INTERNET OF CARE
IoC®[Internet of Care]: a one-stop shop for smart electro-medical devices
The digital transformation is driving change in the practices of both health professionals and patients, and manufacturers are equipping medical devices with new functionalities. These are helping to make taking treatments safer, monitor health data and make it possible for people to remain in their own homes. There are numerous issues, all of which converge on certain key objectives: optimising the monitoring of certain constants, helping health professionals to manage their patients, simplifying the care pathway and as a result, improving patient comfort.
Certified to NF EN ISO 13485 for over 15 years, SGH Healthcaring has recently extended the scope of its certification to the manufacturing, assembly and packaging of electro-medical devices. From design to delivery, every connected object responds to the requirements of the pharmaceutical quality system, because we train all our staff in Good Manufacturing Practices. Thanks to the excellent partners we work with, we have created a development platform for communicative electro-medical devices: IoC®[Internet of Care]. From design to manufacturing, CE marking and international deliveries, we use all our expertise to respond to our customers’ needs in relation to digital health.
Our job is to guide you smoothly and agilely through a complex and ever-changing regulatory environment. Our smart devices are produced in line with regulatory frameworks and standards:
• NF EN 60601: general requirements for the safety and essential performance of medical electrical equipment
• NF EN 62304: development and maintenance of MD software
• ISO 14971: application of risk management to MDs
• NF EN 62366-1: application of usability engineering to MDs
The MDs we design meet both FDA 21 CFR Part 11 and Directive 93/42/EEC, depending on our customers’ marketing requirements. Every project is unique. The regulatory constraints and quality tools used in the development of bespoke devices vary from one project to another. It takes a special level of attention to detail to evaluate and apply them. A development quality manager is therefore entirely dedicated to supporting your project, from the initial idea to delivery of the finished product, in close collaboration with the project manager.
Design and intellectual property
From your initial requirements to the production phase, our engineers and regulatory specialists are tasked with:
• Drawing up functional specifications (usability, risk analysis, specification)
• Generating concepts, ideas, prototypes and models of the final version
• Mechanical, electronic and software development
• Pilot series
We manage procedures concerning the protection of industrial property (assistance with analysing and filing patents) and filing CE marking documentation (preparing the technical file). We also help you manage data (hosting, processing and analysis) collected by the MD.
Manufacturing and assembly
With our state-of-the-art industrial facility, we provide:
• Plastic injection
• Incorporation of electronic components into plastic solutions
• Assembly using a variety of techniques: automated gluing, electronic screwing, welding
• Visual inspections, development of serialisation software
• Functional tests at each stage of integration
• Monitoring of mechanical, electronic and software manufacture using an MES (Manufacturing Execution System), batch record
• Full traceability of all components
• Tailor-made packaging (cardboard, plastic, fabric)
• Worldwide deliveries
discover our connected conceptsFrom plastic to plastronics, we inject intelligence into our communicative devices.
Some examples of e-health devices
Thess, a smart solution for dispensing solid medicines
The patented Thess system is made up of separate mobile electronic devices linked to a digital management and traceability interface. The system makes treatment safer and allows doctors to personalise and monitor prescriptions in real time. It reassures patients, helps them to take their medication and therefore improves compliance.
Time-stamped needle dispenser for auto-injectors
Designed for a clinical trial, the auto-injector needle dispenser developed for Ipsen can be used to monitor needle use in relation to daily injections and supports accurate treatment monitoring. Linked to a mobile application, the needle dispenser records how many needles the patient has taken out and can report the data in due course.
Sublimed has worked with SGH Healthcaring to develop the actiTENS medical device, an innovative, transcutaneous, electrical nerve stimulation system to treat chronic pain. It is based on a proven, non-invasive analgesic technique used to relieve chronic pain: stimulating the peripheral nervous system using a low-intensity electrical current, blocking the transmission of the pain signal and prompting the secretion of endorphins.