Is it all about the evidence? How can you secure it?

David Gregory, healthcare/life sciences consulting leader, moderated a panel discussion at the 2019 MedTech Conference entitled, “How medical device coverage decisions are made...really.” His panelists included Dr. Steven Stern, principal at Stern Health; Dr. Jim Cross, president at Jim Cross MD Consulting, LLC; and Dr. Lynne Milgram, MBA, chief medical officer at Sharp Community Medical Group.

This video features commentary to a common question among medical device companies of medical directors, “Is it all about the evidence? How can you secure it?”

 Key takeaways:

• Is level one evidence practical for your device?
• A well designed level 2 study – longer follow-up and larger end for insurers to be consistent with their certificate of coverage
• It is important to show real world evidence, show health outcomes data. How is your device going to offset other costs?
• Other types of longitudinal studies and prospective registries are also important
• Know your audience - It’s not one-size-fits all to getting coverage