Background (project summary)
The main objective of the TREMIRS project “Minimally Invasive Robotic Surgery Systems” is to address the needs of the Extremaduran and Spanish Healthcare System in the field of minimally invasive surgery by developing innovative solutions in surgical robotics that improve existing systems in the field of laparoscopic surgery and microsurgery. This project seeks to improve the service provided to the patient, improve the surgeon’s ergonomics, and offer greater benefits to the surgical team, with the consequent increase in the quality of care.
During the three years of the project, a robotic platform for laparoscopic surgery will be developed that will facilitate new surgical approaches, improvements in the ergonomics of surgeons, advances in vision systems for the entire surgical team, and the availability of new portable training tools.
In the field of microsurgery, TREMIRS will develop a teleoperated robotic platform for reconstructive microsurgery, consisting of robotic microinstruments with high maneuverability and precision. It will be used for the manipulation of soft tissues to perform microsurgical techniques such as anastomosis, suture, and ligation in small anatomical structures such as blood vessels, nerves, and lymphatic ducts.
This TREMIRS project is part of the Innovation Promotion from Demand Line for Public Procurement of Innovation (FID-CPI Line) of the Ministry of Science and Innovation with file number CPI-2019-33-1-TRE-14, according to the definitive resolution proposal of April 8, 2020, of the Deputy Director General for the Promotion of Innovation, being co-financed with European funds, the ERDF Smart Growth Operational Program 2014-2020, «A way to make Europe», and co-financed by the Ministry of Economy, Science and Digital Agenda of the Regional Government of Extremadura.
Based on the background outlined above, the Jesús Usón Minimally Invasive Surgery Centre Foundation (FCCMIJU) publishes this call for a Preliminary Market Consultation (hereinafter CPM), thereby informing technology operators about the challenges and needs to be addressed.
Purpose of the CPM
The purpose of this CPM is to collect the information necessary for innovative public procurement of the “Robotic platform for laparoscopic surgery (Challenge 1) and the “Robotic platform for microsurgery” (Challenge 2), and to inform technology operators about their plans and contracting requirements.
This consultation, which allows the participation of both natural and legal persons, allows the presentation of innovative solutions aimed at responding to the challenges posed by technologies that exceed the performance of those currently existing in the market, defining functional specifications that imply innovation and that are easy to achieve with subsequent public procurement.
The FCCMIJU needs to gather information from the market on the following Challenges for its correct execution:
Challenge 1. Robotic platform for laparoscopic surgery
Global objectives:
The main objective of this challenge is to have a robotic platform for laparoscopic surgery that improves the systems already existing in the market and that optimizes the conditions during the development of the surgery for the patient, the surgeon, the surgical team, and medical professionals in training in surgical robotics. To this end, and as aspects of improvement and innovation, it is intended to address the main limitations of current robotic systems for laparoscopic surgery, such as their application in new surgical approaches, limited ergonomic conditions for the surgeon, limited access to 3D vision for the rest of the surgical team and recording of the 3D image of the surgical procedure carried out for later reproduction, and availability of training tools compatible with 3D vision technologies, portable devices, and online services.
Specific objectives:
The above general objectives of the challenge entail the development of a series of specific objectives:
- To offer greater precision, maneuverability, and quality in minimally invasive surgical procedures.
- To apply robotic surgery to new procedures and surgical approaches.
- To improve and personalize the ergonomic conditions of surgeons during the performance of robotic procedures in minimally invasive surgery, with the consequent reduction in the appearance of possible musculoskeletal disorders and their effects on the quality of the surgeon’s surgical performance and the possible sick leave that may result.
- To provide new surgical assistance tools to the entire surgical team, such as the use of 3D, virtual, augmented, and mixed imaging techniques.
- To offer new portable tools for remote training in robotic laparoscopic surgery, as well as better training material, such as the reproduction of three-dimensional videos of real robotic laparoscopic procedures.
Challenge 2. Robotic platform for microsurgery
Global objectives:
The main objective of this challenge is the development of a teleoperated robotic platform to carry out open microsurgery procedures with articulated and interchangeable microinstruments. The platform will consist of a set of robotic microinstruments with high maneuverability and precision, handled intuitively and similarly to that presented during conventional microsurgery. These microinstruments will allow the manipulation of small soft tissues to perform microsurgical procedures such as anastomosis, suture, and ligation in small anatomical structures such as blood vessels, nerves, and lymphatic ducts. The system will be compatible with most optical microsurgical microscopes.
Specific objectives:
The above general objectives of the challenge entail the development of a series of specific objectives:
- Development of initial studies for the definition of the clinical and technical specifications of micro-surgical instruments.
- Design and implementation of a set of multi-articulated robotic microinstruments with the necessary characteristics to carry out the performance of basic microsurgical procedures, mainly for vascular and lymphatic surgery.
- Design and implementation of the intuitive control system for robotic microinstruments. These controls will allow the microsurgeon to work in an ergonomically appropriate position and similar to that presented during conventional microsurgery.
- To eliminate the surgeon’s physiological tremors during the handling of surgical instruments and the scaling of surgical movements.
- To allow vascular and lymphatic microsurgical procedures to be carried out with precision and safety. Although during the development of the project the safety and feasibility of other microsurgical procedures such as epineural and perineural neuroanastomoses, nerve grafts, vaso-vasostomies, vascularized transfer of lymph nodes and lymphatic-lymphatic anastomoses, among other procedures of interest, will also be evaluated.
- Validation of the teleoperated platform for microsurgery in the performance of basic microsurgical procedures
Deadline for submitting forms: May 27, 2021 at 2:00 p.m.
- Presentation of the CPM Conferences
- FAQ Document
- Resolution extending the deadline for submitting responses to the CPM
- Resolution approving fees for expert collaborators within the framework of the project (TREMIRS)
- Resolution approving fees for the Technical Committee of Experts of Procedure 06/2021 within the framework of the TREMIRS Project
- Resolution appointing and approving fees for the Technical Committee of Experts of Procedure 07/2021 within the framework of the TREMIRS Project
- Award of the contract with file number 06/2021 «Innovative solutions for the challenge of robotic platform for laparoscopic surgery of the project «Minimally invasive robotic surgery systems (TREMIRS)», relating to Lot no. 1 called «Robotic platform for laparoscopic surgery within the framework of the project»
- Award of the contract with file number 06/2021, «Innovative solutions for the challenge of robotic platform for laparoscopic surgery of the project «Minimally invasive robotic surgery systems (TREMIRS)» relating to Lot no. 2 of the contract called Portable training system for robotic laparoscopic surgery»
- Award of the contract with file number 07/2021 relating to an innovative solution for the challenge of robotic platform for microsurgery of the project “Minimally invasive robotic surgery systems (TREMIRS)”, within the framework of a Pre-Commercial Public Procurement process
- Resolution appointing the Monitoring and Control Team and approving fees for the Panel of Expert collaborators of the Monitoring and Control Team of Procedure 06/2021 within the framework of the TREMIRS project
- Resolution appointing the Monitoring and Control Team and approving fees for the Panel of Expert collaborators of the Monitoring and Control Team of Procedure 07/2021 within the framework of the TREMIRS project
- Resolution of the evaluation for the transition from Phase I to Phase II of the awarded companies of Procedure 07/2021 within the framework of the TREMIRS project.
Anti-fraud
- Institutional declaration of fight and anti-fraud commitment of the CCMIJU Foundation.
- Adhesion to the institutional declaration of the DGFE on anti-fraud matters.
To report anti-fraud suspicions: https://www.igae.pap.hacienda.gob.es/sitios/igae/es-ES/Paginas/denan.aspx
More anti-fraud information: https://www.tremirs.com/proyecto-tremirs/antifraude/
