The development of any medical device or healthcare solution is complex, time consuming and involves many disciplines. Connectivity for medical devices is now a prerequisite to enable seamless data reporting at all levels of the diagnostics and treatment cascade. Timely, accurate and reliable data has always been essential in the fight against disease and has become even more vital in recent times.
When considering adding connectivity to existing medical devices, or developing a new product, there are a number of considerations and disciplines that are essential for success. Connected Diagnostics are leaders in this area and our knowledge and expertise is proven to deliver successful connected health projects. Below are some of the areas we can help with.
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Requirements & Design
It is essential that connectivity solutions address both the current and future needs of the diagnostic programme, whether those needs are technical features and functions, integration with other systems or financial in nature. It is also critical that solutions are fit for purpose - incorrectly identified and implemented solutions can lead to under-utilisation, resource wastage and discontent.
Connected Diagnostics helps to design and build various connectivity components for medical devices, as well as guide manufacturers through the important elements of communications and networking, component evaluation and device management to support a multi-faceted global eHealth strategy.
Communications & Networking
It is of paramount importance that medical devices have the capability to communicate via the internet in order for connectivity use cases to be achieved. Communication can operate successfully through a simple LAN or Wi-Fi network, but these are not ubiquitous in many rural locations globally. Under more difficult circumstances, connectivity may only be possible through cellular or satellite networks. There are, however, a multitude of complexities and challenges when using cellular connectivity within medical devices.
These complexities span radio technologies (2G, 3G, 4G, LTE etc.), modem form factors, region and band requirements, SIM cards and IMSI switching, through to the additional areas of data billing and cost optimisation. Our expertise in this area is second to none and we are available to guide you through it.
Guided by your connectivity strategy and product requirements, the internal connectivity components of your medical device will need to be identified. These will then require rigourous evaluation to comply with quality processes, anticipated product lifecycle, supply chains, vendor support, unit costs and integration needs. Other considerations such as global of regional SKUs also need to be taken into account.
Our team of experts can support you to ensure that the connectivity components within your medical devices are fit for purpose, as well as sustainable and cost effective.
62304 Software Development
The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonised by the European Union and the United States and is used as a benchmark to comply with regulatory requirements from both these markets.
Our product development team are fully versed with developing software under IEC 62304 and ensure a rigorous process is followed in all projects; investigating and analysing the objectives and scope of the project, evaluating the viability of the design, as well as the implementation and ongoing maintenance of the final solution.
Connected Diagnostics are experienced in delivering software using this methodology, and we consistently attain excellent outcomes as a result. We can operate as a standalone development team or integrated with existing resources as required.
Reliable and timely diagnostic information is vital to the proper functioning of health systems. It is important for diagnostic instruments to provide data in accessible and standardised formats to enable integration with customer information systems and databases, such as electronic patient records. Integration capabilities must be considered within the product development stage as a fundamental part of the process, ensuring that customer needs are met and benefits are realised.
Visibility of device performance is crucial to the success of your connected diagnostic instruments. Monitoring performance should make up a key part of a connected health strategy, including positive user experiences as well as erroneous functionality. Post market surveillance is a legal requirement for all manufacturers and as a result, this should be considered in the development stage to ensure there is adequate capability to cope with reporting after launch.
Where diagnostic instruments are planned for isolated or global locations, the advantage of remote device access for technical troubleshooting or software updates cannot be underestimated. By using Connected Diagnostics’ professional and knowledgeable team to assist in the design of your medical devices, you can be sure to save time and money with your future maintenance programme. Efficient device management will contribute to a cost-effective and sustainable connectivity strategy.
Verification & Validation
The success of a connected device relies upon the strength of its corresponding testing frameworks. It is a legal requirement to complete a thorough verification and validation programme. Field testing is of paramount importance, but many testing scenarios can be challenging for manufacturers to implement, particularly in remote areas.
Connected Diagnostics has the capability to test components in their intended setting, whether in the UK or elsewhere around the world. Our team has experience of executing testing activities in some of the world’s most complex and challenging environments. We already have the networks in place to test your product, so let us take care of it for you.