MEDevice Silicon Valley, an MD&M Event

November 20–21, 2024
Santa Clara Convention Center
www.medevicesiliconvalley.com

MEDevice Silicon Valley — formerly BIOMEDevice Silicon Valley — is the launching pad for tomorrow’s groundbreaking medical devices. At MEDevice Silicon Valley, your medical device projects in development can make the leap to the real world with cutting-edge components, materials, cybersecurity innovations, 3D printing technologies, and more from leading and disruptive new suppliers on the scene — all on display for hands-on discovery.

KEYNOTES:

Wednesday, November 20 1–2 PM, Center Stage

Jennifer Samproni,

Chief Technology Officer Health Solutions, Flex Ltd.

Transforming the Future of Patient Care with Human Machine Interfaces (HMI)

Jennifer Samproni, Chief Technology Officer of the Health Solutions business at Flex, brings over three decades of experience in medical device development, leading both engineering and scientific organizations. She is an expert on the mega trends taking place across the healthcare industry — the rise of chronic illness, shifting sites of care delivery, increasing cost pressures across the continuum of care, and technological advancements ushering in a new era of digital health.

At MEDevice, Samproni will share her vision for the growing role that human machine interfaces (HMI) will play in the future of medical device innovation. With the human experience becoming inherently more digital and connected — consumer devices and applications now manage a wide range of tasks for users every day — Samproni will focus on how medtech companies can approach product design to remain competitive. Beyond utilizing HMI to create innovative medical devices that meet consumer expectations, they should also take a closer look at how it can transform the future of health and patient care.

This keynote will highlight the critical importance of HMI innovation and strategies for medical device designers and manufacturers. Topics include:

• The role that medical devices will play in helping to manage the increasing demands of a healthcare system caring for an aging population.

• The rise of connected health – and how to ensure that devices powering connected health have intuitive designs to facilitate their use and improve health outcomes.

• How to design innovative, future-proof medical devices to deliver easier, faster, and reliable access to quality care to the increasing numbers of patients facing chronic illness.

Attendees will leave with a better understanding of how to overcome technical challenges in medical equipment, devices, and drug delivery – and how to approach HMI innovation to improve patient care and ultimately save lives. The session will also feature Adam Scraba, Director of Product Marketing, NVIDIA, on the intersectionality of HMI, AI, and machine learning.

Thursday, November 21, 1–2 PM, Center Stage

Ashley Mancuso,

Vice President, MedTech BISO & Product Security, Johnson & Johnson

Advancing Cybersecurity in Supply Chain Operations

In this keynote, Ashley Mancuso will delve into the critical topic of cybersecurity in supply chain operations. With her extensive experience in securing medtech information assets and overseeing product security, Mancuso will provide a comprehensive overview of how organizations can enhance their cybersecurity posture in the ever-evolving landscape of supply chain operations. Key topics include:

• Creating a Culture of Cybersecurity Advocates:

  • Understand the importance of fostering a culture where every employee is a cybersecurity advocate

  • Learn strategies for embedding cybersecurity principles into the fabric of the organization

  • Explore training and awareness programs that can transform employees into vigilant defenders against cyber threats.

• Enhancing Security Through Proactive Engagement:

  • Discover the value of proactive engagement with suppliers, partners, and stakeholders in the supply chain.

  • Gain insights into building strong relationships that prioritize security from the outset.

  • Examine case studies demonstrating successful proactive security measures that have mitigated risks before they escalate.

• Risk Sensing for Resilient Manufacturing and Distribution:

  • Explore advanced risk sensing techniques that can identify potential vulnerabilities and threats in real-time.

  • Understand how to implement robust risk management frameworks that enhance the resilience of manufacturing and distribution processes.

  • Learn about cutting-edge technologies and tools that can bolster risk sensing and response capabilities.

• Key Takeaways:

  • Practical steps to cultivate a cybersecurity-minded workforce.

  • Strategies for proactive security engagement in supply chain operations.

  • Advanced risk sensing methods to ensure resilient manufacturing and distribution.

  • Don’t miss this opportunity to learn from a leading expert in the field and gain actionable insights to strengthen your organization’s cybersecurity in supply chain operations.

MUST-SEE SESSIONS

Product Development 101

Many entrepreneurial medical professionals have great ideas for a new product, but what does the path to market look like? We have all heard of design controls, verification and validation, and regulatory approval, but what does this all mean? This session will focus on the classic path through a stage/gate process from concept through V&V to regulatory approval and finally design transfer to manufacturing. Chad Herremans, VP Quality and Operations at Meddux Development Corporation, will discuss when the proper time is to implement design controls and what that means. He will discuss the necessary milestones/end points to move into the next phase of the process. He will also address lessons learned that resulted in either good or bad outcomes from a failure to gain regulatory approval to spiraling costs and an inability to exist the V&V phase. Finally, he will introduce V&V strategies and use case studies as supporting examples of good and bad strategies.

Strategies and Techniques to Translate from Medical Device Research into Product Development

In this practical session, Timothy Looney, President & CEO at Northeast Biomedical, Inc., will discuss the nuances of transitioning medical technologies from research into product development and manufacturing. He will explore the challenges of recognizing the right time to move forward, taking into account the risks associated with premature advancement. Moving too quickly can lead to wasted time and resources, necessitating additional funds, research, and time to market.

This session will shed light on the real-world challenges faced by management teams, who are often compelled to make decisions before the technology is ready to meet stakeholder expectations. We’ll address the balance between satisfying upper management and stakeholders and the associated risks.

Throughout the session, Looney will delve into practical techniques for identifying and assessing areas of risk, enabling informed decisions on the progression of medical technology. We’ll also discuss the implementation of pragmatic plans and processes to mitigate these risks, aiming for a smoother path to market while improving patient outcomes. The session will be a down-to-earth exploration of the decision-making process in medical technology development, gaining insights into optimizing the path from development to market in today’s dynamic landscape.

Regulatory Strategy for AI-Enabled Medical Software Manufacturers

In this session, Balazs Bozsik, Technical Director – Medical Audit at SGS North America Inc., will provide an overview of current and foreseeable regulatory controls for AI-enabled medical software for the major markets (EU+UK, MDSAP countries) and outlines considerations for manufacturers to prepare their QMS and product technical documentation to improve the chances of a successful regulatory submission for new and changed AI-enabled software products.

GenAI Security Challenges and Solutions in Medical Devices

Investment in artificial intelligence (AI) and machine learning (ML) is skyrocketing, with the global AI market valued at $196.63 billion in 2023 and projected to grow at a CAGR of 36.6 percent from 2024 to 2030. The U.S. leads with $62.5 billion in private investment, followed by China and the EU. AI’s impact spans industries, with the manufacturing sector expected to gain $3.78 trillion by 2035. Significant growth is also anticipated in AI applications like self-driving vehicles and AI-driven customer service.

Healthcare AI/ML systems are particularly vulnerable, with healthcare ransomware attacks costing, on average, $11 million per incident and posing. Healthcare ransomware attacks cost, on average, $11 million per incident and pose risks to patient safety.

In this session, Rajesh Kanungo, CEO at Tala Secure, Inc., will outline these problems and proposes mitigations, including robust security measures, continuous monitoring, strong data validation practices, and GenAI-driven auto-remediation solutions to ensure the reliability and integrity of AI/ML systems. Addressing these risks is crucial for leveraging AI’s full potential while protecting against threats and safety concerns.

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