Developing a medical-device formulary for council of health insurance beneficiaries in Saudi Arabia: stakeholder challenges and policy recommendations

Abstract

Ensuring equitable access to dispensed-to-patient (DTP) medical devices is an important policy priority for health insurance systems. This mixed-method study examined stakeholder perspectives on barriers and policy priorities for developing a DTP medical-device formulary for health insurance beneficiaries in Saudi Arabia. An exploratory online survey was distributed to 58 purposively selected stakeholders, and 17 responded (29.3%). Survey findings were summarized descriptively as n/N (%) with 95% confidence intervals. A subsequent stakeholder consultation workshop with 42 stakeholders was used to explore survey themes and identify policy-relevant recommendations. Survey respondents identified several recurring barriers, including lack of standardized evaluation criteria for including new devices (15/17, 88.2%; 95% CI 65.7–96.7), lack of clarity on reimbursement policies (13/17, 76.5%; 95% CI 52.7–90.4), limited reimbursement coverage for certain devices (10/17, 58.8%; 95% CI 36.0–78.4), and fragmented coding and categorization systems. Qualitative findings highlighted the need for explicit eligibility criteria, transparent pricing, risk-based assessment pathways, and coding systems that support claims processing and post-market evidence generation. The findings support an evidence-informed, stakeholder-informed formulary process with clear governance, standardized assessment criteria, transparent reimbursement rules, and improved coding infrastructure. Given the small exploratory survey sample, the quantitative findings should be interpreted as preliminary and validated in larger stakeholder studies.

Introduction

Medical devices pose distinctive regulatory and reimbursement challenges because they vary widely in complexity, risk, lifecycle, operator dependence, and evidence requirements. Unlike pharmaceuticals, medical devices often undergo rapid development, and their real-world value may depend on training, clinical setting, and integration with local care pathways (Drummond et al. 2009; Kramer et al. 2012; Sorenson and Drummond 2014). These characteristics make device assessment, pricing, and reimbursement particularly challenging for payers and regulators.

Medical-device formularies can support more transparent and consistent coverage decisions by specifying device categories, eligibility criteria, evidence requirements, reimbursement rules, and update mechanisms. International experience suggests that health technology assessment (HTA), coding standardization, and structured stakeholder engagement are important components of technology coverage decisions (Ciani et al. 2015; Panteli et al. 2016; Tarricone et al. 2017). However, device-specific assessment remains methodologically challenging because traditional HTA methods were largely developed for pharmaceuticals and may not fully capture device-specific uncertainty, learning curves, and incremental innovation (Drummond et al. 2013; Henschke et al. 2015; Rothery et al. 2017).

In Saudi Arabia, rapid healthcare transformation and insurance-sector development have increased the need for clearer processes governing access to dispensed-to-patient (DTP) medical devices. Although devices may be covered under insurance benefit structures, uncertainty can remain regarding medical necessity, eligibility criteria, reimbursement limits, device categorization, and payer-specific approval processes. These gaps can create variation in access and administrative burden for patients, providers, payers, and manufacturers (Alharbi 2018; Alkhamis 2018; Almalki et al. 2011; Al-Omar et al. 2021).

This study aimed to examine stakeholder perspectives on the challenges and policy priorities associated with developing a DTP medical-device formulary for health insurance beneficiaries in Saudi Arabia. Specifically, it explored perceived barriers in insurance coverage and reimbursement, stakeholder expectations for formulary development, access to innovative devices, and coding and categorization systems. The findings are intended to provide an evidence-informed roadmap to support development of a transparent, stakeholder-informed formulary process.

Methodology

Study design

This research used a sequential explanatory mixed-methods design, combining an exploratory online survey with a stakeholder consultation workshop (SCW). The survey was used to identify preliminary stakeholder-perceived barriers and priorities. The SCW was then used to explore these themes in greater depth and develop practical policy recommendations. (Creswell and Plano Clark 2018; Fetters et al. 2013). The design was chosen because mixed-method approaches can support integration of descriptive quantitative patterns with contextual qualitative explanations in complex health-policy questions (Creswell and Plano Clark 2018; Fetters et al. 2013; Morgan 2014).

Participant selection and recruitment

Participants were purposively selected based on their professional relevance to medical device regulation, reimbursement, prescribing, supply, or patient access. Eligible participants were stakeholders with at least one year of relevant professional experience in healthcare regulation, insurance or payer policy, healthcare provision, medical-device manufacturing or supply, or patient advocacy. Individuals without relevant experience in these areas were not eligible. Incomplete survey responses were excluded from the final analytic sample.

Survey invitations were distributed by email through CHI-related professional networks and stakeholder contacts identified by the study team. Additional eligible stakeholders were identified through professional referral. A total of 58 participants were invited to participate in the online survey, with 17 completing responses (29.3% response rate). Because this was a purposive expert survey addressing a specialized policy topic, no formal power calculation was performed. The survey was intended to generate exploratory descriptive evidence and to inform subsequent qualitative discussion rather than to estimate population parameters with high precision (Palinkas et al. 2015; Patton 2015). For the subsequent stakeholder consultation workshop, 42 stakeholders representing governmental, private-sector, academic, payer, provider, manufacturer, and regulatory organizations participated in a structured 2.5-h facilitated discussion designed to validate and expand upon survey findings.

Data collection instruments

The 25-item survey questionnaire was developed for this study. It was informed by literature on medical-device reimbursement, formulary development, access barriers, coding, and HTA, and then adapted to the Saudi health insurance context through consultation with local experts.

The survey utilized a combination of 5-point Likert-scale ratings (1 = strongly disagree to 5 = strongly agree), multiple-choice items, and open-ended prompts to obtain both quantitative trends and qualitative insights (Dillman et al. 2014; Fowler 2013). The instrument was pilot-tested with five healthcare policy experts to assess clarity, relevance, and face validity before distribution. The SCW guide was semi-structured and developed after preliminary review of survey responses. It explored insurance coverage, reimbursement challenges, stakeholder roles, formulary design, access to innovative devices, and coding or categorization needs. The semi-structured format allowed participants to discuss emergent issues while maintaining focus on the study objectives (Krueger and Casey 2014; Morgan 2019).

Data collection procedures

The survey was administered online via Qualtrics between January and February 2025, with two reminder emails sent one and two weeks after initial distribution to maximize response rates. Participants provided informed consent and were assured of data confidentiality and anonymity in reporting. The SCW was conducted on 27 February 2025 at the Council of Health Insurance (CHI) office in Riyadh, lasting 2.5 h. Because the objective was policy consultation across multiple stakeholder groups rather than in-depth exploration of a homogeneous population, a larger consultation format was intentionally selected. This approach enabled representation from a broad range of stakeholders involved in medical device regulation, reimbursement, provision, and utilization. Nevertheless, the large group size may have limited the depth of discussion achievable from each participant and should be considered when interpreting the findings. The session moderator was independent from the study analysis team. To minimize moderator influence, the moderator used a semi-structured guide, neutral prompts, directed questions, and round-robin techniques. The moderator was an experienced healthcare policy researcher with expertise in qualitative methods, assisted by two note-takers who documented non-verbal cues and group dynamics. The SCW was audio-recorded with participant consent and transcribed verbatim within 72 h of completion. Field notes documenting group interactions, non-verbal communication, and emerging themes supplemented the transcript. Recurring themes were observed during the latter part of the discussion; however, no formal saturation matrix was used.

Data analysis

The survey data were analyzed descriptively using frequencies and percentages. For single-choice items, percentages represented the proportion of all survey respondents selecting each response category. For multiple-choice items, percentages represent the proportion of all survey respondents selecting each option; therefore, percentages for a given item may sum to more than 100%. Responses to 5-point Likert and other rating items were treated as ordinal/categorical and summarized as frequencies and proportions (n/N, %) with 95% confidence intervals; where useful, adjacent categories were combined in the narrative (e.g., strongly agree/somewhat agree) to summarize overall agreement.To reflect the small sample size, key proportions were reported with 95% confidence intervals (CI) calculated using the Wilson score method in R 4.6.0 (binom package). No inferential comparisons were conducted because the survey was exploratory and not powered for hypothesis testing. Of the 25 questionnaire items, this manuscript reports all closed-ended items that generated tabulable response distributions (Tables 1, 2, 3, 4); the remaining items comprised respondent screening/demographic questions, summarized narratively in the Participant Characteristics subsection, and open-ended qualitative prompts, whose content was analyzed thematically together with the SCW transcript rather than reported as response percentages. No closed-ended item was omitted from Tables 1, 2, 3, 4.

Table 1.

Current insurance coverage and reimbursement challenges (N = 17)

Item	n	%	95% CI
Current state of insurance coverage (Q1.1, single-select)
Average	9	52.9	[31.0, 73.8]
Good	6	35.3	[17.3, 58.7]
Poor	2	11.8	[3.3, 34.3]
Effectiveness of current policies (Q2.1, single-select)
Neutral	6	35.3	[17.3, 58.7]
Somewhat effectively	5	29.4	[13.3, 53.1]
Somewhat ineffectively	4	23.5	[9.6, 47.3]
Very effectively	2	11.8	[3.3, 34.3]
Gaps in insurance coverage (Q3.1, single-select)
Limited coverage for specific device categories	6	35.3	[17.3, 58.7]
Other	5	29.4	[13.3, 53.1]
Strict pre-approval requirements	3	17.6	[6.2, 41.0]
Lack of patient awareness about coverage options	3	17.6	[6.2, 41.0]
Prescriptions limited by insurance coverage (Q6.1, single-select)
Yes, to some extent	9	52.9	[31.0, 73.8]
Yes, significantly	5	29.4	[13.3, 53.1]
Unsure	2	11.8	[3.3, 34.3]
No, not at all	1	5.9	[1.0, 27.0]
Policy flexibility for individual patient needs (Q6.2, single-select)
Somewhat inflexible	10	58.8	[36.0, 78.4]
Neutral	5	29.4	[13.3, 53.1]
Somewhat flexible	2	11.8	[3.3, 34.3]
Out-of-pocket costs pose financial challenges (Q7.1, single-select)
Somewhat agree	8	47.1	[26.2, 69.0]
Strongly agree	5	29.4	[13.3, 53.1]
Neither agree nor disagree	4	23.5	[9.6, 47.3]

N = 17. CI = 95% confidence interval. For single-select items, response options that received no responses are not shown; displayed categories therefore sum to 100%

Table 2.

Stakeholders' role in formulary development: expected features and barriers (N = 17)

Item	n	%	95% CI
Expected formulary features (Q8.1)
Regular updates with inclusion of new devices	17	100.0	[81.6, 100]
Clear categorization of devices	15	88.2	[65.7, 96.7]
Transparent reimbursement criteria	13	76.5	[52.7, 90.4]
Affordability consideration	10	58.8	[36.0, 78.4]
Other	4	23.5	[9.6, 47.3]
Barriers to formulary implementation (Q8.2)
Lack of regulatory guidelines	11	64.7	[41.3, 82.7]
Resistance from stakeholders	11	64.7	[41.3, 82.7]
Budget constraints	10	58.8	[36.0, 78.4]
Inadequate clinical evidence for certain devices	7	41.2	[21.6, 64.0]
Other	1	5.9	[1.0, 27.0]

Multi-select questions; respondents could select all applicable options. CI = 95% confidence interval

Table 3.

Enhancing access to innovative medical devices (N = 17)

Item	n	%	95% CI
Priority factors for framework development (Q9.1)
Clinical effectiveness and safety	14	82.4	[59.0, 93.8]
Patient demand and necessity	11	64.7	[41.3, 82.7]
Cost-effectiveness	9	52.9	[31.0, 73.8]
Regulatory approvals	9	52.9	[31.0, 73.8]
Other	3	17.6	[6.2, 41.0]
Barriers to accessing innovative devices (Q10.1)
Limited reimbursement coverage	13	76.5	[52.7, 90.4]
Strict pre-approval requirements	12	70.6	[46.9, 86.7]
Lack of awareness among healthcare providers	9	52.9	[31.0, 73.8]
High cost for patients	7	41.2	[21.6, 64.0]
Other	3	17.6	[6.2, 41.0]
Changes to improve access to innovative devices (Q10.2)
Expanding insurance coverage to include more devices	15	88.2	[65.7, 96.7]
Reducing pre-approval requirements	10	58.8	[36.0, 78.4]
Enhancing patient awareness programs	9	52.9	[31.0, 73.8]
Increasing reimbursement rates	7	41.2	[21.6, 64.0]
Other	5	29.4	[13.3, 53.1]
Improvements to health insurance coverage (Q13.1)
Expanding coverage for more devices	14	82.4	[59.0, 93.8]
Improving transparency in insurance policies	12	70.6	[46.9, 86.7]
Simplifying claims and pre-approval processes	11	64.7	[41.3, 82.7]
Increasing reimbursement rates	9	52.9	[31.0, 73.8]
Other	3	17.6	[6.2, 41.0]

Multi-select questions; respondents could select all applicable options. CI = 95% confidence interval

Table 4.

Coding, categorization, and standardization (N = 17)

Item	n	%	95% CI
Impact of current categorization system (Q11.1)
Has no significant impact; relies on insurer discretion	8	47.1	[26.2, 69.0]
Creates overlapping categories, causing delays	4	23.5	[9.6, 47.3]
Ensures transparency and standardization	4	23.5	[9.6, 47.3]
Other	4	23.5	[9.6, 47.3]
Simplifies cost-effectiveness evaluation	3	17.6	[6.2, 41.0]
Current coding system support for claims (Q12.1)
Neutral	11	64.7	[41.3, 82.7]
Somewhat poorly	4	23.5	[9.6, 47.3]
Very well	1	5.9	[1.0, 27.0]
Somewhat well	1	5.9	[1.0, 27.0]

Q11.1 is multi-select; Q12.1 is single-select. CI = 95% confidence interval. For single-select items, response options that received no responses are not shown; displayed categories therefore sum to 100%

Qualitative data from open-ended survey responses and the SCW transcript underwent thematic content analysis using NVivo 12 software. Two researchers reviewed the data, applied an initial coding framework based on the survey themes, discussed discrepancies, and refined the thematic structure through consensus. A third researcher reviewed the final thematic structure. A formal inter-rater reliability statistic was not calculated before consensus. The coding process was informed by established thematic-analysis procedures, including familiarization with the data, generation of initial codes, review and refinement of themes, and interpretation in relation to the study objectives (Braun and Clarke 2006).

Integration of findings

Integration followed the sequential explanatory design. Preliminary survey findings informed the SCW discussion guide, and final interpretation connected quantitative response patterns with qualitative explanations and policy recommendations. Integration occurred by connecting the survey and SCW phases and interpreting qualitative findings in relation to the preliminary survey patterns (Creswell and Plano Clark 2018; Fetters et al. 2013).

Ethical considerations

The research protocol, including the anonymous online survey for professionals and a single SCW with experienced stakeholders, was submitted to the King Saud University Institutional Review Board (IRB) and received exemption status (No. E-25–10129), because the study involved adult professional stakeholders, used survey and interview/focus-group methods, and did not collect patient-level data or sensitive personal health information. Survey responses were collected anonymously. SCW participants provided consent for audio-recording. Transcripts and field notes were de-identified before analysis, and findings were reported in aggregate or thematic form without attributing views to named individuals or institutions.

Results

Results from the survey analysis

Participant characteristics

The final analytic survey sample included 17 respondents from 58 invited stakeholders, corresponding to a response rate of 29.3%. Respondents included manufacturers (5/17, 29.4%), regulatory stakeholders (4/17, 23.5%), other specified stakeholder categories (4/17, 23.5%), healthcare providers (2/17, 11.8%), and insurance representatives (2/17, 11.8%). These results are summarized in Fig. 1. Most respondents reported more than five years of professional experience: 6/17 (35.3%) had 5–10 years, 6/17 (35.3%) had 10–15 years, and 3/17 (17.6%) had more than 15 years of experience. Two respondents (11.8%) reported 1–5 years of experience.

Fig. 1.

Survey respondent characteristics (N = 17)

Theme 1: Current insurance coverage and reimbursement challenges

When assessing the current state of medical device insurance coverage in Saudi Arabia, over half of the respondents (n = 9, 52.9%) rated it as “Average,” while 35.3% (n = 6) considered it “Good,” and 11.8% (n = 2) rated it as “Poor.” The effectiveness of current policies in ensuring timely access to devices was viewed neutrally by 35.3% (n = 6), while 29.4% (n = 5) found them “Somewhat effectively” and 11.8% (n = 2) “Very effectively” facilitating access. Conversely, 23.5% (n = 4) believed the policies were “Somewhat ineffectively” serving this purpose (Table 1).

Respondents identified several challenges in the decision-making process for including new devices in insurance coverage (Fig. 2). The most prominent barrier was the “Lack of standardized evaluation criteria,” cited by 88.2% (n = 15) of participants. This was followed by “Delays in approvals” (n = 10, 58.8%), “Budget constraints of insurers” (n = 8, 47.1%), and “Limited clinical evidence for new devices” (n = 5, 29.4%).

Fig. 2.

Main challenges in decision-making for including new medical devices in insurance coverage (N = 17). Note. Multi-select item; percentages are calculated using N = 17 as the denominator. Categories are not mutually exclusive

From the patient perspective, stakeholders highlighted multiple challenges in seeking reimbursement for DTP medical devices (Fig. 3). The primary obstacle was a “Lack of clarity on reimbursement policies” (n = 13, 76.5%), followed by “Limited reimbursement coverage for certain devices” (n = 10, 58.8%), “High rejection rates for claims” (n = 9, 52.9%), and “Long processing times for claims” (n = 4, 23.5%). Furthermore, 76.5% (n = 13) of respondents agreed (strongly or somewhat) that out-of-pocket costs pose significant financial challenges for patients requiring essential medical devices (Table 1).

Fig. 3.

Common patient reimbursement challenges for dispensed-to-patient medical devices (N = 17). Note. Multi-select item; percentages are calculated using N = 17 as the denominator. Categories are not mutually exclusive

Theme 2: Stakeholders' role in formulary development

There was unanimous agreement among respondents (n = 17, 100%) that a standardized medical-device formulary should feature “Regular updates with inclusion of new devices.” Other highly prioritized features included “Clear categorization of devices” (n = 15, 88.2%), “Transparent reimbursement criteria” (n = 13, 76.5%), and “Affordability consideration” (n = 10, 58.8%) (Table 2).

However, participants anticipated several barriers to implementing such a formulary. The most frequently cited challenges were the “Lack of regulatory guidelines” (n = 11, 64.7%) and “Resistance from stakeholders” (n = 11, 64.7%). Additional barriers included “Budget constraints” (n = 10, 58.8%) and “Inadequate clinical evidence for certain devices” (n = 7, 41.2%) (Table 2).

Theme 3: Enhancing access to innovative medical devices

When prioritizing factors for the inclusion of innovative devices in the formulary, respondents emphasized “Clinical effectiveness and safety” (n = 14, 82.4%), followed by “Patient demand and necessity” (n = 11, 64.7%), “Cost-effectiveness” (n = 9, 52.9%), and “Regulatory approvals” (n = 9, 52.9%) (Table 3).

The primary barriers to accessing innovative medical devices were identified as “Limited reimbursement coverage” (n = 13, 76.5%) and “Strict pre-approval requirements” (n = 12, 70.6%). To address these barriers, the most recommended improvement was “Expanding insurance coverage to include more devices” (n = 15, 88.2%), along with “Reducing pre-approval requirements” (n = 10, 58.8%) and “Enhancing patient awareness programs” (n = 9, 52.9%) (Table 3).

Theme 4: Coding, categorization, and standardization

The survey revealed mixed perceptions regarding the current categorization of medical devices by insurance companies. A substantial proportion (n = 8, 47.1%) felt the current categorization “Has no significant impact,” while others noted it “Creates overlapping categories” (n = 4, 23.5%) or, conversely, “Ensures transparency and standardization” (n = 4, 23.5%). Regarding the effectiveness of the current coding system (e.g., CPT, HCPCS) in facilitating reimbursement, the majority (n = 11, 64.7%) held a “Neutral” view, and 23.5% (n = 4) felt it worked “Somewhat poorly” (Table 4).

Stakeholder consultation workshop analysis

Participant characteristics

The SCW findings generally expanded on the survey findings and provided contextual explanations for the policy challenges identified. Participants discussed the need for clearer medical-necessity criteria, explicit eligibility rules for device categories, transparent reimbursement criteria, coding standardization, and mechanisms to accommodate innovation while managing uncertainty. Thematic findings are summarized in Table 5.

Table 5.

Summary of key findings from the stakeholder consultation workshop (SCW)

Theme	Key Findings
Theme 1: Insurance Coverage & Reimbursement	Essential Benefit Package is nonspecific for medical devices; specific criteria exist only for insulin pumps; no centralized pricing list; pricing affected at point of dispensing; lack of structured policies leads to provider misuse; insurance companies reject expensive devices without considering clinical benefits
Theme 2: Stakeholder/Formulary Role	Three-tiered classification system proposed (Tier 1: full coverage; Tier 2: prior authorization; Tier 3: non-covered); HTA recognized as key but time-consuming; local data requirements essential (e.g., HbA1C thresholds differ between countries); rapid device innovation (new versions every 6 months) challenges formulary maintenance
Theme 3: Enhancing Access to Innovative Devices	Risk-based evaluation approaches discussed (e.g., German model for Class C/D devices); patient awareness identified as significant barrier; improved communication channels needed between patients, manufacturers, and insurers; conditional coverage with evidence development recommended for promising technologies
Theme 4: Coding, Categorization & Standardization	GMDN system provides 25,000 + codes; Arabic version recently launched (GMDN Agency 2025); manufacturer-neutral codes improve consistency; unified coding similar to pharmaceutical systems needed for better stakeholder communication

SCW conducted at the CHI office, Riyadh. N = 42 participants, categorized at the broad level recorded in attendance records: governmental/regulatory (n = 12, including patient- and disability-advocacy representation via the Family Affairs Council and the Authority for the Care of Persons with Disabilities), private sector (n = 28, comprising manufacturers, providers, and other commercial/industry attendees; 66.7% of participants), other organizations (n = 2). Attendance records did not permit finer disaggregation of the seven stakeholder categories described in the Methods (e.g., manufacturers cannot be separated from providers within "private sector"), and patient/disability-advocacy representation is embedded within the governmental/regulatory category rather than separately identified; this coarse categorization and the resulting industry-heavy composition of the qualitative phase are acknowledged as a limitation (see Limitations)

Participants described nonspecific coverage criteria as a source of variation in payer decisions and administrative burden for providers. Pricing was also discussed as a key challenge because devices may move through multiple supply-chain and dispensing points, creating variability in the final reimbursed price. Participants also emphasized that rapid device innovation requires formulary processes that can be updated regularly and that evidence requirements should be proportionate to device risk, maturity, and clinical need.

Coding and categorization were viewed as infrastructure issues rather than purely administrative tasks. Participants emphasized the need for a standardized nomenclature and coding system that can support claims processing, device traceability, post-market monitoring, and evidence generation. These qualitative findings were consistent with survey responses identifying reimbursement ambiguity, limited standardization, and coding limitations as recurring barriers.

Discussion

Principal findings

This exploratory mixed-methods study identified four interrelated barriers to developing a DTP medical-device formulary in Saudi Arabia: ambiguity in coverage and reimbursement rules, insufficiently standardized device assessment processes, challenges in access to innovative devices, and fragmented coding and categorization. The survey findings should be interpreted cautiously because the sample was small; however, the SCW findings provided convergent contextual support for the same policy domains.

The most prominent survey signal was the perceived lack of standardized evaluation criteria for including new devices in insurance coverage. This was reinforced qualitatively by stakeholder discussion of unclear eligibility criteria, variation in payer interpretation, and the absence of structured evidence-submission pathways for some device categories. These findings suggest that a formulary should not only list covered devices but also define medical-necessity criteria, evidence requirements, reimbursement rules, update processes, and appeal mechanisms.

Comparison with previous literature

The findings align with international literature showing that medical devices require assessment and reimbursement approaches that differ from pharmaceutical models. Device evidence is often affected by short product lifecycles, learning curves, operator dependence, and incremental modification (Drummond et al. 2009; Henschke et al. 2015; Tarricone et al. 2017). Prior research also emphasizes that reimbursement and pricing policies can influence device adoption, access, and value generation (Sorenson et al. 2013; Wilkinson and Drummond 2014).

Stakeholder engagement is also central to formulary development because coverage decisions involve trade-offs among clinical benefit, patient need, budget impact, operational feasibility, and innovation incentives. This is consistent with broader literature on stakeholder involvement in health policy and health research, which emphasizes transparency, role clarity, and structured engagement methods (Boaz et al. 2018; Concannon et al. 2019; Greenhalgh et al. 2019).

Saudi-specific policy considerations

One exploratory finding relates to the current Saudi health insurance context, where medical device coverage is generally embedded within a broad Essential Benefit Package rather than a dedicated medical device formulary. Stakeholders highlighted that the absence of device-specific eligibility criteria may contribute to variation in payer interpretation and coverage decisions, resulting in administrative burden and inconsistent access pathways.

Participants proposed a three-tier classification framework distinguishing routinely covered devices, specialized devices requiring defined clinical eligibility criteria, and innovative technologies requiring enhanced evidence review and assessment. During the SCW, stakeholders raised insulin pump coverage, for which device-specific clinical eligibility criteria already exist, as an illustrative example of how explicit criteria could improve transparency, consistency, and predictability of reimbursement decisions for other device categories; this example reflects participant discussion during the workshop rather than a documented CHI policy analyzed as part of this study.

Another theme raised by participants was the potential need for standardized coding and nomenclature systems that support reimbursement, claims processing, utilization monitoring, and post-market evidence generation. Participants emphasized the potential value of adopting internationally recognized device nomenclature systems while ensuring compatibility with local reimbursement requirements and Arabic-language implementation needs. These findings represent policy considerations that are particularly relevant to the ongoing evolution of the Saudi health insurance system and the development of a structured medical device formulary framework.

Policy implications

The findings support several policy implications for developing a DTP medical-device formulary. First, a multi-stakeholder governance structure should define decision rights, conflict-of-interest procedures, update cycles, and appeal mechanisms. Second, device assessment criteria should include clinical effectiveness, safety, budget impact, cost-effectiveness where feasible, patient need, and implementation considerations. Third, reimbursement rules should be linked to transparent pricing and coding systems. Fourth, risk-based and conditional coverage pathways may be useful for innovative devices with promising value but incomplete evidence (Basu and Hassenplug 2012; Oortwijn et al. 2018; Rothery et al. 2017; Shuren and Califf 2016).

Coding standardization emerged as a cross-cutting requirement. A unified coding and categorization system would support claims processing, price transparency, formulary maintenance, post-market surveillance, and real-world evidence generation. International nomenclature and unique device identification approaches may provide useful foundations, but implementation would need adaptation to Saudi reimbursement, claims, and digital-health infrastructure (Stern et al. 2019). A CHI-led device formulary would not operate in isolation and would need to interface with existing national institutions. Device classification, registration, and post-market surveillance in Saudi Arabia fall under the Saudi Food and Drug Authority (SFDA), so eligibility tiers and coding standards proposed by SCW participants would need to align with SFDA device categories rather than duplicate them. A centralized device pricing mechanism does exist through the National Unified Procurement Company (NUPCO), but its scope is limited to public-sector procurement and does not extend to CHI-insured private-sector beneficiaries; device pricing for this population is instead established through direct negotiation between manufacturers, distributors, and payers, with no equivalent centralized reference price. This distinction is consistent with the absence of a centralized pricing list reported by SCW participants (Table 5) and helps explain the pricing-transparency and coverage-consistency concerns raised throughout this study. The stakeholder consultation did not directly probe the SFDA interface in depth, and this is noted as a gap for subsequent policy development work rather than a finding of the present study.

Strengths and limitations

A strength of this study is its mixed-methods design, which allowed preliminary survey findings to be explored in greater depth through stakeholder discussion. The study also addressed a practical policy issue involving regulators, payers, providers, manufacturers, and patient-related perspectives.

The study has important limitations. First, the survey component included only 17 respondents and should therefore be interpreted as exploratory. The confidence intervals are wide, reflecting imprecision. In addition, stakeholder representation within the survey sample was not proportionally balanced across all stakeholder groups. Manufacturers constituted the largest respondent category, whereas payer and provider participation was comparatively lower. Accordingly, the survey findings should be interpreted as reflecting the perspectives of participating stakeholders and as exploratory in nature rather than representative of the relative influence or distribution of stakeholder groups within the healthcare system. Relatedly, survey and SCW invitations were distributed through CHI-related professional networks and stakeholder contacts identified by the study team. To mitigate potential selection bias associated with this recruitment approach, manufacturer participation was additionally verified against market share, and regulatory participation was based on official institutional nomination by the relevant entity, so that these two groups reflected defined external criteria rather than the study team's contacts alone. Recruitment for other stakeholder groups relied solely on these CHI-related networks, which remains a limitation on the independence of the sampling frame overall and is distinct from the manufacturer overrepresentation described above. Because of the small sample and this recruitment approach, subgroup analyses by stakeholder category were not conducted, and whether barriers and priorities differ systematically by respondent type (e.g., manufacturers versus payers or providers) remains an open question for future research. Second, a formal non-response bias analysis could not be conducted because detailed characteristics of non-respondents were unavailable. Third, the available SCW attendance records were categorized only at a broad level (governmental/regulatory, private sector, other) and did not permit complete disaggregation of all seven stakeholder categories described in the Methods; private-sector attendees, who comprised 66.7% of SCW participants, could not be separated into manufacturers, providers, and other commercial roles. Patient- and disability-advocacy representation was present through the participation of the Family Affairs Council and the Authority for the Care of Persons with Disabilities, both categorized within governmental/regulatory attendance, but could not be separately disaggregated within that broader category. The qualitative component was conducted as a single stakeholder consultation workshop involving 42 participants and was numerically dominated by private-sector/industry attendees. Although this format enabled broad representation across stakeholder groups, it may have limited the depth of individual contributions compared with smaller traditional focus groups, and the industry-heavy composition should be considered when interpreting the SCW themes. Fourth, inter-rater reliability was not calculated before consensus coding, although the coding process included consensus discussion and third-reviewer review of the final thematic structure. Fifth, although recurring themes were observed during the latter.

Conclusion

This exploratory mixed-methods study identified stakeholder-perceived barriers to establishing a DTP medical-device formulary in Saudi Arabia, including unclear reimbursement rules, limited pricing transparency, insufficient device-specific assessment processes, and fragmented coding systems. The findings support the development of an evidence-informed formulary process with clear governance, standardized assessment criteria, transparent reimbursement mechanisms, and improved coding infrastructure. Given the small survey sample, the quantitative findings should be interpreted as preliminary and should be validated through larger stakeholder studies and prospective evaluation of formulary implementation.

Author contributions

Conceptualization and study design: Shabab AlGhamdi, Amer Alanazi, Ibrahim AlJuffali, and Nada AlAgil. (contributed equally).

Material preparation and data collection: Mohammed AlJumah and Nada AlAgil.

Data analysis: Saeed Mastour Alshahrani and Hadeel Alkofide.

Writing original draft: Hadeel Alkofide.

Writing review and editing: all authors.

Project administration and supervision: Shabab AlGhamdi and Nada AlAgil.

All authors read and approved the final manuscript.

Funding

This study received no external financial funding. The Council of Health Insurance provided logistical and in-kind support related to stakeholder coordination, meeting venue arrangements, and access to relevant administrative and technical input. The involvement of CHI-affiliated authors is described in the Author Contributions and Competing Interests sections.

Data availability

The survey dataset and qualitative materials are not publicly available because of the small and potentially identifiable professional stakeholder community. De-identified aggregate survey outputs may be available from the corresponding author upon reasonable request and subject to institutional approvals.

Declarations

Competing interests

Several authors are employees of the Council of Health Insurance (CHI), which provided logistical and in-kind support for this study. CHI-affiliated authors contributed to study design, stakeholder engagement, data collection, project administration, and manuscript preparation, as described in the Author Contributions statement. To minimize the potential for bias, survey responses were collected anonymously, the stakeholder consultation session was moderated by a facilitator independent of the study analysis team, and qualitative findings were reviewed by multiple researchers. The authors declare no financial conflicts of interest.