Why Medtech Needs Active, Always-Audit-Ready Compliance with Seth Goldenberg, President of Veeva MedTech

The Dominican Republic has been manufacturing medical devices for more than 30 years, but many in the industry still don't know it. In this episode, Johannes Kelner, Director of the Free Zones Council of the Dominican Republic, talks about the country's opportunity for medtech manufacturing. Recorded live at the MedTech Conference in Boston, he explains how the council approves companies into the free zone regime, where he says companies do not pay duties or income tax. He shares how the country's long-standing medical device sector grew alongside Puerto Rico, and why he points to political and economic stability as a draw. He also talks about resilience, port and air connections to the U.S., and why the country now needs more suppliers to build a robust ecosystem. Tune in to hear why the Dominican Republic wants to get the word out about medtech manufacturing! Resources: Connect with and follow Johannes Kelner on LinkedIn. Follow the Free Zones Council of the Dominican Republic on LinkedIn and explore their website!

Medtech companies that treat compliance as always-on will move faster than those that catch up after the fact. In this episode, Seth Goldenberg, President of Veeva MedTech, discusses shifting compliance from a passive, catch-up mindset to an active one in which companies are always audit-ready. He shares why medtech teams are not in this alone and how connecting data, sites, health authorities, and internal teams can break down silos. He explains how practical AI works best when models, agents, and applications are designed together. He also discusses Veeva's move away from token-based AI pricing and its new product lifecycle management suite built for medtech. Tune in to hear how an active approach to compliance and AI can help medtech teams move faster! Resources: Connect with and follow Seth Goldenberg on LinkedIn. Follow Veeva MedTech on LinkedIn and explore their website!

Receiving a diagnosis later in life can change how someone understands themselves, their work, and the care they need. In this episode, Kendra Koch, Founder and CEO of Divergently, shares how her late ADHD diagnosis during pregnancy led her to rethink everything she had learned in the wellness industry. She explains why traditional wellness approaches often fall short for neurodivergent women, why founders and leaders need to prioritize their own mental health, and how storytelling and self-compassion support healing. Kendra also discusses where mistrust in the healthcare system comes from, how patients and providers can see each other as partners, and how Divergently gives late-diagnosed women a place to find vetted information, peer support, and community. Tune in to hear how self-understanding, lived experience, and community can help women get their needs met! Resources: Connect with and follow Kendra Koch on ⁠LinkedIn.⁠ Follow Divergently on⁠ LinkedIn⁠ and join the waitlist at⁠ joindivergently.com⁠.

Why the future of ambulatory surgery centers hinges on strategic adaptation, increasing access to care, and redefining the outpatient experience. In this episode of ASC Insights, recorded live at ASCA SAMBA 2026, Lindsay Alexander and Alexis Anderson are joined by Austin Cheng, CEO of Gramercy Surgery Center. As a second-generation owner/operator, Austin shares his unique journey of taking over his mother's legacy just before the pandemic and navigating the rapid evolution of the ASC landscape in New York City. He discusses the shift of higher-acuity cases—like spine and cardiovascular procedures—to the outpatient setting, the ongoing challenges of staffing and out-of-network insurance disputes, and his pragmatic approach to adopting new AI and operational technologies. Austin also sheds light on the benefits of private equity capital and the innovative move toward weekend procedures to enhance both patient and provider experiences. Tune in as Austin Cheng explores how independent surgery centers can position themselves as vital access points and why a strong business plan is essential for navigating today’s complex healthcare environment. Resources: Connect with and follow Austin Cheng on LinkedIn. Follow Gramercy Surgery Center on LinkedIn and explore their website!

Everyone talks about human-in-the-loop. Right now, it is still AI in the loop. In this episode, Alfred Olivares, Healthcare and Life Sciences Industry Leader at HTEC Group, talks about what it really takes to make AI work in medtech. He shares how his background as a manufacturing engineer shapes his view that companies should run a value stream analysis before starting an AI program. He explains why data governance, data ownership, and data maturity matter, and why AI models now need managed services with people who understand the business context. He also shares how HTEC took its own AFib detection device through to FDA submission readiness, and why he sees conferences as a place to build long-term relationships. Tune in to hear why AI still needs people to validate the data and the output! Resources: Connect with and follow Alfred Olivares on LinkedIn. Follow HTEC Group on LinkedIn and explore their website!

Doctors learned to listen to the heart decades ago. Now they are learning to see. In this episode, Joe DeVivo, Chairman and CEO of Butterfly Network, talks about putting handheld ultrasound in the hands of every doctor and nurse. He shares how care is moving to where patients are, from nursing homes and patients' homes to rural clinics, and how remote reads can keep people out of higher-cost settings. He explains how data from connected devices is helping build AI tools that make ultrasound easier to use. He also shares why medtech companies should build direct relationships with clinicians, and how Butterfly is opening its semiconductor-based ultrasound technology to partners. Tune in to hear how the next wave of medtech growth could start with the clinician, not the contract! Resources: Connect with and follow Joe DeVivo on LinkedIn. Follow Butterfly Network on LinkedIn and explore their website!

Ireland's medical device ecosystem took decades to build, and that depth is hard to replicate. In this episode, Michael Storan, Vice President of Life Sciences at IDA Ireland, talks about how Ireland became a global hub for medical devices. He explains how IDA Ireland supports multinational companies expanding overseas, from scale manufacturing to innovation partnerships. He shares how Galway is moving from manufacturing excellence into earlier-stage product design, and how AI and digital manufacturing are shaping what comes next. He also traces the agency's history and why decades of skills, quality experience, and suppliers are so difficult to copy. Tune in to hear what it takes to build a medtech ecosystem that lasts! Resources: Connect with and follow Michael Storan on LinkedIn. Follow IDA Ireland on LinkedIn and explore their website!

Medical devices can no longer be secured once at launch and left alone.  In this episode, Joe Gullo, Commercial Sales Leader at Red Balloon Security, discusses how the company protects connected devices while they are running. Recorded live at the MedTech Conference, Joe explains how Red Balloon embeds a lightweight code called Symbiote into device firmware to monitor memory and tasks, and block rogue processes before they cause harm. He shares how the company's work with ARPA-H's UPGRADE program is opening doors across the medical device industry, and why AI is shrinking the time attackers need to find and exploit a vulnerability. Joe also explains why FDA expectations for lifetime security mean a one-time cybersecurity check is no longer enough, and how runtime protection can reduce emergency patching and free engineers to focus on improving products.  Tune in to hear how self-protecting devices help keep patients' care on schedule! Resources: Connect with and follow Joe Gullo on LinkedIn. Follow Red Balloon Security on LinkedIn and explore their website. Visit Red Balloon Security's medical device solutions page. Email Joe at [email protected].

AI is powerful, but most health systems still can't point to the savings. In this episode, Zach Silverzweig, Co-Founder and CEO of CipherHealth, talks about turning AI's potential into real results for health systems. He shares how CipherHealth has brought new technology into hospitals for 17 years, including the products that failed along the way. He explains why the last mile from a promising AI project to a live, working solution is so hard, and why security and governance matter. He also shares two opportunities for health systems: reviewing underused application spend and using AI to make existing teams more productive while keeping humans in the loop. Tune in to hear how health systems can get real value from AI! Resources: Connect with and follow Zach Silverzweig on LinkedIn. Follow CipherHealth on LinkedIn and explore their website!

Neuroscience is advancing faster than ever, and the biggest risk is the shift from science to commercial reality. In this episode, Ginger Johnson, Senior Vice President at Lumanity, and Isabella (Bella) Giaquinta, Senior Consultant at Lumanity, discuss why commercial thinking needs to start early in neuroscience development. They explain why teams should define a target product profile before entering the clinic, covering the intended patient, the value the product is meant to deliver, and the evidence needed to support it. Ginger shares why the largest market is not always the right first indication, and why smart sequencing can build confidence in a mechanism, shape physician and payer perception, and set up future indications. Bella explores how psychedelics illustrate the challenge, from monitoring and site-of-care needs to access and reimbursement. They also unpack the evolving role of biomarkers and how precision psychiatry, supported by AI, could help match patients to the treatments most likely to work for them. Tune in to learn how defining the patient, the meaningful benefit, and the real-world use case early can turn promising neuroscience into products that succeed! Resources: Connect with and follow Ginger Johnson on LinkedIn. Connect with and follow Isabella Giaquinta on LinkedIn. Learn more about Lumanity’s Neuroscience expertise. Follow Lumanity on LinkedIn and explore their website.