September 10, 2024 | 11:00 AM CST | Virtual | Sponsored by MDIC

The Future is Here: Harnessing Advanced Manufacturing in the Medical Device Industry

Medical device companies often lag behind other industries in adopting advanced technologies, such as artificial intelligence (AI), to digitally transform their organizations throughout the total product life cycle. Join us for a webinar on September 10th to hear from thought leaders as they discuss the challenges and drivers identified through industry feedback.

During this engaging virtual panel discussion, subject matter experts will share their insights on the current landscape of digital transformation in the medical device industry. The discussion will also explore how to overcome perceived challenges to accelerate the adoption of advanced technologies.

Thought Leadership Panel:

• Moderator: Joseph (Joe) Sapiente, VP, Clinical Science & Technology, Medical Device Innovation Consortium (MDIC)
• Daniel Walter, FDA-CDRH (official confirmation pending)
• Daniel R. Matlis, President & Founder, Axendia
• Steve Zera, Senior Manager, Advanced Manufacturing Clearing House (AMCH)
• Parker Tyler, Director of Reliability Engineering, Edwards Lifesciences

Panelists

Joseph (Joe) Sapiente, Vice President, Clinical Science & Technology, Medical Device Innovation Consortium (MDIC)

Joe Sapiente joined MDIC 2021 with 38 years of medical device experience in quality and regulatory compliance, product registration, continuous improvement and new product development and innovation. He has held executive roles in quality, regulatory, clinical affairs for Hologic, Medtronic, Covidien, Tyco HealthCare and US Surgical. He led the Quality Begins with Me culture initiative for Covidien and the enterprise – wide QBWM role out at Medtronic.  Before joining MDIC Joe was the Industry Chair of MDIC’s Case for Quality collaborative community and AdvaMed Case for Quality Working Group.  Joe has been an active member of the Case for Quality since 2012.

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Daniel Walter is a member of the Compliance and Quality Staff’s ‘Case for Quality’ team in the Office of Product Evaluation and Quality’s Immediate Office within the Center for Devices and Radiological Health (CDRH), FDA. The Case for Quality is an ongoing strategic priority for CDRH to improve access and outcomes for patients and improve device quality by engaging industry, payers, providers, and patients to focus on the quality and performance of medical devices. 

Daniel has been with the FDA for over 14 years in roles, including as a compliance supervisor for 10 years, with a broad experience that covers many device fields and regulatory scenarios.  Daniel joined the Case for Quality team in 2020.

Prior to working with FDA, Daniel was a Validation Engineer for several contractors in the pharmaceutical industry, which lead to becoming a Lead Quality Auditor and Director of Quality.  Daniel’s experience includes facility, utility, equipment, and process validations for automated and non-automated systems.

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Daniel R. Matlis is President and Founder Axendia, Inc. an analyst firm providing trusted advice to Life-Science Executives on Business, Technology and Regulatory issues.

Dan has over three decades of industry experience spanning the Life-Science value chain.

He is an active contributor to FDA’s Case for Quality Initiative (since 2014), is a member of FDA’s Advisory Council on Modeling, Simulation and in-Silico Clinical Trial, and co-chaired the Product Quality Outcomes Analytics initiative with Agency officials.  He has also provided input to the Agency on guidance on “Computer Software Assurance for Production and Quality System Software.”

Dan began his career at Johnson & Johnson, where he provided leadership in the areas of technology, regulatory compliance and business. Before founding Axendia, Dan was a Partner, VP and General Manager at a leading Life-Science consultancy firm.

He is a frequent lecturer at Industry events and has presented Axendia’s research findings to industry executives and the FDA officials.  He has published numerous research reports, eBooks, and articles on key issues facing the Life-Sciences and Healthcare industries. 

In 2021, Dan was named one of the Top 20 Life Science Influencers to follow by Dot Compliance.

Dan holds a BS in Electrical Engineering from Polytechnic University (now NYU School of Engineering) in NY and a MS in Management from the New Jersey Institute of Technology.

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Steve Zera, with over 30 years of experience and leadership in Operational Excellence, Operations, Quality, Engineering, and Program Management within the Automotive, Pharmaceutical, and Medical Device Industries, Steve has led both Lean and Quality Cultural transformations for several companies with manufacturing sites around the world.  Steve was instrumental in the development and use of operational quality and culture assessments used by Manufacturing sites, Contract Manufacturers, and Component Suppliers to drive sustained improvements in their operations. Steve brings a passion for driving continuous improvement and quality centric mindset through employee empowerment, collaboration, and engagement.

Steve joined MDIC in January 2023 to develop the Advanced Manufacturing Clearing House (AMCH) Program, in partnership with the FDA, to promote the use of Advanced Technologies, such as Artificial Intelligence (AI), Machine Learning, Digital Twin/Thread, Internet of Things, etc. as part of a company’s Digital Transformation strategy within the Medical Device Ecosystem and Total Product Life Cycle.

Steve received his BS in Mechanical Engineering from Virginia Tech, is a certified Project Management Professional (PMP) through the Project Management Institute (PMI) and holds 6-Sigma Green/Black Belt and Lean Manufacturing certifications.

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Parker Tyler has over 11 years of experience at Edwards Lifesciences working in various functions including manufacturing, new product development, and reliability engineering. She has developed, commercialized, and scaled multiple structural heart products. Through this experience she has developed a unique perspective on the challenges that products encounter due to user, patient, and manufacturing variation increasing post commercial launch. Throughout her different roles she has maintained a passion for and focus on better understanding and improving system and device performance to be robust to variation, to limit the surprises in the field. In her current role as Director of Reliability Engineering, she is creating new frameworks and technology to improve our ability to understand system performance and has recently been very active in the virtual patient and in silico clinical trial community. She believes that virtual patient and in silico modeling will transform how medical devices are developed, commercialized, and scaled. These technologies will be integral for ensuring reliable and high performing medical devices in diverse and highly variable patient populations.