As part of the Engineers-in-Scrubs training program that I helped pilot, we had a “Medical Innovation” team project component where we discussed various observations made during our Orientation to the Clinical Environment course, which included a healthy amount of time spent in the OR.

Loosely following the chapters of the Stanford Biodesign textbook, we started by creating a strategic focus for our team, aligned with the course objectives and timeline, then moved into identifying needs based on key observations made in the hospital.

The cumulative 80 hours of OR shadowing turned up a few recurring themes:

  • Surgical nurses being overwhelmed by the number of tools during joint replacement surgeries
  • Nurses grabbing the wrong implant size/type
  • Scrub nurses crudely checking for holes in wrapping after a potentially unsterile tool has entered the sterile field

Tours of the hospital Sterile Processing Department, called the Medical Device Reprocessing Department (MDRD) also revealed some concerns:

  • Problems getting the right tool to the OR on demand due to the way pick lists are generated
  • Unsterilizable objects being left inside toolsets during reprocessing, compromising the sterile field in the OR

From these bullet points, we formed needs statements and went through a selection process, including stakeholder analysis and economic impact, ultimately focusing on minimizing contamination incidents in the OR due to the presence of MDRD process tags being left in toolsets.

A formal design process ensued, including concept generation with a facilitator, and concept selection with feedback from MDRD staff and pugh selection matrices.

We ended up recommending a commercially available product that would solve the identified problem rather than creating a custom solution, as we couldn’t compete on cost due to economies of scale and manufacturing limitations. Because of the department-based billing structure of the hospital, the modest cost-increase of the proposed solution made it prohibitive to adopt despite manifesting benefits in both the MDRD and OR, while eliminating the risk to patients. This proved to be a valuable lesson for future work in this area, particularly after learning about several medical device startups that have failed due to similar reasons.

You can read our final dossier here: APSC 598D Final Report