UK Medical Technology Innovation Classification Framework

1. Publication Details

Published 9 April 2024 by Department of Health and Social Care. Licensed under Open Government Licence v3.0. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

2. Introduction and Aim

The Medical Technology Innovation Classification Framework (the framework) was developed by the UK Department of Health and Social Care in response to the medical technology strategy published in February 2023. The strategy outlines a vision for delivering the right product, at the right price, and in the right place within the UK's health and social care system. During consultations with stakeholders from the health and social care system, industry, and patient organisations, a key priority identified was establishing innovative and dynamic markets. Stakeholders highlighted the lack of clear criteria to describe a product as innovative, leading to inconsistent language, assessment, funding, and procurement pathways that hinder innovation adoption. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework The framework addresses this by providing a common language for innovation in medical technologies, building on existing sector terminology. It classifies innovations as incremental, transformative, or disruptive, emphasising that no form is superior and all can positively impact the system at scale. It aims to streamline the end-to-end innovation pathway as set out in the medical technology strategy. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework Four objectives guide the framework:

• Establish a common language for discussing innovation across the medical technology sector.
• Provide clear criteria for describing a device as innovative in different forms.
• Clearly convey the change a device introduces compared to existing market options and its benefits to patients and the system.
• Support prioritisation and adoption of the most impactful innovations. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework The framework was developed through an extensive literature review on innovation language and consultations, including workshops and a roundtable with stakeholders such as NHS England, NICE, MHRA, trade associations, and patient representative organisations. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

3. Audience

The framework targets the medical technology sector, including government departments, partner organisations (NICE, MHRA), trade associations, medical technology suppliers, and patient groups. It was developed in consultation with stakeholders listed in Annex C, who welcomed the common understanding of innovation and committed to testing and refining the framework. Implementation will be considered across regions, with classifications potentially varying based on local health system capabilities. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

4. Scope

The framework applies to medical devices, defined per the medical technology strategy and the Medical Device Regulations 2002 (SI 2002 No 618, as amended) as any instrument, apparatus, appliance, software, material, or other article intended for human use in diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or handicap, or for investigation, replacement, or modification of anatomy or physiological processes, without achieving primary action by pharmacological, immunological, or metabolic means. This includes general medical devices (e.g., syringes, ECG monitors), active implantable medical devices (e.g., pacemakers), in vitro diagnostic devices (e.g., pregnancy test kits), and digital health/software (e.g., mobile apps). https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework It covers devices classified as incremental, transformative, or disruptive. Excluded categories are:

• Continuous improvement: Enhancing processes using existing technology without changing the device, possibly repurposed for efficiency.
• Copycat device: No functional difference from existing devices, lacking substantial value-add in care, sustainability, finances, or system efficiency.
• Discovery and invention: New concepts or technologies fundamentally changing understanding in healthcare or other specialties. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

5. Defining Innovation

5.1 Overarching Definition

A device is innovative if it demonstrates incremental improvement, a novel application, or a novel device meeting an unmet clinical need or improving upon existing technology/models of care. It must be scalable to benefit the system, patients, and/or care providers. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

5.2 Incremental Innovation

Defined as an improvement to an existing device in the health system that positively affects care delivery or the wider system. Criteria:

• Already exists in the health and care system.
• Offers improvements to care provision or system (e.g., meeting net zero goals). https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework Implementation criteria:
• Retains basic clinical pathway roles and responsibilities; improvements from updates to existing products, processes, or systems.
• Requires operational-level support with limited resources, possibly time-limited workforce/patient training for confidence-building.
• Needs manageable operational support with minimal extra resources; may involve limited staff/patient training.
• Results in minor changes to patient or clinical pathway. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

5.3 Transformative Innovation

Defined as applying an existing technology to the health and care system for the first time or in a novel way (e.g., to a new specialty). Criteria:

• Offers improvements over existing care.
• Novel application of an existing device (or similar), possibly from outside healthcare.
• Adds digital services/benefits to an existing offline product. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework Implementation criteria:
• Changes one clinical pathway element with downstream effects, improving efficiency and outcomes.
• May require reassessing regulatory/payment arrangements due to novel technology introduction.
• Needs substantial/prolonged workforce support (training, pathway updates).
• Involves changes to multiple clinical pathway parts. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

5.4 Disruptive Innovation

Defined as novel. Criteria:

• Offers improvements over existing care.
• Novel format not existing elsewhere (within/beyond health sector) to meet clinical need; may exist elsewhere but applied novelly.
• First provision of care (e.g., for rare diseases). https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework Implementation criteria:
• Requires entirely new ways of working.
• Needs ongoing evaluation/surveillance for real-world impact and adverse effects.
• May require new teams/roles, substituting old ones.
• Enables shift from acute to community/home settings.
• May need new payment/regulation mechanisms and cost considerations.
• Demands significant/prolonged workforce training and new pathway creation. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

6. Considering Technology Versus Implementation

A device may be one innovation type, but its implementation another. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

7. How It Works

Classification starts with the overarching innovation definition. If met, evaluate novelty and impact:

• Novel and not previously seen: Disruptive (technology may exist elsewhere).
• Exists elsewhere, first use in health: Transformative.
• Exists in health: Incremental (if improvements met). https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework

8. Using the Framework

Developed with devolved administrations and partners. Classifications may vary by region based on local health system capabilities. Reviewed after 6 months for effectiveness. Initially guidance for classification; tested over 6 months with MHRA, NHS England, NHS Supply Chain, NICE. Feedback at 6 months to refine and align with innovation ecosystem. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework Long-term: Determine funding/support suitability (e.g., IDAP for transformative unmet needs); cost-effectiveness assessment (NICE early-value for disruptive, late-stage for others); qualification for framework agreements (e.g., NHS Supply Chain for disruptive new devices, existing for incremental/transformative). https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework Currently guidance; does not formally classify or inform funding. https://www.gov.uk/government/publications/medical-technology-innovation-classification-framework/medical-technology-innovation-classification-framework