How EU MDR is bringing IoT healthcare into the mainstream

Ana Maria Gimenez, global partners director, Sigfox, writes about how the EU MDR can make IoT more mainstream.

The integration of the internet of things (IoT) into the healthcare environment is accelerating quickly — and the Internet of Medical Things (IoMT) is expected to grow to a worth of £409 billion within the next decade. The current pandemic can be expected to increase demand further as healthcare systems race to roll out contactless solutions to minimise direct exposure between healthcare workers and patients.

Concurrently, the European Union has been updating its regulations around medical devices. While these do not necessitate that providers adopt any specific technological solution, including IoT, they do provide an opportunity for healthcare teams to increase their adoption of the IoT in order to make the job of compliance easier.

Of particular importance to manufacturers is the 2020 update to the European Medical Device Regulation (MDR). Due to the pandemic, this April, the European Council (EC) unanimously voted to defer the implementation deadline for the regulation by one year. But once that date arrives, providers will need to make sure they are compliant with its provisions, particularly the need to maintain an inventory of medical devices.  

Integrating more IoT, to streamline the collection of information, will allow those in healthcare environments to understand what is truly happening in their systems — which in turn will yield its own crop of benefits. This article will provide a quick overview of the regulatory environment facing those operating medical devices. And explain why, in light of the new provisions, now is a great time for wider adoption of IoT in healthcare.

Current regulatory environment

The EU Medical Devices Directive (MDD), which MDR is replacing, has been the core regulatory framework governing medical devices in the EU since its introduction in 1993. It consists of three directives, which provides broad governance for medical devices in the EU plus Iceland, Liechtenstein, Norway, Switzerland, and Turkey. The Directive defines what constitutes a medical device and sets out standards relating to the conformity mark which these devices need to bear. The Directive also requires that medical devices can be proven to be working and requires that their benefits can be shown to outweigh any negatives which their operation might entail.

This framework has been expanded upon with the Medical Device Regulation (MDR). The updated version of this regulation, as noted, was due to be introduced in May and now imposes more onerous requirements on manufacturers who will have to prove that their devices work as intended — and also commit to having a system in place for ongoing surveillance for the efficacy of their product. The framework also imposes more onerous requirements on the 500,000 types of medical and in vitro diagnostic devices on the worldwide market including instituting heightened pre-market risk assessments and reinforcing a pan-European coordination mechanism for clinical investigation of high risk devices.

Additionally, the updated MDR, which is based upon similar specifications adopted by the Food and Drug Administration (FDA), requires that all medical devices have a unique device identification (UDI) code. This code then needs to be entered into the Eudamed database. The objective is that medical devices should be traceable to their point of origin throughout the world. This is expected to be very costly for those that need to implement the solutions.

The IoT enables streamlined data collection required by the MDR 

Achieving compliance with MDR dovetails perfectly with health system administrators’ current need to reduce contact between patients. And IoT networks such as Sigfox are suitable technology solutions to help engineer this change in hospital and other healthcare environments. 

IoT-specific networks can be used in conjunction with local connectivity solutions such as Wi-Fi or BLE to enable medical devices to achieve reliable network connectivity no matter where they are deployed in a healthcare setting. They can maintain contact with central inventory tracking systems irrespective of whether they are being used in patients’ homes, as telemedicine devices, or in hospitals. They can also be easily integrated with other local connectivity options to connect multiple endpoints in a hospital network through one endpoint. 

For European healthcare systems with many medical devices in active deployment, IoT is a perfect means to achieve compliance with MDR and can simplify inventory-gathering and monitoring processes.

After ensuring that all devices contain a UDI, the process of inventorisation of a healthcare system’s medical devices and uploading them to the central database can be carried out more efficiently in batches. Additionally, by ensuring that each device is connected to a network the process of keeping track of the devices in service can be carried out much more efficiently.

Rather than looking at the updated MDR as yet another piece of regulation to grapple with, administrators can look at its requirements as providing a perfect opportunity to implement better internal device tracking and data management systems. For those that have yet to widely use IoT in their healthcare systems, the regulation provides the perfect opportunity to do so. Given that the current pandemic in itself creates a strong incentive for administrators to roll out this technology the updated regulation could be regarded as a positive catalyst for growth.

Greater internal visibility

In addition to assisting with compliance efforts, connecting medical devices to monitoring systems through IoT networks can help administrators gain great insights into device utilisation throughout their systems. 

This benefit of IoT adoption has been seen in a variety of use-cases. For instance, the local authority Conseil Général du Loiret in France implemented a Sigfox-powered Lysbox system which they used to track staff and contractors’ activity in a facility for the elderly. After implementing the system, managers were able to identify £3.14 million worth of fraud in the form of services billed by providers but not rendered. To avoid this happening again, those accessing the site simply need to carry a badge which is read by an IoT-connected sensor. 

The same technology could be deployed in another healthcare setting to make sure that devices are not being stolen or misplaced. A comprehensive cataloguing and inventorising process could easily yield similar cost savings — while cutting down on fines for non-compliance with the incoming updated MDR.

Obtaining these sorts of insights through IoT-connected sensors could help healthcare workers to actually understand how and where tagged and connected devices were being used. In turn, inefficiencies could be easily detected so that the overall efficiency of managing the facility could be improved upon.

If healthcare administrators prefer to draw inspiration from outside their industry, the logistics sector has excelled in deploying IoT to both track resources in operation and pinpoint their whereabouts. Working with Deutsche Post and ALPS Electric, Sigfox has formed a partnership to heighten the freight companies’ ability to identify the location of rolling cages. More than 250,000 cages will be tracked. This kind of implementation can also be used in healthcare systems to locate and keep an inventory of all medical devices currently being used in order to greatly ease the process of achieving compliance with the updated EU medical device regulations.

Regulation-led innovation

The medical device industry is used to dealing with regulation. The updated version of MDR calls for stronger controls over device surveillance and places an increased burden upon vendors and healthcare institutions to prove that the devices they utilize for patient care are both safe and logged in a centralized database. 

These goals can be achieved much more effectively with an ongoing and robust data stream. Beyond simply keeping an inventory of devices in use, healthcare operators can achieve insights into their utilisation and better manage these critical assets. As its many successful case studies in the healthcare setting demonstrate, IoT is the perfect connectivity system to help the healthcare sector achieve these objectives — and to do a lot more.