Market Pathways

“We were forced to collaborate with such speed and collective work, and  collective passion, and the results were very good. That’s going to  shape how we think about public policy I think from this point on.”    Scott Whitaker, president and CEO of AdvaMed, didn’t have “respond to a  global pandemic” on his five-year strategy plan when he took the helm of  the powerf...

Digital health is increasingly central to the overall medtech story, and FDA has placed a major emphasis on refining its approaches to meet the needs of this evolving space. In this panel discussion from the MedTech Strategist Innovation Summit San Francisco 2021 that took November 3, two regulatory affairs experts talk about FDA’s efforts. Yarmela Pavlovic, VP of regulatory strategy at Medtronic,...

In this panel discussion from our virtual Dublin Innovation Summit  Conference 2021 experts dive deep on FDA’s recent revival of early  feasibility studies in the US. The initial findings from an MDIC working  group indicate that FDA’s efforts to promote early feasibility studies  appear to be working to increase both the number and efficiency of these  trials in the US, d...

Nadim Yared is a medtech CEO who is not afraid of digging into the  details—the regulatory details; the nooks and crannies of Medicare  coverage, coding, and payment; the finer-points of p-values and novel  clinical trial designs. He has dug in deep on these matters and more  during his 15 years at the helm of CVRx Inc., which as recently  transitioned to a commercial phas...

As the calendar turns from summer to fall, there is no shortage of issues important to the medical device industry emerging on all fronts, addressing legislative, regulatory and policy matters. No one is better aware of the state of play of these issues than Mark Leahey, CEO of MDMA. Here Mark touches all bases with Medtech Strategist/Market Pathways editor-in-chief Stephen Levin, including discus...

China continues its recent trend of reforming its regulatory system to make it more attractive for Western companies to introduce innovative technologies to the Chinese market. This presents a window, particularly for small to mid-sized companies, to access what historically has been a difficult market to crack. Read the full article: https://bit.ly/3AGxCc9 View the latest issue of Market Pathways...

Device companies seeking global market access can no longer ignore  health technology assessment bodies, but there are an expanding number  of HTA pathways that firms can utilize, particularly for truly  innovative, next-generation technology, experts said during a recent  panel discussion at MedTech Strategist’s Virtual Innovation Summit  Dublin 2021. Check out the full v...

Opportunities for companies to engage with FDA during the development  and review of new devices have grown over the years. And if Jeff Shuren,  Director of the agency’s Center for Devices and Radiological Health,  has his way, there will be even more fundamental change in the years to  come.    In this conversation, Shuren talks about the evolution of FDA-sponsor &nb...

After all the years leading up to the implementation of the new EU Medical Device Regulation (MDR) on May 26, 2021, it is fair to assume that regulators and industry would have worked out most of the basics of the new rules in advance of launching the new regimen, especially given the added year delay due to the pandemic. Yet, as you’ll see in this conversation with Serge Bernasconi, CEO of MedTec...