A groundbreaking workshop was held by the Galician Health Agency (Axencia Galega de Coñecemento en Saúde) to demonstrate the clinical application of the UNI-VEC device, revolutionizing the resection of advanced rectal tumors through flexible endoscopy. This initiative stems from the Código 100 Innovation Plan and marks a significant advancement in minimally invasive surgical techniques.
Collaboration and Development of UNI-VEC
The UNI-VEC device emerged through a strategic partnership under the Public Innovation Procurement framework, specifically utilizing the Association for Innovation model as outlined in the Public Sector Contracts Law. This collaboration between SERGAS and Vecmedical facilitated the co-development and clinical validation of a solution tailored to the unique needs of the Galician healthcare system, positioning SERGAS not merely as a purchaser but as a co-creator and patent holder of the device.
Regulatory Success and Clinical Integration
UNI-VEC successfully navigated the stringent European Regulation (EU) 2017/745 for medical devices, achieving CE certification from the National Center for Medical Product Certification after extensive technical, pre-clinical, and clinical trials, many conducted at CHUAC. The device now features in the SERGAS product catalog, meeting efficacy, safety, and efficiency standards set by the Health Assistance and Economic Resources Directorate, ensuring its readiness for gradual integration into clinical services.
- Public health leadership in medical device innovation enhances system-specific solutions.
- Co-development models can accelerate the creation and approval of medical technologies.
- Regulatory compliance ensures safety and effectiveness, fostering trust among healthcare providers.
UNI-VEC represents a significant leap in minimally invasive surgery, offering precise, less traumatic interventions with improved postoperative outcomes. This advancement not only elevates patient care but also optimizes resource efficiency by reducing surgical times and hospital stays.
Healthcare professionals can anticipate more efficient surgical procedures and enhanced patient recovery experiences with the adoption of UNI-VEC. The device’s integration into clinical practice underscores the importance of public-private partnerships in driving medical innovation tailored to specific healthcare needs.
The successful implementation of UNI-VEC highlights the potential of co-developed medical technologies to meet the evolving demands of healthcare systems. By fostering collaboration between public health entities and private companies, the Galician Health Agency sets a precedent for future innovations aimed at improving patient outcomes and operational efficiency in the medical field.
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