May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons

2023-05-01

Endolumik’s illuminated device takes a big step for safety The top orthopedic device news out of AAOS 2023 SaMD development lessons from Cordio’s voice AI heart failure app Orthopedic device tech advances High in the Wind River mountains of present-day Wyoming, the inhabitants of a remote alpine village — perhaps the oldest in North America — may have used fresh rawhide soaked in water as a splint to immobilize fractured bones thousands of years ago. Before them, the ancient Egyptians used tree bark and linens, and native tribes of South Australia used thick clay. They would all no doubt be amazed by the modern practice of orthopedics on display at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting — after they recovered from the shock of the scintillating sights of Las Vegas. In this edition of Medical Design & Outsourcing, Executive Editor Chris Newmarker rounds up the biggest launches, updates and findings at AAOS, including news from Stryker, Zimmer Biomet, Smith+Nephew, Orthofix and more. And in our Orthopedics department, I spoke with former Medtronic Spine VP of R&D Tommy Carls about his new endeavor, the Proprio system for spinal procedure visualization. The technology is already observing in operating rooms and could one day be used for joint procedures. Contributions from expert authors in this edition cover the use of transducer arrays to disrupt solid tumor cell division, digitization in medtech manufacturing, and hurdles standing between device developers and patients. Sadly, this edition also includes a final contribution from Sean Hägen, the late founder of user research and product design firm BlackHägen. Also in this edition, Pharma Editor Brian Buntz explores promising new therapies that could make a big difference for patients with high blood pressure, cancer, Alzheimer’s and other conditions. Senior Editor Danielle Kirsh has the latest on a 3D-printed, pumping heart replica, while Associate Editor Sean Whooley reports on a surgical robot prototype that might one day bioprint inside the human body to repair defects and wounds. In Software, I spoke with the CEO of heart failure app developer Cordio Medical for tips on making software as a medical device (SaMD) products — and it all starts before you write a single line of code. I also spoke with the co-founders of Endolumik after their device won the first product clearance through a new FDA program meant to get safer products to patients faster. They and their regulatory consultant shared advice on working with the FDA through the agency’s new process, which offers several key benefits for device developers. And finally, DeviceTalks Editorial Director Tom Salemi offers an extensive preview of DeviceTalks Boston. Make sure to visit us online May 10 and 11 during the show and after for full coverage from our entire team. I hope you enjoy this edition of Medical Design & Outsourcing. As always, thanks for reading. – Jim Hammerand, Managing Editor Medical Design & Outsourcing jhammerand@wtwhmedia.com

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