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Health Economics and Outcomes Research in Medical Device

Cost Effectiveness and Resource Allocation invites you to submit to our new 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. Manuscripts should be submitted by 31 December 2022.  

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.


  1. Renal cell carcinoma (RCC) is the most common type of kidney cancer. VEGF inhibitors and mTORs are the most common therapeutic options among the different classes of available treatments. In this study, the ef...

    Authors: Zahra Goudarzi, Mehrdad Mostafavi, Mahmood Salesi, Mojtaba Jafari, Iman Mirian, Amir Hashemi Meshkini, Khosro Keshavarz and Younes Ghasemi
    Citation: Cost Effectiveness and Resource Allocation 2023 21:10
  2. This article aims to summarize the development and challenges of real-world data (RWD) and real-world evidence (RWE) in China and introduce a unique opportunity for medical devices to gain accelerated regulato...

    Authors: Jiahe Li, Lichang Liu, Haijun Cao, Mei Yang and Xin Sun
    Citation: Cost Effectiveness and Resource Allocation 2023 21:7
  3. Image-guided system (IGS) has been gradually applied in the field of rhinology, making functional endoscopic sinus surgery (FESS) a truly minimally invasive and precise surgery. This study was based on real-wo...

    Authors: Zaixing Wang, Chunling Liu, Baoying Tan, Guoqing Sun, Poucheok Pang, Kangchen lv, Hui Xie, Xiong Ou, Xianhai Zeng and Jianwei Xuan
    Citation: Cost Effectiveness and Resource Allocation 2023 21:1
  4. Has the medical arms race (MAR) increased healthcare expenditures? Existing literature has yet to draw a consistent conclusion. Hence, this study aims to reexamine the relationship between the MAR and medical ...

    Authors: Paicheng Liu, Xue Gong, Qianhui Yao and Qiong Liu
    Citation: Cost Effectiveness and Resource Allocation 2022 20:73
  5. Surgical lung resection involves a critical task of stapled ligation and transection of major vascular structures and tissue, which may lead to bleeding and complications. A newer powered stapling system with ...

    Authors: Chongzhi Gan, Fuchun Zeng, Wei Cong, Tiange Tang and Gang Feng
    Citation: Cost Effectiveness and Resource Allocation 2022 20:72
  6. An inefficient health system wastes scarce resources even if it makes considerable gains in accountability and equity. Such a system is expected to perform better. Therefore, it is vital to examine the current...

    Authors: Siamak Aghlmand, Sadegh Feizollahzadeh, Behrouz Fathi, Hasan Yusefzadeh and Mina Alinejhad
    Citation: Cost Effectiveness and Resource Allocation 2022 20:65
  7. Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical de...

    Authors: Jian Ming, Yunzhen He, Yi Yang, Min Hu, Xinran Zhao, Jun Liu, Yang Xie, Yan Wei and Yingyao Chen
    Citation: Cost Effectiveness and Resource Allocation 2022 20:54
  8. The objective of this paper is to assess the economic profile of Enzyme Replacement Therapy (ERT) to symptomatic patients with Pompe, Fabry, Gaucher disease and Lysosomal acid lipase (LAL) deficiency.

    Authors: Eleni Ioanna Katsigianni and Panagiotis Petrou
    Citation: Cost Effectiveness and Resource Allocation 2022 20:51

    The Correction to this article has been published in Cost Effectiveness and Resource Allocation 2022 20:64

  9. In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, ...

    Authors: Moritz Hadwiger, Laura Schumann, Nora Eisemann, Nikolaos Dagres, Gerhard Hindricks, Janina Haug, Michael Wolf, Ursula Marschall, Alexander Katalinic and Fabian-Simon Frielitz
    Citation: Cost Effectiveness and Resource Allocation 2022 20:48
  10. This study aimed to examine the economic and clinical benefits of a new powered circular stapler for left-sided colorectal construction in China.

    Authors: Junwei Bai, Yingnan Zhao, Hong Liang, Junmeng Li and Chao Zhang
    Citation: Cost Effectiveness and Resource Allocation 2022 20:45
  11. Chronic kidney disease (CKD) is a health problem due to its increasing prevalence and imposes a significant economic burden on the health system. This study aimed to analyze the cost–benefit of kidney transpla...

    Authors: Farzaneh Abdi, Cyrus Alinia, Ali Taghizadeh Afshari and Hasan Yusefzadeh
    Citation: Cost Effectiveness and Resource Allocation 2022 20:37
  12. The misconception of the purpose of strabismus treatment has, on the one hand, affected the motivation of strabismus patients to seek care and, on the other hand, has resulted in strabismus not being covered b...

    Authors: Lei Yang, Yiduo Min, Zhiyan Jia, Yupeng Wang, Rihui Zhang and Bitong Sun
    Citation: Cost Effectiveness and Resource Allocation 2022 20:27