Digital Transformation for Medical Devices: Webinar

Randy Horton

Published on: September 10th, 2024

Going Digital: Best Practices for Achieving Digital Transformation for Medical Devices

Manufacturers of traditional hardware medical devices who want to connect their products to smartphones and the cloud face sizable challenges. While they may have a clear, strategic vision of what a successful digital transformation looks like, the tactical steps needed to get there can be less clear.

From retraining R&D teams with new tools and techniques, to updating design controls and regulatory compliance practices to cover both medical device hardware and software, to staying ahead of guidance from the FDA, there’s a significant pile of responsibilities, documentation and best practices to be dealt with.

Overcoming challenges to achieve both a strategic- and tactical-level digital transformation with high ROI is possible – especially when manufacturers learn from peers who are further along in their connected software journeys.

Orthogonal and BLUR Product Development held a webinar that discussed the nitty-gritty of digitizing existing medical device hardware organizations. Our speakers reviewed strategic-level requirements and shared best practices for manufacturers looking to expand into connected medical devices and SaMD.

Webinar Recording

Watch Webinar Recording

Speakers

Keith Gausmann, Partner, BLUR Product Development

Keith is a results-driven mechanical R&D engineer with over 20 years of experience innovating, solving tough problems and designing commercially successful products for medical, consumer and industrial use. He brings a strong focus on user experience design and integrating all aspects of product development, from idea through implementation, to ensure commercial success. Keith has extensive hands-on experience with idea generation, conceptual design, detailed design with 3D modeling (Solidworks and ProE), medical device design controls, regulatory submissions, US and Asian manufacturing, program management, data science, engineering analysis (FEA) and working within aggressive cost and time constraints.

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).