Ming et al.

Cost Effectiveness and Resource Allocation (2022) 20:54 Cost Effectiveness and
https://doi.org/10.1186/s12962-022-00389-6 Resource Allocation

REVIEW Open Access

Health technology assessment of medical

devices: current landscape, challenges,
and a way forward
Jian Ming1,2†, Yunzhen He1†, Yi Yang2, Min Hu2, Xinran Zhao1, Jun Liu1, Yang Xie1, Yan Wei2* and Yingyao Chen2*

Abstract
Background: 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
devices differ from that of drug therapies, and what innovations can be adopted to overcome the inherent challenges
in medical device HTA?
Method: HTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA
bodies, and a literature search was conducted to understand the growth trend of relevant HTA publications in four
case studies. Another literature review was conducted for a narrative synthesis of the characteristic differences and
challenges of HTA in medical devices. We further conducted a focused Internet search of guidelines and a narrative
review of methodologies specific to the HTA of medical devices.
Main body: The evidence of HTA reports and journal publications on medical devices around the world has been
growing. The challenges in assessing medical devices include scarcity of well-designed randomized controlled tri-
als, inconsistent real-world evidence data sources and methods, device-user interaction, short product lifecycles,
inexplicit target population, and a lack of direct medical outcomes. Practical solutions in terms of methodological
advancement of HTA for medical devices were also discussed in some HTA guidelines and literature.
Conclusion: To better conduct HTA on medical devices, we recommend considering multi-source evidence
such as real-world evidence; standardizing HTA processes, methodologies, and criteria; and integrating HTA into
decision-making.
Keywords: Health technology assessment, Medical devices, Challenges, Real-world evidence, Review

Introduction stages of their life cycle. HTA aims to provide evidence

Health Technology Assessment (HTA) is a multidis- for health policy decision-making and for establishing
ciplinary process that uses a number of methods to an equitable, efficient, and high-quality health system
determine the value of health technologies at different [1]. Since its first application in the United States in the
1970s, HTA has developed rapidly and has been applied
globally, becoming the basis for health decisions such as
†
Jian Ming and Yunzhen He contributed equally to this work pricing and reimbursement in many different countries
*Correspondence: yanwei@fudan.edu.cn; yychen@shmu.edu.cn and regions. However, more of the existing HTA research
2
concerns medicines rather than medical devices. Medi-
National Health Commission Key Laboratory of Health Technology
Assessment, School of Public Health, Fudan University, Shanghai 200032, cal devices differ considerably from drug therapies in
China terms of their product lifecycle, regulatory environment,
Full list of author information is available at the end of the article diversity, user–device interaction, and so on [2]. Even

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Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 2 of 9

within medical devices, there are significant differences intend for the case studies to be representative of all med-
between therapeutic, instrumental, and diagnostic prod- ical devices as there is a great deal of diversity in medical
ucts. Moreover, various studies have investigated how devices beyond those four cases, such as diagnostic or
these differences have posed great challenges to the HTA instrumental devices. Instead, through our choice of tar-
of medical devices and have thus called for applying a get devices, we aimed to cover a range of heterogeneous
more innovative approach to medical devices compared cases in terms of disease epidemiology, procedure char-
to drugs. However, few studies have offered practical or acteristics, technology maturity, and demographics. We
actionable solutions. There is still a lack of consensus on used the number of HTA-related publications to measure
the HTA of medical devices with regard to dimensions, the activity level of the current HTA research. We con-
process, criteria, and methods. ducted a literature search and tracked the growth trend
This study aimed to (1) describe the current landscape of relevant HTA publications on PubMed, Embase, and
of HTA activities specific to medical devices; (2) analyze Web of Science. We included HTA studies and economic
the characteristics of medical devices and the resulting evaluations and excluded relevant systematic reviews or
challenges in the HTA of medical devices compared to meta-analyses. The detailed search strategy in each data-
pharmaceuticals; (3) perform a focused search of web- base is listed in Additional file 1: Table S1.
sites of official HTA agencies to identify international In addition, a narrative literature review was conducted
HTA guidelines specific to medical devices, intending to for a synthesis of the characteristic differences and chal-
summarize implementable solutions to the HTA of medi- lenges of HTA in Medical Devices. The literature search
cal devices. In addition, we supplemented the analysis of was performed using PubMed, Embase, and Web of Sci-
HTA guidelines with a narrative review of existing stud- ence. We included relevant empirical studies or reviews
ies discussing the challenges of, and potential suggestions discussing the use of HTA for medical devices. The
for, the HTA of medical devices. detailed search strategy in each database is listed in Addi-
tional file 1: Table S2.
Method Two reviewers (J.M. and Y.H.) independently assessed
To understand the landscape for HTA conducted on the titles and abstracts of all identified study and then
medical devices, we performed a retrospective analysis reviewed full text to determine the potential eligibility
using IQVIA’s HTA Accelerator Database (www.​iqvia.​ for the above narrative literature review. Disagreements
com/​landi​ng/​hta-​accel​erator). It contains over 33,000 on whether a specific study should be considered were
HTA publications that cover 100 HTA bodies in 40 coun- resolved by a third investigator (X.Z.).
tries. The primary data source came from the HTA sub- To guide the efficient application of HTAs, we per-
missions that could be tracked by local language. Market formed a gray literature search of official websites of
access experts from IQVIA were responsible for regularly major HTA agencies to identify HTA guidelines with
tracking and translating all newly published HTA reports. respect to medical devices. As guidelines represent a
The database captured over 250 available data elements consensus in the academic community, we believed that
such as the general information in the HTA report, international HTA guidelines have reflected, to some
including publication country, agency, publication date, extent, the current best possible practice. We comple-
disease area, product types, comparators, recommenda- mented the search by reviewing the bibliographies of
tions, etc. In this study, we focused only on HTA reports relevant literature identified through a target literature
specific to medical devices in the HTA Accelerator Data- review of methodological publications on the HTA of
base by selecting the product type as “medical device.” medical devices. Only those (either guidelines or arti-
We limited the assessment type of HTA submissions to cles) that were specific to medical devices and elaborate
health technology assessment or rapid review (includ- economic evaluation, decision-analytic modeling, and/or
ing the assessment of safety, efficacy, cost-effectiveness, HTA were included.
etc.), while other submissions such as clinical guidelines
and public health reviews were excluded. As the earliest Current status of the HTA of medical devices
reports dated back to the year 2000, we extracted HTA Published reports from HTA bodies
reports published from 2000 onwards. In total, around 2300 HTA reports from agencies across
To better demonstrate the current research progress 30 countries or regions were identified. We presents
on the HTA status of medical devices, we examined four the overall trend of HTA report submissions in Fig. 1.
case studies on medical devices, including (1) stents (2) Overall, the body of HTA reports for medical devices
hip and knee arthroplasty, (3) the da Vinci Surgical Sys- increased across the world. Before 2010, the number of
tem, and (4) transcatheter aortic valve implantation HTA reports published for medical devices was limited,
(TAVI) and mitral valve repair (TMVR). We did not ranging from three in 2000 to 20 in 2009. Since 2011, the
Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 3 of 9

Journal publications on HTA of medical devices

400
Figure 2 shows the growth trend of HTA-related publica-
350
tions on the four selected devices, respectively. Overall,
300
we observed a general upward trend in the four products,
250 despite annual fluctuations, indicating that the HTA of
200 medical devices has been growing rapidly. In addition,
150 the level of development of HTA was also related to the
100 characteristics of the medical device, such as technol-
50
ogy maturity and disease epidemiology. We observed
from Fig. 2a that there was a larger body of publications
0
on stents compared to other devices since the stent was
2000
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
a mature device with broader applicable patient popula-
Fig. 1 Number of Health Technology Assessment (HTA) reports for
tions, indications, and long years of availability. In a com-
medical devices by country-year: 2000–2020
parison, TAVI and TMVR, as a relatively new product,
had fewer relevant HTA publications. Additionally, there
was significant growth in HTA publications for all four
number of published HTA reports has increased rapidly devices since their first market launch. The overall trend
to reach 340 reports in 2019. Within the last 20 years, in relevant publications suggested a progressive increase
there has been a 100-fold increase in the number of HTA in the HTA publications and academic interest in medi-
reports for medical devices. cal devices.

120 120

100 100

80 80

60 60

40 40

20 20

0 0
2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020

(a) (b)

120 120

100 100

80 80

60 60

40
40
20
20
0
0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020

2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020

(c) (d)
Fig. 2 Summary of HTA-related literature. a Annual number of HTA-related publications on stents; b annual number of HTA-related publications
on hip and knee arthroplasty; c annual number of HTA-related publications on Da Vinci; d annual number of HTA-related publications on TAVI and
TMVR
Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 4 of 9

Narrative synthesis of characteristic differences our review after title and abstract screening or full text
and challenges of HTA of medical devices review. The PRISMA flowchart of literature review is
After a literature search on journal publications dis- provided in Additional file 1: Fig. S1.
cussing HTA of medical devices, a total of 1646 records The characteristic differences and challenges of
were identified, and 26 publications were included in HTA in medical devices are summarized in Table 1.

Table 1 Summary of characteristic differences and challenges of HTA of medical devices

Characteristic differences and challenges Description References

Available clinical evidence The characteristic differences between pharmaceuticals and medical devices [3–23]
may lead to a large gap in terms of the availability of evidence, especially clinical
evidence
• Considerable challenges exist in performing an RCT for medical devices. For
example, a double-blind procedure was usually hard to implement due to differ-
ences in the appearance of medical devices
• Another reason was that implantable medical devices require informed con-
sent from a patient before implantation as they involve an invasive procedure
• There was a lack of infrastructure, e.g., qualified clinical centers and trained
professionals to conduct RCTs for medical devices
Device-user interaction Unlike drugs, the performance of medical devices sometimes depends on their [3–9, 11–27]
users’ experience as well
• The so-called “learning curve”: the launch of a medical device is followed by a
training or initiation period during which healthcare professionals learn how to
handle the technology. As healthcare professionals gain more experience over
time, they were able to grasp the subtle differences that affected the overall
clinical benefits, thus making the best use of the technology
• The learning curve had inevitably interfered with the HTA of medical devices
because the comparative effectiveness between newly-launched and traditional
products was a function of the product itself and operators’ proficiency, which
was hard to quantify
• The clinical adoption of medical devices may also associate with wider impact
of organizational change, for instance, there may be a need for additional train-
ing of physicians or other health professionals, or the introduction of a given
device may require a hospital to reorganize services to accommodate the new
technology or procedure
Short product life cycle and quick upgrade Unlike drugs, the product life cycle of medical devices is usually as short as one [4–9, 11–20, 22, 25–28]
to 3 years
• The key contributing factor was that medical devices undergo continuous
improvement and incremental innovation, which might result in the existence
of various models and specifications within a single product class
• Recognizing the iterative nature of medical devices, regulatory agencies
exempted such variants from rigorous clinical trials as long as the safety of the
new variant was the same as the original. As a result, manufacturers had neither
enough time to collect data for economic evaluations nor an incentive to invest
in clinical research and HTA
• From researchers’ perspective, the short life cycle required the HTA of medical
devices to be done in a timely manner, otherwise the results could become
outdated
• Pricing was typically more dynamic than that of pharmaceuticals, which
increased the complexity of calculating costs
• Rapid product iteration also made it difficult to conduct HTA since the defini-
tion of standard of care was unclear or constantly changing among medical
devices with multiple specifications and models
Inexplicit target population and lack of The economic evaluation of medical devices used in screening or diagnostics [3, 20, 23, 24, 27]
direct clinical outcomes was ever more challenging as most did not have an explicit target population,
nor do they produce clinical outcomes directly
• These devices were used in multiple disease areas or as part of the care
pathway with a group of other devices. For example, the positron emission
tomography-computed tomography (PET/CT) was used in the diagnosis and
follow-up of a number of malignant tumors (e.g., cervical cancer, colorectal
cancer, non-small cell lung cancer, melanoma, and ovarian cancer)
• Since these devices or diagnostics are integrated as a specific part of the clini-
cal pathway. As a result, it is hard to quantitatively observe the direct impact of
these medical devices on patients’ ultimate medical outcomes
Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 5 of 9

Overall, there were several key characteristic differ- Available clinical evidence
ences between drugs and medical devices, including Given that RCT evidence for medical devices was gen-
the availability of treatment outcomes and other factors erally limited, an open-minded and flexible attitude
that may impact efficacy. First, the treatment outcome to other forms of evidence e.g., case reports (series),
for medical devices was not as clear and straightfor- cohort studies, case control studies, and real-world
ward as it would be with drugs, because an intervention studies was highly recommended [29, 34, 35]. Both
with device involves the medical devices themselves the UK and EUnetHTA guidelines have pointed out
as well as other subsequent treatments. Furthermore, the high risk of bias in non-randomized controlled tri-
devices usually had multiple applications, making it als [30, 35]. At the same time, several tools have been
hard to assess each application in the same way that developed, although they may not be specific for medi-
traditional drugs were assessed for an individual indi- cal devices. The Cochrane Risk of Bias Assessment Tool
cation. Second, Randomized Controlled Trials (RCTs) for Non-Randomized Studies of Interventions (ACRO-
for medical devices are rare compared to drugs, result- BAT-NRSI) could be used to assess the risk of bias in
ing in a lack of sufficient efficacy/effectiveness data non-randomized controlled studies [36]. In addition,
and making it difficult for economic evaluation. Third, the quality assessment for case reports (series) could
the product life cycle of medical devices was generally refer to the checklist developed by the Canadian Insti-
much shorter than that of drugs, which may result in tute of Health Economics [37].
multiple specifications within a single product class The draft guidance released by the United States
and unclear definition of standard of care. Additionally, Food and Drug Administration (FDA) in 2016 has
the efficacy of medical device treatments depends on spurred a surge in the literature describing how real-
the medical devices themselves and their use. world evidence (RWE) can be used to support regula-
tory approval for medical devices [38]. RWE refers to
any evidence on healthcare generated from multiple
Discussions on practical solutions sources outside clinical trial settings, which is usually
for the challenges of HTA of medical devices in the form of electronic medical records (EMR), elec-
We obtained a total of eight HTA guidelines specific tronic health records (EHR), hospital databases, patient
to medical devices issued by HTA agencies or research registries, claims data, etc. [39]. In addition to market
initiatives across six regions. The National Institute authorization, RWE was also relevant in post-market-
for Health and Care Excellence (NICE) in the United ing surveillance, coverage decisions, outcome-based
Kingdom issued an HTA methods guide for their Medi- contracting, resource use, and treatment compliance
cal Technologies Evaluation Programme in 2011 [29]. [40, 41]. Especially for medical device products for
Following the methods guide, NICE also issued the which the regulatory environment does not require
Diagnostics Assessment Programme manual specifi- RCTs, or in situations where RCTs traditionally have
cally for diagnostic technologies demonstrating higher been lacking such as measuring disease burden and
test accuracy, but at a greater cost compared to those detecting new safety signals, RWE could offer unique
in current use [30]. In Canada, Health Quality Ontario perspectives.
(HQO) released a method and process guide for HTA Unlike randomized clinical trials, most RWE comes
in 2018, with a scope spanning from medical devices, from observational studies and might have many draw-
diagnostics, and surgical procedures to complex health backs. While current medical device-specific HTA guide-
system interventions [31]. In Australia, two HTA guide- lines have underscored the potential bias associated with
lines have been developed separately for therapeutic RWE and several tools may be available for assessment
and diagnostic devices by the Medical Services Advi- of bias for non-randomized studies, few guidelines have
sory Committee (MSAC) [32, 33]. In the Asia–Pacific addressed other common issues including data quality,
region, the Singapore Agency for Care Effectiveness availability, standards, and privacy [29, 30, 32, 33, 35, 42].
(ACE) was the only national HTA organization that has For example, a European study that mapped RWE stud-
released HTA guidelines on medical devices [34]. Apart ies of three medical device products has revealed that
from these official HTA agencies, an international col- the accessibility of data sources for RWE varied greatly
laborative network also contributed to the methodo- across European countries. The study also suggested the
logical advancement of HTA for medical devices. For types and definitions of variables included in each data
example, the European Network for Health Technol- source were not consistent, making a comparison across
ogy Assessment (EUnetHTA), has launched a series of databases impossible [43]. Therefore, there is a need for
research initiatives to develop a methodological frame- RWE guidance on medical devices which would not only
work for HTA of therapeutic medical devices [35]. provide overarching frameworks but also standardize
Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 6 of 9

methods and processes ranging from data storage, collec- data of comparator products could be a source for prior
tion, and sharing to analytic approaches. information used in the Bayesian approach.

Inexplicit target population and lack of direct clinical

Device–user interaction
outcomes
International medical device-specific HTA guidelines
Given the lack of direct clinical outcomes for screen-
have emphasized the need to account for the learning
ing and diagnostic devices, the HQO allows the use of
curve effect in HTA. The EUnetHTA has suggested that it
established surrogate endpoints or intermediate clinical
is necessary to establish a break-in period before the for-
indicators to predict patients’ final medical outcomes.
mal evaluation to ensure that users have sufficient time
For instance, the association between intermediate indi-
to adapt to the new technology. Also, various degrees
cators (e.g., blood pressure) and cardiovascular-related
of operator proficiency across different types of medical
deaths has already been established through statistical
research centers (e.g., teaching hospitals and non-teach-
models [31]. In terms of evaluating screening or diag-
ing hospitals) would lead to heterogeneity in HTA. There-
nostic technologies, NICE, MSAC, and EUnetHTA stress
fore, the EUnetHTA proposed a three-tiered approach to
that product performance should be reflected in the
accounting for the learning curve in its HTA guidelines
entire care pathway. In this way, the HTA should not only
for therapeutic devices. Firstly, assessors should screen
evaluate the test accuracy, but also consider the impact
for studies that estimate an association between user
of the diagnostic results (no matter how accurate they
proficiency or healthcare settings (e.g., teaching or non-
were) on subsequent treatment pathways and the final
teaching hospitals) and clinical outcomes. Secondly, if
medical outcomes [30, 32, 35]. One particular technique
the effect of the learning curve was not reported in the
described by international HTA guidelines is the linked
RCT and relevant information could not be obtained by
analysis [30, 32]. In its first step, a linked analysis collects
contacting the investigators, then other types of evidence
comprehensive data on the test accuracy of diagnostic
such as non-randomized controlled and non-compar-
technologies and the effectiveness of subsequent clini-
ative effectiveness studies could also be considered in
cal interventions following the diagnostic results. Then,
order to explore the association between operator pro-
these data are modeled to simulate the whole care path-
ficiency, types of study centers, and clinical outcomes.
way and to estimate the impact of the diagnostic device
Lastly, subgroup analyses could be applied where existing
on the final medical outcome [30]. However, it is worth
studies were divided into different subgroups based on
mentioning that there were two premises for conducting
the level of operator proficiency. Statistical methods such
linked analysis: (1) the effectiveness of clinical interven-
as meta-analysis could be used to estimate the differ-
tions subsequent to the diagnostic results must be estab-
ence in medical outcomes between these subgroups and
lished by confirmatory trials and should be available; (2)
hence quantify the effect of the learning curve [35]. The
Patients’ baseline characteristics in these confirmatory
radiofrequency ablation (RFA) for liver tumors treatment
trials of the subsequent clinical interventions should
serves as an example. In a systematic review, researchers
resemble the population to which the diagnostic devices
divided 100 case reports into four subgroups according
were applied.
to the surgeons’ previous RFA experience (i.e., having
done < 20, 21–50, 51–99, > 100 cases respectively). The
results of the meta-analysis showed the tumor recurrence Prospects
rate decreased (18%, 16%, 14%, and 10% respectively in Considering multi‑source evidence such as real‑world
the four subgroups) as surgeons accumulated experience evidence
[44]. Most HTAs of pharmaceuticals have been performed
using economic evaluations with parameters derived
from RCTs. However, the market authorization for most
Short product life cycle and quick upgrade medical devices does not require rigorous RCTs, lead-
In practice, a Bayesian approach was recommended to ing to limited clinical evidence. The scarcity of clinical
account for the iterative nature of medical devices in research has made RWE particularly important in gen-
HTA [35]. The Bayesian approach is a statistical method erating clinical effectiveness and safety data for the HTA
that infers the posterior distribution of unknown param- of medical devices. Unlike the ideal experimental envi-
eters according to Bayes’ theorem based on prior knowl- ronment of RCTs, the “real world” refers to actual clini-
edge and sample data. Considering that medical devices cal settings where patients have not been selected based
are incrementally upgraded with minor modifications, on pre-specified criteria. Patients enrolled in RWE stud-
clinical trials and/or early research data of the former ies tend to cover different subgroups so that they are
version of the medical device product, sometimes even representative of the whole population. For this reason,
Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 7 of 9

RWE reflects the true effects of clinical interventions. Conclusion

Correspondingly, HTA based on RWE could provide The body of HTA reports and journal publications
healthcare decision-makers with insights that came from on medical devices around the world has been grow-
real-world settings. As the uptake of newly introduced ing. Our analysis revealed that medical devices differ
medical devices often requires a break-in period, this cre- considerably from pharmaceuticals in many respects,
ates the perfect timing to collect real-world data on prod- which has made the HTA of medical devices quite
ucts’ safety and effectiveness. In addition to RWE, HTA challenging. These challenges include scarcity of well-
could also collect public opinions from multiple third designed RCTs, inconsistent RWE data sources and
parties (patients, manufacturers, health care provid- methods, device-user interaction, short product lifecy-
ers) regarding current evidence, treatment pattern, and cle, inexplicit target population, and lack of direct med-
patient categories. ical outcomes.
Practical solutions found in the HTA guidelines to
account for these challenges include (1) adopting an
Standardization of tools and evaluation criteria for HTA open mind toward evidence other than that generated
of medical devices through an RCT, such as RWE, especially as newly
Existing HTA guidelines mainly focus on drugs and can- introduced medical devices often require a break-
not be applied directly to the HTA of medical devices in period; (2) accounting for the learning curve that
even with adaptation. Therefore, we suggest that separate impacts the device-user interaction through several
HTA guidelines for medical devices are needed to stand- means including subgroup analyses; (3) applying a
ardize the topic identification, selection of comparator, Bayesian approach to account for the iterative nature
evaluation methods, cost measurement, effect/utility of medical devices; and (4) ensuring that product per-
measurement, evidence synthesis, systemic review, and formance is measured across the entire care pathway
ethnic requirements. Moreover, the HTA report should through techniques such as linked analyses.
follow a consistent reporting paradigm. We also recom- Based on the results of the above analysis, we call on
mend that decision-makers follow the same HTA guide- both academic communities and relevant agencies to
lines to conduct HTA appraisals. The formulation of standardize the process, methodologies, and criteria of
HTA guidelines should be transparent and publicly avail- HTAs on medical devices, particularly when an HTA
able. At the same time, regular updates are necessary to has involved RWE studies. We also recommend that
reflect the evolution of HTA methods, and international national authorities better integrate the HTA of medi-
collaboration is needed in overcoming the inherent chal- cal devices into decision-making and promote a more
lenges in medical device HTA. evidence-based culture.

Intergration of HTA of medical devices Supplementary Information

The online version contains supplementary material available at https://​doi.​
into decision‑making
org/​10.​1186/​s12962-​022-​00389-6.
As a bridge connecting scientific research and health
decision-making, the development of HTA is closely Additional file 1: Table S1. Search strategy of journal publications on
interwoven with established mechanisms such that the HTA of selected medical devices. Table S2. Search strategy of journal
publications on discussing HTA of medical devices. Figure S1. PRISMA
results of HTA could be translated into real practice. flowchart of literature review of journal publications on discussing HTA of
HTA as well as value assessment methods have been medical devices.
adopted around the world in national coverage decisions
for pharmaceuticals. Nevertheless, the application of Acknowledgements
HTA in medical devices decision-making is in an earlier The authors would like to thank the following persons, who graciously
stage with higher uncertainty. Therefore, it is essential contributed their valuable time, knowledge, and input over the course of this
research: Yanfeng Ren (Fudan University), Xinyu Liang (University of Michigan),
to explore an effective mechanism that would enable the Guanqi Hong (employee of IQVIA), Xinyi Wang (employee of IQVIA), Yaping Ai
translation of the results of HTA of medical devices into (employee of IQVIA), Min Jin (employee of IQVIA).
decision-making. Specifically, the decision translation
Institutional review board statement
mechanism could take the form of regulatory authoriza- Not applicable.
tion, market access and reimbursement, and price nego-
tiations where HTA could be introduced. We believe that Author contributions
Conceptualization, JM, YH, YW, YC and MH; methodology, JM, JL and YX;
better integration of HTA into decision-making would investigation, YH and YY; formal analysis, YH and JM; data curation, JM, YH, XZ
further encourage evidence generation and the adoption and YY; writing—original draft preparation, YH and JM; writing—review and
of HTA standards and ultimately promote an evidence- editing, YY, MH, XZ, YW and YC; supervision, JL, YX, MH and YC. All authors read
and approved the final manuscript.
based, decision-making culture.
Ming et al. Cost Effectiveness and Resource Allocation (2022) 20:54 Page 8 of 9

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1
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Health, Fudan University, Shanghai 200032, China. Health. 2020;8: 612410.
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