Guidance

Medical technology innovation classification framework

Published 9 April 2024

Aim

In February 2023, the government published its first medical technology strategy, setting out our vision for the right product, at the right price and in the right place.

In developing the strategy, we consulted extensively with stakeholders across the UK health and social care system, industry and patient organisations, to identify policy priorities where we can bring about substantive change to further strengthen the UK’s medical technology ‘medtech’ sector. A key identified priority was to establish innovative and dynamic markets.  

To support innovation, we heard from colleagues across the sector that there are no clear criteria to describe a product as innovative. The benefits of innovation are often lost in translation with no consistent language to express how a device offers improvements to what already exists on the market. As a result, the innovation pathway across assessment, funding and procurement, can be inconsistent with a lack of clarity or consistency in decision making, that makes it harder for innovation at all levels to be adopted.   

In response, we have developed a medical technology innovation classification framework (the framework) following an extensive review of literature available on innovation language and in consultation with stakeholders across the health system and industry.  

Since publication of the strategy in February 2023, the department has hosted a series of workshops and a roundtable with colleagues and wider stakeholders from across the health system including NHS England, National Institute for Health and Care Excellence (NICE), Medicines and Healthcare products Regulatory Authority (MHRA), trade associations as well as patient representative organisations.  

We set 4 objectives:  

1. To establish a common language for discussing innovation across the medical technology sector.
2. To establish clear criteria for a device to be described as innovative in different forms.
3. To clearly convey the change in a device compared to what already exists on the market, and its benefits to patients and the system.
4. To support prioritisation and adoption of the most impactful innovations.

The framework builds on the existing terminology already in use across the sector. It is intended to be a single version of truth for innovation language, providing clarity on what is meant when medical technologies are classed as either incremental, transformative or disruptive.  

Key to the use of the framework is understanding that no form of innovation is superior to another, and that any innovation could have the potential to enact a positive improvement on the system at scale. The framework will underpin our work set out in the medical technology strategy going forward, in particular to streamline the end-to-end innovation pathway.   

Audience

The audience of this document is the medical technology sector, including government departments, government partner organisations including NICE and MHRA, trade associations, medical technology suppliers and patient groups.

We have developed the framework in consultation with stakeholders across the sector, these stakeholders are listed in annex C.

Following engagement, stakeholders across the health system welcome the work to pursue a common understanding of innovation in medical devices. We have reached broad agreement on the scope of the framework and have commitment to test and refine the framework, and consider circumstances for implementation with colleagues across the system including:

• Association of British HealthTech Industries (ABHI)
• British Association for Anaesthetic and Respiratory Device Suppliers (BAREMA)
• British Healthcare Trades Association (BHTA)
• Department for Business and Trade (DBT)
• Department for Science, Innovation and Technology (DSIT)
• Health Innovation Research Alliance - Northern Ireland (HIRANI)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS England
• NHS Innovation Service
• NHS Supply Chain
• National Institute for Health and Care Excellence (NICE)
• Office for Life Sciences (OLS)

Scope

The framework is applicable to medical devices, which are defined as per the medical technology strategy published in 2023 in line with the Medical Device Regulations 2002.  

The framework only applies to devices that are incremental, transformative or disruptive. Products that fall into the following categories are out of scope:  

• continuous improvement: enhancing a process at the working level using technology or devices that are already available. The device does not change but may be used in a new way to increase efficiency
• copycat device: a device that does not differ in function to devices already on the market fulfilling the same clinical function. The device does not demonstrate substantial ‘value-add’ to care givers, patients, sustainability, finances and/or to the efficiency of the wider system
• discovery and invention: introducing a new concept or technology that fundamentally opens or changes current understanding or thinking within healthcare or another specialty

Defining innovation

Overarching definition of innovation

For a device to be defined as an innovation it should demonstrate an incremental improvement, be a novel application or is a novel device that meets an unmet clinical need or provides improvements upon existing technology or models of care. The device can be scaled with the end-goal of benefiting the system, patients and/or care providers. 

Incremental innovation

Incremental innovation is defined as an improvement to a device that already exists within the health system that positively affects the delivery of care or wider system.

For a device to be defined as incremental, it should:

• already exist in some capacity in the health and care system
• offer improvements to the existing provision of care or wider health system for example, meeting net zero goals

The implementation of an incremental innovation should meet one of the following criteria:

• the implementation of the device would retain the basic roles and responsibilities of the clinical pathway or workflow when implemented. Improvements are based on updates to an existing product, process or system
• the implementation of the device would require implementation support that can be managed at an operational level with limited additional resource but may require time-limited support for workforce training and/or patients administrating the care themselves and to build confidence in the workforce or patients
• the implementation of the device will need manageable support at an operational level, requiring minimal extra resource. However, it may necessitate limited training for staff or patients who will be using the device
• the implementation may result in minor changes to the patient or clinical pathway

Case study: Sedaconda ACD-S

This medical device reduces the release of volatile inhaled anaesthetic gases to the atmosphere, which supports net zero priorities for the NHS, and is an adaptation to existing systems in use. For further information regarding this device see NICE medical technologies guidance [MTG65].

Introduced improvement in regard to the device

The Sedaconda ACD-S (anaesthetic conserving device S, from Sedana Medical) is a volatile anaesthetic delivery system for delivering isoflurane or sevoflurane to people who are mechanically ventilated, usually in an intensive care setting. In terms of improvements, the technology conserves inhaled anaesthetics within the delivery system and any waste gas is captured by a passive or active gas scavenging system.

Introduced change to implementation

The innovative aspect is that Sedaconda ACD-S allows conserved delivery of inhaled anaesthetic in an intensive care setting in both adults and children.

Transformative innovation

Transformative innovation is defined as an existing technology that is applied to the health and care system for the first time or the application of a technology which is already in the healthcare system in a novel way for example, an existing device being applied to a new speciality.

For a device to be defined as transformative, it should:

• offer improvements compared to the existing provision of care
• be a novel application of an existing device (or similar) either to the health system as a whole or a specific area of healthcare. The technology may exist elsewhere outside of the health and care sector for a different application
• be the addition of digital services or benefits to an existing (offline) product to offer improvements compared to the existing provision of care

The implementation of a transformative innovation should meet one of the following criteria:

• the device would lead to a change to one element of the clinical pathway or workflow that leads to a knock-on effect downstream, while improving overall efficiency and patient outcomes
• the device could lead to existing regulatory and payment arrangements being reassessed to reflect the introduction of technology for the first time
• the device could require substantial and prolonged implementation support for the workforce in terms of training and updating clinical pathways or workflow
• the device may require changes to multiple parts of the clinical pathway or workflow

Case study: Kardiamobile

Kardiamobile is a portable electrocardiogram (ECG) recorder for detecting atrial fibrillation. The device works with a compatible smart mobile device. A reading is taken through the portable ECG and sent wirelessly to the Kardia app. The app then shows the ECG trace and classifies as either normal, possible atrial fibrillation, tachycardia, bradycardia or unclassified. This trace can then be emailed to healthcare professionals. The device is intended for use for people experiencing arrhythmia symptoms more than 24 hours apart, to support clinical decision making. See further information regarding this device in NICE medical technologies guidance [MTG64].

Introduced improvement in regard to the device

The device is a portable ECG for specific arrhythmias which can be monitored via a personal smartphone or app with shareable ECGs (device offers improvements to existing ECG technology by introducing portability but principles of the technology are the same. The introduction of this element improves existing provision of care). The device introduces a digital service or benefit to an existing offline product (the portable ECG works alongside a digital interface).

Introduced change to implementation

The device supports earlier detection of arterial fibrillation outside of a hospital setting and enables detection in people who experience symptoms more than 24 hours apart (the device leads to a change in one element of the clinical pathway, earlier diagnosis improves efficiency and overall outcomes). The device involves multiple interacting components that require changes to multiple parts of the clinician pathway or workflow (the implementation could require restructuring arterial fibrillation pathways to supplement or replace ambulatory ECGs).

Disruptive innovation

A disruptive innovation is novel.  

For a device to be defined as disruptive, it should:

• offer improvements compared to the existing provision of care
• be novel and the proposed format should not exist elsewhere (either within or beyond the health and care sector) to fulfil the clinical need. As per the glossary, it may exist elsewhere but is being applied to the device for the first time in a novel format
• be the first provision of care made available for example, in the treatment of rare diseases

The implementation of a disruptive innovation should meet one of the following criteria:

• the device may require entirely new ways of working
• the device would require ongoing evaluation and surveillance to determine the impact of the disruptive innovation in the real world and identify unforeseen adverse effects
• the device may require new teams and/or substituting old roles and responsibilities in line with the concept or technology
• the device may enable a change in healthcare provider setting, away from acute settings and into community or home settings
• the device may require new payment mechanisms and regulation, and consideration of implementation costs including service provision
• the device may require significant and prolonged implementation support for workforce training, creating new pathways for clinical pathway or workflow

Case study: placental growth factor test

A placental growth factor (PlGF) test is a diagnostic tool used in obstetrics to assess the risk of pre-eclampsia in pregnant women. See further information in NICE diagnostics guidance [DG49].

Introduced improvement in regard to the device

The PlGF test enables early detection and precise risk stratification for pre-eclampsia in prenatal patients to support clinical decision making. This approach would lead to tailored monitoring and treatment and improves upon the existing provision of care which lacks sensitivity. The device introduces a novel diagnostic blood test for placental growth factor. (The diagnostic test is novel.)

Introduced change to implementation

As the technology is novel it will require ongoing evaluation and surveillance of its performance in a real-world environment (ongoing surveillance and evaluation).

The adoption of the PlGF test marks a substantial change in prenatal care, primarily by enhancing the early detection and management of pre-eclampsia. This test offers a more accurate risk assessment, allowing healthcare providers to tailor monitoring and treatment to individual needs. It significantly reduces unnecessary hospital admissions, especially for low-risk pregnancies, thereby improving patient experience and promoting efficiency (introduction of new ways of working and to the clinical pathway).

Considering technology versus implementation

Following engagement with the sector, we heard that a device itself may be classed as one type of innovation, however when it comes to its implementation into the health system, a different classification may be more appropriate. An example of this is set out in the case study below.

Case study: AposHealth

A non-invasive device worn on the feet to reduce pain and improve function in patients with knee osteoarthritis. See further information in NICE medical technologies guidance [MTG76].

It is a disruptive innovation that requires an incremental implementation.

Introduced change to device

Disruptive: it is a pair of AposHealth shoes with 2 curved pods on the heel and forefoot of each shoe. (The device is novel.) The device is recommended as a cost-saving option to manage knee osteoarthritis in adults where non-surgical standard care has not worked well enough and patients who opt to not have knee surgery.

Introduced change to implementation of the device

Incremental: the implementation of the device does not replace the need for knee-surgery but can support patients in managing their symptoms where surgery has not worked well enough, patients awaiting surgery or if they have opted to not have surgery. (Implementation would retain the basic roles and responsibilities of the clinical pathway or workflow when implemented as the device).

The training of workforce to administer the device would not be complex (require time-limited support for workforce training). Follow-up visits would be recommended to assess effectiveness (minor change to the patient or clinical pathway).

Implementation

The framework has been developed and agreed in consultation with many of our partners across the medical technology sector, including the devolved administrations. It should be noted classifications of implementation may differ both within and across regions, based on existing capabilities within the local health system.

In recognition of the pace and breadth of innovation in the sector we will review the effectiveness of the framework in supporting classification 6 months following publication.

In the immediate term, the framework is to be used as guidance to support the classification of innovative technologies. By sharing the framework as guidance, we intend for the language to be tested by our colleagues across the sector including government, industry and patient organisations, on how it delivers against the aims set out in the first section of this document.  

Over the next 6 months, we will continue to work with our partners including MHRA, NHS England, NHS Supply Chain and NICE to test the implementation of the language into existing processes and systems and test its suitability or applicability across the innovation pathway.

At the 6-month mark, we will request feedback from the sector on the relevance and utility of the framework and supporting guidance, including consideration of how the framework aligns and supports with the wider innovation ecosystem. This will inform a review of the framework and further developed plans for implementation across the end-to-end innovation pathway. 

As an indication of implementation plans in the long term, the framework is expected to be used to determine the following:

1. Suitability for funding and other support opportunities targeted at supporting different types of innovation - for example, the Innovative Devices Access Pathway (IDAP) is intended to support devices that meet an unmet need (transformative).
2. Assessment of cost effectiveness - for example, new and emerging technology and devices through a NICE early-value assessment (disruptive) and existing devices (incremental and transformative) through a NICE late-stage assessment.
3. Qualification for national framework agreements in place to support market access - for example, the NHS Supply Chain Medical Technology Dynamic Purchasing System for Innovative Products is intended to support new devices (disruptive), with existing NHS Supply chain category frameworks intended to support existing products offering value (incremental and transformative).

To note, these are long term aspirations for the framework. The framework is published as guidance in its current form and therefore at this stage will not inform suitability for funding or formal classification of technologies. 

Annex A: classification flowchart

The diagram below outlines the process for classifying a device according to its novelty and impact within the health system. Initially, it questions whether the device meets the overarching definition of ‘innovative’. If the answer is, ‘no’, the device does not receive further classification.

For devices that are classified as innovative, the next step determines whether they exist in the health system. Devices not previously seen in any context are labelled as disruptive. To note, as per the framework, the technology of the device may exist outside the health system.

If the device is already present, either within or external to the health system, it is further evaluated to establish its status. Devices in use elsewhere but being used in the health system for the first time are defined as transformative.

Annex B: glossary

Clinical pathway

The clinical pathway is the route from triage, diagnosis, treatment and post-treatment monitoring a patient will go through when receiving treatment.

Clinical unmet need

Clinical unmet need is where there exists no satisfactory method of diagnosis, prevention, or treatment of the condition in question, or if such method exists the device will be of significant benefit to those affected by that condition.

Improvements

Improvements recognised under the incremental definition are:

• benefits for care providers encompassing both primary and secondary care workforce, social care providers, and carers by equipping them with tools that enhance efficiency and prioritise patient care
• cost reduction benefits through device-focused enhancements, leading to either lower initial expenses or reduced costs throughout the pathway
• patient benefits characterised by enhancements in safety and patient experience, aimed at promoting patient comfort and compliance, ultimately improving patient outcomes
• sustainability improvements that are device-focused, signifying significant advancements in the device’s contribution to achieving net zero
• system benefit through enhancements that improve overall efficiency

Iteration

Iteration is defined as a new version of an existing device.

Medical device

A medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
• investigation, replacement or modification of the anatomy or of a physiological process
• control of conception

 A medical device does not achieve its main intended action by pharmacological, immunological or metabolic means although it can be assisted by these - Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Medical devices can be:

• general medical devices - such as syringes, dressings, heart valves, ECG monitors, CT scanners and dialysis machines, including any software used to drive them
• active implantable medical devices (AIMDs) - powered implants or partial implants that are left in the human body, such as implantable cardiac pacemakers, implantable nerve stimulators, cochlear implants and implantable active monitoring devices
• in vitro diagnostic medical devices (IVDs) - equipment or systems intended for use in vitro to examine specimens including all instruments, software, reagents and calibrators, such as blood grouping reagents, pregnancy test kits and hepatitis B test kits
• digital health and software - such as standalone software, decision support and mobile apps

Novel

Novel is defined as a device that does not already exist.

Technology

Technology is defined as the application of scientific knowledge to a medical device.

Annex C: stakeholder engagement

Organisations

• Accelerated Access Collaborative (AAC)
• Association of British HealthTech Industries (ABHI)
• Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care (AXREM)
• British Association for Anaesthetic and Respiratory Device Suppliers (Barema)
• British Healthcare Trades Association (BHTA)
• British In Vitro Diagnostic Association (BIVDA)
• Department for Business, Energy and Industrial Strategy (BEIS)
• Department for Science, Innovation and Technology (DSIT)
• Health Innovation Network (HIN)
• Heath Innovation Research Alliance (NI)
• Health Technology Wales (HTW)
• Innovate UK
• Medicines and Healthcare products Regulatory Agency (MHRA)
• MedTech Group
• National Clinical Lead for Innovation - Professor Tony Young
• National Institute for Health and Care Excellence (NICE)
• National Institute for Health and Care Research (NIHR)
• NHS Innovation Accelerator Programme
• NHS Innovation Service
• NHS Innovation Sites Programme
• NHS England
• NHS Supply (NHSSC)
• Northern Ireland Department of Health
• Office for Life Sciences (OLS)
• Scottish Health Technologies Group (SHTG)
• UK Trade Association for Instrumentation, Control, Automation and Laboratory Technology (GAMBICA)