Medical Device R&D
Imaging Device for Lumbar Puncture Site Identification
This startup was developing a handheld device to aid in spinal punctures. Their device integrates imaging of the spine with needle guidance to help physicians correctly insert a variety of procedure needles on the first try.
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They initially requested support with an ergonomics evaluation and creation of Human Factors documents in preparation for a Pre-Submission meeting with the FDA. Documents included a Task Analysis, UFMEA, HF Plan, and a Formative Testing Protocol. Following the completion of these documents, the scope was increased to include Formative Testing support, Industrial Design management, instruction design (QRG and IFU), user interface/experience design, packaging consultation, and regulatory guidance throughout.
HF Document Creation
Kick-off meeting and design review to understand device and progress to-date
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Task Analysis to inform the UFMEA
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UFMEA to inform the research protocol
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Protocol to guide Formative Testing
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Formative Testing to begin to validate risk hypotheses
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Industrial Design
Ergonomics evaluation and Industrial Design overhaul to incorporate ergonomics recommendations
UI/UX Design
Workflow mapping, user needs mapping, information architecture, and visual design to create the embedded UI
Instructional Design
Collaboration with a medical illustrator to design and develop the device Instructions for Use (IFU) and Quick Reference Guide (QRG)
