This year's theme is Designing for Reality: Building MedTech That Works Across Systems, Not Just in Ideal Conditions.

Now in its seventh installment, the Women in MedTech Breakfast has become a cornerstone of the DeviceTalks experience. On May 28, the tradition continues with a fireside chat with Carla Goulart Peron, MD, Chief Medical Officer of Royal Philips, where we will discuss the importance of designing medical devices for the full spectrum of real-world conditions from the outset, ensuring innovations are accessible, scalable, and effective across all economic environments, not just ideal settings.

The program continues with curated small-group breakout discussions led by senior leaders from Medtronic, Abbott, Boston Scientific, and more.

Thank you to our sponsors!

Pre-registration required. Additional fee applies, must be added to your event registration to attend.

In this FOMO, Prash Chopra, the founding CEO of Petal, will highlight a turning point in our industry: the beginning of an era where healing does not begin with harm. He will reflect on the foundation of today’s surgical robotic industry. Then he will confront a shared frustration: a trajectory in which surgery is becoming more technical, more complex, more costly, and paradoxically less human. Finally, he will make a case that incisionless surgery is not optional - it is inevitable.

Ashley McEvoy, President & CEO of Insulet, shares how a consumer-centered mindset, grounded in real-world patient insights, is redefining what’s possible in MedTech. This keynote explores how purposeful leadership, disciplined execution, and an unwavering commitment to value delivery create medical technologies that empower people to live fully—while driving innovation, trust, and sustainable growth. Attendees will gain a leadership perspective on building enduring and impactful outcomes without compromising clinical rigor, quality, or performance.

Stroke remains one of the leading causes of death and disability worldwide. Yet stroke is largely preventable, treatable and recoverable. Today’s advanced technologies support faster diagnosis, targeted treatment and effective aftercare. With the support of AI and telehealth, expert care can now reach remote communities where local resources are limited.

Despite these innovations, access to timely stroke care remains limited worldwide. Every minute counts. Every minute between stroke onset and treatment can result in the loss of around 1.9 million brain cells. For stroke, time truly is brain.

In this panel discussion, Philips Chief Medical Officer Dr. Carla Goulart Peron and other stroke care leaders will share where efforts are being focused across the stroke pathway to help more people receive the care they need, when it matters most.

Creating a successful medical device requires more than engineering excellence—it demands deep empathy for the people who use it every day. In this conversation, Insulet’s Joel Goldsmith shares how the team behind Omnipod approaches design, from engaging directly with patients to refining interfaces that must work seamlessly in real life. He will discuss how Insulet incorporates patient feedback into the design and development of Omnipod, the challenge of building intuitive interfaces that support daily diabetes management, and key lessons from designing consumer-grade experiences in a regulated medical device environment.

Through a new partnership, sensor-integrated spinal cages are evolving into implantable data acquisition platforms. These platforms combine advanced biomaterials, embedded sensing, and low-power telemetry to capture in vivo biomechanical loading and fusion progression. This discussion explores how the delivery of objective, actionable data enhances visibility into patient recovery, biomechanics, and fusion progression and the ways this approach is designed to support more informed clinical decision-making and strengthen outcomes across the continuum of care.

PCI remains a cornerstone of revascularization therapy, yet outcomes in patients with complex lesions or significant comorbidities can be compromised when treatment decisions rely solely on angiographic assessment. Optical coherence tomography (OCT) offers high resolution visualization of vessel structure, plaque composition, and calcium burden, enabling more precise characterization of lesion severity. An OCT platform that integrates AI driven analysis can automate key measurements and highlight clinically relevant features that support evidence based PCI planning. This session will discuss how enhanced intravascular insight can reduce uncertainty, improve procedural strategy, and ultimately support better patient outcomes.

Catheter development challenges often appear during verification or scale-up, but their root causes frequently trace back to earlier engineering decisions. Architecture choices, material assumptions, tolerance stackups, and extrusion design all interact to shape device performance and manufacturability long before teams fully understand their impact.

This session explores the hidden complexity inside catheter systems and how early decisions, including those that define extrusion profiles, influence performance, manufacturability, and program timelines. Drawing on real-world experience, panelists will share practical approaches for aligning design intent with manufacturing reality to reduce risk and move programs from concept to clinic more efficiently.

Building solutions for human interaction with healthcare professionals, NOT replace a Doctor, but to enable the doctors to get to know us better and for what we need.

Health data is growing rapidly through wearables, medical devices, and digital platforms, yet most people still struggle to understand what their data means or how to act on it. Fragmented signals, isolated metrics, and lack of context leave individuals and clinicians without clear guidance. This session explores how integrating digital biomarkers with established medical knowledge can transform raw data into meaningful insight. Attendees will learn how longitudinal health intelligence can reveal patterns, identify early signals, and help individuals and healthcare professionals make more informed, proactive decisions about health and care.

Presented By: Qoluna Health

There is a reason some medical device companies consistently outperform their peers in DTC marketing while others may spend more but still fall behind. Nearly 15 years of delivering exceptional digital marketing results for leading MedTech and healthcare brands has informed a proven, repeatable approach to delivering standout performance. This session shares the strategic roadmap behind that approach, illustrated with real outcomes from some of the most recognized names in the industry, so you’ll leave knowing exactly where to invest and why.

Presented By: 

Details coming soon.

Presented By:

The Exhibit Hall Food Court is open for all attendees to purchase lunch, refreshments, and snacks. Please note that lunch is not provided, but ample seating is available throughout the hall for your convenience.

Brian Miller spent more than two decades at Intuitive, advancing surgical robotics and shaping the future of telesurgery. A longtime advocate for practical innovation, he emphasizes that adoption must be driven by real clinical needs—not technology alone. Now at Sovato Health, Miller brings that grounded perspective to expanding access, usability, and impact in next-generation care delivery.

Across the industry, medical device OEMs are developing products that are pushing the limits of what’s possible. While these advances expand clinical capability, they also place growing strain on development teams, often showing up as late‑stage timeline drift, repeated rework, and prolonged effort. In this panel discussion, engineering leaders from HiArc will share why common fixes like adding resources or extending schedules often amount to expensive band‑aids, and how purpose‑built control system foundations can reduce friction, accelerate iteration, and enable more predictable execution. Drawing on the experience that led HiArc to develop its proprietary control system solution, this session will highlight how stronger foundations help teams build complex devices and avoid the late‑stage pitfalls that cost teams time and money.

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In this powerful closing keynote, Noland Arbaugh shares what it means to become the first person to use a Neuralink brain-computer interface and how it has reshaped his independence, creativity, and connection to the world. This conversation explores not just how the technology works, but what it makes possible. With a live demonstration of neural control in action, attendees will witness the profound impact that precision robotics, advanced electronics, and AI can have on a person’s life.

Join the DeviceTalks, MassDevice, and Medical Design & Outsourcing Editors for a live recording of the DeviceTalks Weekly Podcast.

CPR can double survival chances after cardiac arrest, yet bystander CPR is often inadequate, and nearly 90% of out-of-hospital victims do not survive. HeartBridge is a mechanical CPR device designed for rapid deployment by untrained users in public spaces. Jack and Helena, members of this MIT start-up, will illustrate the core engineering challenges of building life-critical devices for non-expert users: designing robust safety systems, minimizing cognitive load under stress, and validating performance against clinical guidelines. In the future, HeartBridge aims to integrate with AEDs to optimize bystander resuscitation response. Following the same commercial pathways as AEDs, HeartBridge aims to achieve similar widespread public adoption for emergency response.

Additive manufacturing is widely used in medical device development, yet many organizations still struggle to determine where it delivers real value and how to implement it reliably in regulated production. Drawing on decades of experience supporting additive manufacturing in highly regulated industries, Stratasys Direct will share how additive manufacturing can be successfully applied across the medical device lifecycle — from development through production.

In this session, we will examine common medical applications, key technology considerations, and practical approaches to achieving repeatable, production-ready additive manufacturing within ISO 13485 quality systems. We’ll also share the validation fundamentals such as the role of IQ/OQ/PQ in establishing process stability and production readiness. Real-world lessons will highlight where additive delivers the greatest impact, how to avoid common implementation challenges, and what it takes to translate additive capability into dependable, production-grade medical manufacturing with the right validated manufacturing partner.

This session is ideal for teams that are evaluating where additive manufacturing fits in their product cycle, transitioning toward production, or seeking a validated manufacturing partner for regulated medical device programs.

Attendees will leave with:
 A clear understanding of where additive manufacturing delivers value across the medical device lifecycle
 Insight into selecting the right additive technologies and materials for medical applications
 Understanding of what enables repeatable, production-ready additive manufacturing in regulated environments
 A practical view of how ISO 13485 and validation — including IQ/OQ/PQ —support reliable medical manufacturing
 Awareness of common pitfalls when implementing additive manufacturing
 Clarity on how experienced, validated manufacturing partners help move programs from concept to dependable production

Learn the development path of critical components for interventional procedures from early concept to scalable production: By analyzing the integration of ground core wires and vascular implants, MeKo and Wytech highlight how making the right engineering decisions early – specifically around materials and tolerances – defines the success of scalable manufacturing and robust supply chains. This review provides technical leaders with practical insights for identifying supply chain partners that enable robust manufacturable designs, that ensure early-stage innovation translates into reliable, high-volume commercial production.

Software teams inside FDA-regulated environments often struggle with slipping release dates and long, unpredictable V&V cycles before launch. In this case study with Smith+Nephew, we examine how three software teams improved predictability and transparency within design controls. By redefining “done,” integrating quality activities into each sprint, and creating clearer release evidence throughout development, the teams reduced the regulatory tail at the end of projects and established more regular, reliable release cycles. Attendees will leave with practical steps for improving audit confidence, increasing delivery transparency, and making predictable software releases possible inside a QMS.

As AI adoption accelerates across medtech, manufacturers face a critical question: how do you harness AI’s speed and scale without compromising quality, compliance, or engineering accountability?

In this session, Protolabs experts examine how a human‑in‑the‑loop approach to AI is redefining digital manufacturing for medical devices. From AI‑enhanced DFM and automated inspection to intelligent similarity analysis and documentation support, attendees will learn how AI can reduce design risk, improve manufacturability, and enable faster, more predictable outcomes—without replacing engineering judgment. The discussion will also explore how manufacturers can prepare for the next phase of AI adoption while meeting the demands of ISO 13485, traceability, and regulatory readiness.

Join Rita King, Founder and CEO of MethodSense, Inc. as she discusses the practical realities of medical device design across the product lifecycle. King, a medical device regulatory expert with 35 years of hands-on experience will share strategies for maintaining connected decisions, continuous traceability, and evolving regulatory strategy to ensure designs hold up from prototype through market release.

Drawing from real-world submissions, audits, and product challenges, King will examine why well-engineered decisions made early in development are often challenged under regulatory review, not due to poor engineering, but due to disconnects between design choices and downstream requirements. The session covers critical areas including cybersecurity architecture, AI regulatory pathways, clinical evidence expectations, and human factors integration. It will also explore how funding pressures, regulatory complexity, and siloed team operations create predictable gaps and how a more connected lifecycle approach can help teams anticipate and manage them.

Two years ago, a regulatory crisis forced a different question — not how to automate compliance, but how to amplify the experts who understand it. The more you automate with black-box AI, the more you erode the expertise regulators demand. ThELix OS resolves that tension: autonomous agents handling the workflow, domain experts governing every decision.

Two acts. One platform.

ViTel™ transforms fragmented material records, supplier data, and compliance obligations into a living Material DNA layer across the product lifecycle. AnaTel™ reimagines not retrofits — how regulated software is built: FDA submission acceleration, bidirectional traceability, and clinical evidence intelligence.

Real outcomes: 70% reduction in regulatory research labor. 60% reduction in clinical review effort. 72 hours versus eight weeks on SaMD change assessment.

Compliance is not the opposite of competitive advantage. Done right, it is the source of it.

For: Engineering, regulatory, QA, and digital health leaders in medical device and SaMD organizations.

Medical devices rarely fail because of weak ideas - they fail when strong concepts cannot survive the transition from design to manufacturing, validation, and commercialization. The challenge is not an invention; it is an integration.

Syrma Johari MedTech will show how this challenge can be solved by managing the entire product lifecycle as one connected system, rather than a series of disconnected handoffs across design, engineering, manufacturing, and regulatory functions - A lifecycle-driven approach linking design to industrialization.

This perspective is brought to life through a real-world collaboration with a pioneer in point-of-care diagnostics, where a complex device program was advanced from concept through engineering to production readiness. The journey reveals a critical truth: scalability is not achieved at the end - it is engineered from the beginning.
Session will also focus on 2 critical dimensions often underestimated. First, scalability - how design and engineering decisions were aligned early to support reliable, repeatable manufacturing at higher volumes. Second, Cost - addressing the practical challenge of achieving cost efficiency even before scale is realized. This will demonstrate how engineering and design choices drive cost efficiency without relying on scale.

Attendees will hear both the product owner perspective and the lifecycle partner execution perspective, gaining practical insights into what worked, what didn’t, and how integration across stages enabled seamless progression from idea to scalable product.

As medical device design continues to evolve, engineers are under increasing pressure to deliver softer, more compliant devices without sacrificing long-term performance, durability, or manufacturability. This panel discussion will explore how advances in polycarbonate-based thermoplastic polyurethane (PCTPU) are reshaping material options for patient-contacting and implantable applications by delivering silicone-like softness alongside the mechanical integrity required for demanding long-term use.

Panelists will examine the evolution of medical TPU—from early flexibility-driven materials to today’s platform-based polymer architectures designed for enhanced softness, mechanical strength, and long-term implantability. The discussion will highlight how polymer architecture can be used to achieve silicone-like softness while maintaining critical performance characteristics and thermoplastic processability.

As medical devices shrink across electrophysiology, electrosurgery, cardiovascular, and endoscopic imaging, engineers face growing challenges in manufacturability, reliability, and scale. In this talk, ATL’s Vice President of Engineering shares how successful teams turn highly miniaturized concepts into production‑ready devices. Using real‑world examples—including high‑density mapping catheters, chip‑on‑tip imaging, and fine‑wire ribbonization—this session shows why design‑for‑manufacturability, testability, and regulatory thinking must start on day one. The takeaway: miniaturization succeeds only when innovation is structured to work reliably, repeatedly, and at scale.

Design for Test (DFT) plays a critical role in successful device validation and scalable manufacturing but common oversights introduce unnecessary risk and cost.

This session examines five frequent DFT mistakes:

• Poorly designed test plan
• Accepting the status quo
• Reinventing existing solutions
• Miscalculating total cost of ownership
• Failing to anticipate future design changes

Through practical examples, attendees will learn how early and intentional test strategy decisions improve flexibility, reduce validation delays, and support longterm manufacturing efficiency.

Get actionable guidance to help teams integrate DFT thinking earlier in the development lifecycle and avoid pitfalls that hinder product readiness and scalability.

Developing advanced medical devices and robotic systems demands engineering expertise across multiple physical disciplines, but applying that depth of expertise to product development timelines is rarely straightforward. Veryst Engineering was founded to meet that challenge and
help our clients develop extraordinary products, technologies, and processes.

In this presentation, we walk through case studies drawn from public work, including:

• physics-based performance prediction for dual-chamber autoinjectors, enabling faster iterations of design tools and feedback to drug developers
• simulation of needle coring in prefilled syringes to ensure device safety
• multiphysics modeling of smart-pill drug delivery devices to reduce design iterations and time-to-market
• wear predictions of xenograft heart valves using in silico testing to rapidly evaluate designs
• performance and V&V of polymer stents to ensure device safety and deliver regulatory approval
• design and analysis of soft robotic grippers to optimize performance and test design ideas

Our team consists of experts in solid mechanics, fluid mechanics, polymer and materials engineering, heat transfer, and multiphysics simulation. We have an in-house mechanical testing laboratory purpose-built to generate the high-quality data that accurate models require.

Veryst partners with our clients to understand a design failure, evaluate a new technology or device, reduce costly physical testing through virtual prototyping, and optimize manufacturing processes to reduce cost and increase yield. Veryst's integrated simulation and testing capabilities offer a powerful and practical path forward for engineers and designers in medtech, combination products, and robotics.

IQNECT is redefining traceability by elevating it from a maintenance activity to a foundational engineering primitive that enables true system and product understanding. This presentation explores how modern engineering organizations can move beyond disconnected data and manual impact analysis toward intelligent, relationship-driven systems that understand how requirements, design, risk, testing, and validation interact. Through practical engineering change scenarios and product demonstrations, attendees will see how unified traceability enables faster change management, more defensible decisions, improved audit readiness, and AI-driven engineering insight. Attendees will gain a new perspective on digital transformation and the future of unified engineering.