We speak to Dunstan Power of ByteSnap Design about planned changes to medical devices regulations and how this will impact the UK market and drive innovation
Changing medical device regulations in the EU and the UK could spur wider use of the Internet of Things (IoT) and the Internet of Medical Things (IoMT), predict industry experts.
“In recent years the use of IoT in healthcare has been advancing. Then came the COVID-19 pandemic and a need for social distancing and, where possible, contactless healthcare, which has been aided by advancing technology, such as IoT,” explains Dunstan Power, director of ByteSnap Design.
The global IoMT market – covering products which are connected to each other, or to a network, and are capable of sharing information via the internet – is predicted to reach a value of £103billion by 2026, growing by a compound rate of nearly 30%.
And the use of smart medical technology, both by healthcare providers and consumers at home, is also expected to grow substantially.
And the transition within the EU from the Medical Devices Directive (MDD) to the European Medical Device Regulation (MDR), which is set to come into full effect on 26 May, could further accelerate the use of new healthcare innovations.
With changing and increasing regulation, IoT adoption can aid the collection of information and the understanding of technology presence and use, supporting efficiency in the healthcare sector overall
Power said: “After May, the EU MDR will require manufacturers and healthcare providers to be fully compliant with its provisions, including the necessity for an inventory of all medical devices.
“With changing and increasing regulation, IoT adoption can aid the collection of information and the understanding of technology presence and use, supporting efficiency in the healthcare sector overall.”
For the UK, which has left the EU via Brexit, regulation is perhaps less clear.
As part of the EU, the UK would have been required to fully comply with EU MDR.
But the UK introduced The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to mirror the EU MDR for UK legislation. This came into effect from 31 December last year.
Advancing technology is helping to drive efficiencies within healthcare
“The old MDD was the core regulatory framework for medical devices, covering classification, standards of conformity, and also requiring that devices were proven to work and that the benefits outweighed any negatives,” said Power.
The new EU MDR expands this framework, adding stricter requirements for manufacturers to prove their products work as intended and that they have a governance system in place to ensure ongoing efficiency.”
Currently there are 500,000 types of medical device in use worldwide. And manufacturers must now have greater pre-market risk assessments and there must be a pan-European co-ordination process for the clinical investigation of high-risk devices.
MDR compliance can actually work hand in hand with the need to limit contact between patients, and IoT networks are a perfect technology solution
“The EU MDR requires that medical devices each have a Unique Device Identification (UDI) code that must be entered into the Eudamed database. This guarantees that each unit is fully and globally traceable right back to the point of origin,” said Power.
“The UK MDR broadens its remit to cover other technology, including instruments used for aesthetic and other non-medical purposes. And it amends its classifications, resulting in stricter regulations for many devices.”
The UK MDR also:
If medical devices are monitored via IoT networks, not only do they achieve MDR compliance, but they also provide deep insights into product use
Under the Medicines and Healthcare products Regulatory Agency (MHRA) and UK MDR all medical devices placed on the market in the United Kingdom in 2021 must also be registered with the MHRA.
“MDR compliance can actually work hand in hand with the need to limit contact between patients, and IoT networks are a perfect technology solution,” said Power.
“IoT network systems can be integrated with existing connectivity, such as Wi-Fi, to give medical devices reliable network connectivity and to connect multiple endpoints in a healthcare provider’s network.
“IoT networks and IoT connected devices can also co-ordinate with inventory tracking systems, whether they are being used in hospitals or remotely by patients in their homes.
“And IoT connectivity can make inventory monitoring simpler, making it easier to achieve MDR compliance.”
The COVID-19 pandemic, and a need for social distancing and, where possible, contactless healthcare, has been aided by advancing technology, such as IoT
He adds: “If devices are connected to one central network, they can be individually tracked and inventory systems updated in real-time.
”Each one eventually gets its own UDI code and can be added to a central database in batches, building MDR compliance quickly.
“In this way MDR could be an incentive and opportunity, instead of being seen as restraining regulation.
“It offers the prospect of improved device tracking and management systems, for the benefit of healthcare organisations and healthcare delivery.
“And, coupled with coping with the COVID-19 pandemic, there is a positive catalyst for the growth of IoT in healthcare.”
If medical devices are monitored via IoT networks, not only do they achieve MDR compliance, but they also provide deep insights into product use.
In an example of this approach, GCE Healthcare began working with ByteSnap Design when poor 2G availability started to affect the connectivity of its Portable Oxygen Concentrators which are used to deliver oxygen to patients in homes and hospitals.
GCE was building a new solution where device data would be transmitted via Bluetooth and connected to a hub system in hospitals. And it needed software to ensure guaranteed connectivity.
Working with ByteSnap, GCE Healthcare has created its GCE Healthcare Gateway using ByteSnap’s Linux software and integration of MQTT, TLS and Bluetooth services, and has created a viable product for better connectivity.
ByteSnap is also working on bespoke healthcare connectivity solutions with the likes of Siemens, Phillips Healthcare, and Cole-Parmer.
“IoT connectivity, if implemented more broadly, can provide seamless, real-time visibility of devices, their use and performance,” said Power.
Insights gleaned from usage data could aid both medical care and product development, with clarity on how patients are using digi-health, as well as how efficiently technology is deployed within a healthcare network
“And insights gleaned from usage data could aid both medical care and product development, with clarity on how patients are using digi-health, as well as how efficiently technology is deployed within a healthcare network.
“Devices, for example, can be distributed more evenly across departments, or be quickly located when not in use, to be moved to where they are needed.
MDR also adds a stricter pre-market risk assessment requirement for manufacturers.“Our engineers at ByteSnap believe in early error detection to speed up a project’s lifecycle, in testing to compliance standards before ever reaching compliance, and in projects where testing is built into development and not just at the end,” said Power.
“ByteSnap has found that this reduces the risk of failing product certification and regulation, such as MDR, and that changes made earlier during the development process, based on real-world feedback, saves money long term and delivers a more-effective product.”
He concludes: “The MDR in Europe and in the UK calls for stronger controls over medical devices and adds to the work of manufacturers, suppliers and healthcare organisations.
“IoT offers the opportunity to manage this workload while adding many other efficiencies.
“IoT can provide medical device identification, tracking, and integrate with centralised databases required to demonstrate MDR compliance.
“And, while IoT can provide device inventory, an even greater benefit is that IoT is able to deliver valuable insights for the management of device utilisation.
“During the COVID-19 pandemic, and beyond, IoT device monitoring and tracking should help ensure the effective deployment of critical assets.
“The implementation of MDR in Europe and the UK is just the beginning of MDR regulation.
“The 2021 deadline applies to the most safety sensitive of devices. There are also deadlines for compliance for other medical technology in 2023 and 2025.
“And MDR won’t be the last change to medical device regulation. As healthcare relies more heavily on emerging tech, further regulations will be updated to encompass these developments.”