Cybersecurity Essentials for MedTech - Strategies to Fortify your Devices

Too often, companies wait until the Biologics License Application (BLA) stage to think about their Target Product Profile (TPP)—by then, it’s lost much of its strategic value. The TPP is not just another set of specifications or acceptance criteria. According to FDA guidance, it's a strategic development tool meant to guide smarter decisions throughout the drug development process. Without a well-structured TPP, teams risk wasting time and resources. For instance, an analytical team working without a clear understanding of the product may develop methods that miss the mark entirely. A solid TPP prevents such missteps by aligning development with the end goals from the outset.

Imagine a neighbor asking how long to bake a dessert. You’d need more details—what dessert, how big, what temperature? Similarly, the TPP gives the FDA and development teams critical context about the product, making responses and evaluations more meaningful and efficient.

In parallel, the digital transformation of medical devices is bringing tremendous innovation to healthcare—but also serious cybersecurity risks. Modern devices rely heavily on interconnected software, wireless communication, and long operational lifespans. Without regular updates or strong safeguards, they become easy targets for cyberattacks. These threats endanger not only sensitive data but also patient safety.

To address these concerns, regulators are pushing for stronger cybersecurity standards. This webinar dives deep into the risks facing medical devices, the evolving regulatory environment, and real-world case studies of breaches and recovery. Participants will explore proven strategies for identifying vulnerabilities, complying with regulations, and protecting devices throughout their lifecycle. The session also looks ahead to emerging technologies, offering a forward-thinking approach to securing the future of healthcare innovation.

WHY SHOULD YOU ATTEND

With cyber threats on the rise, medical devices have become prime targets for attacks, exposing patient data and critical healthcare infrastructure to potential breaches. Failure to comply with FDA, ISO, and global cybersecurity regulations can result in product recalls, legal liabilities, and reputational damage.

This training will provide:

• In-depth insights into medical device vulnerabilities—from embedded systems to wireless communication risks.
• Clarity on evolving regulatory standards, including FDA 21 CFR Part 820, ISO/IEC 27001, and EU MDR cybersecurity guidelines.
• Best practices for securing devices throughout their development lifecycle, from risk assessments to post-market surveillance.
• Real-world case studies that illustrate the consequences of security breaches and how companies successfully mitigated them.
• A roadmap for proactive cybersecurity strategies, helping manufacturers and healthcare providers stay ahead of emerging threats.

Whether you're in medical device manufacturing, IT security, regulatory compliance, or healthcare operations, this webinar will equip you with the tools to enhance cybersecurity resilience and regulatory readiness.

AREAS COVERED

• Introduction
  • Overview of the Growing Importance of Cybersecurity in Medical Device Technology
  • Brief Statistics and Examples of Recent Cybersecurity Incidents in Healthcare
• Understanding the Landscape
  • Overview of Medical Device Technology in Healthcare
  • Types of Medical Devices and Their Integration into Healthcare Systems
  • The Interconnected Nature of Healthcare Networks and Devices
• Key Cybersecurity Challenges
  • Complexity of Medical Devices and Embedded Systems
  • Vulnerabilities in Wireless Communication
  • Lifecycle Challenges: Outdated Devices and Lack of Regular Updates
  • Potential Impact on Patient Safety and Data Security
• Regulatory Framework
  • Overview of Current Regulatory Standards for Medical Device Cybersecurity
  • FDA 21 CFR Part 11 & 820, ISO 13485, ISO/IEC 27001, NIST Cybersecurity Framework
  • Compliance Requirements for Device Manufacturers and Healthcare Providers
  • Case Studies Highlighting Regulatory Responses to Cybersecurity Incidents
• Best Practices for Mitigating Cybersecurity Risks
  • Collaboration Between Healthcare Providers, Device Manufacturers, and Cybersecurity Experts
  • Implementing Robust Security Measures in Device Design and Deployment
  • Importance of Regular Updates, Patches, and End-of-Life Planning for Devices
• Risk Management Strategies
  • Conducting Risk Assessments for Medical Devices
  • Developing Incident Response Plans
  • Training Healthcare Professionals on Cybersecurity Best Practices
• Future Trends and Emerging Technologies
  • Exploring the Impact of IoT and AI in Medical Device Technology
  • Anticipating Future Cybersecurity Challenges and Innovations

WHO SHOULD ATTEND

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Software development, programming, documentation, testing teams
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Purchasing Departments
• Everyone working in Medical Device Manufacturing Organizations

Course Director: Charles Paul

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.