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Crossing the Chasm: Growing Tech Professionals into MedTech Professionals
Crossing the Chasm: Growing Tech Professionals into MedTech Professionals
Can a software engineer or data scientist working in the social media, logistics or cruise ship industries be successful in MedTech? When these new hires are brought on by MedTech firms, it’s with the hope that their experience using modern methods of software development and project management will help MedTech firms Move Faster. But we often see the opposite happen: New hires, frustrated by MedTech's processes, systems, requirements and acronyms, fail to synergize the best ideas from the tech world with the frameworks and constraints of MedTech regulations.

Before they can help us Move Faster, we need to onboard new employees to the Break Nothing ideal. We need to go beyond giving them a crash course on ISO 13485, IEC 62304, QMS, SOP, CAPA, 510(k) and De Novo approvals that teaches them the whats of MedTech software. These industry newcomers need to also be engaged with the whys behind what we do. Outside hires can help MedTech firms raise the collective knowledge of our teams, bring about culture change and up our software game, but unless we change our approach to onboarding, we’ll continue to have unrealized potential, frustrating results and unmet expectations.

How do we successfully bridge the chasm between tech and MedTech, and help our industry take advantage of what these tech experts working in other industries can bring to the table to rapidly evolve successful devices? Join Orthogonal on January 26th, 2023 from 12–12:50 PM EST as we discuss onboarding strategies. Our guests will share their experiences crossing that chasm, followed by a 40-minute Q&A session.

01:23:00

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Speakers

Larkin Lowrey
Engineering Leader & Technologist
Larkin Lowrey most recently worked at Tandem Diabetes Care as a Senior Director for Software Engineering. He implements Agile best practices learned over 20+ years from building high-performance software engineering teams and products for two other critical infrastructure industries: telecommunications and automotive.
Xenios Papademetris
Author and Professor @Yale University School of Medicine
Xenios the lead author of the new textbook Introduction to Medical Software: Foundations for Digital Health, Devices and Diagnostics (Cambridge University Press, 2022), and the main instructor for the companion Coursera Class Introduction to Medical Software. He has 25+ years of experience in medical image analysis and software. He has been involved in medical projects including cardiac image analysis, image-guided epilepsy neurosurgery, image-guided prostate biopsy, development of methods for real-time fMRI, vascular image analysis and general neuroimaging analysis. His software work was part of the original Yale BioImage Suite software package. More recently, he has focused on the creation of server-less tools that can be run in a browser.
Bernhard Kappe
CEO @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.
Melissa Gill
Principal Product Owner @Orthogonal
Melissa has 10 years of experience in Agile Project/Product Management and four years of experience in QA. She has worked in enterprise, security, pharma and SaMD industries on web, mobile and cross-platform projects. Melissa brings her experience implementing Jira/Confluence and Agile processes at numerous organizations to Orthogonal, where she also implements eQMS tooling and process improvements.
Randy Horton
Chief Solutions Office @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).