Abstract
I am delighted that NICE is publishing these articles. ‘Medical technologies’ are a diverse range of devices and diagnostic or therapeutic tests which have the potential to offer real value for patients and for the health system. They do, however, have important differences from other medical interventions, for example:
Technologies may be modified over time in ways that change their effectiveness;
The clinical outcomes resulting from the use of technologies often depend on the training, competence and experience of the user (sometimes referred to as the ‘learning curve’);
Clinical evidence on technologies, in particular newer products, is often limited, especially comparative studies against appropriate alternative treatments or methods of diagnosis;
The healthcare system benefits of adopting medical technologies often depend on organizational factors, such as the setting in which the technology is used or the staff who use it, in addition to the benefits directly related to the technology;
When the technology is a diagnostic test, improved clinical outcomes depend on the subsequent delivery of appropriate healthcare interventions.
The need to take account of these characteristics of medical technologies was uppermost in our minds in developing and introducing two new NICE guidance programmes in 2010. We are mindful that medical technologies must satisfy basic tests of safety and efficacy, through regulation, before their value to the NHS can be evaluated. Two of the articles following this supplement focus on the existing regulatory requirements for manufacturers who wish to bring their medical technologies to market. These articles will be of interest to health professionals who use medical technologies, as it is these regulatory processes which provide the initial assurance that tests and devices are safe and fit for their intended purpose.
A further important feature about medical technologies is the profile of the industry developing the products, which is composed of mainly small-to-medium sized companies. The final article was commissioned to explore the challenges which industry faces and our new evaluation programmes would need to take into account to ensure they work effectively with companies.
I hope this supplement will serve as a useful educational resource for those working in this rapidly-evolving field.