Article type
Abstract
Background:
MedTech encompass medical devices, in vitro diagnostics, or digital health applications. Innovation in this space can bring value to the health care system, patients, and society in many ways, including transforming care pathways, improving health, stimulating economic growth, and delivering resource efficiencies with the system. Horizon scanning (HS) can play a crucial role in the early identification of, and preparedness for, MedTech development. However, innovation in MedTech happens in a very inconsistent way, with many innovations rapidly evolving and appearing only toward the end of their innovation lifecycle. The nuance of MedTech development and regulatory pathway makes translating HS methods from medicines very challenging.
Methods:
We undertook an analysis of HS case studies across health topics published by the National Institute for Health and Care Research (NIHR) Innovation Observatory (IO) in the last 4 years (2020-2024). We used the MedTech development and regulatory pathways to provide a framework to map the different challenges posed for the practice of HS and explore transparency in reporting.
Results:
A total of 21 case studies were included. The mapping allowed for a list of barriers, methods, and reporting elements to be mapped. These lists will be translated into (1) a guide to aid in the selection of HS methods at different points in the MedTech development pathway and (2) an outline reporting framework to support transparency, consistency, and openness in HS practice.
Conclusion:
The practice of HS in MedTech remains in its infancy, which offers an opportunity to ensure that it develops in a robust manner. There are real challenges to this practice, but when looking at the gaps, we believe the application of well-established evidence synthesis methods to the HS process will only contribute to better outcomes. We believe the creation of a framework to support appropriate method selection, drawing on both HS and evidence synthesis methods, alongside a reporting framework will enhance the quality and impact of MedTech HS, thus allowing decision-makers to fully exploit the intelligence and evidence these methods offer.
MedTech encompass medical devices, in vitro diagnostics, or digital health applications. Innovation in this space can bring value to the health care system, patients, and society in many ways, including transforming care pathways, improving health, stimulating economic growth, and delivering resource efficiencies with the system. Horizon scanning (HS) can play a crucial role in the early identification of, and preparedness for, MedTech development. However, innovation in MedTech happens in a very inconsistent way, with many innovations rapidly evolving and appearing only toward the end of their innovation lifecycle. The nuance of MedTech development and regulatory pathway makes translating HS methods from medicines very challenging.
Methods:
We undertook an analysis of HS case studies across health topics published by the National Institute for Health and Care Research (NIHR) Innovation Observatory (IO) in the last 4 years (2020-2024). We used the MedTech development and regulatory pathways to provide a framework to map the different challenges posed for the practice of HS and explore transparency in reporting.
Results:
A total of 21 case studies were included. The mapping allowed for a list of barriers, methods, and reporting elements to be mapped. These lists will be translated into (1) a guide to aid in the selection of HS methods at different points in the MedTech development pathway and (2) an outline reporting framework to support transparency, consistency, and openness in HS practice.
Conclusion:
The practice of HS in MedTech remains in its infancy, which offers an opportunity to ensure that it develops in a robust manner. There are real challenges to this practice, but when looking at the gaps, we believe the application of well-established evidence synthesis methods to the HS process will only contribute to better outcomes. We believe the creation of a framework to support appropriate method selection, drawing on both HS and evidence synthesis methods, alongside a reporting framework will enhance the quality and impact of MedTech HS, thus allowing decision-makers to fully exploit the intelligence and evidence these methods offer.