Program

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American Medical Device Summit 2023 Program (1.2 MiB)

September 26, 2023

* JOIN US FOR THE PRE-EVENT HAPPY HOUR on September 25, 2023 FROM 6:00 PM – 7:00 PM

7:00 am – 7:55 am CST

Delegate Registration and Networking Breakfast

8:00 am – 8:10 am CST

Chair's Welcome and Opening Remarks

Design

Session notes coming soon

Product Development

Session notes coming soon

Quality & Regulatory

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical
ZimVie

Innovation

Session notes coming soon

8:10 am – 8:45 am CST

Opening Keynote

Developing High-Performing Leaders Within The Medical Device Industry: Setting The Tone For Company Culture and Community

Introducing well-rounded executives to lead teams, resulting in constructive peer development
How to become a focused, flexible, and personable leader within the medical device industry
Building on leadership efficiency through long-term learning opportunities to further continuous education
Defining leadership as action-driven individuals who strive for impactful change and a future-looking lens

8:45 am – 9:20 am CST

Plenary

Jennifer Paine

SVP, Global Regulatory Affairs
Johnson & Johnson

Regulatory Affairs as a Driver of Business Growth

Communicating the value of RA, including the role we play in strategically shaping the external environment
Identifying and developing new RA skills and competencies that address current and future business needs
Elevating RA as an innovator by embracing digital technologies to transform data into insights that drive business growth

9:20 am – 9:55 am CST

Plenary

Driving Your Medical Technology Innovation Through Collaboration To Keep Up With Rapid Change

The medical device industry changes at such a rapid pace, how are we keeping up?
Strategies to stay ahead of the curve while improving quality of care
Increasing reliance on synchronization across patients, providers, and manufacturers to learn and adopt new procedures and technology
Discussing how outreach and collaboration to all corners of the healthcare industry can lead to greater strides in the ecosystem

10:00 am – 11:40 am CST

Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings

11:45 am – 12:20 pm CST

Sessions

Design

Teshtar Elavia

Worldwide VP, Research and Development, BD Surgery
Becton Dickinson

INNOVATIVE MODELS FOR PRODUCT DESIGN AND DEVELOPMENT

What are the key drivers that influence which projects to invest in early-on, and how do you work to de-risk certain activities?
Emphasizing speed-to-manufacturability in the surgery division: How to be efficient with the budget yet drive device development, manufacturing and innovation forward
Case study: New product design and development insight under Becton Dickinson's surgical portfolio

Product Development

Implementing Artificial Intelligence Within Product Development: The Future Of Medical Devices

Reviewing AI implementations over the last decade: What have we learned about product development and speed to manufacturability?
Utilizing AI to deliver treatments to patients while regulating consistent monitoring and distribution
How can AI be used as a tool to advance medical imaging, increasing clarity and accuracy?
Steps to increase the volume of data interpretation to achieve high-caliber results

Quality & Regulatory

Deep Pal

Global VP, Regulatory Affairs
Cardinal Health

Leveraging Growth and Development Across the Quality and Regulatory Portfolio

Reviewing the state of global regulatory convergence efforts and initiatives and how this relates to Cardinal Health's quality culture and QMS
What steps are needed to effectively digitize the quality and regulatory landscape?
How to work with internal stakeholders in a way that makes them see the value that digital QA/RA initiatives bring to the organization
Career progression: Identifying entry points to a career in QA/RA and establishing how to grow your career to the next level

Innovation

Improving Patient Recovery through Minimally Invasive Devices

Tackling challenges of invasive surgery, such as infection risks and slower recover risks through improved minimally invasive devices
Integrating miniaturized sensors in the tips of devices similar to haptic vibrations that can provide feedback to operating physicians
Reducing patient trauma, discomfort, infections, recovery time, and costs
Case study: How we’re using minimally invasive devices to provide targeted patient-centric therapy

12:25 pm – 1:00 pm CST

Workshops

Design

SPEAKER TBA

Invotec

Devising Better Outcomes for Complex Industries and Overcoming Production Challenges

Applying cross-industry experience to specialized medical device projects
Breaking down the complexity of building precision parts into repeatable, consistent processes
Keeping up with the latest techniques for inspection and error-proofing assembly

Product Development

Speaker TBA

IZiel Healthcare

Exploring comprehensive evaluation and monitoring systems to ensure effective and timely deliveries within your organization

How can you improve process engineering and product development, thereby increasing compliance to regulation and improving production yield
Develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations
Understand gaps within the design and development process in a methodical and comprehensive manner

Quality & Regulatory

Speaker TBA

RegDesk

INTRODUCING A MEDICAL DEVICE REGULATORY INTELLIGENCE PLATFORM WITHIN OPERATIONS

How to get instant access to the most up-to-date regulatory requirements
Monitor the entire lifecycle of your product development
Receive compliance alerts when regulatory changes occur
Improve document management by having all essential paperwork accessible on one platform

Innovation

Speaker TBA

Gocious

Aligning your product strategy through business objectives and customer needs

Manage product data in a single location, making it easy for access, to make updates, see the impact of changes, and communicate everything broadly across the company
Visualize your whole product portfolio and strategic plan, while tracking updates and progress
Connect to your existing systems or import data from legacy spreadsheets

1:05 pm – 2:05 pm CST

Lunch & Learn Roundtable Discussions and Open Seating Lunch

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers.
Choose from:

Speaker TBA

Providence Enterprise

Successfully Manufacturing for Class I and II Medical Devices: Experience The Tightest Tolerances, Quality thresholds, and Timelines

Speaker TBA

Altia

Delivering modernized integration and production possibilities to achieve GUI project goals

Speaker TBA

Harman Connected Systems

Understanding ever-changing needs: Producing technology that is dynamic and effective

Speaker TBA

Indegene

Make the most of your data to enhance your competitiveness and elevate customer experience

SPEAKER TBA

BSI Compliance Navigator

Avoiding Risk, Staying Competitive, and Maximizing Profitability Through Faster, Accelerated Workflows

SPEAKER TBA

Technimount Medical

Increasing Safety and Efficiency for Healthcare Providers to Improve Patient Care

2:10 pm – 2:45 pm CST

Sessions

Design

The Complexities of Product Development and Design Requirements: Overcoming Setbacks and Paving The Way to Success

How to efficiently understand specific design requirements and functionalities to avoid future complications
Emphasizing the importance of medical device regulations and their impact on being market-ready
How to compete with other industry experts while meeting the demand for rapid product development
Exploring the benefits of expanding your resources when it comes to material selection for medical device products

Product Development

Enhancing The Product Development Lifecycle: Medical Device Design and Development Processes Unwrapped

Ensuring FDA standard stages are followed while developing new products in the medical device industry
Guaranteeing a successful preclinical research prototype in the initial stages to warrant product efficiency
Emphasizing the importance of monitoring device performance after a device has been approved through manufacturer inspections, reporting problems, and active surveillance

Quality & Regulatory

Mizanu Kebede

Chief Quality and Regulatory Officer
Smith&Nephew

Highlighting Medical Device Regulatory Auditing Guidelines: Actionable Strategies to Form Resilience Within The Industry

Defining processes including preparation, execution, and adequate reporting of auditing practices by understanding the critical impact each step provides
Utilizing programs such as the Quality System Regulation, Compliance Program, and Medical Device Single Audit Plans, as structured parameters for regulatory principles
Case study: How can we honor regulatory practices to uphold the integrity of the industry and avoid compromising innovative product creation?

Innovation

Nick West

Chief Medical Officer and DVP, Global Medical Affairs, Abbott Vascular
Abbott

Beyond Intervention: Best Practices for Adoption of Technology to Improve Patient Care

What are the main barriers to the uptake of innovative technology for medical device executives and patients alike?
Understanding what ‘personalised’ healthcare should look like from a patient’s perspective and how medical device executives can address these needs
How technology can help to remove the barriers to optimal tailored care
How to lead cutting-edge tools and technologies for a large, small and mid-sized portfolio

2:50 pm – 3:25 pm CST

Workshops

Design

SPEAKER TBA

MethodSense

Bringing Your Medical Device to Market While Focusing on Safety, Reliability, and Compliance

Strategies to expedite FDA and international regulatory submissions
Anticipating and addressing the critical requirements that lead to success
Discussing ways to minimize risk, stay agile, and speed up time to market

Product Development

SPEAKER TBA

Phillips-Medisize

Enabling Your Next Generation Medical Technology Through Connectivity and Precision Molding

Analyzing how performance and reliability are critical for innovation
Utilizing design expertise and technical capabilities to keep up with the evolving needs of the industry
How high speed interconnects can support your real-time data and image integration and processing requirements

Quality & Regulatory

SPEAKER TBA

ISACA

Strategies in Improving Product Quality While Adhering to Regulatory Requirements

Enabling device makers to measure their capability to produce high-quality devices
Accelerating improvements to device quality and manufacturing
How we’re improving product quality, availability & cost with an accelerated time to market
Case study: Discussing how the Medical Device Discovery Appraisal Program (MDDAP) is helping promote efficiency, increase cost savings, and improve overall business performance

Innovation

SPEAKER TBA

IPM

Transforming Strategies into Sustainable Results Through Exceptional Leadership

Using new project prioritization processes and effective change management to make strategic decisions with predictability, visibility, and accountability
Harmonizing regulatory and quality systems to improve existing processes
Responding to urgent corporate needs or organizational change

3:30 pm – 4:05 pm CST

Plenary

Curbing the Growing Waste Issue Through Sustainability Initiatives

Analyzing sustainability mandates and goals at our company
Discussing how the increased use of medical devices and accessory can contribute to growing waste issues
Designing materials and devices with sustainability in mind from the ground up
Reusing and repurposing electronics for medical purposes

4:10 pm – 5:30 pm CST

Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings

5:35 pm – 6:10 pm CST

Panel Discussion

Learning From The Past While Planning For The Future of the Medical Device Industry

Analyzing how the industry has changed in the last 5 years and some of the past biggest challenges
Why will investment in cybersecurity be instrumental in the future of medtech?
What will be the biggest disruptors in the industry in the next few years?
Why is collaboration in the space essential for the growth of the industry?
What are your personal goals for the industry moving forward?

6:10 pm – 6:15 pm CST

Chair's closing remarks

Design

Session notes coming soon

Product Development

Session notes coming soon

Quality & Regulatory

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical
ZimVie

Innovation

Session notes coming soon

6:15 pm – 7:15 pm CST

Networking drinks reception

September 27, 2023

7:00 am – 8:00 am CST

Empower Hour

Ann Vu
SVP, Regulatory Affairs, Quality Assurance and Clinical
ZimVie
Jeannette Bankes
President and General Manager, Global Surgical Franchise
Alcon
Christina Arnt
VP, Global Corporate Quality
Zimmer Biomet
Karen Phillips
Chief Medical Officer, Respiratory Interventions
Medtronic
Huiling Zhang
Global Chief Medical Officer, Connected Care
Philips
Jennifer Paine
SVP, Global Regulatory Affairs
Johnson & Johnson

Women in Leadership Panel

Enjoy breakfast refreshments and informal networking in the Exhibition Hall. We also invite our attendees to network at the Women in Leadership Panel with discussion from inspirational leaders in design, product development, quality, regulatory and more. Seating is limited, so please sign up early.

Who inspired you to be a leader and why?
How have you built confidence and/or resiliency over the course of your career?
Describe your leadership style and how you “lead” others. Is it different from your male counterparts?
As a leader, how do you stay mindful of who’s at the table and who’s missing?
What do you think is the most significant barrier to female leadership?
What next steps or call to action should the audience take to build a culture that empowers women in leadership?

8:00 am – 8:10 am CST

Chair's Welcome and Opening Remarks

Design

Session notes coming soon

Product Development

Session notes coming soon

Quality and Regulatory

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical
ZimVie

Innovation

Session notes coming soon

8:10 am – 8:45 am CST

Opening Keynote

Karen Phillips

Chief Medical Officer, Respiratory Interventions
Medtronic

Recruiting and Retaining Robust MedTech Talent to Stand Out From The Crowd

How to narrow the scope down to candidates that have the highly specialized skills required to meet the medical industry's demands
Seeking talent that is well versed in FDA regulations and international standards who are aware of the differing needs of various market segments within the industry
Promoting transparency within the hiring process to ensure that expectations are aligned with potential candidates
Case study: Adopting an in depth understanding of your company’s needs in order to select the most applicable leadership executives

8:45 am – 9:20 am CST

Plenary

Philip Adamson

Chief Medical Officer, Divisional VP, Heart Failure Division
Abbott

Utilizing Modern Technology To Revolutionize Medical Devices: A Deep Dive Into Where The Industry Is and Where We Are Headed

Which technology can be used to advance cardiovascular medical devices?
Taking advantage of remote monitoring of physiologic signals from implanted devices
Case study: Discussing the comprehensive technology behind Abbott's cardiac resynchronization therapy, the CardioMEMS HF™ system and our Mechanical Circulatory Support portfolio, including the HeartMate 3™ heart pump

9:25 am – 10:00 am CST

Workshops

Design

Advancing Software to Meet Current Medical Technology Trends and Standards

What is Software as a Medical Device? How did it become established as a globally harmonized definition through the International Medical Device Regulators Forum?
Coordinating scientific efforts for digital health, software, and emerging technologies
How to create, implement and influence national and international public health strategies and policies
Case study: Fast-tracking FDA regulations for medical devices with the Digital Health Software Precertification Program

Product Development

Addressing Business-Critical Challenges for Medical Device Design and Manufacturing

Investigating the critical trends driving future strategies, commercial models, operations, and technologies of the medical device industry
Enhancing collaboration between R&D and manufacturing operations
How the product development process informs clinical trial design
Case study: Breaking down barriers and challenges that may slow down the innovation and FDA approval process

Quality and Regulatory

Integrating Medical Device Product Development, Design for Six Sigma and Quality Systems Requirements

Employing Six Sigma to produce high quality products, reduce costs, improve efficiencies and increase profits of existing products, processes and services
Driving positive change and impact into business processes and the reliability and quality of products
Engaging cross-functional groups within the organization to define and communicate priorities and functional objectives that drive towards the execution of the organization’s vision and mission

Innovation

Pioneering Emergency and Early Intervention Treatment Options

Integrating early stage product development with full-scale commercial manufacturing
The 50 year evolution: advancements in auto-injector drug delivery systems
Managing a wide range of acute and chronic care medications
Insights on developing safe and effective medical countermeasures for rapid responses in time-sensitive and life-or-death situations
Diving into the differences between providing solutions for commercial customers and for government agencies
Takeaways from the COVID-19 pandemic: responding to unprecedented supply and demand challenges

10:05 am – 11:25 am CST

Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings

11:30 am – 12:05 pm CST

Sessions

Design

Using Immersive Technology To Bolster Healthcare Applications Across the Industry

Analyzing how immersive technology can allow for closer inspection and first person views of medical images and videos
Discussing trends in immersive technology, such as VR/AR/IR, and how they benefit the industry
Using VR and AR to improve product design and allow for greater efficiency and adaptability
Combining immersive technology with other digital technologies to allow for more care options for patients, regardless of where they are

Product Development

Embracing Artificial Intelligence As An Integral Piece of the Healthcare Puzzle

Analyzing the impact and implementation of AI across the industry and forecasting future use cases
Examining how AI improves processing and analysis of large amounts of data that digital medical devices gather
Using AI in drug discovery to predict outcomes in clinical trials and potential side effects
Case Study: how using different applications of AI to improve efficiency and increase annual savings

Quality and Regulatory

Medical Device Biocompatibility Testing: Taking The Necessary Steps To Ensure Safe and Efficient Product Development

Utilizing biocompatibility testing to determine the fitness of a device for human use and any potentially harmful physiological effects
How can your company seek modernized approaches to testing?
Case study: Interpreting the roles of Cytotoxicity in vitro, Sensitization, Genotoxicity, systemic toxicity, and hemocompatibility in 2022

Innovation

Leonard Ganz

Divisional VP, Medical Affairs, Chief Medical Officer Cardiac Rhythm Management
Abbott

Revolutionizing Patient Care and Comfort Through In-Home IoMT Devices

Discussing the on-body segment wearables trend that ranges from clinical-grade to consumer health wearables
Enhancing personal emergency response systems, remote patient monitoring, and telehealth virtual visits
How can your company combat IoMT legal, regulatory, technical, and privacy challenges with regards to home IoMT devices?

12:10 pm – 12:45 pm CST

Workshops

Design

Translating Safety Needs Into Design Concepts

Linking engineers, clinicians, scientists, and experts together to identify, analyze, and develop innovative solutions to high risk safety issues
Ensuring independent expertise and technical assistance of products is fair, rational and scientific
Fostering partnerships with outside stakeholders to advance patient safety
Case study: the process behind the creation of the development tools used for regulatory reviews

Product Development

The Future of 3D Printing: Advancing Medical Device Opportunities and Its Endless Possibilities of Design

Introducing 3D designs for the development of tools for surgical procedures
How can 3D printing change the game for the design of implants and prosthetic devices?
Modernizing anatomical models with more accurate designs with the use of 3D printing

Quality and Regulatory

Strengthening Regulatory Compliance Strategies to Adapt to Evolving Rules in the Global Market

How medical device regulatory affairs teams are tackling challenges preventing them from securing product approval
Exploring regulatory changes following the COVID-19 pandemic
Creating strategies to identify and mitigate risks in the medical device portfolio
Building and maintaining relationships across multiple business units and global regulatory agencies

Innovation

Building an Innovation Pipeline that Fuels Growth

Leveraging inorganic growth that contributes to sustainable business expansion
What is the future of the peripheral interventions market?
Managing a comprehensive range of medical products addressing some of the most challenging global health issues
Investing in the right people, programs and technologies to get the best results

12:50 pm – 1:50 pm CST

Lunch & Learn Roundtable Discussions and Open Seating Lunch

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 2 is limited, but open and available to all.
Choose from:

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical
ZimVie

Putting Quality and Regulatory Strategy Into Practice

Implementing Modern Technology To Promote An Ever-Changing Environment

Becoming An Industry Leader: Striving Towards Effective Leadership Approaches

Keeping Innovation Alive Within The Medical Device Industry: Fostering A Drive For Transformation

Juan Daccach

VP, Global Product Safety
Merz Aesthetics

Developing A Prosperous Team: How To Thrive As A Unit

Introducing Robotics And The Future Of Medical Devices For Surgeries

1:55 pm – 2:30 pm CST

Plenary

Designing the Next Generation of Medical Robots

Analyzing current use cases of medical robots and their impact on the industry
Designing surgical robots with patient care in mind, leading to smaller incisions, reduced blood loss, and a faster recovery
Discussing how medical robots allow for greater benefits for healthcare professionals with improved ergonomics and dexterity during surgery
Offloading tasks on medical robots to allow for a greater focus on patient care and diagnosis

2:30 pm – 3:05 pm CST

Empower Hour

Rob Schlissberg

President, Cardinal Health at-Home Solutions
Cardinal Health

Diversity Equity and Inclusion Panel

How do you define diversity, equity and inclusion in an ever-changing work environment?
What has influenced your thinking around DEI and motivated you to get involved in being an advocate for change?
What success/outcomes has your organization realized from diversity initiatives or best practices?
What next steps or call to action should the audience take to build a culture that empowers DEI?

3:05 pm – 3:35 pm CST

Closing Keynote

Session notes coming soon

3:35 pm – 3:45 pm CST

Chair's closing remarks and survey Prize giveaway

Design

Session notes coming soon

Product Development

Session notes coming soon

Quality and Regulatory

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical
ZimVie

Innovation

Session notes coming soon