June 20, 2024

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MedTech strategy update and new definition of “innovative” – key points for medical device manufacturers and developers

The Department of Health and Social Care has provided an update on the UK’s Medical Technology Strategy and how it envisages innovative medical devices being assessed, funded and adopted by the NHS in the future.

DHSC published its MedTech Strategy in February 2023, with the aim to improve treatment, encourage innovation and ensure the NHS could access the right product, at the right price, in the right place.

One year on, they have updated on progress, published a new Medical Technology Innovation Classification Framework and stated key milestones for implementation over the next 12 months.

Key points for manufacturers of medical devices and products

  • The new emphasis on the entire product lifecycle, as show in the NICE early and late stage assessments, review of the Part IX Drug Tariff and value-based procurement methodology, provides an opportunity and a challenge for manufacturers – continuing to collect data from development right the way through to adoption and continued use will be essential to provide evidence of the cost-effectiveness of products. It also opens the door for more sophisticated analyses of the “value” of a product, especially in an environment where production costs have risen and there is an increased focus on ESG/Net Zero.
  • The digitisation and collation of information on Medtech products across the Healthcare sector is intended to provide users and purchasers of products with a wealth of information on patient safety, use and value. For further detail see the sections in the report on the National Equipment and Inventory Tracking System, Product Information Management Database and the Outcome and Registries Programme.
  • The new definition of an “innovative” medical device has been drafted broadly, including improvements to existing devices, new ways of using them and novel technologies. While helpful for manufacturers to be able to point to an explanation of why their products (or improvements to them) are “innovative”, it is unclear exactly how the definition will be used by key stakeholders such as MHRA, NICE and Trusts.

We explain the new classification for innovative medical devices, look at future milestones and examine how some of the key developments under the MedTech strategy may impact manufacturers and developers below.

The one-year update highlighted initiatives across four “pathway stages” in the lifecycle of medical devices as shown below:

The initiatives span work by key Government stakeholders (DHSC, NHS England, NHS Supply Chain, NICE and the MHRA) across the UK Healthcare sector. While many initiatives are not new, the report and webinar which accompanied it, did give an indication of how the bodies leading the initiatives see them progressing over the next financial year.

The key milestones for the 2024/25 financial year can be read in full here and include the following:

  • Q1 NHS should be able to purchase the first products under the DPS for Innovative Products; response to consultation on Part IX of Drug Tariff; engagement on value-based procurement methodology; Design for Life roadmap published.
  • Q3 pilot programme for National Equipment Tracking and Inventory System; onboard all NHS and independent providers to the Medical Device Outcome Registry Platform; use of the classification for innovative medical devices will evolve; publication of the first category recommendations arising from NICE’s Late Stage Assessments.
  • Q4 all NICE Late Stage Assessments launched and publications made available online; pilot phase of the Innovative Devices Access Pathway completed with agreement as to the continuation of the programme; proof of concept for Product Information Management database giving standardised information on all MedTech products.
  • By the end of the 24/25 Financial Year, it is expected that the core medical device regulatory framework will be implemented including alternative routes to market being in place. For further details see our previous post Health Tech Series: Key regulatory changes for Health Tech developers.

MedTech Strategy initiatives and their impact on manufacturers

We summarise some of the developments below.

1. Entry point

The introduction of the Medical Technology Innovation Classification Framework (the “Innovation Framework”) attempts to provide a common language for developers, regulators and adopters when discussing innovative medical technology, including establishing criteria for when a device will be considered innovative.

DHSC explained that they do not see the Innovation Framework as a fixed statutory definition, but as a starting point to allow stakeholders to have common understandings of what it means for a medical device to be innovative. The hope is that it will be embedded into the conversations and decision-making processes in order to help developers, regulators and NHS stakeholders work together to bring improvements to patients.

Under the Innovation Framework a medical device will be innovative if:

(a) it demonstrates an incremental improvement,

(b) is a novel application or

(c) is a novel device that meets an unmet clinical need(s) or provides improvements upon existing technology or models of care.

If a device meets the overarching definition of innovative, it will then be classified as either disruptive, transformative or incremental innovation according to the diagram below:

2. Approvals

The broad programme of MHRA regulatory reform is aimed at prioritising patient safety, giving patients access to the medical devices they need as well as ensuring that the UK remains an attractive market for medical technology. More detail on the proposed regulatory changes can be found here.

Introduction of Late Stage Assessment by NICE will assess whether existing medical devices which are already in use, or features of technology, in a device category represent value for money and whether price variations are justified by the incremental differences and advancements. Following each Late Stage Assessment, NICE will publish recommendations which will be used to inform NHS commissioning and procurement. NICE are currently reviewing colostomy bags and it is expected that NICE will carry out LSAs for another six (6) products during the course of this year.

These Late Stage Assessments follow NICE’s Early Value Assessments of MedTech, which provided early stage assessments of promising technologies and recommended them for use while further evidence was collected. Together, the early and late assessments move NICE towards an approach which examines the entire lifecycle of medical devices, and not just their recommendation following regulatory approval. They provide opportunities for manufacturers to adapt their approach to market-access, providing access to earlier assessment of new technologies, but also requiring manufacturers to ensure they are collecting and can update evidence for devices already in use so they can to ensure continued recommendation by NICE after any LSA.

3. Funding and commercial

The Medical Technology Dynamic Purchasing System for Innovative Products was launched by NHS Supply Chain in February 2024. The DPS will run for seven years and will enable public sector organisations to purchase a variety of goods and services across a range of innovative MedTech categories. To simplify the procurement process for industry, it is proposed that products available for purchase under the DPS will have a ‘passport’ which will enable a product to be assessed once centrally.

The DHSC is also in the process of developing a value-based procurement methodology which will assess products in terms of patient safety and productivity, representing a shift from emphasising one-off product costs to looking at how the product impact costs over the entire patient pathway. Guidance is expected later in 2024 which will explain to manufacturers how NHS bodies can assess the impact of products over the entire patient pathway (rather than simply initial product costs). This provides an opportunity for manufacturers to present evidence linked to the lifecycle of products and their impact on overall NHS costs.

The majority of procurements using this guidance will likely fall under the new Procurement Act 2024 (due to come into force at the end of October 2024). Further information on how this will change NHS procurement is available here Burges Salmon P.A.T.H. (Procurement Act Training & Help).

3. Adoption:

The DHSC is reviewing Part IX of the Drug Tariff to ensure medical devices which are of good quality and demonstrate value to the NHS are listed and address variation in prescribing practices. The DHSC anticipates responding to its consultation relating to MedTech prescribed in the community in Spring 2024.

The consultation looked at expanding the categories within Part IX, introducing a renewal process every 4-5 years to ensure listed products remained relevant and good value, and expanding the assessment process for applications to ensure products were safe, appropriate and cost-effective. Further details on how these proposals will impact manufacturers will be available once the response is published. As with the new NICE LSAs, manufacturers of relevant products will need to ensure they continue to collect patient safety and use data to ensure their products remain listed.

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