Throughout 2023, Orthogonal and MedSec’s joint Bluetooth Low Energy (BLE) for Medical Devices Webinar Series has shared best practices that developers and manufacturers can implement in the here and now to address edge cases, cybersecurity risks, FDA requirements and mobile-side connectivity for Bluetooth-enabled medical devices. But wireless technology is always advancing, creating new opportunities and new challenges. What may the future hold for wireless medical devices, and how do we start preparing for that future today?
Orthogonal, MedSec and premier wireless chip maker Nordic Semiconductor hosted a webinar featuring a discussion on the future of wireless technology for medical devices. Kjetil Holstad, Executive Vice President of Strategy & Product Management at Nordic, gave his prediction on the trajectory of wireless technologies in the next 5-10 years and how it may affect the MedTech industry.
Kjetil was joined by Bernhard Kappe, Orthogonal’s CEO and Founder, Randy Horton, Chief Solutions Officer at Orthogonal, and Buddy Smith, MedSec’s Director of Technical Consulting.
Kjetil Holstad, Executive Vice President of Strategy & Product Management, Nordic Semiconductor
Kjetil Holstad is a member of the Executive Management Team since 2019 and took on a strategy role in July 2023. Kjetil has a B.Sc degree in Electronics from Sør-Trøndelag University College (HiST). After working 15 years in various technical and marketing positions related to MCUs and wireless technologies in Atmel Corporation and Texas Instruments, he joined Nordic in 2015 as a Product Manager for the short-range wireless business. Kjetil Holstad is based in Oslo, Norway.
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.
Buddy Smith, Director of Technical Consulting, MedSec
Buddy Smith is a security engineer focused on protecting electronic devices from attack. He has an extensive background in firmware development, bringing his passion for embedded development to the security world. In his 15 years of experience, Buddy has worked in cryptography, hardware design, firmware engineering, and information security. In his role at MedSec, he has supported clients with regulatory filings, performed penetration tests of devices and created threat models for systems, from long-lived implantable devices to bedside infusion pumps.
Buddy holds a Bachelor of Science in Computer Engineering from the Georgia Institute of Technology, and is an Offensive Security Certified Professional. He is also an IEEE Senior member.
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).