DIGITAL TOOL FOR TECHNICAL EVALUATION OF SINGLE-USE MEDICAL DEVICES IN MERCOSUR PUBLIC PROCUREMENT
Author(s)
Michelle Sauer II, MASc1, José Cassiolato, doctorate2, Thais Zarili, doctorate3, Renato Machado, doctorate4, Gustavo Borges, student4, Diogo Ribeiro, student4, Luciana Fabriz, doctorate4;
1Universidade Estadual do Oeste do Paraná, Student, Cascavel, Brazil, 2Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil, 3Universidade Estadual do Oeste do Paraná, Cascavel, Brazil, 4Universidade Estadual do Oeste do Paraná, Foz do Iguaçu, Brazil
1Universidade Estadual do Oeste do Paraná, Student, Cascavel, Brazil, 2Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil, 3Universidade Estadual do Oeste do Paraná, Cascavel, Brazil, 4Universidade Estadual do Oeste do Paraná, Foz do Iguaçu, Brazil
Presentation Documents
OBJECTIVES: To develop a digital, standardized instrument to support the technical evaluation of single-use medical devices in public procurement across MERCOSUR Member States, integrating key regulatory, documentary, and functional criteria to strengthen decision-making and promote regional convergence in health technology assessment.
METHODS: This methodological study followed five structured stages: (1) development of the conceptual framework; (2) definition of the instrument’s objectives and target users; (3) construction of assessment items and response scales; (4) selection of items and workflow organization; and (5) instrument structuring. The framework was informed by a documentary analysis of MERCOSUR regulatory standards and a scoping review of evaluation instruments, enabling identification of relevant criteria represented in a logical model. Business Process Management methods were applied to design the operational workflow. The instrument was implemented as a Minimum Viable Product (MVP), named SADIM-MERCOSUR, developed as a web application based on REST architecture (FastAPI/Python backend; React/TypeScript frontend) using an agile, prototype-oriented approach.
RESULTS: The conceptual framework defined four essential components for procurement-related assessments: (1) analysis of the electronic bidding proposal; (2) verification of product documentation; (3) verification of supplier documentation; and (4) functional evaluation of the device. A structured matrix with 43 items was developed to ensure consistency, reproducibility, and traceability. BPM modeling detailed activities, decision points, and document flows. The MVP enabled standardized data entry, automated results, and the generation of categorized technical reports (compliant, non-compliant, or pending).
CONCLUSIONS: The preliminary version of SADIM-MERCOSUR demonstrates the feasibility of a digital tool that enhances transparency, standardization, and reproducibility in evaluating medical devices in MERCOSUR public procurement. By supporting harmonized assessment practices, the system contributes to improved governance of acquisition processes and may serve as a platform for regional collaboration and alignment in health technology assessment.
METHODS: This methodological study followed five structured stages: (1) development of the conceptual framework; (2) definition of the instrument’s objectives and target users; (3) construction of assessment items and response scales; (4) selection of items and workflow organization; and (5) instrument structuring. The framework was informed by a documentary analysis of MERCOSUR regulatory standards and a scoping review of evaluation instruments, enabling identification of relevant criteria represented in a logical model. Business Process Management methods were applied to design the operational workflow. The instrument was implemented as a Minimum Viable Product (MVP), named SADIM-MERCOSUR, developed as a web application based on REST architecture (FastAPI/Python backend; React/TypeScript frontend) using an agile, prototype-oriented approach.
RESULTS: The conceptual framework defined four essential components for procurement-related assessments: (1) analysis of the electronic bidding proposal; (2) verification of product documentation; (3) verification of supplier documentation; and (4) functional evaluation of the device. A structured matrix with 43 items was developed to ensure consistency, reproducibility, and traceability. BPM modeling detailed activities, decision points, and document flows. The MVP enabled standardized data entry, automated results, and the generation of categorized technical reports (compliant, non-compliant, or pending).
CONCLUSIONS: The preliminary version of SADIM-MERCOSUR demonstrates the feasibility of a digital tool that enhances transparency, standardization, and reproducibility in evaluating medical devices in MERCOSUR public procurement. By supporting harmonized assessment practices, the system contributes to improved governance of acquisition processes and may serve as a platform for regional collaboration and alignment in health technology assessment.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR62
Topic
Health Policy & Regulatory
Topic Subcategory
Procurement Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas