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									 市场调查报告书 
										商品编码 
											1848535 
										医疗设备契约製造市场按产品类型、服务类型、製程类型、材料类型和最终用途划分-2025年至2032年全球预测Medical Device Outsourced Manufacturing Market by Product Type, Service Type, Process Type, Material Type, End Use - Global Forecast 2025-2032 | 
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预计到 2032 年,医疗设备契约製造市场将成长至 821.3 亿美元,复合年增长率为 11.30%。
| 关键市场统计数据 | |
|---|---|
| 基准年 2024 | 348.7亿美元 | 
| 预计年份:2025年 | 388.6亿美元 | 
| 预测年份 2032 | 821.3亿美元 | 
| 复合年增长率 (%) | 11.30% | 
医疗设备的製造外包正从一种成本驱动型策略转变为一种策略能力,这种能力塑造着创新流程、监管结果以及全球供应链的韧性。製造商不仅越来越多地将生产活动,还将复杂的工程设计、监管支援和端到端的供应链物流给专业合作伙伴。这种转变源于医疗设备製造商专注于核心竞争力,例如临床开发和市场推广策略,同时依赖外部供应商来获得规模、流程专业知识和合规基础设施。
因此,契约製造製造商和服务供应商正在扩展其技术组合,涵盖先进材料、积层製造和整合灭菌製程。这些供应商正在投资数位双胞胎、流程分析和验证框架,以满足更严格的品质要求,并加快先进植入和诊断系统的上市速度。因此,采购和产品团队必须应对更复杂的供应商生态系统,其中技术能力、监管记录和地理覆盖范围都同等重要。
本执行摘要概述了当今医疗设备製造外包的营运动态、监管阻力和商业机会。它重点阐述了重塑伙伴关係的变革力量,分析了新贸易壁垒的累积影响,并将市场区隔和地理影响转化为可供业务决策者和负责采购、品质和产品开发的职能领导者参考的战术性建议。
过去几年,技术、监管和市场力量的共同作用从根本上改变了医疗设备原始设备製造商 (OEM) 的委託製造方式。积层製造和精密数控加工技术的进步拓展了可外包产品的范围,实现了复杂几何形状、患者客製化植入以及更短的原型製作週期。同时,灭菌技术和物流能力的成熟,使得全球分散生产高品质产品成为可能。
监管机构对组合产品和数位健康设备的监管期望正朝着更严格的流程控制、更严格的供应商监管以及更完善的文件编制方向发展。因此,受託製造製造商正在将监管方面的专业知识融入他们的服务中,以确保新产品过渡期间技术文件和验证包的顺利转移。同时,永续性和循环经济的概念正在加速生产营运中材料替代和废弃物最小化实践的实施。
竞争格局正在不断演变,专业供应商凭藉其在可製造性设计支援、可扩展的大批量生产和端到端物流的综合能力,赢得了长期伙伴关係。同时,医疗器材製造商正在采用混合采购模式,将策略性长期合约与灵活的、针对特定项目的供应商相结合,以实现快速的创新週期。总而言之,这些转变正在为外包关係建立新的基准,使那些能够在产品开发、灭菌、法规支援和上市后监测等方面展现综合能力的合作伙伴更受青睐。
近期海关制度的调整以及影响零件进口和成品的新关税的出台,为依赖跨境供应链的製造商带来了额外的复杂性。海关制度的变化迫使采购团队重新评估供应商选择标准,权衡货物的总到岸成本、前置作业时间可靠性以及合规负担。因此,企业正在调整筹资策略策略,以控制海关风险,同时保持与关键市场和临床试验地点的接近性。
为因应不断变化的贸易政策,内部相关人员正在评估近岸外包或双重采购策略,以降低对单一供应商的依赖并减轻关税波动的影响。此类策略通常需要投资于合格的替代供应商、转移製程知识以及更新供应商审核通讯协定。此外,一些公司正在加快向区域製造合作伙伴进行技术转让,以避免连续产品被重复征收关税,并更好地控制库存和分销。
这些贸易措施的整体效果是促使各方重新关注供应链图谱绘製、情境规划和合约弹性。跨职能团队正优先考虑统一产品规格和模组化零件设计,以简化供应商过渡。此外,法律和商务负责人正在将关税触发的重新定价条款和更长的技术转移前置作业时间纳入主服务协议,以保护净利率并确保患者照护服务的连续性。
有效的細項分析需要清楚了解产品系列、服务范围、製程能力、材料选择和最终用途环境如何相互作用,从而确定外包的适用性和供应商的兼容性。产品类型的差异会影响监管路径和污染控制要求。例如,植入和整形外科植入等医疗器械比许多牙科和外科器械需要更严格的冶金控制和认证。导管和管道需要考虑流体动态和生物相容性,并与灭菌方式的选择密切相关。诊断设备则着重于电子元件和感测器的整合。
不同的服务类型决定了外包关係中价值的实现方式。提供设计和开发服务(包括概念开发和工程分析)的供应商可以透过及早解决可製造性和验证问题来降低生产转移风险。涵盖初级和二级包装的组装和包装服务能够提高下游环节的效率,例如标籤、序列化和低温运输要求。物流能力(例如低温运输和一般物流)对于温度敏感型诊断至关重要,而灭菌方式(例如电子束、环氧乙烷和伽马射线辐照)必须符合材料相容性和监管核准。从过渡製造和快速原型製作到大规模生产,不同的物流模式需要不同的品质系统和资本结构。
製程类型的选择对前置作业时间、成本结构和设计自由度有显着影响。积层製造方法,包括电子束熔化、熔融沉积建模、选择性雷射烧结和光固化成形法,能够製造病患客製化的医疗器材和连网组件,但需要完善的后处理和可追溯性。而射出成型、吹塑成型、挤出成型和数控加工等传统工艺,对于公差和表面光洁度要求极高的聚合物和金属零件的大批量生产仍然至关重要。
材料类型的选择决定了供应商的产能需求和风险管理优先顺序。电路基板和感测器等电子元件需要供应链的连续性和过时管理,而铝、不銹钢和钛等金属的加工和腐蚀特性各不相同。聚碳酸酯、聚乙烯、聚丙烯和聚氯乙烯等塑胶必须评估其生物相容性和耐灭菌性。无论是高黏度硅酮或液态硅酮,硅酮配方都具有柔软的触感和良好的密封性能,但需要专业的成型和固化技术。
医院和专科中心要求设备和植入在严格的临床工作流程下具备可靠性;门诊医疗中心和诊所通常优先考虑紧凑易用的系统;而居家医疗场景则需要耐用、易用且消毒和维护流程简化的产品。将这些细分维度整合到供应商选择框架中,可以帮助设备製造商将技术要求与营运能力、监管历史和地理覆盖范围相匹配,从而优化开发成本和生命週期成本。
区域动态是筹资策略的核心,因为区域监管预期、人事费用和物流基础设施直接影响供应商的能力和产品上市时间。在美洲,毗邻主要临床中心和成熟的监管路径有利于高复杂度设备的快速迭代,并促进与拥有成熟验证经验的契约製造製造商建立深度伙伴关係。同时,对关键电子元件可靠供应的需求正在推动区域化策略的发展,以减少对漫长远洋运输和海关不确定性的影响。
欧洲、中东和非洲的监管环境日益趋于统一,但市场进入却依然分散。欧洲部分地区拥有大量技术人才和先进材料供应商,推动植入式医疗设备和精密仪器的创新,但製造商仍需应对各国法规和标籤要求的差异。此外,该地区物流复杂,因此需要采用多式联运方案,并利用区域品质中心集中管理无菌储存和最终组装。
亚太地区仍然是大规模製造、先进聚合物加工和快速成长的零件供应商的中心。不断增长的国内需求和不断扩大的临床基础设施正推动亚太地区的製造商向价值链高端发展,提供大规模生产和专业加工服务,例如高精度射出成型和增材製造服务。儘管如此,瞄准亚太市场的公司必须投资于供应商发展,以应对各种法律规范,并确保文件记录的一致性、可追溯性和合规性。
领先的契约製造製造商和服务供应商正从多个方面实现差异化:整合面向製造的设计、灭菌和物流等一体化服务组合;投资于数位化品质体系,实现即时过程监控和审核;以及建构增材製造和先进材料方面的专项能力。市场领导正在实施标准化的验证手册和跨站点认证通讯协定,以减少跨国生产的摩擦,并随着需求的变化加速产能扩张。
同时,一些中型专业供应商正透过专注于特定产品类型和技术而获得市场认可,例如用于整形外科植入的高精度钛加工或用于诊断外壳的先进聚合物包覆成型。这些专业供应商在研发阶段通常具有更高的灵活性,能够快速原型製作并进行迭代设计调整,而这是规模更大、以大规模生产为导向的供应商难以企及的。医疗器材创新者与这些专业供应商之间的策略伙伴关係通常包括共同投资医疗器材认证和联合提交监管文件,以简化商业化流程。
投资者和企业支持的供应商正透过整合和跨国扩张重塑供应商格局,将集中化的合规职能和标准化的营运流程引入新收购的地区。这一趋势提高了跨国製造商的一致性,但也带来了与文化、IT系统和品质指标协调相关的整合风险。最终,成功的公司需要在技术深度、监管能力和商业灵活性之间取得平衡,以满足OEM厂商在产品生命週期中不断变化的需求。
高阶主管应优先考虑策略性供应商细分,将核心产品与拥有监管经验和材料专业知识的合作伙伴相匹配。对于复杂的植入和诊断系统,应要求供应商提供验证活动、灭菌相容性和上市后监测支援的综合证据。同时,对于早期项目,应采用灵活的供应商体系,因为在这些阶段,快速原型製作和迭代设计变更比规模效益更为重要。这种双管齐下的方法既能保持创新步伐,又能保障商业供应的可靠性。
在营运层面,企业应投资完善技术转移流程手册,明确文件标准、验收标准与升级通讯协定。整合研发、品质、采购和监管团队,可确保跨部门协作、顺利交接,并为所有相关人员提供一套统一的成功指标。此外,还应建立合约机制,以应对关税波动、材料替代和产能扩张里程碑等问题,从而在不抑制供应商投资的前提下,共用商业性保障。
最后,领导者应加快数位化倡议,提升多层供应链的透明度。实施端到端可追溯性系统,与关键供应商采用相容的製造执行系统,并使用数据驱动的主导评分卡,综合考量准时交付、品质表现和应对力变化的能力。这些措施有助于在供应链中断时快速进行根本原因分析,并支援持续改进计划,从而提升产品品质和成本可预测性。
本摘要的分析是基于对设备製造商和服务供应商的高级采购、品质和工程负责人进行的访谈,以及与监管和物流专家的专题讨论。这些定性资讯与已发布的监管指南、技术白皮书和公司揭露资讯进行交叉比对,以检验能力声明并梳理反覆出现的营运挑战。访谈通讯协定主要围绕着供应商选择标准、技术转移经验、灭菌策略以及对近期贸易政策变化的因应措施。
二次研究包括对植入、诊断设备和一次性耗材等医疗器材相关的技术标准、灭菌验证方法和製程控制框架进行系统性回顾。在适用情况下,我们将已记录的审核结果与监管机构的检查趋势进行比较,以评估供应商群体的成熟度。调查方法强调可重复性,为此我们制定了访谈指南、资料来源记录以及检验循环机制,将调查结果草稿与专家共用,以获得回馈并进行完善。
快速发展的技术和企业层面的策略转变可能会改变不同研发週期之间的能力格局。为了因应这个问题,我们的研究在评估新兴技术时采用了较保守的解释阈值,并纳入了基于情境的敏感性检验,以考虑供应商绩效和地缘政治环境的变化。
对于寻求在创新敏捷性、法规遵循和成本控制之间取得平衡的医疗设备公司而言,製造外包已成为一项至关重要的策略槓桿。先进的製造流程、不断发展的灭菌方案以及细緻入微的材料选择之间的相互作用,要求原始设备製造商 (OEM) 以投资组合的视角来处理供应商关係,将供应商的优势与产品的复杂性和生命週期阶段相匹配。监管和贸易环境增加了营运风险,而这些风险可以透过积极主动的风险评估、多元化的采购管道以及合约保障措施来降低。
展望未来,竞争优势将属于那些能够将严格的供应商资质认证、灵活的合约签订以及对数位化系统(可即时监控生产和品质指标)的投资相结合的企业。医疗设备製造商若将外包视为一种能力而非单纯的成本削减手段,便能加速创新,透过更高品质的产品改善病患疗效,并建构更具韧性的供应链网络,从而抵御政策和市场衝击。
The Medical Device Outsourced Manufacturing Market is projected to grow by USD 82.13 billion at a CAGR of 11.30% by 2032.
| KEY MARKET STATISTICS | |
|---|---|
| Base Year [2024] | USD 34.87 billion | 
| Estimated Year [2025] | USD 38.86 billion | 
| Forecast Year [2032] | USD 82.13 billion | 
| CAGR (%) | 11.30% | 
Outsourced manufacturing for medical devices has transitioned from a cost-driven tactic to a strategic capability that shapes innovation pipelines, regulatory outcomes, and the resilience of global supply chains. Manufacturers increasingly transfer not only production activities but also complex engineering, regulatory support, and end-to-end supply logistics to specialist partners. This shift is driven by device makers' focus on core competencies-such as clinical development and go-to-market strategy-while relying on external providers for scale, process expertise, and compliance infrastructure.
Consequently, contract manufacturers and service providers are expanding their technical portfolios to include advanced materials, additive manufacturing, and integrated sterilization processes. These providers are investing in digital twins, process analytics, and validation frameworks to meet stricter quality expectations and to reduce time-to-market for sophisticated implantables and diagnostic systems. As a result, procurement and product teams must navigate a more complex supplier ecosystem where technical capability, regulatory track record, and geographic footprint are equally important considerations.
This executive summary synthesizes the operational dynamics, regulatory headwinds, and commercial opportunities that characterize outsourced manufacturing for medical devices today. It highlights the transformative forces reshaping partnerships, analyzes the cumulative effects of new trade barriers, and translates segmentation- and region-level implications into tactical recommendations for executive decision-makers and functional leaders responsible for sourcing, quality, and product development.
The last several years have seen a confluence of technological, regulatory, and market forces that are fundamentally altering how device OEMs approach outsourced manufacturing. Advances in additive manufacturing and precision CNC machining have expanded the set of products that are viable for outsourcing, enabling complex geometries, patient-specific implants, and faster prototyping cycles. Meanwhile, sterilization technologies and logistics capabilities have matured to support globally distributed production with consistent quality outcomes.
Regulatory expectations have shifted toward tighter process control, more rigorous supplier oversight, and enhanced documentation for combination products and digital health-enabled devices. Consequently, contract manufacturers are integrating regulatory affairs expertise into their service offerings, enabling a smoother transfer of technical documentation and validation packages during new product transitions. At the same time, sustainability imperatives and circularity considerations are accelerating material substitution and waste-minimization practices within manufacturing operations.
From a commercial perspective, the competitive landscape is evolving: specialized providers that combine design-for-manufacturability support, scalable volume manufacturing, and end-to-end logistics are winning longer-term partnerships. In parallel, device makers are adopting hybrid sourcing models that blend strategic long-term agreements with agile, program-specific suppliers for rapid innovation cycles. Collectively, these shifts favor partners that can demonstrate integrated capabilities across product development, sterilization, regulatory support, and post-market surveillance, creating a new baseline for outsourcing relationships.
Recent adjustments to tariff regimes and the introduction of new duties affecting component imports and finished goods have introduced additional complexity for manufacturers dependent on cross-border supply chains. Tariff changes have prompted procurement teams to reevaluate supplier selection criteria, weighing the total landed cost of goods against lead-time reliability and regulatory compliance burdens. As a result, businesses are recalibrating sourcing strategies to manage customs exposure while preserving proximity to key markets and clinical study sites.
In response to trade policy shifts, internal stakeholders are assessing nearshoring and dual-sourcing strategies to mitigate single-source dependencies and to reduce the impact of tariff volatility. These approaches often require investments in qualification of alternate suppliers, transfer of process knowledge, and updating of supplier audit protocols. Moreover, some companies are accelerating technology transfers to regional manufacturing partners to avoid repeated customs duties on successive product iterations and to maintain tighter control over inventory and distribution.
The aggregate effect of these trade actions is a renewed focus on supply chain mapping, scenario planning, and contractual flexibility. Cross-functional teams are prioritizing harmonized product specifications and modular component designs that simplify supplier transitions. In addition, legal and commercial negotiators are including tariff-triggered repricing clauses and longer lead times for technology transfer into master services agreements to protect margins and ensure continuity of patient care delivery.
Effective segmentation analysis requires a clear understanding of how product portfolios, service scopes, process capabilities, material selection, and end-use contexts interact to determine outsourcing suitability and supplier fit. Product Type differentiation influences regulatory pathways and contamination control requirements; devices such as cardiology implants and orthopedic implants demand tighter metallurgical controls and more exacting certification than many dental devices or surgical instruments. Catheters and tubing introduce fluid dynamics and biocompatibility considerations that intersect with sterilization choices, while diagnostic equipment places a premium on electronic components and sensor integration.
Service Type distinctions determine where value is realized in an outsourced relationship. Providers that offer design and development services, including concept development and engineering analysis, can de-risk manufacturing transfers by resolving manufacturability and validation issues early. Assembly and packaging services that encompass both primary and secondary packaging create downstream efficiencies in labeling, serialization, and cold chain requirements. Logistics capabilities such as cold chain and general logistics are pivotal for temperature-sensitive diagnostics, and sterilization options-spanning e-beam, ethylene oxide, and gamma irradiation-must align with material compatibility and regulatory acceptance. Manufacturing modalities that range from bridge manufacturing and rapid prototyping to volume production require different quality systems and capital structures.
Process Type choices materially shape lead times, cost structures, and design freedom. Additive manufacturing modalities including electron beam melting, fused deposition modeling, selective laser sintering, and stereolithography enable patient-specific devices and consolidated assemblies but necessitate robust post-processing and traceability. Traditional processes such as injection molding, blow molding, extrusion, and CNC machining remain essential for high-volume polymeric and metallic components where tolerances and surface finishes are critical.
Material Type selection drives supplier capability needs and risk management priorities. Electronic components such as circuit boards and sensors require supply chain continuity and obsolescence management, while metals like aluminum, stainless steel, and titanium present differing machining and corrosion profiles. Plastic families, including polycarbonate, polyethylene, polypropylene, and PVC, must be evaluated for biocompatibility and sterilization resilience. Silicone formulations, whether high consistency or liquid silicone, offer soft-touch interfaces and sealing properties but demand specific molding and curing expertise.
End Use context also affects outsourcing decisions: hospitals and specialty centers expect equipment and implant reliability under rigorous clinical workflows, ambulatory care centers and clinics often prioritize compact, easy-to-use systems, and home healthcare scenarios require durable, user-friendly designs with simplified sterilization and maintenance pathways. Integrating these segmentation dimensions into supplier selection frameworks enables device makers to match technical requirements with operational capabilities, regulatory history, and geographic presence to optimize both development and lifecycle costs.
Geographic dynamics are central to sourcing strategy because regional regulatory expectations, labor costs, and logistics infrastructure directly affect supplier capabilities and time-to-market. In the Americas, proximity to major clinical centers and established regulatory pathways supports rapid iterations for high-complexity devices and fosters deep partnerships with contract manufacturers that have proven validation experience. Meanwhile, the need for secure supply of critical electronic components is shaping localized strategies that reduce exposure to long ocean freight lanes and customs uncertainty.
Europe, the Middle East & Africa present a heterogeneous landscape where regulatory harmonization in some subregions coexists with fragmented market access in others. Strong engineering talent pools and advanced materials suppliers in parts of Europe drive innovation in implantable devices and precision instruments, but manufacturers must reconcile differing national regulations and labeling requirements. In addition, logistical complexity across this broader region encourages multi-modal distribution plans and the use of regional quality hubs to centralize sterile storage and final assembly.
Asia-Pacific continues to be a source of scale manufacturing, advanced polymer processing, and a rapidly growing base of component suppliers. Rising domestic demand and expanding clinical infrastructures are enabling regionally based manufacturers to move up the value chain, offering both volume manufacturing and specialized processing such as high-precision injection molding and additive manufacturing services. Nevertheless, companies targeting Asia-Pacific markets must navigate variable regulatory frameworks and invest in supplier development to ensure consistent documentation, traceability, and compliance.
Leading contract manufacturers and service providers are differentiating along several axes: integrated service portfolios that combine design-for-manufacturing with sterilization and logistics; investments in digital quality systems that enable real-time process monitoring and auditability; and targeted capability builds in additive manufacturing and advanced materials. Market leaders are deploying standardized validation playbooks and cross-site qualification protocols to reduce the friction of multi-country production and to accelerate capacity scaling when demand shifts.
At the same time, mid-tier niche providers are gaining traction by specializing in particular product categories or technical capabilities, such as high-precision titanium processing for orthopedic implants or advanced polymer overmolding for diagnostic housings. These focused providers often offer greater agility during development phases, enabling rapid prototyping and iterative design adjustments that larger, volume-oriented suppliers may find harder to accommodate. Strategic partnerships between device innovators and these niche suppliers frequently include co-investments in equipment qualification and joint regulatory submissions to streamline commercialization.
Investor-backed and corporate-backed providers are also reshaping the supplier landscape through consolidation and cross-border expansions, bringing centralized compliance functions and standardized operating procedures to newly acquired sites. This trend is improving consistency for multinational manufacturers but also introduces integration risks related to culture, IT systems, and harmonized quality metrics. Ultimately, successful companies balance technical depth, regulatory competence, and commercial flexibility to meet the evolving needs of OEMs across product life cycles.
Executives should prioritize strategic supplier segmentation that aligns core products with partners possessing demonstrable regulatory experience and material expertise. For complex implants and diagnostic systems, require suppliers to present consolidated evidence of validation activities, sterilization compatibility, and post-market surveillance support. At the same time, adopt an agile supplier roster for early-stage programs where rapid prototyping and iterative design changes are more valuable than scale efficiencies. This dual approach preserves innovation velocity while safeguarding commercial supply reliability.
Operationally, organizations should invest in strengthened technology transfer playbooks that codify documentation standards, acceptance criteria, and escalation protocols, thereby reducing cycle time during supplier transitions. Cross-functional readiness-bringing together R&D, quality, procurement, and regulatory teams-will create smoother handoffs and ensure that all stakeholders share a single set of success metrics. In addition, introduce contractual mechanisms that address tariff volatility, material substitution, and capacity ramp milestones to provide commercial protections without stifling supplier investment.
Finally, leaders should accelerate digitalization initiatives that improve transparency across multi-tier supply chains. Implement end-to-end traceability systems, adopt manufacturing execution systems compatible with key suppliers, and use data-driven supplier scorecards that combine on-time delivery, quality performance, and responsiveness to change. These steps enable faster root-cause analysis during disruptions and support continuous improvement programs that enhance both product quality and cost predictability.
The analysis underpinning this summary synthesizes primary interviews with senior procurement, quality, and engineering leaders at device manufacturers and service providers, coupled with targeted discussions with regulatory and logistics experts. These qualitative inputs were triangulated with publicly available regulatory guidance, technical white papers, and company disclosures to validate capability claims and to map recurring operational challenges. Interview protocols focused on supplier selection criteria, technology transfer experiences, sterilization strategies, and responses to recent trade policy shifts.
Secondary research included systematic review of technical standards, sterilization validation methodologies, and process control frameworks relevant to device types such as implants, diagnostic equipment, and disposable consumables. Where applicable, capabilities were cross-referenced against documented audit outcomes and regulatory inspection trends to assess maturity levels among supplier cohorts. The methodology emphasized reproducibility through documented interview guides, source logs, and a validation loop in which draft findings were shared with subject matter experts for feedback and refinement.
Limitations of the approach are inherent to any cross-industry synthesis: rapidly evolving technologies and company-level strategic changes can alter capability footprints between research cycles. To address this, the study applied conservative interpretation thresholds when evaluating nascent technologies and incorporated scenario-based sensitivity checks to account for variability in supplier performance and geopolitical conditions.
Outsourced manufacturing has become an indispensable strategic tool for medical device companies seeking to balance innovation agility with regulatory compliance and cost management. The interplay of advanced manufacturing processes, evolving sterilization options, and nuanced material selections requires that OEMs approach supplier relationships with a portfolio mindset-matching supplier strengths to product complexity and life-cycle stage. Regulatory and trade environments add layers of operational risk that can be mitigated through proactive mapping, diversified sourcing, and contractual safeguards.
Looking ahead, the competitive advantage will accrue to organizations that combine rigorous supplier qualification, agile contracting, and investment in digital systems that provide real-time visibility into production and quality metrics. By treating outsourcing as a capability rather than a mere cost lever, device companies can accelerate innovation, improve patient outcomes through higher-quality products, and create more resilient supply networks that withstand policy and market shocks.