ARTICLE SUMMARY:
The top five most-read articles in 2022: Our Document Depot database of global policy documents; MedTech Europe's Oliver Bisazza on changes coming to MDR; reimbursement remains a barrier to medtech innovation, particularly digital technologies, although some new paths emerge for reimbursing digital therapeutics; and eSTAR, CDRH's new electronic reality.
The top five Market Pathways articles from 2022.
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#1: Pathways Document Depot: Cataloging Medtech Policy
Our popular sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
#2: Prescription Digital Therapeutics: Reimbursement Picture Comes into Focus
Makers of FDA-grade software platforms emerging to treat mental health conditions in recent years have been pulling at whatever reimbursement threads they can to support commercial rollouts. But several recent policy developments may help the sector streamline their paths to payment and crack into the Medicare market.
#3: US Re-Emerges as Medtech Innovation Leader, But Reimbursement Is Major Barrier
A report authored by UCLA Biodesign and the Boston Consulting Group on the current regulatory and reimbursement landscape for both traditional and digital devices confirmed that the US has replaced Europe as the first market of choice for medtech innovation due to improvements at FDA and EU confusion resulting from MDR. Reimbursement remains the leading obstacle for all products, along with greater uncertainty for digital devices.
#4: eSTAR Is Born: Advice for CDRH’s New Electronic Reality
Starting next October, every 510(k) sent to FDA will have to be compiled with CDRH’s eSTAR electronic template and submitted via its new online portal. Here’s a look at this big shift from the device center’s analog past and some expert tips on making the transition.
#5: MDR Changes Ahead: An Interview with MedTech Europe’s Oliver Bisazza
The newly named successor CEO of the EU medical device trade association talks about the impending changes that could be adopted to the new Medical Device Regulation to address at least some of the concerns expressed by both industry and regulators, reaffirming that change is the only certainty when it comes to MDR.
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