Periodic Reporting for period 1 - SoftDesign_Orthotic (INNOVATIVE MEDICAL SOFTWARE DESIGN FOR ORTHOTIC THERAPY)
Reporting period: 2022-06-01 to 2023-05-31
Orthotics is an unique example of mass customization and it is strongly driven by the aging of a society since the individualization for this age group is not a matter of added value but rather of fundamental need. This is due to the fact that off-the shelf products do not meet the morphological or problem specific diversity needed to assure the functionality of the products. 30% of orthotics do not function correctly resulting in movement disorders and slowing rehabilitation. In extreme cases like diabetes an improper orthotic insole can cause foot amputation. As a result, the new MDR regulation requires quantified evidence of orthotics functionality which impose the orthotic manufacturer to apply sensors for: orthotics evaluation, remote monitoring and post-market surveillance.
The 5.5 Bln. market for custom made orthotics is currently undergoing a digital transformation: 3d scanning, digital design, 3d printing manufacturing appealing aesthetics is getting a standard requirement sensors application for digital feedback need for remote services. Digital transformation boosts the efficiency of orthotic technicians which increases the number of served patients (as well as remote patients) and the sales accordingly. The new doors are open for companies which are able to introduce digital technologies to orthotic and prosthetic design, manufacturing to support/automatize the manual processes, innovative materials and enabling the feedback loop between orthotic engineers and the patients.
The 5.5 Bln. market for custom made orthotics is currently undergoing a digital transformation: 3d scanning, digital design, 3d printing manufacturing appealing aesthetics is getting a standard requirement sensors application for digital feedback need for remote services. Digital transformation boosts the efficiency of orthotic technicians which increases the number of served patients (as well as remote patients) and the sales accordingly. The new doors are open for companies which are able to introduce digital technologies to orthotic and prosthetic design, manufacturing to support/automatize the manual processes, innovative materials and enabling the feedback loop between orthotic engineers and the patients.
We focused on software development:
1. a web-based software - sendance-cloud to be able to transfer, save, analyze, and visualize the sensors data on both the clinical surface of the orthotics and the 3D scanned model of a foot
At the current stage, we are building a sendance-cloud data platform, which is based on the Unity Real-Time Development Platform and offers the following services:
- Print data visualization on the clinical surface of the orthoses
- Pressure visualization on the 3D scanned model
- Live data from the individual sensors (the user can choose from which sensors the data should be monitored)
- Maximum and averaged pressure over the surface of the orthoses
- Gait analysis
2. backend platform to maintain the orthotics devices (insoles, prosthesis shaft, gloves) as a medical device.
We currently develop, as the next step for software development is, a collection of backend services around the sendance-grid, including device management (i.e. grid management with OTA updates, etc.), sensor data (measurements), provision of analytics, etc.
The main activities of the projects were:
1. Software planning and development (Yana Vereshchaga, Bernhard Handler) -> web-based software (see D2). As a deliverable, we demonstrate here the software sendance-cloud with MVP. The link to the recorded video and the software demo will be provided.
2. Planning QM activities and a roadmap for sendance products -> D3
3. First stage of QM establishment along ISO13485 and the first version of technical documentation-> D3, The report about the activities to establish the QM system, the first version of the technical documentation, and the plan for QM system establishment is delivered.
4. Project Management and coordination (Yana Vereshchaga) -> D1
1. a web-based software - sendance-cloud to be able to transfer, save, analyze, and visualize the sensors data on both the clinical surface of the orthotics and the 3D scanned model of a foot
At the current stage, we are building a sendance-cloud data platform, which is based on the Unity Real-Time Development Platform and offers the following services:
- Print data visualization on the clinical surface of the orthoses
- Pressure visualization on the 3D scanned model
- Live data from the individual sensors (the user can choose from which sensors the data should be monitored)
- Maximum and averaged pressure over the surface of the orthoses
- Gait analysis
2. backend platform to maintain the orthotics devices (insoles, prosthesis shaft, gloves) as a medical device.
We currently develop, as the next step for software development is, a collection of backend services around the sendance-grid, including device management (i.e. grid management with OTA updates, etc.), sensor data (measurements), provision of analytics, etc.
The main activities of the projects were:
1. Software planning and development (Yana Vereshchaga, Bernhard Handler) -> web-based software (see D2). As a deliverable, we demonstrate here the software sendance-cloud with MVP. The link to the recorded video and the software demo will be provided.
2. Planning QM activities and a roadmap for sendance products -> D3
3. First stage of QM establishment along ISO13485 and the first version of technical documentation-> D3, The report about the activities to establish the QM system, the first version of the technical documentation, and the plan for QM system establishment is delivered.
4. Project Management and coordination (Yana Vereshchaga) -> D1
We focused on the regulatory aspects of our product and market entry:
- the class of medical device and timeline
- MDR/reimbursement roadmap
- the framework to enter the orthopedical market as an accessory product
- first preliminary steps for certification of the quality management system refers to ISO13485
IPR:
- We received the first report (Vorbescheid) of the AT patent office in June and replied to it with only minor changes (documents are included in IPR files). The publication is due 18 months after filing, so by the end of 12/2022. Usually, a second report must be replied to until the patent is finally granted. There is no time limit for the second report, so this can take a very long. ● The WO publication from the PCT application will appear until 03/2022. We will have to nationalize the patent by 12/2023.
- the class of medical device and timeline
- MDR/reimbursement roadmap
- the framework to enter the orthopedical market as an accessory product
- first preliminary steps for certification of the quality management system refers to ISO13485
IPR:
- We received the first report (Vorbescheid) of the AT patent office in June and replied to it with only minor changes (documents are included in IPR files). The publication is due 18 months after filing, so by the end of 12/2022. Usually, a second report must be replied to until the patent is finally granted. There is no time limit for the second report, so this can take a very long. ● The WO publication from the PCT application will appear until 03/2022. We will have to nationalize the patent by 12/2023.