Stephen Levin | Expert MedTech Insight & Analysis

Medtech has been accelerating innovation in product development with a record 124 new #devices approved by the FDA in 2023. Yet, this speed is not matched in #medtech trials, which can take up to seven years to complete. By Nicole Bongers, @veevasystems: bit.ly/3FnXkJU

How are VCs adapting to an evolving #medtech market? At #InnovationDublin25, leading investors discuss strategies, challenges, and trends in raising new funds to fuel the next wave of medical technology innovation.

Federal agencies including #FDA have retreated from various forms of public and stakeholder engagement during the opening weeks of the Trump administration. In #medtech, that’s starting to impact global standards development efforts and more: bit.ly/3F4L0OL

NEW EP. of @Market_Pathways Podcast: Following a robust 2024, the medical device sector continues to thrive in 2025 and remains somewhat insulated from dramatic shifts in #healthcare policies, at least in the short term: bit.ly/42nb0hG

Be the expert in the room. Stay ahead of the curve in #medtech regulatory, reimbursement, and policy with Pathways' Document Depot: bit.ly/4kCLqMi

Ortho, spine, and #medtech are thriving, but elective procedures face economic and political uncertainties. @MedTechStrat talks with @ThisIsBTIG's Ryan Zimmerman on the 2025 outlook and what he hopes to learn at AAOS 2025 (March 10-14, San Diego): bit.ly/3FcPUt1

#Robotics pioneer @IntuitiveSurg continues to be the dominant player with greater than 80% market share, nearly 10,000 da Vinci systems placed, and revenue growth in the mid to high teens, more than 20 years after it introduced the da Vinci robot: bit.ly/4hg6bum

Explore the barriers and opportunities learn directly from key decision-makers and read stories of companies that are persevering along every pathways of the #medtech market with @Market_Pathways. Learn why you need us for your market access strategy: bit.ly/46Q3lIz

The future of medtech is taking shape at @MedTechStrat #InnovationDB25. From April 29–May 1, join 300+ #medtech leaders, investors, and innovators for exclusive insights, strategic networking, and in-depth industry discussions. Register today: bit.ly/42UeKaX

ICYMI: Life Science Hub CEO Dr. Mark A. Turco discussed his career journey and vision for RI's life sciences sector with @MedTech Strategist. 💻Read the full article: mystrategist.com/medtech-strate…

Join @GildeHealthcare's Janke Dittmer, @SofinnovaVC's Aantoine Papiernik, and @EndeavourVision's Alexander Schmitz at #InnovationDublin25 in the panel session "Scaling for Success: Strategies in Later-Stage and Growth Investing" during Day 1 from 12:35pm-1:15pm.

Each month in Global Spotlight we provide #marketaccess facts from the country spotlighted on the cover of Market Pathways' print issue. The February 2025 cover features Brazilian Health Regulatory Agency (ANVISA) headquarters in Brasília: bit.ly/3QfyUEC

What is the biggest #regulatory challenge your #medtech company faces?

Medtech CEOs, investors, and #reimbursement authorities share their views on the current state of #medtech coding, coverage, and payment in the US and the EU, and tell us how #AI and chatbots should be on product companies’ payment radar screens: bit.ly/3CyDgDO

Everyone can appreciate a two for one deal. And MyStrategist is your one digital home for two of the #medtech industry's most trusted publications. Take a break. Log in to MyStrategist.com to access strategic medtech intelligence: bit.ly/3OnD8su

Orphan devices—specialized #medicaldevices for rare conditions—face #regulatory hurdles under the EU MDR. While new guidance allows some flexibility, challenges remain. How should the EU address orphan device shortages?

Europe just enacted new requirements for device manufacturers to report anticipated product supply disruptions, and @US_FDA wants the US Congress to follow suit: bit.ly/4jygqwn #MedTech

The biggest issue for #medtech execs isn’t regulatory—it’s #reimbursement. With CMS transparency concerns and complex Medicare Advantage navigation, how can companies bridge the gap? Experts weigh in on balancing innovation, coverage, and patient access: bit.ly/40muxfK

Will the U.S. follow Europe’s lead on device shortage reporting This compares the EU’s new Article 10a, which mandates proactive reporting, to the U.S.’s PHE-tied approach. Without broader mandates, the U.S. risks falling behind: bit.ly/4jygqwn #regulatory

Everyone can appreciate a two for one deal. And MyStrategist is your one digital home for two of the #MedTech industry's most trusted publications. Take a break. Log in to access strategic medtech intelligence and stay informed today: bit.ly/3OnD8su