Meeting FDA Requirements for BLE Mobile Medical Apps: Webinar

Despite a lack of specific guidance and constantly evolving standards, mobile medical apps and their companion Bluetooth Low Energy (BLE)-enabled medical devices consistently make it through the FDA clearance process. Manufacturers obtain clearance for their apps by meeting the FDA’s standards for mobile platform compatibility, cybersecurity and other domains. What are those standards, how do you fulfill them, and how do you maintain device safety and effectiveness when mobile platforms and cybersecurity threats inevitably change?

Orthogonal and MedSec hosted a webinar on Wednesday, September 20th, part of our joint Bluetooth Low Energy for Medical Devices Webinar Series. Bernhard Kappe, Orthogonal’s CEO and Founder, Randy Horton, Chief Solutions Officer at Orthogonal, and Buddy Smith, MedSec’s Director of Technical Consulting, discussed insights on the FDA requirements for mobile medical apps connected to Bluetooth-enabled medical devices, and how to meet those requirements.

Video Recording

Speakers

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.

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).