Case Studies
Real programs. Real outcomes. Explore how JALEX helps medical device companies accelerate development, navigate regulatory complexity, and deliver commercialization-ready solutions with speed, quality, and execution rigor.
Augmented Reality Surgical Navigation
JALEX partnered with an OEM to develop an augmented reality navigation system for shoulder arthroplasty, delivering intraoperative surgical guidance through FDA 510(k) clearance in approximately 27 months.
Ligament Reconstruction Fixation System
JALEX developed a multi-component fixation system for arthroscopic ligament reconstruction procedures, achieving FDA 510(k) clearance in approximately 18 months with a 98-day FDA review period.
Shoulder Arthroplasty Instrumentation Advancements
JALEX partnered with an OEM to design and develop next-generation instrumentation for a commercialized shoulder arthroplasty system, from concept through FDA 510(k) clearance in approximately 20 months.
