Move Faster and Break Nothing with Med Devices, SaMD and DTx

MedTech Experts Discuss Best Practices for Accelerating Medical Device Software Development

Presented by:

  • Free

Why attend?

To paraphrase a famous tech industry quote, “In the future, all MedTech companies will become software companies.” Digital MedTech (powered by software, data, algorithms, the cloud, smartphones and ubiquitous connectivity) is delivering a continually increasing share of the new value and innovation in medical devices.

There are tremendous opportunities for the firms that can move faster than the traditional pace of regulated medical devices – those that can find the middle ground between moving slow and breaking nothing and moving fast and breaking things. Operating at Internet speeds allows firms to create tremendous revenue streams at higher margins, continually improving healthcare outcomes and better managing healthcare costs.

As a result, a whole range of players are now fiercely competing with investments and talent in what was once the sizable but fairly cloistered world of medical device manufacturing. Traditional medical device manufacturers that are quickly creating connected devices and new digital business models find themselves competing with:

  • Giants in the technology industry (including cloud-based Internet giants and consumer electronics innovators) looking to further expand their (often $1T+) fast-growing market valuations by capturing a large share of the revenue in healthcare and life sciences –  the same ways they have in virtually every other industry.
  • Pharmaceutical manufacturers that are now developing pipelines of digital therapeutics.
  • An entire range of traditional brick-and-mortar healthcare providers and newer virtual and hybrid healthcare providers providing a range of telemedicine services, chronic disease management and wellness offerings.
  • Startups (often well funded) with innovative ideas for Software as a Medical Device (SaMD) that want to compete with or exit with a sale to any of the above firms.

The potential gains to winners and patients are huge, and the risks to losers are just as large. But virtually everyone working in the connected medical devices, DTx and SaMD space is finding the same thing – that it’s still very difficult to effectively fuse the velocity and agility of the web world with the safety, efficacy and constraints of regulated MedTech and the healthcare ecosystem it operates within.

Join us and cram 10+ hours worth of high-value, timely learning into a 90 minute session.

This event will feature a mix of industry leaders and pioneers, sharing first-hand lessons learned from their groundbreaking case studies on accelerating the development of medical device software at the dawn of the age of digital health. They’ll discuss the best and worst practices learned through their leading edge efforts. They will also cover how to leverage a variety of tech industry approaches, such as fast feedback loops (e.g., Agile and Lean Startup), design thinking and non-traditional leadership approaches – and how to best fuse those approaches with the constraints and decades of experience already established in the world of regulated MedTech.

Target Audience

  • Director
  • VP
  • SVP
  • EVP
  • DVP
  • General Manager (GM)
  • C-level
  • CEO
  • COO
  • Chief Medical Officer
  • Chief Clinical Officer
  • Chief Marketing Officer
  • Chief Technology Officer
  • Chief Information Officer


Select a speaker to learn more

Michael Iglesias
Global Quality Advisor, Roche

Michael Iglesias will be leading software quality at Roche and was previously the Lead Quality Engineer at Novo Nordisk, focused on SaMD and Digital Therapeutics. With nearly a decade of experience in the SaMD and connected devices, he has delivered several successful mobile apps to market and clinical trials worldwide. Michael also champions and is an expert with eQMS and SDLC tools for SaMD.

Over his career in mobile technology, Michael has worked for Apple- launching the first-generation iPhone and iPad, Janssen (Johnson & Johnson), Eli Lilly, Philips, Novo Nordisk, and Roche. He holds several patents in mobile apps as well as many industry certifications.

Next speaker
Carl Washburn
Senior Consultant, Digital Health Quality, IDM, Lilly

Carl works at Lilly in Digital Health Quality, which is part of IDM (Indianapolis Device Manufacturing) where he ensures that the medical device software Lilly develops complies with medical device regulations in the global markets in which Lilly operates.

Carl has previously presented at the FDA Pre-Cert Public Meeting, PDA/FDA Joint Regulatory Conference, and at the Atlassian Summit on agile development and medical device software quality.

Carl is regularly sought out for issues regarding regulatory requirements for medical device software, implementation of Agile methodology for regulated software, and process improvement.

Carl serves as the Chair of and Secretary of Lilly governance teams for Change Management and Medical Device Software Risk Management.

Carl has an MBA from the University of Utah, and has previously worked at Johnson & Johnson and Siemens Medical.

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Bernhard Kappe,
CEO and Founder, Orthogonal

Bernhard Kappe is the Founder and CEO of Orthogonal. For the last decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical devices. As a leader in the Chicago-tech 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 FDA Regulated Environments and co-author of the AAMI consensus report on cloud computing for medical devices. Bernhard is founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge, the top startup competition based on lean startup principles. Bernhard 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.

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Don Jennings
Advisor of Digital Health Technology, Eli Lilly and Company

Donald Jennings is an Advisor of Technology within the Eli Lilly Digital Health organization where he leads engineers in developing SaMD solutions to manage complex disease states. Previously, Mr. Jennings led teams in the development of eSource technologies, automated clinical information exchange, PK/PD simulators and genomic analytics in support of Lilly R&D.

Before joining Eli Lilly and Company, Mr. Jennings served as manager and senior engineer at Celera Genomics (2000-2007) where he participated in the original sequencing of the human and rat genomes. He also contributed to a number of NASA and ESA high energy astrophysics missions (XTE, ASCA, INTEGRAL, Compton GRO) as a senior and chief software engineer (1991-2000) while assigned to Goddard Spaceflight Center and the University of Geneva.

Mr. Jennings holds an MBA from Butler University, an M.S. in Physics from Iowa State University, and bachelor’s degrees in Physics and Computer Science from the University of Missouri.

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Randy Horton,
VP of Solutions and Partnerships, Orthogonal

Randy Horton is VP of Solutions and Partnerships at Orthogonal, where he works with pharmaceutical, diagnostics, and medical device companies to help them accelerate the development and rapid improvement of Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical devices. Randy has spent much of his career guiding healthcare and life sciences organizations in applying the latest in strategic thinking, business models, and technology trends to improve healthcare outcomes and bend the healthcare cost curve.

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Mark Brincat
Senior Director of AI and Advanced Analytics, Zimmer Biomet

Mark has a thirty year career in software with over twenty year of that in Life Sciences and MedTech. He led numerous Pfizer digital therapeutics projects in the earliest days of mobile healthcare and went on to work with Pharma’s top twenty companies in developing patient and clinician mobile solutions. Mark then led healthcare products and then the healthcare business at McLaren Applied Technology, focused on advanced analytics. He joined Zimmer Biomet in 2021, leading the delivery of emerging AI and advanced analytics data products. Key areas of interest are in driving the shift towards data centric strategies and delivering sustainable and scalable digital services into healthcare.

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Larkin Lowrey
Senior Director of Software Engineering for Digital Health, Tandem Diabetes Care

Larkin Lowrey is Senior Director of Software Engineering for Digital Health at Tandem Diabetes, which he joined two years ago. A veteran of the software industry, Lowrey spent the prior 20 years architecting and building technology for a telematics company. Over the course of his career, he’s developed a passion for IoT solutions, time-series data, big data analytical tools and using software testing patterns to improve efficiency and quality, as well as an appreciation for the philosophy and practice of science.

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Torrey Loper
Director of Marketing, egnite Health

Torrey Loper is Director of Marketing at egnite Health. She previously served in product management roles at Edwards Lifesciences and Medline Industries. She has BS and MBA degrees from the University of Illinois at Urbana-Champaign.

egnite is a digital healthcare company dedicated to improving care for structural heart disease patients by delivering actionable insights through intuitive digital health platforms, proprietary A.I. powered analytics, and deep clinical expertise.

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