Scoliosis (spinal curvature) affects 1.6M children in Europe. Treatment for mild to moderate cases is primarily bracing with orthoses, with severe cases requiring surgery. Traditional manufacturing methods use plaster of Paris casts, requiring the patient to be immobilised for 30-60 minutes ? distressing for young children. Braces need changing every 6 months and manufacture can take up to 3 months; some children have outgrown the brace before it is produced and the process is restarted.
We will deliver a robust and tested, globally scalable, back brace service-pathway for people with spinal deformities to assist and restore function. We will exploit advanced 3D imaging technology, machine learning and novel additive manufacturing methods to deliver a complete end-to-end solution (from consultation to delivery) and overcome the challenges of personalised medical treatment and orthotic service provision.
Our proposed project is an innovative (both technically and commercially) manufacturing process and business model. Our overarching aim is to address the deficits in orthosis manufacturing capability and the orthotics service pathway. Using the combined expertise of Andiamo, Drammen Ortopediske Institutt (DOI) and Nordiamo, we will build a digital end-to-end solution for back-brace service provision for people with spinal deformities based on our design platform. Our project culminates in an automated orthosis design and manufacturing process that takes torso capture data and automatically generates an orthosis design and manufacturing file for back braces. Using context specific inputs and machine learning (ML), our braces will go beyond simply providing support for spinal deformities, but will enable the user to undertake normal activities such as running, dancing or sports. Our back braces can also include a pressure and telemetry unit to provide real-time patient monitoring and feedback.
Andiamo are world leaders in additively manufactured (AM) orthotic services. They were the first in the world to make a clinically-approved ankle-foot orthosis (AFO) using AM technology. Andiamo’s streamlined orthotic 3D imaging, design and manufacture service one of the few services in the world capable of delivering a clinically-effective custom orthosis within 1 week of consultation.
1. Creating unique 3D patient files from scanning data correcting for movement
2. Using clinical input and patient 3D data provide automated design of scoliosis bracing solutions
3. Completion of three patient cohorts using the end-to-end design process and Andiamo back brace for DOI, demonstrating clinical effectiveness (no deterioration of the major or minor curve, or Cobb’s angle) and measuring patient reported outcomes (quality of life).
4. Use ML-based software with complex algorithms to enable remote monitoring and predictive analytics for compliance monitoring and early interventions.