Home-use devices can provide significant benefits to patients and families, including quality of life improvements and cost savings. However, there are special challenges involved in developing devices designed for home use including regulatory and reimbursement issues that need to be considered.

In this MassMEDIC sponsored webinar; Jim Turner, Sunrise Labs Director of Software Development, Vicki Anastasi, Regulatory Consultant at VJA Associates, and Justin Kelly, Regional VP of Health Policy, at Novocure share strategies in navigating regulatory pathways and reimbursement barriers.


Key topics to be discussed:

  • Challenges and opportunities for risk mitigation of home-use devices
  • Life Cycle management of home-use devices 
  • Special considerations related to Telemedicine/Cybersecurity
  • Claims being made about the device being developed
  • Device classification and SW safety class based on claims and device type
  • Special considerations or implications related to EUA (Emergency Use Authorization) both near term and longer-term
  • Coverage, Coding and payment opportunities
  • Identifying potential reimbursement barriers and the means by which a device will be reimbursed
  • Use of clinical evidence to secure coverage