Cost Effectiveness and Resource Allocation is delighted to publish a thematic series on ‘Health economics and outcomes research in medical devices’.
Outcomes research for medical devices has always lagged behind drugs, with good reason. Regulatory and reimbursement initiatives for medical devices will spur higher demand for high quality data, which will translate to better quality outcomes research in medical devices. For example, the FDA has recently published several guidance documents/frameworks pertaining to the use of Real-World Evidence (RWE) to support regulatory decision-making for drugs, biologics, and medical devices. While RWE is increasingly used for drugs and biologics, there may be some unique challenges to generate RWE, specifically for medical devices. This in turn, creates potential barriers towards the broader utilization of RWE for medical devices. Additionally, the diversity of methodological issues associated with the conduct of outcomes research under the umbrella of medical devices, with products ranging from diagnostics to implantable devices, makes it difficult to develop a unifying set of standards for the industry., As a result, there is an urgent need to explore the opportunities and challenges of a wide range of health outcomes research in medical devices from the perspectives of all relevant stakeholders. If we are to realize the full promise of outcomes research in medical devices, we must address the unmet needs in health care where the utilization of medical devices can positively impact on quality, access, and cost.
With this thematic series, we invite you to submit high-quality original research articles or reviews that provide solid new findings extending the current state of knowledge. Preference will be given to contributions using longitudinal data such as electronic health records, claims, and patient-reported outcomes. All manuscripts will undergo the journal’s normal peer review process and be subject to an article-processing charge. Manuscripts should be formatted according to our submission guidelines and submitted via the online submission system. In the submission system please make sure that the correct collection title is chosen from the drop down list on the 'details' tab. Please also indicate clearly in the covering letter that the manuscript is to be considered for this collection. This series is currently open to new submissions. This series is now closed to new submissions.
Edited by Lizheng Shi and Mihajlo Jakovljevic
In the last five years, Lizheng Shi received research funding from the Patient-Centered Outcomes Research, Centers for Disease Control and Prevention, National Institute of Health, China Medical Board, Louisiana Department of Health, and Industry (Argenx, Astra Zeneca, BioMarin, Chiasma, Eli Lilly, Genentech, Intuitive Surgical, Johnson and Johnson, Sanofi, and Takeda). Lizheng Shi is one of the co-owners of the BRAVO4HEALTH, LLC, which owns a pending patient of BRAVO diabetes risk equations and simulation model.
Mihajlo (Michael) Jakovljevic received research funding from the Japanese Society for Promotion of Science (JSPS), or Gakushin ; Swedish FORTE government funding agency under the Swedish Ministry of Health and Social Affairs ; European Commission and diverse national science funding agencies across Europe without Conflict of Interests issues related to this thematic series.