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市场调查报告书
商品编码
1844223
儿科介入性心臟病市场按产品类型、年龄层、应用和最终用户划分 - 全球预测 2025-2032 年Pediatric Interventional Cardiology Market by Product Type, Age Group, Application, End User - Global Forecast 2025-2032 |
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预计到 2032 年,儿科介入性心臟病学市场规模将成长 75.2 亿美元,复合年增长率为 14.38%。
| 主要市场统计数据 | |
|---|---|
| 基准年 2024 | 25.6亿美元 |
| 预计年份:2025年 | 29.4亿美元 |
| 预测年份:2032年 | 75.2亿美元 |
| 复合年增长率 (%) | 14.38% |
儿科介入性心臟病学是一个独特的领域,它融合了临床创新、器材工程和专科诊疗管道。过去十年间,临床医生和器械研发人员已从创伤性较大的矫正手术转向基于导管的介入治疗,从而缩短住院时间、降低围手术全期风险,并支持对多种先天性心臟疾病进行早期疗育。这些临床进展与材料科学、影像引导和微型化技术的迭代改进相辅相成,进一步拓展了适用于新生儿、婴幼儿、儿童和青少年的手术手段。
同时,由儿科循环系统、介入医师、麻醉师和专科护理人员组成的多学科团队不断完善患者筛选标准、术前术后通讯协定以及追踪机制,以优化安全性和治疗效果。因此,医疗机构正在增加对基础设施和培训的投入,以提升微创儿科心血管手术的能力。政策制定者和支付者也正在重新调整报销模式,以平衡长期临床效益与领先手术成本,这促使医院管理者和临床负责人重新评估其服务线策略。
鑑于各方力量的汇聚,从医疗器材製造商到医院管理者再到专科诊所等相关人员必须重新评估其策略重点。本执行摘要总结了近期临床和商业性格局的变化,探讨了关税相关的不利因素,分析了市场细分和区域差异,介绍了关键的公司动态,并为希望将市场情报转化为营运优势的领导者提出了切实可行的建议。
儿科介入性心臟病学正经历一个新阶段,其驱动力来自于技术、临床实践和医疗系统经济方面的变革性转变。新型器械材料和经导管输送系统的进步,使得以往无法为幼小患者实施的手术成为可能,拓展了新生儿和婴儿的治疗选择。同时,包括高解析度超音波心动图和融合引导导航在内的影像技术的进步,提高了手术的精确度,并降低了透视辐射暴露。
临床上,针对特定先天性心臟病,早期介入的趋势日益显着。这种临床趋势正在催生卓越中心,这些中心汇聚专业知识,改善治疗效果,并成为培训和创新的枢纽。在财务方面,医院和门诊平台正在调整其服务组合,以充分利用门诊和短期住院模式带来的效率提升,同时为重症监护病例维持强大的手术全期安全保障。
在产业方面,医疗器材创新者与临床中心之间的策略伙伴关係正透过反覆的真实世界回馈加速产品改进。儘管监管管道正在调整以适应儿科特定证据的生成,但医疗器材开发商在招募儿童受试者时仍需应对复杂的试验设计和伦理考量。总体而言,这些转变正在催生一个更动态、以患者为中心的产业,在这个产业中,技术敏捷性和协作性临床网络决定着竞争优势。
美国新关税措施的实施增加了儿科介入性心臟病相关人员供应链和筹资策略的复杂性。关税调整影响了进口零件和成品的成本动态,促使製造商和医疗系统重新评估筹资策略和合约条款。在许多情况下,供应商被迫承受短期成本压力或与经销商进行价格调整,这会对医院的采购週期和资本规划产生连锁反应。
为因应这一局面,医疗设备製造商正采取多项缓解措施,包括供应商多元化、在经济可行的情况下将部分生产环节转移到国内,以及与主要医院客户重新谈判长期合约以稳定价格。同时,医院和专科诊所的采购团队正在加强对供应商的实质审查,扩大竞标范围,并探索能够更好地应对关税波动的集团采购模式。这些采购调整往往有利于那些物流稳健、成本结构透明且能够在多个司法管辖区维持合规的供应商。
临床医生和行政管理人员也在积极调整,重新安排设备库存优先级,并将现有产品线与临床管道相匹配,以确保医疗服务的连续性。关税主导的成本压力虽然不会改变临床适应症,但会影响资本分配决策、择期手术计画的安排、采用新技术的经济效益。因此,那些积极建构关税情境模型并将供应链弹性纳入策略规划的机构,将更有能力在不断变化的贸易政策环境下保持创新能力并保障病患获得医疗服务。
了解市场细分对于协调儿科介入性心臟病学领域的产品开发、临床培训和商业策略至关重要。按产品类型划分,此细分市场包括导管、阻塞设备、支架和瓣膜。在导管中,球囊导管和诊断导管分别扮演不同的角色:前者用于辅助手术操作,后者用于病变评估。设计上的差异反映了对可追踪性、管腔大小以及针对小型解剖结构的外形等优先考虑因素。封堵器包括房间隔缺损封堵器、开放性动脉导管封堵器和室间隔缺损封堵器,每种封堵器都旨在满足不同的解剖结构和长期生物相容性需求。支架分为冠状动脉支架和非冠状动脉支架,针对儿童血管床的血管尺寸、径向强度和输送性能进行了优化。瓣膜包括球囊瓣膜和经导管心臟瓣膜,目前正在进行研究,以改善瓣膜技术,使其适应年轻患者的生长发育和提高瓣膜的耐用性。
年龄细分进一步优化了临床和商业性策略,因为患者群体涵盖青少年、儿童、婴幼儿和新生儿。每个群体都有独特的解剖结构限制、手术全期风险特征和追踪注意事项,这些都会影响器械选择和手术方案规划。基于应用的观点着重于临床手术,例如血管成形术、房间隔缺损封堵术、动脉导管开放性动脉导管、瓣环成形和室间隔缺损封堵术,并展示了根据病变复杂程度和患者体型量身定制的手术流程。最后,终端使用者洞察区分了手术开展地点以及在门诊手术中心、医院和专科诊所等不同基础设施、人员专业水平和采购方式各异的机构中器械的采购和使用方式。整合这些细分维度,使相关人员能够更好地进行研发投资,优先考虑培训项目,并制定能够反映不同器材、年龄层、应用和医疗环境细微需求的商业化策略。
区域动态对儿科介入性心臟病学的临床实践模式、监管预期和商业化管道有显着影响。美洲临床网路的特点是卓越中心集中、微创技术逐步普及以及对培训和基础设施的大力投入。该地区的医保报销机制和支付方谈判决定了器械采购週期和新技术引进的时机,而区域中心通常也扮演着创新中心的角色,将最佳实践推广到更广泛的国内市场。
欧洲、中东和非洲的医疗服务模式和法律规范各不相同。西方市场通常强调严谨的临床证据和成本效益评估,而该地区的新兴市场则优先考虑可融入不同医疗体系的可扩展干预措施。中东和非洲各地儿科心臟病专科医疗服务的可近性差异很大,主要集中在都市区三级医院。在这些市场,公私伙伴关係通常有助于医疗能力的提升和技术的应用。
在亚太地区,医疗基础设施的快速扩张、外科手术和介入治疗能力的提升以及对本地化生产的日益重视,共同塑造了该地区的竞争格局。在整个亚太地区,专业培训计画和合作研究的投资正在加速临床应用,同时,医疗监管机构也在完善监管管道,以满足儿科器械核准的特定需求。因此,每个地区都需要量身定制的合作模式,充分考虑报销标准、临床人员配备、培训系统和物流,从而更有效地进入市场并产生持续的临床影响。
儿科介入性心臟病学市场的竞争动态主要由全球领先的医疗器材製造商、专注于特定领域的创新企业以及合作的临床伙伴共同主导。成熟的医疗设备製造商凭藉其规模优势、丰富的监管经验和广泛的分销网络,提供多元化的产品系列和综合培训项目。这类公司通常专注于渐进式创新、稳健的供应链以及全面的服务,包括临床医生教育和手术支援。
同时,一些规模较小、更专注于特定领域的公司正透过有针对性的设计创新、独特的材料应用和深入的临床研究,推动颠覆性改进,以满足新生儿和婴儿尚未满足的需求。这些灵活的公司通常与领先的儿科心臟中心建立紧密的伙伴关係,以改善设备功能、提供快速的临床回馈并产生真实世界证据。此类合作能够提高产品的可靠性,并加速临床医生对产品的接受度。
诸如授权协议、共同开发契约和选择性收购等策略性企业活动仍是连结技术能力与临床管道的重要机制。对于医疗系统和专科诊所而言,供应商的选择越来越不仅取决于设备性能,还取决于上市后监测的品质、培训资源以及建立长期伙伴关係的潜力。最终,那些展现出对临床的同理心、拥有严格的安全保障并致力于临床医生教育的公司,将最有希望在儿科医疗领域获得持续的关注和支持。
致力于巩固儿科介入性心臟病学领域地位的产业领导者应采取多管齐下、切实可行的策略,将创新与临床实际情况和供应链韧性相结合。首先,透过与儿科心臟中心持续合作,优先发展以临床医生为中心的产品开发,可以改善器械对小儿解剖结构的适应性,并加速手术推广。将人因工程测试和迭代回馈机制融入产品开发生命週期,确保器材符合实际需求,并减少推广应用的阻力。
第二,透过供应商多元化、投资品质有保障的二级采购以及在经济条件允许的情况下考虑高价值製造流程的部分本地化,提高供应链的灵活性。这些措施将缓解关税和物流中断的影响,同时保障关键手术的交付时间。第三,建立全面的临床医师教育和指导计画可以提升介入医师和手术团队的信誉度。此类项目应包括模拟训练、手术流程研讨会和术后结果评估,以培养可持续的专业技能。
第四,相关人员应采取实证策略,在符合伦理的小儿科临床试验设计与可靠的真实世界数据收集之间取得平衡,从而使监管机构和支付方能够评估临床效用和持久性。最后,使商业策略与当地医疗保健系统的特征相符,并使定价、合约和支援模式与当地的报销和基础设施实际情况相符,可以促进更广泛的医疗服务可及性。协调一致地实施这些措施将增强市场地位,并确保儿科患者获得持续的医疗服务。
本次高阶主管综合报告的调查方法结合了定性和定量调查方法,旨在确保儿科介入性心臟病学相关相关人员获得严谨、透明且有效的研究结果。主要研究内容包括对儿科介入性心臟病学领域的医生、导管室主任、采购专家和临床工程师进行结构化访谈,以获取关于器械易用性、手术趋势、推广挑战等方面的第一手观点。除临床医生访谈外,还与高级商业领导和监管专家进行了讨论,以了解市场准入动态和合规性方面的考虑。
二次研究包括对同行评审的临床文献、手术登记资料、监管指导文件和临床学会意见进行全面审查,以深入了解该技术的性能和安全性。供应链和政策分析利用公开的贸易和製造数据、采购手册以及医院采购行为的案例,评估了物流和经济效益。资料三角验证透过交叉检验不同资讯来源的资讯、透过后续专家咨询解决差异以及优先考虑最新证据来实现。
此分析架构强调按产品类型、病患年龄层、临床用途和护理环境进行细分,以揭示对研发和商业规划具有实际意义的启示。在相关情况下,采用情境分析来探讨对采购和政策的影响。在整个过程中,伦理考量指导了小儿科临床医生参与和患者结局的讨论,确保临床福祉始终是解读结果的首要视角。
儿科介入性心臟病学的当前发展轨迹表明,未来微创手术将在所有年龄段儿科先天性心臟疾病的治疗中发挥日益重要的作用。导管系统、阻塞设备、支架和瓣膜技术的进步,以及影像学和手术通讯协定的改进,都为扩大适应症和优化患者选择提供了支援。投资于卓越中心、临床医生培训和灵活采购方式的医疗系统,将更有能力将技术创新转化为更好的患者疗效和更高的营运效率。
贸易政策动态和供应链因素将持续影响医疗设备的取得和筹资策略,因此灵活性和供应商合作将成为一项策略重点。不同地区在监管严格程度、报销标准和基础设施成熟度方面的差异,需要量身定制的合作模式;同时,敏捷的创新者与成熟的临床中心之间的伙伴关係仍然是加速技术应用推广的有效机制。最终,那些能够将临床同理心与供应链前瞻性、可靠的循证实践以及本地化商业化相结合的机构,将引领该领域,并确保儿科介入心臟病学的进步能够为患者和医疗保健系统带来切实可见的益处。
The Pediatric Interventional Cardiology Market is projected to grow by USD 7.52 billion at a CAGR of 14.38% by 2032.
| KEY MARKET STATISTICS | |
|---|---|
| Base Year [2024] | USD 2.56 billion |
| Estimated Year [2025] | USD 2.94 billion |
| Forecast Year [2032] | USD 7.52 billion |
| CAGR (%) | 14.38% |
Pediatric interventional cardiology occupies a unique intersection of clinical innovation, device engineering, and specialized care pathways. Over the past decade, clinicians and device developers have shifted from highly invasive corrective surgeries toward catheter-based interventions that reduce hospital stays, lower perioperative risk, and support earlier intervention across diverse congenital heart conditions. These clinical advances are complemented by iterative improvements in materials science, imaging guidance, and miniaturization that together have broadened the procedural toolbox for neonates, infants, children, and adolescents.
In parallel, multidisciplinary teams comprising pediatric cardiologists, interventionalists, anesthesiologists, and specialized nursing staff have refined patient selection criteria, peri-procedural protocols, and follow-up pathways to optimize safety and outcomes. As a result, institutions are increasingly investing in infrastructure and training to expand their capacity for minimally invasive pediatric cardiac procedures. Policymakers and payers are also recalibrating reimbursement models to balance long-term clinical benefit with upfront procedural costs, prompting hospital administrators and clinical leaders to re-evaluate service line strategies.
Given these converging forces, stakeholders-from device manufacturers to hospital administrators and specialty clinics-must reassess strategic priorities. This executive summary synthesizes recent shifts in the clinical and commercial landscape, explores tariff-related headwinds, dissects segmentation and regional nuances, profiles key corporate dynamics, and concludes with practical recommendations for leaders seeking to translate market intelligence into operational advantage.
The landscape of pediatric interventional cardiology is being reshaped by transformative shifts that span technology, clinical practice, and health system economics. Novel device materials and advances in transcatheter delivery systems have enabled procedures that were previously infeasible in the smallest patients, thereby expanding therapeutic options for neonates and infants. Concurrent improvements in imaging-such as higher-resolution intracardiac echocardiography and fusion-guided navigation-have tightened procedural accuracy and reduced fluoroscopy exposure, which in turn diminishes long-term radiation risks for young patients.
Clinically, there is a discernible trend toward earlier intervention in selected congenital heart lesions, driven by evolving evidence that timely minimally invasive correction can mitigate downstream morbidity. This clinical momentum is fostering specialized centers of excellence that concentrate expertise, improve outcomes, and serve as hubs for training and innovation. Financially, hospitals and ambulatory platforms are reconfiguring service portfolios to capture the efficiencies offered by outpatient and short-stay models, while maintaining robust perioperative safety nets for higher-acuity cases.
On the industry side, strategic partnerships between device innovators and clinical centers are accelerating product refinement through iterative real-world feedback. Regulatory pathways are adapting to accommodate pediatric-specific evidence generation, though device developers must still navigate complex trial design and ethical considerations when enrolling children. Altogether, these shifts are catalyzing a more dynamic, patient-centered field in which technological agility and collaborative clinical networks define competitive advantage.
The introduction of new tariff policies in the United States has introduced an additional layer of complexity to supply chain and procurement strategies for pediatric interventional cardiology stakeholders. Tariff adjustments have affected the cost dynamics of imported components and finished devices, prompting manufacturers and health systems to re-evaluate sourcing strategies and contractual terms. In many cases, suppliers have had to absorb short-term cost pressures or implement price adjustments to distributors, which has ripple effects through hospital purchasing cycles and capital planning.
In response, device manufacturers are pursuing multiple mitigation approaches, including diversifying supplier bases, shifting certain manufacturing stages domestically where economically viable, and renegotiating long-term agreements to stabilize pricing for key hospital accounts. Meanwhile, procurement teams within hospitals and specialty clinics are intensifying supplier due diligence, expanding competitive bidding processes, and exploring group purchasing arrangements that can better absorb tariff-related variances. These procurement adaptations tend to favor suppliers that demonstrate resilient logistics, transparent cost structures, and the ability to maintain regulatory compliance across multiple jurisdictions.
Clinicians and administrative leaders are also adapting by re-prioritizing device inventories and aligning clinical pathways with available product lines to ensure continuity of care. Although tariff-driven cost pressures do not alter clinical indications, they influence capital allocation decisions, timing of elective programs, and the economics of adopting newer technologies. Consequently, organizations that proactively model tariff scenarios and embed supply chain flexibility into their strategic plans will be better positioned to sustain innovation and patient access in an environment of evolving trade policy.
Understanding market segmentation is critical for aligning product development, clinical training, and commercial strategy across pediatric interventional cardiology. When viewed through the lens of product type, the field encompasses Catheters, Occlusion Devices, Stents, and Valves. Within Catheters, both Balloon Catheters and Diagnostic Catheters play distinct roles in procedure facilitation and lesion assessment, respectively, and design differences reflect priorities such as trackability, lumen size, and profile for small anatomy. Occlusion Devices include Atrial Septal Defect Occluders, Patent Ductus Arteriosus Occluders, and Ventricular Septal Defect Occluders, each engineered to meet varied anatomical configurations and long-term biocompatibility needs. Stents are differentiated into Coronary Stents and Non Coronary Stents, which are optimized for vessel size, radial strength, and deliverability in pediatric vascular beds. Valves comprise Balloon Valves and Transcatheter Heart Valves, with ongoing work to adapt valve technologies for growth accommodation and durability in younger patients.
Age group segmentation further refines clinical and commercial approaches, as patient cohorts span Adolescents, Children, Infants, and Neonates; each group presents unique anatomical constraints, perioperative risk profiles, and follow-up considerations that influence device selection and procedural planning. Application-based perspectives focus on clinical procedures such as Angioplasty, Atrial Septal Defect Closure, Patent Ductus Arteriosus Closure, Valvuloplasty, and Ventricular Septal Defect Closure, with procedural workflows tailored to lesion complexity and patient size. Finally, end user insights distinguish where care is delivered and how devices are procured and used, spanning Ambulatory Surgery Centers, Hospitals, and Specialty Clinics, which vary in infrastructure, staffing expertise, and procurement practices. By integrating these segmentation axes, stakeholders can better target R&D investments, prioritize training programs, and design commercialization strategies that reflect the nuanced needs across devices, ages, applications, and care settings.
Regional dynamics strongly influence clinical practice patterns, regulatory expectations, and commercial pathways in pediatric interventional cardiology. In the Americas, clinical networks are characterized by concentrated centers of excellence, progressive adoption of minimally invasive approaches, and robust investment in training and infrastructure. Reimbursement systems and payer negotiations in this region shape device procurement cycles and the uptake timing for novel technologies, while regional centers often serve as innovation hubs that disseminate best practices across broader national markets.
Across Europe, Middle East & Africa, healthcare delivery models and regulatory frameworks present a heterogeneous landscape. Western European markets typically emphasize rigorous clinical evidence and cost-effectiveness assessments, whereas emerging markets within the region prioritize scalable interventions that can be integrated into diverse health system capacities. The Middle East and Africa exhibit variable access to specialized pediatric cardiac services, with centers concentrated in urban tertiary hospitals; partnerships between public and private entities often underpin capacity expansion and technology adoption in these markets.
In Asia-Pacific, rapidly expanding healthcare infrastructure, growing surgical and interventional capabilities, and an increasing focus on localized manufacturing are shaping the competitive environment. Regional investment in specialized training programs and collaborative research is accelerating clinical adoption, while health authorities are refining regulatory pathways to accommodate device approvals with pediatric-specific considerations. Each region therefore demands tailored engagement models that account for reimbursement norms, clinical staffing, training ecosystems, and logistics, enabling more effective market entry and sustained clinical impact.
Competitive dynamics within pediatric interventional cardiology are governed by a mix of global device leaders, specialized niche innovators, and collaborative clinical partners. Established medical device manufacturers leverage scale, regulatory experience, and wide distribution networks to support multi-product portfolios and integrated training programs. These companies often focus on incremental innovation, supply chain robustness, and comprehensive service offerings that include clinician education and procedural support.
At the same time, smaller and more specialized firms are driving disruptive improvements through targeted design innovations, unique material applications, and focused clinical studies that address unmet needs in neonates and infants. These nimble players frequently engage in close partnerships with leading pediatric cardiac centers to refine device features, fast-track clinical feedback, and generate real-world evidence. Such collaborations enhance product credibility and facilitate clinician acceptance.
Strategic corporate activity-such as licensing deals, co-development agreements, and selective acquisitions-remains a key mechanism to combine technical capabilities with clinical channels. For health systems and specialty clinics, vendor selection increasingly weighs not only device performance but also the quality of post-market surveillance, training resources, and long-term partnership potential. Ultimately, companies that demonstrate clinical empathy, rigorous safety profiles, and a commitment to clinician education are best positioned to achieve sustained engagement within pediatric practice communities.
Industry leaders seeking to strengthen their position in pediatric interventional cardiology should adopt a multifaceted, actionable approach that aligns innovation with clinical realities and supply chain resilience. First, prioritizing clinician-centric product development through sustained engagement with pediatric cardiac centers will improve device fit for small anatomies and accelerate procedural adoption. Embedding human factors testing and iterative feedback loops into the development lifecycle ensures devices meet real-world needs and reduces adoption friction.
Second, manufacturers and distributors should increase supply chain agility by diversifying suppliers, investing in quality-assured secondary sourcing, and considering partial localization of high-value manufacturing steps where economically justified. These moves will mitigate tariff and logistics disruptions while preserving delivery timelines for critical procedures. Third, building comprehensive clinician education and proctoring programs will enhance confidence among interventionalists and operating teams; such programs should include simulation, procedural workshops, and post-procedure outcome reviews to foster sustainable proficiency.
Fourth, stakeholders should pursue evidence generation strategies that balance ethical pediatric study design with robust real-world data collection, enabling regulators and payers to evaluate clinical benefit and durability. Finally, aligning commercial strategies with regional health system characteristics-adapting pricing, contracting, and support models to local reimbursement and infrastructure realities-will facilitate broader access. Implementing these actions in a coordinated manner will strengthen market position and ensure continuity of care for pediatric patients.
The methodology underpinning this executive synthesis combines qualitative and quantitative research techniques designed to ensure rigor, transparency, and relevance for stakeholders operating in pediatric interventional cardiology. Primary inputs include structured interviews with practicing pediatric interventional cardiologists, catheterization laboratory directors, procurement specialists, and clinical engineers to capture first-hand perspectives on device usability, procedural trends, and adoption challenges. These clinician engagements are complemented by discussions with senior commercial leaders and regulatory experts to understand market access dynamics and compliance considerations.
Secondary research involved a comprehensive review of peer-reviewed clinical literature, procedural registries, regulatory guidance documents, and clinical society position statements to contextualize technology performance and safety considerations. Supply chain and policy analyses drew on publicly available trade and manufacturing data, procurement manuals, and case studies of hospital purchasing behavior to assess logistical and economic levers. Data triangulation was achieved by cross-verifying insights across sources, resolving disparities through follow-up expert consultations, and prioritizing contemporary evidence.
Analytic frameworks emphasized segmentation by product type, patient age cohort, clinical application, and care setting to surface actionable implications for R&D and commercial planning. Where relevant, scenario analysis was used to explore procurement and policy sensitivities. Throughout the process, ethical considerations guided engagements involving pediatric clinicians and patient outcome discussions, ensuring that clinical welfare remained the primary lens for interpretation.
The current trajectory of pediatric interventional cardiology points to a future in which minimally invasive solutions become increasingly central to the management of congenital heart conditions across all pediatric age groups. Technological advances in catheter systems, occlusion devices, stents, and valve technologies, coupled with improved imaging and procedural protocols, support expanded indications and the refinement of patient selection. Health systems that invest in centers of excellence, clinician training, and resilient procurement practices will be better equipped to translate innovations into improved patient outcomes and operational efficiencies.
Trade policy dynamics and supply chain considerations will continue to influence device accessibility and procurement strategies, making flexibility and supplier collaboration strategic priorities. Regional differences in regulatory rigor, reimbursement norms, and infrastructure maturity require tailored engagement models, while partnerships between nimble innovators and established clinical centers will remain a potent mechanism for accelerating adoption. Ultimately, the organizations that marry clinical empathy with supply chain foresight, robust evidence generation, and regionally informed commercialization will lead the field and ensure that advances in pediatric interventional cardiology deliver measurable benefits for patients and health systems alike.