Cybersecurity Challenges in Med Tech

Many companies overlook the Target Product Profile (TPP) until the Biologics License Application (BLA) stage—by then, its strategic value is lost.

A common misconception is that the TPP is just a set of specifications or acceptance criteria, but in reality, the FDA defines it as a "Strategic Development Process Tool". Without a well-structured TPP, drug development teams risk making costly mistakes, such as developing analytical methods that fail to deliver meaningful data, wasting valuable resources.

Think of it like baking: If a neighbor asks, "How long should I bake my dessert?", you can't answer without knowing the type of dessert, batch size, and oven temperature. Similarly, the TPP helps the FDA understand your product’s development goals, ensuring efficient regulatory interactions and avoiding unnecessary roadblocks.

In an era of digitized and interconnected healthcare, medical devices are more vulnerable than ever to cybersecurity threats. With wireless communication, embedded software, and outdated security updates, these devices become easy targets for cyberattacks, risking patient safety and data confidentiality.

This webinar will break down key cybersecurity risks, regulatory expectations, and best practices for securing medical devices. Through real-world case studies, you'll gain actionable insights to strengthen device security, ensure compliance, and mitigate cyber risks effectively.

WHY YOU SHOULD 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
• Quality Control Departments
• Regulatory Affairs Departments
• Compliance Departments
• Research and Development Departments
• Engineering Departments
• Software Development Departments
• IT Security and Risk Management Teams
• Cybersecurity & Incident Response Teams

Course Director: CHARLES H. PAUL 

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm.  Charles has been a regulatory consultant for over 30 years and has published numerous white papers on various regulatory subjects.  His firm works with both domestic and international clients designing solutions for complex regulatory, Lean, training, and documentation issues.