Panel Discussion: Overcoming the Challenge of a Fast-Paced Software World in A Slow-Paced Regulatory World

Time: 8:15 am
day: Conference Day One


A Q&A session hosted by the Chair addressing how to integrate regulatory awareness into technical software design

  • How do you adapt the best of modern software engineering, modern product design, and modern product management to the device world? 
  • What are the unique challenges for your device in terms of evolving global regulations?
  • As device manufacturers continue to navigate the evolving global regulatory framework (especially for SaMD) what is the biggest stride you have taken to drive innovation in this ‘regulatory whitespace’?
  • What is the impact of new cybersecurity regulations on the development of innovative, compliant medical device software? What are some early steps you have taken to remain compliant? Can you share best practices?
  • What is your general approach to innovation and bringing new software products to market?