Background: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce the evidence gaps and interpret findings; applicability of the EUnetHTA Core Model (CM) in South Africa on a medical device and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound.Methods: To substantiate the evidence obtained from the literature different stakeholders were identified and consulted. The scoping of the assessment was defined by involving the policy makers to select the domains and the analogous questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. The evidence generated from the four steps was used to populate the high-ranked assessment elements of the CM. Results: The HTA took into account the clinical benefit in screening low-risk pregnant women in primary healthcare settings using the technology. It incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on “health problem” and “safety” had a higher rank than the rest of the nine domains. Conclusions: A multi-stakeholder participation in the assessment process provided the necessary transparency and accountability, thus improving the quality of the recommendation resulting from the assessment. The collection of robust evidence and analysis post-introduction will enable the determination of the value of the technology in real-world settings.

Background: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce the evidence gaps and interpret findings; applicability of the EUnetHTA Core Model (CM) in South Africa on a medical device and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound.Methods: To substantiate the evidence obtained from the literature different stakeholders were identified and consulted. The scoping of the assessment was defined by involving the policy makers to select the domains and the analogous questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. The evidence generated from the four steps was used to populate the high-ranked assessment elements of the CM. Results: The HTA took into account the clinical benefit in screening low-risk pregnant women in primary healthcare settings using the technology. It incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on “health problem” and “safety” had a higher rank than the rest of the nine domains. Conclusions: A multi-stakeholder participation in the assessment process provided the necessary transparency and accountability, thus improving the quality of the recommendation resulting from the assessment. The collection of robust evidence and analysis post-introduction will enable the determination of the value of the technology in real-world settings.