Lessons Learned from 2025, Plans for 2026 for Digital

The end of the year brings an opportunity to step back and assess what 2025 looked like for MedTech organizations building digital capabilities across their medical devices and supporting infrastructure. Many organizations began the year with clear goals tied to device functionality, cloud-backed services, and the broader digital ecosystems that help products grow and stay useful over time. This conversation takes a grounded look at how those plans played out, where meaningful progress occurred, and which unexpected demands shifted priorities.

The session also explores the practical realities of executing digital work throughout the year: where teams stayed on track, where they adjusted, and what they learned as they navigated evolving needs across development, operations, and connected experiences. These reflections set the stage for how leaders are thinking about 2026 and the decisions shaping their next planning cycle.

What We’ll Cover:

✔️ The major digital objectives teams carried into 2025 and how they translated into real outcomes.

✔️ Progress that strengthened device functionality, supporting infrastructure, and overall ecosystem maturity.

✔️ Challenges that surfaced unexpectedly and how they influenced roadmaps and resource allocation.

✔️ Unplanned workstreams that emerged throughout the year and required significant attention.

✔️ Decisions teams would approach differently with the benefit of hindsight.

✔️ How lessons from 2025 are shaping focused, practical plans for 2026.

✔️ Insights to support steadier execution, clearer prioritization, and more reliable momentum going into next year.

Who Should Attend?

▪️ Executive and functional leaders (CEO, COO, CTO, CPO) shaping digital direction for the coming year.

▪️ Regulatory, Quality, and Compliance leaders supporting digital growth while maintaining rigor.

▪️ Product, R&D, and Engineering teams responsible for device functionality, connectivity, and cloud-based services.

▪️ Program owners guiding multi-year roadmaps across apps, data, infrastructure, and connected experiences.

This session will help you reflect on the past year with clarity and enter 2026 with a clearer understanding of what matters most. 

Register for Webinar

Speakers

Mike Alvarez, CEO, Glooko

Mike Alvarez is a healthcare executive with over 20 years of leadership experience spanning medical devices, biotechnology, and digital health. He is CEO, President, and Board Member of Glooko, a global leader in connected care for diabetes and chronic conditions. Previously, he served as CEO of Qardio, driving significant revenue growth and innovation in remote patient monitoring. Mike also held senior leadership roles at Medtronic, St. Jude Medical (Abbott), and Sanofi, where he led large-scale teams, market strategy, and product expansion. Recognized for his entrepreneurial mindset and collaborative leadership, he is dedicated to advancing patient-centric solutions and leveraging technology to transform healthcare delivery worldwide.

Venk Varandan, CEO and Co-Founder, Nanowear

Venk Varadan is the co-founder and CEO of Nanowear, a New York-based healthcare technology company pioneering remote diagnostics through cloth-based nanosensors and AI algorithms. With a unique background spanning healthcare and finance, Venk previously worked in investment banking, advising on transactions worth over $3 billion. He also held roles in product marketing and sales at pharmaceutical companies Eli Lilly and Sanofi. Venk holds an MBA from Columbia University and a BS in Biochemistry from Duke University. Under his leadership, Nanowear has achieved FDA clearance for their innovative SimplECG technology, an undergarment that continuously captures and transmits vital health data.

Bernhard Kappe, CEO and Founder, Orthogonal  

Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Moderator

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).