Ambitious medtech companies need a quicker route to NHS data standards compliance
Healthcare MedTech start-ups have been at the forefront of innovation during the COVID-19 pandemic
Within the UK technology sector, MedTech is second only to financial technology in aggregate size, employing 132,000 people and creating a European market estimated to be worth €140bn.
And healthtech start-ups have been at the forefront of innovation during the pandemic, helping provide new digital tools to connect patients with clinical staff.
But, despite all their success to date, innovators face distinct data challenges when it comes to scaling up and achieving real growth within the NHS.
Duncan Allen (pictured), sales manager at InterSystems, explains: “In the rush to get up and running, MedTech companies often neglect how they can share data so it flows quickly and reliably between their devices or solutions and the systems of a major healthcare provider.
“At the very brink of real success many companies find they are unable to achieve the necessary integration of their own data with the masses of clinical data that exists in NHS systems.
“They cannot share their data because it does not conform to increasingly-rigorous healthcare data standards. In other words, it is not interoperable.
In the rush to get up and running, MedTech companies often neglect how they can share data so it flows quickly and reliably between their devices or solutions and the systems of a major healthcare provider
“And, even if they are succeeding in attracting the right talent, when considering NHS procurement processes it is unsurprising that 90% of healthtech start-up organisations fail in their first five years.”
Without the necessary interoperability, it is a struggle for any MedTech business to achieve uptake in the NHS.
In England and Wales, for example, the NHS has introduced mandatory data standards, HL7 V2 and FHIR, governing interoperability, to which any applications must adhere.
And, although MedTech founders have exciting ideas and robust business plans, they often fail to fully consider the challenges such standards present.
Allen said: “To overlook the precise detail in data standards requirements is perhaps understandable when a business is still embryonic. Yet scaling is much easier if companies start with a thought-through data strategy early on, preparing for the requirement for data to be secure, available, and compliant.”
He adds: “The fact is, the contemporary world of healthcare is increasingly driven by data, and any solution incapable of full interoperability is likely to fail.
“Healthcare providers are relying on MedTech companies to resolve the data challenges themselves.
“What they want are improved patient outcomes and reduced costs, and solutions that optimise the healthcare professional’s work.
even if they are succeeding in attracting the right talent, when considering NHS procurement processes it is unsurprising that 90% of healthtech start-up organisations fail in their first five years
“While many companies possess energy and entrepreneurial talent, they lack the experience of healthcare culture, data, and standards.
“To deliver on expectations, however, they need to set off with NHS requirements at the forefront of their strategy and developers should have an intimate understanding of healthcare systems, interoperability, and regulatory compliance.”
MedTech companies often neglect to consider how data is captured and shared
Anyone entering the healthcare domain has to understand the standards landscape.
The very-active standards bodies, including HL7, ASTM, DICOM, and IHE, know the importance of data models and associated message patterns.
And Medtech developers must become acquainted with the requirements of the Medicines and Healthcare products Regulatory Agency’s medical device regulations and NHS bodies such as the Transformation Directorate, the Data Alliance Partnership, and the Data Standards Assurance Service, which publish a steady stream of updates and guidance papers.
“MedTechs need to know these requirements inside out and build compliance into their solutions,” said Allen
“One mistake businesses commonly make is to dismiss current configurations as legacy, inefficient, or part of a failed project.
“This way of thinking is fundamentally flawed given that most applications depend to some extent on data collected from other applications.
While many companies possess energy and entrepreneurial talent, they lack the experience of healthcare culture, data, and standards
“For a solution to be successful, it is necessary to pull data from multiple data sources, some of which will use legacy standards and others which will be operating to new requirements.”
The latest HL7 standard, Fast Healthcare Interoperability Resources (FHIR), for example, is specifically designed to be RESTful and provide a simple framework for both system-to-system implementations and application developers. All future interoperability projects will need to support FHIR.
Achieving this level of interoperability cost effectively and at pace is beyond most MedTech companies in their early days, given the resource and time constraints.
There is a solution, however.
Building applications on a third-party data platform which provides interoperability, the ability to orchestrate multiple interfaces, high-speed data storage, and ‘in-flight’ data transformation, offers transformational advantages.
One of the biggest benefits from this approach is that data scientists are not burdened with cleaning and preparing data.
Allen said: “A data strategy built on an established, specialised health integration platform allows companies to address a far greater number of interoperability use cases, particularly when combined with the ability to provide real-time analytics such as insight into usage patterns and performance.
“Additionally, a unified platform eliminates the need to integrate multiple technologies and toolsets.
“This not only reduces the amount of code that companies have to develop and test, but can also significantly reduce the time-to-market.
“In-house developers are freed up to focus solely on evolving their product or service offering. This is important when evidence suggests data scientists at start-ups spend as little as a fifth of their time on analysis.”
Given the speed at which wireless technology, miniaturisation, and computing power are evolving and the increasing acceptance of digital health solutions by clinicians and patients alike, there are likely to be ‘first mover advantages’ for MedTech companies that solve the fundamental data interoperability requirements.
“Underpinned by a unified data platform, MedTech companies can lead innovation in remote care, monitoring, and even diagnosis – processing large datasets very quickly,” Allen said.
It is clear that whatever their achievements in diagnosis and treatment, MedTech organisations need to embed a fully-effective data strategy that does not leave them isolated from current and future requirements of NHS systems
“This becomes particularly relevant with 5G connectivity sharing data from the patient’s homes, with their GP, or hospital clinician.
“A compliant data platform will be capable of ingesting millions of records per second while also allowing for simultaneous queries in real time.”
Global consultancy, Deloitte has identified interoperability as ‘arguably the biggest challenge’ in the medical technology sphere, including compliance with ‘various national and international standards and protocols around the exchange and use of data’.
Allen said: “It is clear that whatever their achievements in diagnosis and treatment, MedTech organisations need to embed a fully-effective data strategy that does not leave them isolated from current and future requirements of NHS systems.
“The surest way to achieve this is through a unified data platform, purpose built for interoperability and full integration with the health systems and standards.
“By achieving interoperability, one of the biggest barriers to expansion for MedTech companies is removed and new opportunities for success are made available.”