industry trends and insights.

Alison Bagwell is the CEO of Nephron Nitrile, LLC, an American manufacturer of medical and general purpose gloves. Most recently, Alison served as CEO, President and founder of Shield Manufacturing LLC. Prior to founding Shield, Alison was an R&D engineer with 25 years’ experience in portfolio strategy and product development with Kimberly-Clark Corporation. Alison specializes in medical devices spanning PPE/healthcare suppliers, enteral access devices, fluid management, interventional pain management, neuromodulation, IV therapy, diagnostics, and point of care analytics and wound care. Alison holds over 50 patents of which 75% are still in use today.

Michelle Menendez serves as the Senior Director of Strategic Accounts at Premier’s research and analytics division, where she leads the development and cultivation of key relationships with life sciences partners. Leveraging data-driven insights and value-based solutions, she drives measurable outcomes that align with her clients’ strategic goals.

With a wealth of expertise in healthcare and sales leadership, Michelle excels in strategic account management, business development, and operational optimization. She began her career as a health educator at a regional cardiac hospital, a foundation she built upon to transition into the medical device sector. In this space, she held a series of leadership positions, where she spearheaded the transformation of national sales training programs, managed complex Integrated Delivery Network (IDN) accounts, and pioneered innovative health economics strategies.

A proud U.S. Army veteran, Michelle is recognized for her exceptional ability to execute business objectives, cultivate high-performing teams, and deliver impactful, sustainable solutions for both her clients and organizations. She holds a Master’s in Healthcare Administration and a Bachelor’s in Health Science, underscoring her strong academic foundation in the field.

Myla Maloney is the Chief Growth Officer for PINC AI™ Applied Sciences, a division of PINC AITM, the technology and services platform of Premier. With 24 years of experience in the healthcare industry, Maloney supports Premier’s mission of transforming healthcare by leading population health improvement collaboration between PINC AI Applied Sciences and life sciences organizations. Maloney has been with Premier for the last seven years and previously served as Premier’s Chief Commercial Officer, PAS and Vice President of Strategic Supplier Engagement, where she partnered with leading biopharmaceutical and IT companies.

Myla received her B.S. in business administration and MBA from East Carolina University.

Shibu joined Tecomet in August of 2021 as the Vice President of Quality Assurance and Regulatory and was promoted into his current role in August 2023. He is an experienced leader with over 20+ years’ experience successfully building and leading Quality and Regulatory teams in the medical device industry and is committed to assuring exceptional customer outcomes are achieved. Shibu is responsible for developing, leading and driving the strategy/execution of global quality, regulatory, while partnering with business leaders in obtaining world class customer experience and operational excellence.

Prior to joining Tecomet, Shibu lead the Regulatory Affairs and Quality Assurance at Lincotek Medical, Nanthealth, Endo Pharmaceuticals and Stryker in roles of increasing responsibility.

Shibu graduated from Florida International University with a Bachelor of Engineering Degree and a Master’s of Science in Mechanical Engineering Degree.

Jessica is currently the Corporate Vice President, Global Quality and Chief Regulatory Officer at Integra LifeSciences, based in Princeton, NJ. Integra is a ~$1.5B multinational company and global provider of neurosurgical solutions, regenerative technologies, and surgical instrumentation. Jessica oversees all global RA and QA activities and serves as a member of the Executive Leadership Team. In her tenure at Integra, Jessica transformed the non-centralized regulatory organization into a centralized, highly efficient organization. She oversees and supports global regulatory authority collaboration and regulatory strategies for U.S. Class I, II, and III products. She is also the executive sponsor for the company’s EU MDR program and oversees global QA activities including, but not limited to, design assurance, supplier reliability and validation, quality management system compliance, and post-market activities.

Prior to joining Integra, Jessica held leadership roles with increasing levels of responsibility in regulatory and clinical affairs for Hillrom, Becton Dickinson (BD), and CR Bard. Jessica is passionate about professional mentorship and has been an invited speaker for numerous industry medtech and women’s leadership forums. Jessica also serves on the University of Utah Board of Governors, Engineering Alumni Association Board, and Engineering National Advisory Council. Jessica holds a BSc in Civil Engineering, and a Masters of Engineering and PhD in Bioengineering.

Brian Curran oversees the success of MasterControl’s Manufacturing Excellence (Mx) solution in the quest to digitize the 80% of life sciences manufacturing, large and small, that still use paper for their batch records or device history records. Curran has the privilege of working externally with Mx customers and internally across MasterControl from R&D to sales, services, and support to ensure Mx success and adoption.

Curran joined MasterControl in 2002 to direct and expand MasterControl’s product lines. In 2017 he switched to focus on bringing Mx to market, which happened mid-2019 and now has well over 100 customers who have completed hundreds of thousands of production records.

Curran began his career with IBM, where he led consulting engagements with Fortune 500 companies, such as MCI, Bellsouth, and others. After this he held several director and VP level product management positions for software companies serving the telecommunications and web analytics sectors. Curran has an MBA with an information systems emphasis.

Bill Darcy is a manufacturing quality engineer at Carestream Health based in Rochester, NY. Carestream is a worldwide provider of medical imaging systems; X-ray imaging systems for non-destructive testing; and precision contract coating services for a wide range of industrial, medical, electronic and other applications —all backed by a global service and support network. He also supervises the Document Control Administrators and Manufacturing Quality Technicians on the production line. Additionally, Bill led the launch of MasterControl as the electronic production record system for the equipment manufacturing sites at Carestream globally. This effort has led to increased compliance as well as improved speed and data management for device history records. Prior to Carestream, Bill was a corporate accountant in the private sector as well as a public accountant with PricewaterhouseCoopers.

Vishaka Rajaram’s role as senior director of quality at Veeva MedTech brings together three things she cares deeply about – medtech, quality, and technology. 

Prior to joining Veeva, Vishaka drove digital quality transformations for medtech and biopharma clients as a senior director at PwC. She guided clients through ROI-based digital transformation business cases, strategic system selection, future-state EQS landscape design, business process design/readiness & requirements development for configuration, implementation, UAT, training, and hypercare. She also led PwC’s alliance with a third-party to develop AI/ML and advanced analytics offerings to drive predictive quality.

Prior to PwC, she spent nearly a decade within the medical device industry at Stryker and Zimmer, in both corporate and site quality roles.

Vishaka holds a bachelor’s degree in Electronics & Communications Engineering from the University of Madras and an MSE in Biomedical Engineering from the University of Michigan.

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.