From Design to Clinical Translation: Unraveling Orthotist Perspectives on 3D Printed Accommodative Insoles.

Background: Custom accommodative insoles have become the gold standard for managing plantar pressures and reducing ulceration risk in persons with diabetes. With advances in 3D printing technologies, methods of fabricating 3D printed accommodative insoles have emerged. Clinician feedback is imperative to developing a 3D printed accommodative insole that meets clinical needs and is more effective than the current standard of care. Objective: To inform the development of 3D printed accommodative insoles by gaining clinician perspective on insole requirements and application of the digital workflow for seamless translation into the clinical setting. Study Design: Qualitative study. Methods: Four focus groups with a total of 16 Orthotists were held, prompting discussions on the current standard of care accommodative insole and other 3D printed insoles we have developed. Sessions were recorded, transcribed, and main themes were derived from transcriptions. Results: Review and analysis of the transcripts resulted in four main themes: 1) Reimbursement, 2) Durability, 3) Effectiveness, and 4) Workflow application in clinic. Conclusions: The responses showed areas to focus improvements on the 3D printed insole design and ways to ease the transition into a clinical setting. Clinician support is crucial in the adoption of a new device to clinical practice. Their feedback is essential to ensuring the item meets the clinical needs and the workflow is not disruptive to the clinical setting. Clinical relevance: Understanding clinician perspective on current SoC disadvantages and shortcomings, areas for improvement in the 3D printed insole fabrication, and what is feasible in clinic appointments will help inform insole design and aid in translating new 3D-printing technology to clinical care for improved patient outcomes.