# A value hierarchy for inclusive design of heart valve implants in regenerative medicine

## TL;DR

This paper outlines ethical guidelines for designing heart valve implants that are fair, respectful, and accessible to everyone.

## Contribution

It introduces a value hierarchy translating justice into design norms for inclusive regenerative medicine.

## Key findings

- Three norms for inclusive design are proposed: equal health opportunity, respect for users, and accessibility.
- Design requirements include accounting for user differences, affordability, and global suitability.
- Inclusive communication and diverse design teams are emphasized for ethical development.

## Abstract

Aim: This paper investigates the conditions for inclusive design of regenerative medicine interventions from a bioethical perspective, taking regenerative valve implants as a showcase.

Methods: A value hierarchy is construed to translate the value of justice into norms and design requirements for inclusive design of regenerative valve implants.

Results: Three norms are proposed and translated into design requirements: regenerative valve implants should be designed to promote equal opportunity to good health for all potential users; equal respect for all potential users should be shown; and the implants should be designed to be accessible to everyone in need.

Conclusion: The norms and design requirements help to design regenerative valve implants that are appropriate, respectful and available for everyone in need.

Scientists in the field of regenerative medicine are developing a new type of heart valve implant. After implantation, the synthetic implant slowly breaks down and is replaced by a new living heart valve. These so-called regenerative implants promise a complete cure. However, they also raise ethical questions. For example, questions related to justice and inclusion. In this paper, we explore how regenerative implants can be designed to be inclusive, meaning suitable, respectful and available for everyone. We argue that the design of regenerative implants should be adapted to relevant differences between users. The implants should be affordable in the short and long term. The implants should be suitable for use worldwide. The implants should be designed by teams of diverse age, gender and ethnicity. Users should be engaged in the design. And the communication about the implants to researchers and users should be inclusive. Overall, this paper provides ethical guidance to researchers and clinicians developing regenerative implants.

Health research and care should be inclusive to address inequities in health. Inclusion also deserves attention within the rapidly evolving field of regenerative medicine. However, what inclusion means and what inclusive design should entail in the context of regenerative medicine is not clear.

This paper investigates the conditions for inclusive design of regenerative medicine interventions, taking regenerative valve implants (i.e., in situ tissue-engineered heart valves) as a showcase.

The aim of inclusive design relates to the value of justice. Justice is concerned with recognition (claims about equal respect for marginalized groups and undervalued social identities) and redistribution (the equitable distribution of goods and resources).

A values hierarchy is a deliberative tool to translate a value into norms and design requirements in the context of technology design.

The value of justice can be translated into three norms: regenerative valve implants should be designed to promote equal opportunity to good health for all potential users; in the design process, equal respect for all potential users should be shown; and the implants should be designed to be accessible to everyone in need.

Based on these norms, the following design requirements can be formulated: regenerative valve implants should be designed to account for relevant user differences, be affordable and cost-effective and be suitable for global distribution, and the design process should involve diverse design teams, engage users and use inclusive communication.

Together, the norms and design requirements shape the conditions for inclusive design of regenerative valve implants.

This paper aids the design of implants that are appropriate, respectful and available for everyone in need. More generally, by exemplifying an ethically proactive approach to the design of regenerative medicine technology, it contributes to responsible development of regenerative medicine interventions.