Carnegie Mellon University Mechanical Engineering

shimada@cmu.edu

Mask

Mass Customization of Masks for ALS and Sleep-Disorder Patients

Improved fit and comfort of masks for treating ALS and obstructive sleep apnea using 3D printing and scanning for mass customization

Medical Devicesmedical-masksalssleep-apnea3d-printingmass-customizationpatient-comfort

Project Overview

Patients with ALS and obstructive sleep apnea face significant challenges with standard respiratory masks that create uncomfortable pressure points, air leaks, and poor treatment compliance due to one-size-fits-all designs that fail to accommodate individual facial anatomy and changing physiological needs. Our mass customization platform for respiratory masks addresses this critical healthcare challenge by combining high-resolution 3D facial scanning with advanced additive manufacturing to create personalized mask interfaces that optimize comfort, seal quality, and therapeutic effectiveness. The core innovation involves developing computational algorithms that automatically generate custom mask geometries from 3D scans, utilizing biocompatible multi-material 3D printing to create masks with tailored compliance properties, and implementing scalable manufacturing workflows that integrate seamlessly with clinical practice. Key technical challenges include ensuring biocompatibility and sterilization compatibility of printed materials, achieving precise facial geometry capture and processing, optimizing mask design for both comfort and effective pressure delivery, and developing quality control protocols that meet medical device regulatory standards.

This personalized respiratory mask technology dramatically improves patient outcomes by increasing therapy compliance through enhanced comfort, reducing skin breakdown and pressure sores from ill-fitting masks, and providing more effective respiratory support through optimized seal performance. ALS patients benefit from masks that adapt to progressive facial changes as the disease progresses, while sleep apnea patients experience improved sleep quality through comfortable, leak-free CPAP therapy. The technology enables rapid customization turnaround times suitable for clinical workflows and offers significant cost advantages compared to traditional custom mask manufacturing methods. Clinical partnerships with the Allegheny Health Network ALS Center provide real-world validation of patient outcomes and treatment effectiveness. Our research team combines expertise in biomedical engineering, 3D scanning technology, and respiratory therapy to advance personalized medical device manufacturing. We actively seek partnerships with respiratory equipment manufacturers, medical centers, healthcare systems, and patient advocacy organizations interested in implementing next-generation personalized respiratory care solutions that can transform treatment compliance and quality of life for patients requiring long-term respiratory support.

Related publications

  1. Method for evaluating the fit of custom-fit Continuous Positive Airway Pressure masks using finite element analysis

    Erica Martelly, Sandeep Rana, Kenji Shimada

    Computer Methods in Biomechanics and Biomedical Engineering · 2025

  2. Development of a Novel Soft Tissue Measurement Device for Individualized Finite Element Modeling in Custom-Fit CPAP Mask Evaluation

    Erica Martelly, Summer Lee, Kristina Martinez, Sandeep Rana, Kenji Shimada

    Annals of Biomedical Engineering · 2024

  3. Design and Fabrication of Custom-Fit BiPAP and CPAP Masks Using Three-Dimensional Imaging and Three-Dimensional Printing Techniques

    Erica Martelly, Sandeep Rana, Kenji Shimada

    Journal of Medical Devices · 2021

  4. Moldable Mask: A Reusable, Hot Water Moldable, Additively Manufactured Mask to Be Used as an N95 Alternative

    Erica Martelly, Charles Li, Kenji Shimada

    Materials · 2021

  5. Custom-Fit Three-Dimensional-Printed BiPAP Mask to Improve Compliance in Patients Requiring Long-Term Noninvasive Ventilatory Support

    Ying Ying Wu, Deepshikha Acharya, Camilla Xu, Boyle Cheng, Sandeep Rana, Kenji Shimada

    Journal of Medical Devices · 2018

Related articles