Deliverables

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D1.1 Project Management Platform
Submitted Mar 31, 2025, sensitive
This deliverable describes the basic functionalities of the internal project management platform set up for the SMILE project. Those functionalities include, inter alia, the preparation of deliverables, reportings, the organization of meetings and keeping an overview of upcoming dissemination/ communication activities and publications. The project management platform is a tool set out to support an efficient and effective project management in SMILE.
D1.2 Management Guide
Submitted Mar 31, 2025, sensitive
The Management Guide will lay down standard workflows and processes for the most common and recurring management activities on SmILE consortium level. In addition, it will give guidelines and recommendations with regard to communication within the project and dissemination of project results. The Guide will be made available to all project partners at the beginning of SmILE to foster active collaboration and a smooth implementation from the start.
D1.3 Data Management Plan (DMP)
Submitted Nov 27, 2025, sensitive
The present document is the initial version of the SmILE data management plan (DMP), which will be revised and updated during the entire project duration if necessary. The DMP serves as an indicative plan outlining the types of data the project participants anticipate generating and how these data will be managed. This DMP adheres to the standard DMP template provided by the EC. Section 2 provides some information about the data used, gathered, and shared in SmILE whereas section 3 presents an overview about the use of FAIR data. Section 4 highlights all other aspects of data handling. The objective of SmILE is to develop a generic chip platform for the instrumentation of medical devices, particularly implants, transforming conventional products into data sources that facilitate the creation of evidence-based, integrated, effective, preventive, and patient-centered healthcare solutions. Furthermore, SmILE aims to establish a health platform that effectively represents data to both patients and healthcare professionals, thereby enhancing the treatment of musculoskeletal (MSK) disorders and preventing health deterioration through the integration of novel sensors, actuators, and AI-based systems that monitor healing progression and predict adverse events. Throughout the project, data will be generated from various activities, including needs assessments, user requirement analyses, health technology assessments, and regulatory affairs. Additionally, data will be collected during the development of the SmILE data platform, the hardware design of the chip platform, and the enhancement of various medical devices. Furthermore, data will also be obtained from preclinical, animal, and clinical studies.
D2.1 Regulatory strategy
Submitted Dec 17, 2025, sensitive
The present document is the initial version of the SmILE regulatory strategy report, which will be revised and updated during the entire project duration if necessary. The regulatory strategy report forms a central component of the overall regulatory pathway for the project and provides the foundation for subsequent regulatory activities.
A key objective of this report is to establish a regulatorily compliant overview for each of the six Use Cases. This includes the definition of the Intended Purpose and the corresponding Medical Device Classifications. In doing so, the Regulatory Strategy Report already reflects the structure and required content of the Technical Documentation, particularly the product description, the qualification of the product as a medical device, and the classification rationale. Furthermore, the report includes the analysis and documentation of the applicable standards for Use Case 1. Together, these elements form the basis for the Technical Documentation and, consequently, for the conformity assessment of the Use Cases.
To support further regulatory activities and strategic planning, the report includes a detailed assessment of potential approval routes for each Use Case. This analysis is essential for shaping the regulatory strategy for the final medical device, as it enables the early identification of regulatory risks and factors that may significantly impact the conformity assessment, the overall approval pathway, as well as the associated cost and time requirements.
The report is structured to present each Use Case individually and in a consistent sequence. Specifically:
Chapters 2 to 7
- Use Case 1 – mobility aids (crutch, foot orthoses)
- Use Case 2 – osteosynthesis plate
- Use Case 3 – bone nail
- Use Case 4 – total hip endoprosthesis
- Use Case 5 – total knee endoprosthesis
- Use Case 6 – shoulder ligament sensor
Each of these chapters addresses one of the six Use Cases: For every Use Case, the chapter includes: • A precise, regulatorily compliant Intended Purpose, forming the basis for the qualification and classification. • A Medical Device Qualification and Classification according to the applicable regulatory framework Regulation (EU) 2017/745 (MDR), including the rationale and the specific classification rules applied. • An evaluation of potential approval routes according to MDR including a consideration of regulatory risks and strategic implications, highlighting potential challenges for the conformity assessment and approval of the final medical device.
This consistent structure ensures comparability across Use Cases and provides a transparent basis for regulatory decision-making throughout the project.
Chapter 8
This chapter provides a comprehensive analysis of the applicable standards for Use Case 1, covering essential safety, performance, quality management, and interoperability requirements. This standards assessment is conducted for Use Case 1, as it currently represents the most advanced stage of development within the project. Consequently, it constitutes the appropriate and necessary starting point for a detailed regulatory standards analysis. The insights derived from this assessment will provide a foundational basis for the regulatory planning of the subsequent Use Cases as their development progresses.
This structure offers a clear and systematic presentation of the regulatory considerations for each Use Case and forms the basis for the comprehensive Regulatory Strategy Report.
D4.1 Technical Requirements
Submitted Nov 27, 2025, sensitive
This deliverable report (D4.1) summarizes the technical requirements and the specifications for the hardware platform to be developed within the scope of the SmILE project. A high-level overview of the different use cases supported by the hardware platform is provided in the section Supported use cases by the hardware platform. The second section Hardware platform overview discusses the different types of sensors and actuators that will be accommodated on the hardware platform and their necessary signal processing, along with platform powering and data communication. High-level requirements and specifications for the ASIC are discussed in the section ASIC high level overview. This section highlights the signal processing functionality that will be accommodated on the ASIC and also discusses selected technologies for the ASIC fabrication. Further, the signal interface between the ASIC and the sensors/actuators and the external microcontroller is provided. Specifications for sensors and actuators are summarized at the end of this section. A technical discussion of the wireless interface for power and data transfer is provided in the section Wireless Interface for Power and Data. This section also presents preliminary electromagnetic simulation results that evaluate coupling efficiency and assess the impact of human body structures on wireless transmission. These results are based on representative implantation scenarios using state-of-the-art antenna geometries and design characteristics. Packaging requirements of the hardware platform to meet the necessary area and volume constraints while respecting the biocompatibility and hermiticity requirements are summarised in the section Platform packaging.
D4.2 Sensors and Actuators Implementation
Submitted Jul 9, 2026, public
Deliverable D4.2 documents the design, development, and initial implementation of the sensing and actuation technologies defined in Task 4.2, in alignment with the technical specifications established in D4.1. The objective of this deliverable is to demonstrate that the selected high-TRL components and the developed low-TRL solutions have been translated into concrete hardware implementations suitable for integration within the WP4 electronic system architecture. The work focuses on the engineering realization of sensors and actuators tailored to the clinical use cases, including strain and deformation sensors, infection and environmental monitoring sensors (pH, temperature), structural and bone quality monitoring solutions (acoustic and impedance-based sensing), implant wear sensors, smart drug delivery systems, activity monitoring modules and actuators.
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D5.1 Requirements report
Submitted Nov 27, 2025, sensitive
These specifications of the six use cases are listed in the following sections. These use cases are the osteosynthesis plates and nails, the endoprosthesis for hip and knee, the ligament replacement as well as the interface platform connected to orthoses and crutches, called internet of medical things (IOMT). This document details the outlined objectives of the SmILE project regarding the adaption of the implants. The early known user needs, risk analysis and regulatory are basis for the translation into specifications with exception of different sensor systems and the chip system which is detailed in WP4.
D6.1 Study initiation package 1
Submitted Dec 17, 2025, sensitive
This deliverable report summarizes the protocol of the motion study within Task 6.1: “Motion studies & collection of research data”.
D8.1 Public project website
Submitted Nov 27, 2025, public
This deliverable shortly describes the initial set-up of the SmILE public project website with screenshots of the main pages attached in the annex. The website can be accessed via: https://horizon-smile.eu. Providing information about SmILE’s objectives and work, as well as the results achieved over the course of the project’s lifetime, is of utmost importance to foster the project’s success. The SmILE public website is the project’s primary tool for communication about the project and disseminating results. It aims to reach the broader public, as well as stakeholders and scientists in the musculoskeletal non-communicable diseases field and increase awareness of the project’s activities and future outcomes. As part of WP8: “Communication, Dissemination, Exploitation and Sustainability”, has been developed by the EURICE communications team with contributions from the consortium members and went online on 30/04/2025.
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D8.2 Plan for Dissemination/Exploitation/ Communication (PDEC) Contractual
Submitted Nov 27, 2025, sensitive
The Plan for the Dissemination, Exploitation, Communication (PDEC) is a strategic document, helping the project consortium to establish the basis for an intellectual property strategy, as well as develop and monitor specific communication, dissemination and exploitation activities. The PDEC is part of WP8 “Communication, Dissemination, Exploitation, Sustainability”. This WP focuses on creating visibility and fostering outreach of SmILE through external communication of SmILE activities, progress and achievements, as well as dedicated disseminating activities and strategic planning of exploitation routes for potential results. This PDEC aims to act as a guide and organizing framework for all work relating to dissemination and exploitation of the project’s results, as well as the broader communication activities related to the project and its achievements. It is a central tool for the planning and documentation of communication, dissemination and exploitation activities and will therefore allow close monitoring of the progress of individual activities throughout the project lifetime. It should be noted that the current PDEC in month 6 is an initial version which builds on the plans outlined in the Description of Action (DoA). These plans will be further developed as the project progresses and results become available. PDEC will be updated and submitted as deliverable D8.6 (M36) and D8.7 (M52).
D8.3 SmILE IP Manual
Submitted Nov 27, 2025, sensitive
The IP Manual includes an overview of common IP terms and definitions, as well as providing guidance on IP-related challenges, risks and opportunities in the collaborative innovation processes, and reflects the IP management aspects agreed upon in the Consortium Agreement in greater detail. This will ensure a common basic understanding among all consortium partners on topics, such as how to manage access to background IP, ownership, sharing, protection and use of project results within and beyond the project. Additionally, this document provides an early-stage overview of Key Exploitable Results (KERs) and the related IP management strategies. The manual reflects on the IP portfolio held by the individual members of the consortium and hence will contribute to ensure that consortium partners are free to benefit from their complementarities and are able to fully exploit their research excellence and market position. This IP Manual is a deliverable within WP8 “Communication, Dissemination, Exploitation, Sustainability”.