Although Do-It-Yourself and open access health innovations can offer interesting solutions for patients with needs that are currently not met by the medical industry, they pose new dilemmas in terms of quality and safety. In this study, the authors seek to better understand the dilemmas raised by two examples of popular innovations. To do so, they gathered the views of health care innovators who are familiar with medical device standards and regulations in order to identify practical issues and develop recommendations for public policy.