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Advita (formerly Exactech)

GPS Shoulder navigation system for shoulder arthroplasty, bringing computer-assisted precision to orthopedic surgery.

Role
Product Development Engineer
Type
Medical Device
Industry
Orthopedic Surgery

Project Overview

GPS Shoulder is an FDA-cleared intraoperative navigation system for total shoulder arthroplasty, integrated with the Equinoxe Shoulder System. The system provides surgeons with real-time positional data during shoulder replacement procedures, improving accuracy in component placement and alignment.

I developed prototypes and refined the navigation system through iterative testing with surgeon feedback. Working directly with clinical teams, I translated surgical workflow requirements into engineering specifications, built functional prototypes, and validated designs through bench testing and cadaver studies. The development process balanced precision engineering requirements with real-world surgical constraints and FDA regulatory compliance.

Design & Development

I worked directly with shoulder surgeons to understand the nuances of total shoulder arthroplasty workflows. Observing procedures in the OR, I identified constraints and opportunities where navigation technology could improve outcomes. This clinical insight drove design decisions—from ergonomic instrument grips to tracker placement that wouldn't interfere with surgical access.

The prototyping process was fast-paced and iterative. I built functional prototypes, brought them to surgeon feedback sessions, and refined designs based on their input. Testing progressed from benchtop validation to cadaver studies, where we evaluated navigation accuracy and surgical workflow integration. Each iteration informed the next—adjusting tolerances, refining geometries, and optimizing the system for real-world use.

Precision was critical. Tight tolerance analysis ensured tracker accuracy met sub-millimeter requirements for surgical navigation. I documented design specifications, test protocols, and validation data for FDA submission, translating engineering decisions into regulatory language.

Technical Contributions

  • Prototyping & Testing: Built and validated functional prototypes through benchtop testing and cadaver studies with surgeon feedback
  • Clinical Collaboration: Observed shoulder surgeries to understand workflow constraints and inform design decisions for ergonomics and tracker placement
  • CAD Modeling: Precision 3D modeling of navigation components with sub-millimeter tolerances for surgical accuracy
  • Tolerance Analysis: Dimensional analysis ensuring tracker accuracy met navigation system requirements
  • Technical Documentation: Design specifications, validation protocols, and regulatory submissions for FDA clearance
  • Clinical Research: Co-authored peer-reviewed research on navigation accuracy and two-year clinical outcomes

Impact & Results

The GPS Shoulder navigation system achieved FDA clearance and is used in shoulder replacement procedures worldwide. Clinical validation confirmed the engineering decisions: research demonstrated high intraoperative accuracy with glenoid component placement within 2.5° of the surgical plan and low complication rates in multi-year follow-up studies.

I co-authored peer-reviewed research published in the Journal of Shoulder and Elbow Surgery:

  • Two-year clinical outcomes: Youderian AR, Greene AT, Polakovic SV, Parsons M, Papandrea RF, Jones RB, Byram IR, Gobbato BB, Wright TW, Flurin PH, Davis NZ, Zuckerman JD. "Two-year clinical outcomes and complication rates in anatomic and reverse shoulder arthroplasty implanted with Exactech GPS intraoperative navigation." J Shoulder Elbow Surg. 2023 Dec;32(12):2519-2532. PubMed
  • Navigation accuracy: Larose G, Greene AT, Jung A, Polakovic SV, Davis NZ, Zuckerman JD, Virk MS. "High intraoperative accuracy and low complication rate of computer-assisted navigation of the glenoid in total shoulder arthroplasty." J Shoulder Elbow Surg. 2023 Jun;32(6S):S39-S45. PubMed

Note: GPS Shoulder was developed during my tenure at Exactech (2019–2020). The technology is now owned and distributed by Advita following Exactech's restructuring. The system remains FDA-cleared and in clinical use worldwide.