INTRODUCTION

MedTech20© is a generic measure of patient perceived benefits of medical devices. For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being. This includes product properties that impact an individual's everyday life and quality of life in a wider sense, such as relating to social aspects, integrity, and convenience. Medtech20© captures the benefits relevant to users of medical devices and provides information on how products may impact the quality of life.

MedTech20© can help to identify which benefits patients may have from a medical device and may be applied during early product development to assess the potential value of a medical device from a regulatory, healthcare, and societal perspective.

BACKGROUND

MedTech20^© is designed to facilitate comparisons of the patient-perceived benefit between products as well as across product categories. The aim is to assist in future health care decision-making regarding medical devices, as well as in the development of new medical devices.

The development of MedTech20^© was published in Lesén et al, Int J Technol Assess Health Care. 2017 Jan;33(4):463-71.

APPLICABILITY

The instrument is applicable for evaluations of all types of medical devices used by patients with any type of disease or disability, and can be applied at various phases of the device’s life cycle.

 

The instrument may be applied during early product development to assess the potential value of the medical device from a regulatory and a health care perspective.

SERVICES

To find out in more detail how MedTech20^© can be used, how we can help you conduct a study with your medical device, or to discuss MedTech20^© licensing please contact us.

OUR STUDY SERVICES

• Study protocols
• Patient recruitment
• Development Patient information and informed consent forms
• Ethics Committee Applications / Competent Authority Application
• Statistics and data management
• Publication planning
• Original scientific publications