Webinar - Key Regulatory and Reimbursement Strategies

Key Regulatory & Reimbursement Strategies

MassMedic Webinar Recording

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.

Increasing use of devices to monitor and screen patients’ health conditions, and even provide self-administered therapy, is a trend we’ve seen over the last few years. This trend is accelerating rapidly with Covid-19, presenting both opportunities and new challenges for device manufacturers.

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 will share strategies for navigating regulatory pathways and reimbursement barriers.

Key topics 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 are 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
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The Massachusetts Medical Device Industry Council (MassMEDIC) represents the thriving health technology sector in Massachusetts and New England, representing more than 300 MedTech companies. Through advocacy, events, mentoring networks, and matchmaking, MassMEDIC is the engine of one of the most powerful life sciences clusters in the world. Join MassMEDIC to get access to events like this and many more benefits.

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