Tuesday June 25, 2024

8:00 am
Registration & Coffee

Cybersecurity Workshops

9:00 am Workshop A: Complying with FDA’s Guidance for Cybersecurity to Ensure Secure Product Development & Reduce the Likelihood of a Delayed Product Delivery

  • Chris Doherty Senior Lead GRA Software & Cybersecurity, Fresenius Medical Care Deutschland
  • Leo Park Sr. Dir of Cyber, Click Therapeutics
  • Kevin Stevens Head, Global Regulatory Affairs Device, PDT, Takeda Pharmaceutical Co. Ltd.


  • Delving into company experiences with the SPDF guidance document, exploring collaborative approaches and strategic implementation strategies
  • Identifying and isolating pivotal deliverables outlined in the expansive SPDF guidance, simplifying the document for a more digestible and actionable understanding
  • Illuminating gaps within the document to enhance comprehension, fostering a clearer understanding of potential challenges and areas for improvement
  • Aligning the recognized standard IEC 81001- 5-1 with the deliverables in SPDP Appendix 4, elucidating essential submission requirements for seamless compliance and clarity

11:00 am Morning Break & Networking

12:00 pm Workshop B: Evaluating & Managing Security Risks: CVSS vs STRIDE Methodologies

  • Canwen Liu Senior Manager of Software Quality, Mevion Medical Systems
  • Leo Park Sr. Dir of Cyber, Click Therapeutics


  • Discussing the pro’s and con’s of each methodologies in evaluating potential vulnerabilities within a medical device
  • Learning how to prioritize vulnerabilities and determine the overall risk of your system
  • Explaining the rational between picking which methodology is best for your organization and product and how to use each of the methods to effectively analyse the security of your device

Regulatory Workshops

9:00 am Workshop D: Submission Pitfalls & Strategic Planning for Regulatory Success

  • William Sammons Senior Manager Regulatory Affairs, Baxter BioPharma Solutions
  • Kimberly Colasanti Senior Manager – Regulatory Affairs, Baxter BioPharma Solutions
  • Marc Neubauer Director of Regulatory Affairs, Software, Baxter International Inc.


  • Discussing the importance of strategic planning in regulatory submissions to avoid wasted time and increase the chances of successful approval
  • Highlighting common pitfalls in regulatory submissions, featuring insights into detrimental factors observed by regulatory bodies
  • Exploring different approaches, processes, and methods that may impact submission outcomes and discussing strategies to avoid pitfalls for a smoother regulatory process

11:00 am Morning Break & Networking

12:00 pm Workshop E: Exploring Strategies for Harmonized Compliance to Overcome Regulatory Variation in Global Product Development

  • Sruti Lahkar Senior Lead - Quality, Genentech
  • Damien Sharp Director of Global Quality - Device Quality (Software), AstraZeneca
  • Nathan Sabich Vice President, Head of Global Regulatory Affairs, Butterfly Network Inc.


  • Exploring the concept of a global approach to product development and its implications
  • Addressing the challenge of building a cohesive product strategy to meet both EU and US regulations
  • Examining challenges and opportunities arising from EU MDR, particularly in how it may impact the US regulatory landscape
  • Discussing tips and best practises for successful market access in the EU

2:00 pm
Lunch Break & Networking

3:00 pm Workshop C: Exploring the Latest & Greatest Techniques Related to Software Risk Management to Optimize Your Process


  • Exploring diverse risk management techniques like FMEAs, hazard analysis, and fault tree analysis across companies to identify effective strategies
  • Delving into proven tips to streamline the risk management process for increased efficiency
  • Discussing challenges and extract key insights from each technique to enhance risk management practices

3:00 pm Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together

  • Mary Ann Smith Vice President Quality, Regulatory and Clinical, Chronus Health
  • Michael Chibbaro Vice President, Quality Assurance & Regulatory Affairs (QA & RA), AppliedVR Inc.
  • Ginny Hu Director, Regulatory Affairs, Dexcom
  • Joshua Guo Associate Director, Lead - Emerging Technologies Regulatory and Quality, Biogen


  • Defining SaMD, SiMD, Digital Therapeutics, CDS
  • Exploring the different regulatory expectations for each branch to understanding the correct path to market and how to add a new indication depending on your device type
  • Providing background for regulatory expectations – during development, in submission, post market
  • Linking to other important SW regulations as considerations (production, communication to EHR/ MR, AI, Cybersecurity)

5:00 pm
End of Workshop Day