Translating innovative medical devices from prototype to practice: A Delphi study of urgent financial barriers and promising solutions

Abstract

Objectives

Financial barriers are widely perceived as a major obstacle for translating innovative medical devices from prototype to practice. However, a clear overview of relevant financial barriers, their perceived urgency, and promising solutions is lacking. Therefore, this study aims to identify and prioritize the multitude of barriers and solutions from the perspective of various stakeholders involved in the development and financing of innovative medical devices.

Methods

We performed a Delphi study with three consecutive questionnaires sent to 72 experts from five stakeholder groups in the Netherlands: innovators, (social) venture capital investors, health insurers, healthcare providers, and (semi)governmental agencies.

Results

The response rate was 71 % in the first round and decreased to 46 % in the third round, with each stakeholder group being well-represented. We identified 33 distinctive barriers and 183 associated solutions. Although respondents assigned a consistently high priority to each of these barriers, eight barriers stand out in terms of high priority and degree of consensus. In addition, 22 solutions were considered most promising to solve these barriers. For both the barriers and the solutions, differences in the degree of consensus were larger within than between stakeholder groups.

Conclusions

Our study has identified and prioritized a diverse set of financial and related challenges and potential solutions to translate innovative medical devices, as jointly faced by the stakeholders. Improvement efforts should first focus on addressing the consistently high-priority barriers, using the solutions perceived as being most suitable.

Public interest summary

To progress from an innovative prototype to a medical device in practice, products must be able to pass through a critical phase in the innovation process. This phase is called the valley of death, because a lack of financial opportunities kills many innovative technologies at this stage. The present study provides insight into the multitude of financial barriers that play a role in this innovation phase, and the priorities assigned to these barriers by various groups of relevant stakeholders. In addition, stakeholders were asked to suggest promising solutions to address these barriers. Consequently, this study has shown the prioritized need for financial support of a co-creation process of innovations between innovators and users. In addition, the stakeholders provided suitable solutions focusing on timely communication, alternative payment models, and disincentivizing low-value care. Finally, opinions strongly diverged about solutions that require radical changes towards a more centrally governed innovation system.