Telephone and video consultations have become much more commonplace, benefiting both patients and clinicians. However, should a doctor need to remotely measure vital signs during a consultation, or remotely monitor a patient’s condition over a longer period, they would be challenged to provide a frictionless experience for the patient. If devices are successfully deployed and connected, the clinician would then be overwhelmed with a large amount of normal uneventful data. They need to prioritize useful information to support treatment.
While more medical devices adding wireless connectivity, the way they communicate to the cloud and present their data to the clinician is often proprietary. This rarely interfaces into clinical medical records or provides triage of normal and abnormal readings. To provide clinicians with an integrated method allowing medical devices to be deployed into patients’ homes a new approach is required.
L2S2 has been working on such an approach called Managed Medical Device Cloud (MMDC). MMDC provides a medical device grade integration of a large ecosystem of remote medical devices and hospital medical record systems. The L2S2 System, which is underpinned by Arm technology, provides accredited turnkey compliance with medical device regulation. It also includes, GDPR regulatory approval which permits L2S2 to collect and analyze incoming data from mobile apps or connected medical devices and deliver prioritized insight directly to the patient’s doctor.
This enables doctors to focus their time on new valuable clinical insight derived from data gathered from a growing breadth of sources in a patient’s home. For medical devices and mobile apps, supported deployment is provided by the MMDC platform removing a significant burden from the healthcare providers.
With the MMDC platform, clinicians have the chance to obtain a holistic view on patient trends. This being not from just one measurement parameter, but from a range of complementary sources, devices, and apps.
Combining all the benefits of the fast moving IoT industry with a fully integrated, certified, and experienced NHS partner. MMDC is making the future of remote patient care possible.
MMDC allows a clinician to ‘prescribe’ patient monitoring with the click of a mouse – from then on, real-world information is visible from within the patient record. It enables more medical grade devices to be delivered to more patients for improved monitoring and patient care. And, with more data from more patients, clinicians, and hospitals have improved analytics, insight, and care provision.
For medical device manufacturers, using MMDC facilitates approvals from individual hospitals and they can enjoy the advantages of a single pre-integrated clinical platform.
MMDC, developed by Cambridge-based L2S2 Ltd, is a scalable ISO13485 compliant medical data and analytics SaaS platform that is embedded into the highly guarded healthcare IT ecosystem. It has rapid development tools for regulated healthcare products and provides de-risked, compliant data and product life-cycle management.
MMDC’s unique architecture permits it to remotely collect patient data, analyze this data, present it to clinicians and integrate information directly into patient record systems. Currently the MMDC platform holds more than 100+ million patient records and is now integrated with Arm’s solutions. This makes it easier and more secure to develop, connect, and provision medical devices.
L2S2 is an innovator in the digital health sector. CEO Dr. Philip Gaffney OBE, lectures on medical device engineering in Cambridge University. And, Chief Medical Officer, Dr. Thomas Hughes, designed and introduced the new Emergency Care Dataset into the NHS.
L2S2 is authorised by the UK’s NHS Digital to hold and process over 100 million patient records and analyse the data to produce highly sensitive hospital quality reports. For Public Health England, it has set up and operated a network collecting data for national syndromic disease surveillance. This utilizes the companies many years expertise in information governance and healthcare IT data access.
As a trusted technology partner of companies in a wide range of healthcare fields, it is commissioned by NHS England to undertake a major national study into service transformation through remote patient monitoring using medical devices.
L2S2 is accredited to ISO 13485:2016, ISO/IEC 27001:2013, and operates to NHS Digital IT standards. Its systems comply to MDR, GDPR, HIPAA, FDA 21 CFR Part 11 and to GxP for research.
MMDC is composed of complementary-integrated components that offer:
Integration with electronic health record systems makes it possible to ensure that the patient record is always complete as device reports can be automatically inserted. Bi-directional data transfer permits device data to be analyzed in the context of the patient’s health record and harness the power of machine learning and other techniques.
MMDC has full integration with systems used in 90% of UK primary care, and with multiple secondary care and central NHS systems. New connections are easily established using its open API which meets NHS and other healthcare IT interoperability standards.
Secure and resilient data management and analysis let clinicians rely on insight MMDC derives from patient data, AES 256 encryption helps to ensure confidentiality. Patients can be safely monitored in the community, and clinicians can proactively manage their caseload using risk-stratified information.
With systems in multiple jurisdictions worldwide, MMDC curate’s personal information to meet local legislation. Mass device and patient reported data is held centrally using highly scalable, resilient storage, the data is then linked using UIDs to the patient’s personal information.
Scalable, resilient hosting assures service provision and data centers are accredited to ISO/IEC 27001:2013 and to NHSD DS&PT. In the UK, data centers are physically audited by NHS Digital to higher standards than ISO 27001. Data management has been designed to meet the regulatory requirements of ‘intrinsic’ regulated devices.
For research, data capture and management is compliant with GxP and meets the requirements of major pharmaceutical research organizations.
MMDC extends into physical medical devices by offering compliant reference hardware and firmware designs which include compliant technical files based on Arm Mbed. These new designs can be inserted into the device design file to accelerate development, reduce testing, and provide seamless integration of the device with MMDC. MMDC also enables devices to be remotely configured, managed, and updated, and this provides device manufacturers with critical capabilities for IP protection and smart manufacture.MMDC also provides a highly flexible, user-friendly environment for creating patient, clinician, and researcher SaaS applications. Each application runs automatically as iOS, Android, and UWP apps and in secure web browsers. Sophisticated analytics create dashboards and reports. An app produced for C2-Ai in response to the pandemic recently won several healthcare awards, including the COGX award for best COVID innovation.
And finally, MMDC incorporates its own Quality Management System, into which the components report automatically. This system ensures that all data are properly secured, signed, and tracked throughout the network. It knows their current and historical locations and logs all accesses. It ensures that application and protocol development is fully auditable, and that data are marked with the version of the protocol or application with which they were captured.
MMDC provides a unique combination of complex features and services that most medical devices and their manufacturers now need. Crucially, it allows medical device creators to focus on developing and commercializing their core IP and USPs to drive value creation. MMDC originates from and encapsulates L2S2’s many years of healthcare expertise. It accelerates and de-risks medical device development and then integrates devices into healthcare systems to deliver patient intelligence to clinicians. MMDC benefits not just device manufacturers but the clinicians who can proactively manage their case load and the patients whose lives are improved.
If you would like more information on how the MMDC platform can increase clinical efficiency and improve patient outcomes:
If you are creating a new wirelessly connected medical device and would like more information on how MMDC can help: