Periodic Reporting for period 2 - M.I.L.A.N.O. Robot (Transforming everyday surgery into a painless and scarless experience)
Berichtszeitraum: 2024-04-01 bis 2025-09-30
Historically, abdominal surgery (e.g. general, bariatric, gynaecological, urological, colorectal) required large incisions of 10–12 cm to allow surgeons direct access to organs. This approach caused significant trauma for patients and resulted in frequent postoperative complications such as infections and incisional hernias, often requiring additional surgical interventions.
The introduction of laparoscopy shifted practice from one large incision to multiple 1–3 cm cuts, reducing patient trauma and recovery time. However, this improvement came at the cost of important challenges for surgeons, including reduced dexterity, restricted manoeuvrability, non-ergonomic operating positions, and reliance on 2D vision.
Robotics was introduced to address these limitations by re-establishing 3D vision, improving dexterity in confined anatomical spaces, and enhancing precision. Nevertheless, current robotic systems remain expensive, bulky, and complex to use. As a result, adoption in Europe remains below 40% even in well-established minimally invasive procedures.
VALUEBIOTECH: ONE PRODUCT ALL SOLUTIONS
Valuebiotech is developing a portfolio of solutions called M.I.L.A.N.O. Robotic Platform (Minimally Invasive Light Automatic Natural Orifice), to empower surgeons with robots that can adapt to their own preferred surgical technique developed with years of experience.
The M.I.L.A.N.O. Robotic Platform is made of two typologies of medical devices: Assistive Robots and Operative Robots. Two product categories that are usually separate, are now integrated and can be used seamlessly, thereby allowing hospitals to cover all surgical approaches with the purchase of a single solution.
Valuebiotech solution's unique selling points:
• Assistive Robots are fully integrated into Operative robots, therefore with the purchase of one operative robot, both roboscopic and robotic procedures can be performed
• Operative robots can be used both in multi-port and single-port configuration
• No need for large external robotic structure for external repositioning thanks to internal movement
• Robots are compact, Light and transportable: not requiring a dedicated Operatory Room
• Innovative robotic control for hands-free vision and exposure management, reducing workflow interruptions and improving surgical ergonomics.
The introduction of laparoscopy shifted practice from one large incision to multiple 1–3 cm cuts, reducing patient trauma and recovery time. However, this improvement came at the cost of important challenges for surgeons, including reduced dexterity, restricted manoeuvrability, non-ergonomic operating positions, and reliance on 2D vision.
Robotics was introduced to address these limitations by re-establishing 3D vision, improving dexterity in confined anatomical spaces, and enhancing precision. Nevertheless, current robotic systems remain expensive, bulky, and complex to use. As a result, adoption in Europe remains below 40% even in well-established minimally invasive procedures.
VALUEBIOTECH: ONE PRODUCT ALL SOLUTIONS
Valuebiotech is developing a portfolio of solutions called M.I.L.A.N.O. Robotic Platform (Minimally Invasive Light Automatic Natural Orifice), to empower surgeons with robots that can adapt to their own preferred surgical technique developed with years of experience.
The M.I.L.A.N.O. Robotic Platform is made of two typologies of medical devices: Assistive Robots and Operative Robots. Two product categories that are usually separate, are now integrated and can be used seamlessly, thereby allowing hospitals to cover all surgical approaches with the purchase of a single solution.
Valuebiotech solution's unique selling points:
• Assistive Robots are fully integrated into Operative robots, therefore with the purchase of one operative robot, both roboscopic and robotic procedures can be performed
• Operative robots can be used both in multi-port and single-port configuration
• No need for large external robotic structure for external repositioning thanks to internal movement
• Robots are compact, Light and transportable: not requiring a dedicated Operatory Room
• Innovative robotic control for hands-free vision and exposure management, reducing workflow interruptions and improving surgical ergonomics.
Over the course of the project, Valuebiotech successfully developed, integrated, and validated fully functional robotic units for Assistive Robots. These systems were engineered according to MDR and ISO 13485 standards, underwent full subsystem integration, and were tested both internally and in preclinical environments.
Key achievements include:
- Development of prototypes including mechanical structures, control electronics, firmware, user interfaces, and safety systems.
- Successful execution of accredited functional tests marking the initiation of the MDR conformity-assessment pathway.
- Completion of preclinical tests where surgeons validated ergonomics, stability, usability, and visibility performance.
- Creation of the Academy 4.0 a VR-based training ecosystem supporting surgeon onboarding, with realistic workflows and interaction scenarios.
- Comprehensive Quality and Regulatory documentation.
- Refinement of production and sustainability workflows, establishing a fully ISO 13485–aligned manufacturing chain with qualified suppliers.
Key achievements include:
- Development of prototypes including mechanical structures, control electronics, firmware, user interfaces, and safety systems.
- Successful execution of accredited functional tests marking the initiation of the MDR conformity-assessment pathway.
- Completion of preclinical tests where surgeons validated ergonomics, stability, usability, and visibility performance.
- Creation of the Academy 4.0 a VR-based training ecosystem supporting surgeon onboarding, with realistic workflows and interaction scenarios.
- Comprehensive Quality and Regulatory documentation.
- Refinement of production and sustainability workflows, establishing a fully ISO 13485–aligned manufacturing chain with qualified suppliers.
The project delivered several innovations that go beyond what is currently available in surgical robotics:
- Extremely compact and lightweight robotic units that maintain high dexterity and precision, enabling robotic surgery in hospitals without dedicated infrastructure.
- No need for large external robotic structure for external repositioning.
- Innovative robotic control for hands-free vision and exposure management, reducing workflow interruptions and improving surgical ergonomics.
These results demonstrate advancements in accessibility, affordability, user experience, and technological innovation, directly addressing the main limitations of current robotic platforms and contributing to wider adoption of minimally invasive surgery.
- Extremely compact and lightweight robotic units that maintain high dexterity and precision, enabling robotic surgery in hospitals without dedicated infrastructure.
- No need for large external robotic structure for external repositioning.
- Innovative robotic control for hands-free vision and exposure management, reducing workflow interruptions and improving surgical ergonomics.
These results demonstrate advancements in accessibility, affordability, user experience, and technological innovation, directly addressing the main limitations of current robotic platforms and contributing to wider adoption of minimally invasive surgery.