IoT Health: Industrialization of an HDS-Compliant Smart Pen
David Walter • 6 novembre 2025
Project Context
A prototype of a connected pen designed for the healthcare sector had achieved great success in the market. Faced with growing demand, the client needed to move to an industrialization phase to meet expectations while ensuring compliance with strict health data regulations (Health Data Hosting – HDS).
Objectives
The main objective was to transform a prototype into an industrialized solution by:
- Defining selection criteria and technological options
- Ensuring compliance with health regulations
- Supporting scale-up to meet increasing demand
Mission Duration
A multi-phase mission including scoping, technical testing, compliance implementation, and support for industrial scale-up.
Implementation
Agaetis deployed a comprehensive approach combining IoT and regulatory expertise:
- Definition of selection criteria: Framing of functional and technical requirements
- Technological evaluation: Study and testing of potential solutions and their suitability
- HDS compliance: Support in hosting selection and data model structuring
- Development and industrialization: Assistance with technical implementation and scale-up preparation
Results Achieved
- Accelerated production: Successful industrialization enabling rapid market response
- Regulatory compliance: Solution aligned with HDS and healthcare regulations
- Enhanced innovation: Transition from prototype to a market-ready medical product
- Operational flexibility: Architecture and data model ready to evolve with new use cases
Key Success Factors
- Strong expertise in healthcare IoT and regulated data
- Tailored approach integrating both technical and human dimensions
- Close collaboration with the client’s teams
- Impact-driven vision focused on rapid market delivery
And You?
Are you wondering about:
- Industrializing your healthcare IoT prototypes?
- Ensuring regulatory compliance (HDS, ISO, etc.) for your solutions?
- Preparing your innovations to move from prototype to industrial scale-up?
👉 Contact our experts to transform your IoT prototypes into industrialized and compliant healthcare solutions.
Ressources Agaetis
Project Context Michelin aimed to develop a new generation of digital services based on data from connected tires. The goal was to deliver added value to truck fleet managers and maintenance centers worldwide. The challenge lay in the collection, processing, and supervision of massive sensor data, while ensuring robustness, scalability, and relevance of analytics. Objectives The main objective was to establish a technical and architectural framework to: Efficiently collect and process data from connected tires Monitor data flows and measure the impact of business use cases Create a Big Data platform ready to evolve with growing data volumes Mission Duration A long-term engagement , combining initial architectural study, implementation of monitoring systems, and ongoing support. Implementation Agaetis leveraged its Data and Cloud expertise to: Initial architecture study: Define technological and structural choices Platform monitoring: Implement monitoring principles to ensure robustness and availability Load analysis: Evaluate the impacts of various business use cases Big Data framework definition: Integrate best practices to accelerate implementation Data Science work: Perform domain-specific analysis and develop new indicators and services Results Achieved New digital services: Creation of innovative solutions for fleet managers Robust and scalable platform: A Big Data environment ready to handle massive data volumes Operational optimization: Improved traceability and KPI tracking Enhanced innovation: Data transformed into strategic levers for Michelin Key Success Factors Agaetis’ expertise in Big Data and IoT data processing End-to-end methodology: From architecture to Data Science Immersion in the client’s business environment Proactive supervision ensuring robustness and reliability And You? Are you wondering about: Leveraging data from your connected equipment ? Creating new digital services based on Data? Implementing a robust and scalable Big Data architecture ? 👉 Contact our experts to transform your IoT data into innovative, value-generating services.
Project Context France’s first research foundation dedicated to innovation in pain management aimed to launch a market-ready application resulting from its clinical research and development program. The goal was to transform the app into a Digital Therapeutic (DTx) reimbursed by the national health insurance system. Objectives The organization focuses on driving healthcare innovation through extensive collaborations with hospitals, research institutes, universities, and technology companies. The main challenges included: Transforming an application into a Digital Therapeutic (DTx) reimbursed by the national health system. Managing the transition of patients to this new platform. Preparing a new data warehouse to support scientific research. Mission Duration 3 collaborators over 3 years Methodology Agaetis provided its expertise through targeted and structured actions: Audit of existing systems: Evaluation of current infrastructure to identify needs and areas for improvement. Decision support for partner selection: Assistance in choosing competent and reliable technology partners. Technology advisory: Guidance on application architecture, security, and scalability to ensure long-term viability. Results Achieved Development of an application supporting patients in chronic pain management, progressing toward recognition as a reimbursable DTx. Rigorous technical assessment and selection of strategic partners. Adherence to roadmap milestones , ensuring steady progress and alignment with expectations. This project highlights how Agaetis leverages its technological and strategic expertise to transform challenges into innovative, effective solutions — creating tangible value for clients in the healthcare sector.
