The Other Side with David Filmore

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ARTICLE SUMMARY:

In this video interview, Market Pathways Executive Editor David Filmore and The Other Side host Joe Mullings discuss the regulatory implications of COVID-19 for the global medtech industry.

Key takeaways from David and Joe’s conversation:
  • FDA is employing “maximum flexibility” in expediting policies during the pandemic, while trying to cause no harm.
  • Is COVID-19 making us borderless? Why it might provide a real boost to global harmonization efforts
  • Don’t assume activity has stalled at FDA, Notified Bodies, and other worldwide regulatory agencies. It’s crucial for medtechs, large and small, to keep in touch with their reviewers.
  • CMS has relaxed reimbursement rules to make telehealth more accessible during the COVID-19 crisis. Some private insurers have stepped us as well, but all are offering separate plans.
  • What’s next for the EU Medical Device Regulation now that European policymakers say they will propose a delay?

 

 

About The Other Side

In light of the current challenges facing the world, we have landed in the forefront of the conversation in pursuit of spreading useful knowledge, resources, and state of affairs in the medtech industry. Stay tuned as we take you behind the scenes and provide access to the manufacturers and caregivers who are on the front line of this global pandemic. COVID-19 is far from over. My goal is to be your gateway for information and a central resource of trusted and reliable sources. “Be unreasonably relentless on a daily basis and powerfully patient for the long-term play.” – Joe Mullings. See you on The Other Side.


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Articles from David Filmore:

Regulatory & Reimbursement

Lab-Developed Test Countdown Begins: 4 Medtech Takeaways

From an FDA regulatory history standpoint, it’s a major milestone. From clinical labs’ perspective it’s a power grab. For IVD firms, it’s a welcome, but incremental step. Ultimately, FDA’s lab-developed test rule, published April 29, could just end up being another waystation on the long-winding path to legislative reform.

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