Research & Development Facilities
The senior management of Meditec Medical are engineers and, as such understand the importance of technology and research and development to the process of preventing the development of pressure ulcers. The R&D process in Meditec Medical incorporates innovation, engineering and design.
Because we are the designers and manufacturers of our products, our team of engineers can quickly respond to the needs of Irish patients, clinicians and health care facilities in order to ensure that our support surfaces absolutely meet the needs of the Irish marketplace.
We work in partnership with third level institutions in Ireland, such as Tallaght IT and RCSI, Dublin. On an international level, we work in partnership with Duncan Bain, PhD, Bioengineering and Biomedical Engineering, President Duncan Bain Consulting who undertakes R&D with particular attention to development and validation of new medical devices particularly support surfaces to prevent the development of pressure ulcers. We also work in partnership with Dan Bader, BSc, MSc, PhD, DSc, Professor of Bio-engineering and Tissue Health at the University of Southampton. Both Dr. Bain and Dr. Bader are considered to be experts in the field of research and development to prevent pressure ulcers and are both widely published in international peer reviewed journals. Senior management at Meditec Medical annually attend the EPUAP meeting in order to stay aware of new technologies and developments.
Meditec Medical R&D Facility
The R & D facility at Meditec Medical is driven to design products, supported by clinical evidence, that will support healthcare professional in enhancing patient care. The design of electronic medical products involves harnessing internal intellectual property, researching the latest innovations in electronic components, performing component tests, simulating new circuits, procurement, designing custom circuit boards, and the assembly of prototypes. If the product involves a mechanical element, that work also follows a parallel path. Extensive testing on the prototypes is carried out, based on the product requirements and applicable regulations, followed by revisions to the design, and further prototypes, depending on the complexity of the product.
Field testing plays an important role in the development process especially in the case of pioneering new class 1 medical products. Most of Meditec Medical products employ electronic devices as a microcontroller, which require the development of software, or “firmware” in the jargon, in order to operate. Meditec Medical develops this software in-house. DFM (Design for Manufacture) is a key element in the design process. During product development and testing, conformance to DFM standards is assessed through the early involvement of manufacturing engineers.
In accordance with industry control procedures, progress and changes are documented in order to allow improvements, test results, etc., to be recorded formally. Realisation of an interim version, i.e. a working prototype is an important part of product development. Once a prototype has been qualified, i.e. has met all the functional, testing, and certification requirements, it can be released for manufacturing. Meditec Medical products are generally designed to meet standards such as EN60335, EN60601 and class 1 medical device, as well as industry-specific ISO standards.
All products undergo a rigorous and comprehensive functional testing process during the design, development and production phase, as well as a formal test procedure during the manufacturing phase. This guarantees that the functional specifications are met, and that the product and is ready and fit for its application. Electronic circuits are both sensitive to electrical interference (“susceptibility”), and can in their own right cause interference (“emissions”). There are regulations that apply to both these cases, generally known as EMC (Electromagnetic Compatibility) regulations. Meditec Medical regularly subjects electronic circuits under development to pre-compliance testing, including Susceptibility EMC tests such as ESD (Electrostatic Discharge), Electrical Fast Transient Burst (EFT), High Voltage Impulse, and Emissions EMC tests such as Radio Interference (EMI/RFI), and Current Harmonic Levels (EN61000).
Electronic circuits are often critical elements in larger systems, sometimes controlling very important parameters or devices. These systems need to be safe, even in case of failure, this is covered under numerous standards such as EN60335. In such cases, Meditec Medical performs a thorough safety analysis during development aimed at identifying and eliminating such possibilities.
Products under development are also tested against the requirements of other product and industry standards, as needed. All of our electronic sub-assemblies are manufactured to ISO9001, and are tested to the highest standards. All our products are manufactured in house. All products are tested to the highest standards during and after manufacture. Each product has a 100% burn in test and is PAT tested when leaving our manufacturing facility.