Inari Medical, Inc. (NARI): PESTLE Analysis [Nov-2025 Updated]

You're looking for a clear, actionable breakdown of the external forces shaping Inari Medical, Inc. (NARI) right now. Honestly, the short answer is a tightrope walk: while demographic tailwinds are defintely strong, with an aging US population driving demand for their minimally invasive procedures, policy shifts at the Centers for Medicare & Medicaid Services (CMS) and rapid competitive technology risks require constant monitoring. For a company that is expected to post fiscal year 2025 revenue around $580 million, understanding the Political, Economic, Sociological, Technological, Legal, and Environmental (PESTLE) map is crucial. Here's the full analysis, mapping those near-term risks and opportunities to clear actions.

Inari Medical, Inc. (NARI) - PESTLE Analysis: Political factors

You're running a high-growth medical device business, so political and regulatory shifts can change your market access and profitability overnight. For the Inari Medical, Inc. business, now a key segment of Stryker, the biggest political risks and opportunities in 2025 center on federal reimbursement, FDA oversight, and the ongoing consolidation of your hospital customers. We're seeing a clear trend: the government is rewarding proven, high-value technology with better payment, but they are also demanding more long-term, real-world data.

Shifting Centers for Medicare & Medicaid Services (CMS) reimbursement policies for venous thromboembolism (VTE) procedures.

Reimbursement is the lifeblood of a medical device company, and the news from CMS in 2025 is defintely a tailwind for the Inari Medical, Inc. portfolio. The agency is recognizing the value of advanced VTE procedures, which is great for adoption. Specifically, effective January 1, 2025, Medicare upgraded the payment for the LimFlow transcatheter arterialization of the deep veins (TADV) procedure (CPT 0620T).

CMS reassigned the LimFlow procedure to New Technology Ambulatory Payment Classification (APC) 1579. This positive shift means a significant bump in facility payment rates. Here's the quick math on the national average payment increase for this specific procedure, which treats Chronic Limb-Threatening Ischemia (CLTI):

The FlowTriever and ClotTriever procedures, which treat pulmonary embolism (PE) and deep vein thrombosis (DVT), are primarily performed in the hospital inpatient setting, where device reimbursement is bundled into the Diagnosis-Related Group (DRG) payment. The LimFlow system's eligibility for a New Technology Add-on Payment (NTAP) in the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) Final Rule also provides incremental reimbursement, which helps drive hospital adoption by mitigating the initial cost burden.

Increased scrutiny from the U.S. Food and Drug Administration (FDA) on Class II and III device post-market surveillance.

The FDA is tightening the screws on post-market surveillance (PMS) for high-risk devices, and your VTE devices-Class II and Class III-fall squarely into this category. The political climate is pushing for more real-world evidence (RWE) to ensure long-term safety, especially for devices where failure could cause serious harm.

The shift means simply getting a device cleared isn't the finish line anymore; it's the start of a long-term data collection commitment. Companies must now anticipate:

• Increased requirements for real-world evidence (RWE) to support product claims.
• Stricter post-market reporting obligations to monitor adverse events.
• More frequent use of the FDA's Section 522 authority to mandate PMS studies.

For the Inari Medical, Inc. business, this is an opportunity because your clinical trials (like PEERLESS) already focus on robust data, but it's still a cost. You need to budget for enhanced data collection systems and a larger regulatory affairs team to manage the stricter compliance under 21 CFR Part 822.

Potential for changes in the Affordable Care Act (ACA) affecting hospital consolidation and purchasing power.

The Affordable Care Act (ACA) has been a major driver of hospital consolidation for over a decade, and this trend continues through 2025. Larger health systems are merging to gain scale and diversification, which helps them maintain financial stability in a complex regulatory environment. This consolidation directly impacts your sales strategy.

The key effect is the centralization of purchasing power. Control over buying decisions is shifting away from the individual physician, who is your primary champion, to centralized procurement departments and Group Purchasing Organizations (GPOs). These large entities negotiate volume discounts, which pressures your pricing. For instance, hospitals without competitors within a 15-mile radius can command prices 12% higher than those in markets with four or more competitors, demonstrating the leverage they gain. You're no longer selling to a doctor; you're negotiating with a GPO that manages hundreds of millions of dollars in spend. Your sales pitch must now focus less on clinical outcomes alone and more on the total economic value and cost-effectiveness of your VTE solutions.

Global trade tensions impacting the cost and stability of the medical device supply chain.

The political friction between the U.S. and key global manufacturing hubs, particularly China, is a significant cost-driver for the medical device supply chain in 2025. The US's tariff overhaul, introduced in April 2025, imposed a 10% duty on nearly all imports, which affects everything from manufacturing machinery to medical consumables.

More acutely, the reliance on Chinese-sourced raw materials and components is creating a cost headwind. A 15% tariff on imported raw materials like titanium, plastics, and semiconductors from China is increasing component costs across the industry. The increased Section 301 tariffs on Chinese medical exports to the US, in some cases up to 245% on key components, create significant cost and logistics uncertainty. This means your cost of goods sold (COGS) is under constant pressure. Given that the Inari Medical, Inc. business is now part of Stryker, a multinational, the strategy must be to diversify sourcing and potentially increase domestic or near-shore manufacturing to mitigate the risk of these geopolitical shocks.

Inari Medical, Inc. (NARI) - PESTLE Analysis: Economic factors

Persistent inflation raising the cost of raw materials and specialized labor.

You are seeing the direct impact of persistent inflation not just on consumer goods, but deep within the medical supply chain, which directly pressures Inari Medical, Inc.'s gross margin. While the company's projected Gross Margin for 2025 remains high at around 87.0%, this figure is constantly under fire from input cost increases. For healthcare providers, non-labor expense per calendar day was up 10% year-over-year in late 2024, with supply expense specifically growing by 13% and drug expense by 15%. This reflects the raw material and logistics pressure that device manufacturers face, particularly for specialized components like resins, plastics, and metals used in catheter-based systems.

The cost of specialized labor is also a major headwind. Clinical labor cost growth is outpacing general inflation due to persistent shortages. By 2025, the US is expected to face a gap of 200,000 to 450,000 registered nurses. This labor shortage in hospitals translates to higher wages and overtime, which in turn makes hospitals more aggressive in negotiating the price of high-cost devices like the FlowTriever and ClotTriever systems. Here's the quick math: if raw material and labor costs continue to climb, maintaining that 87.0% gross margin requires either exceptional pricing power or significant manufacturing efficiency gains.

Hospital capital expenditure budgets tightening due to higher interest rates and operating costs.

Higher interest rates and ballooning operational costs are forcing hospitals to scrutinize every capital expenditure (CapEx) dollar, which is a near-term risk for Inari Medical, Inc. While the company's devices are often classified as disposable procedure costs rather than large CapEx items, their adoption relies on hospital budget flexibility and investment in new technologies. The US federal deficit is poised to surpass $1.9 trillion in fiscal year 2025, which puts immense fiscal pressure on government healthcare spending like Medicare and Medicaid.

We are already seeing major hospital operators pull back CapEx. For example, one large hospital operator, Tenet, projected a roughly 15% to 25% year-over-year decline in capital expenditures for FY 2025. This tightening means that even if a new technology shows clinical benefit, the administrative hurdle to get it approved and adopted is higher. You need a compelling economic justification, not just clinical data. Sustained operating profitability, which Inari Medical, Inc. expects to reach in the first half of 2025, is a strong counter-narrative, showing the business can manage these macro pressures.

Strong U.S. dollar potentially making international expansion less profitable.

Inari Medical, Inc. is banking on international expansion as a key growth pillar, with a long-term goal for international sales to eventually make up at least 20% of future revenue. The company is actively moving into key markets like Japan and China. However, a persistently strong U.S. dollar (USD) creates a headwind for this growth strategy.

When the USD is strong, revenue generated in foreign currencies (like the Euro or Yen) translates back into fewer U.S. dollars on the income statement. This currency translation risk can suppress reported international revenue growth and lower the profitability of foreign sales, even if the local market performance is excellent. This is defintely a trade-off. The opportunity is a massive, untapped market, but the risk is a currency headwind that could erode the margin on that growth.

Focus on value-based care models pressuring average selling prices (ASPs) for devices.

The healthcare system is rapidly shifting from fee-for-service (FFS) to value-based care (VBC) models, where payment is tied to patient outcomes and quality, not just the volume of procedures. The Centers for Medicare & Medicaid Services (CMS) has a goal for all Medicare beneficiaries to be in VBC arrangements by 2030. This is a huge paradigm shift for medical device companies.

VBC puts direct pressure on the Average Selling Prices (ASPs) of devices because providers are financially accountable for the total cost of an episode of care (bundled payments). Inari Medical, Inc.'s high-value thrombectomy devices must demonstrate superior long-term clinical and economic benefit-like reduced readmissions or shorter hospital stays-to justify their premium pricing. The company's strong clinical trial data, such as the FLAME trial, is a key defense against this pressure, as it provides the necessary evidence to support the device's value proposition in a VBC environment. Still, you have to be ready to prove the financial return on investment for the hospital. The government is not giving much slack: for 2025, while Medicare plans to raise hospital inpatient payment rates by 2.9% on average, it finalized a 2.83% rate cut in physician payments.

Actions to consider in this environment:

• Accelerate clinical data generation to prove long-term cost-effectiveness.
• Develop economic models that quantify the total cost of care reduction.
• Focus sales efforts on hospital systems that are already engaged in bundled payment programs.

Inari Medical, Inc. (NARI) - PESTLE Analysis: Social factors

You're looking for the social and demographic forces that will either fuel Inari Medical, Inc.'s (NARI) growth or slow its adoption curve. The takeaway is clear: the aging U.S. population creates a massive, structurally growing patient pool, but the company's success hinges on overcoming the social barrier of low market penetration through aggressive physician training and addressing deep-seated health equity issues.

Aging U.S. population drives higher incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE).

The core demographic trend is a powerful tailwind for Inari Medical, Inc. The risk of developing Venous Thromboembolism (VTE), which includes Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), is highly correlated with age. The risk for DVT and PE may double with each passing decade after a person turns 40. This is a simple, defintely compelling math problem for the company's addressable market.

In the U.S. alone, VTE affects up to 900,000 people each year. For the oldest cohort, the incidence rate of VTE reaches over 500 per 100,000 in individuals aged 80 and older, a staggering increase from rates in younger populations. This aging demographic means the patient volume for complex clot removal is structurally increasing, regardless of other market dynamics. The sheer size of this problem is why Inari Medical, Inc. estimates the domestic Total Addressable Market (TAM) for DVT and PE combined is approximately $5.8 billion annually.

Growing patient awareness and demand for minimally invasive, catheter-based treatments.

Patients and physicians are actively moving away from older, more invasive procedures or conservative medical management (like blood thinners) toward minimally invasive, catheter-based thrombectomy. This shift is driven by clinical evidence showing superior clot removal and better long-term outcomes for patients.

Despite the large TAM, the market for these advanced venous treatments is still in its early growth phase. Analysts estimate that the DVT and PE markets are currently less than 20% penetrated, with the majority of patients still receiving conservative medical management. This low penetration signals significant runway for companies like Inari Medical, Inc. The U.S. thrombectomy devices market size is valued at USD 480 million in 2025, and it is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.41% through 2034. This growth rate reflects the increasing awareness and the accelerating adoption of these procedures.

Physician training and adoption curve for new thrombectomy devices remains a key growth driver.

The biggest near-term lever for Inari Medical, Inc. is accelerating physician competence and confidence. New technology adoption (like the FlowTriever and ClotTriever systems) is directly tied to the quality and availability of training, especially for interventional specialists.

Inari Medical, Inc. addresses this with its comprehensive medical education platform, the Clot Warrior Academy. This platform includes:

• On-demand library with 130+ hours of peer-to-peer webinars and case studies.
• Advanced user summits for enhanced interventional techniques.
• The Inari-LEARN program, a full-year curriculum for residents and fellows to build expertise in Venous Thromboembolism (VTE) management.

This heavy investment in education is crucial because it not only trains new users but also helps existing centers navigate the complexities of reimbursement, which the company supports with its dedicated Health Economic and Market Access Managers and a 2025 Procedure Coding Guide. Simply put, getting the technology in the hands of trained, confident physicians is the clearest path to converting that $5.8 billion TAM into revenue.

Increased focus on health equity and access to specialized vascular care in diverse communities.

A critical social challenge and opportunity is the disparity in access to specialized vascular care. Cardiovascular health inequities are a major focus for U.S. healthcare leaders, with organizations like the American College of Cardiology (ACC) hosting a Health Equity Summit in 2025 to address this. The reality is that approximately 11% of Americans lack access to quality healthcare, with this disparity being most severe in minority and low-income communities.

This matters because African Americans have the highest rates of DVT and PE in the U.S. If a medical device company like Inari Medical, Inc. can align its commercial strategy with the national push for health equity-by partnering with hospitals in underserved areas or supporting community-based education-it can unlock patient populations currently underserved by the less than 20% market penetration rate. The MSD Foundation's commitment of $22 million over five years (2025-2030) to improve access to cardiac care in barrier-facing communities highlights the financial and social momentum behind this trend. For Inari Medical, Inc., improving access is both a social imperative and a clear-cut business opportunity to expand its footprint.

Inari Medical, Inc. (NARI) - PESTLE Analysis: Technological factors

Rapid competitive innovation in the catheter-based thrombectomy space, challenging Inari's market share.

The thrombectomy market is a dynamic, high-stakes arena, and Inari Medical, even as a subsidiary of Stryker following the February 2025 acquisition for approximately $4.9 billion, faces relentless innovation from competitors. Your core business, which has historically dominated the venous space, is being challenged by players who are rapidly advancing their aspiration and mechanical platforms. The global thrombectomy devices market is valued at roughly $1.75 billion in 2025, and everyone wants a bigger slice.

Competitors like Penumbra, Medtronic, and Boston Scientific are not standing still. Penumbra, for instance, focuses heavily on material science and precise device engineering to improve procedural safety and efficiency. This constant pressure means Inari must defintely accelerate its own product cycle to maintain a technological edge. The sheer number of new product clearances in 2025 alone demonstrates this competitive velocity.

Integration of artificial intelligence (AI) in imaging and procedural planning to improve outcomes.

The biggest technological shift right now isn't just in the catheter itself; it's in the software that gets the patient to the catheter faster. Artificial Intelligence (AI) is revolutionizing triage and procedural planning, especially for time-sensitive treatments like stroke. This is a crucial area where Inari, and now Stryker, must invest or partner to stay relevant.

AI-driven imaging systems, such as Viz LVO (Viz.ai), are already making a measurable difference in clinical workflow. For stroke patients, the implementation of this AI software has been shown to reduce the critical door-to-procedure time by an average of 11.2 minutes. This is a massive improvement in a field where time is brain tissue.

The benefit is moving beyond just imaging. Large Language Models (LLMs) are being tested for clinical decision-making, achieving an overall accuracy of 88% in determining patient eligibility for mechanical thrombectomy based on radiology reports and clinical data. The future of thrombectomy isn't just a better device, it's a faster, AI-optimized clinical pathway.

High research and development (R&D) expenditure needed to maintain a defintely competitive product pipeline.

Innovation isn't cheap, and the competitive environment mandates a continually increasing investment in R&D. Inari Medical's strategy has been to maintain a high R&D spend to drive its product pipeline, and this pressure won't ease under Stryker's ownership. For context, Inari's R&D expenses for the first quarter of 2024 were $26.9 million, a 21.8% increase year-over-year. This figure shows the pace of investment required just to keep up.

The high R&D is necessary to fund the development and clinical trials for new systems like the Artix Thrombectomy System, which Inari launched in March 2025 as its inaugural entry into the peripheral arterial space. The company was on track to achieve sustained operating profitability in the first half of 2025, but that profitability is directly tied to the success of these R&D investments. Analyst consensus projects a minimal profit of roughly $0.25 per share in FY2025, underscoring how tightly margins are managed against high R&D demands.

Advancements in materials science improving device efficacy and reducing procedure time.

The core of Inari's business is its catheter-based devices, and materials science is the silent engine of their efficacy. New materials and design refinements are enabling devices that are more flexible, have lower profiles, and are more efficient at clot retrieval, all of which directly translate to better patient outcomes and shorter procedure times.

Key areas of advancement include:

• Developing low-profile catheters that can navigate smaller, more tortuous vessels.
• Creating multimodal systems that combine aspiration and mechanical clot removal in a single device, like the Artix System.
• Improving catheter tip design to enhance clot engagement and minimize vessel trauma.
• Integrating tissue-sensing technology to improve precision during clot removal.

The entire mechanical thrombectomy market is seeing a push for devices that offer a more complete clot retrieval, which is a direct function of material and design science. This focus on device efficacy is what will determine market leadership over the next five years. You must ensure your materials innovation pipeline is as strong as your commercial footprint.

Inari Medical, Inc. (NARI) - PESTLE Analysis: Legal factors

For a high-growth medical device company like Inari Medical, the legal landscape isn't just a compliance checklist; it's a major operational risk and a critical part of defending your competitive moat. What we're seeing in 2025 is a convergence of aggressive intellectual property defense, heightened scrutiny on physician relationships, and the fallout from serious product liability issues. The legal costs are real, and they directly impact the bottom line.

Ongoing Intellectual Property (IP) Litigation and Patent Defense Against Competitors

The medical technology space is a patent war zone, and Inari Medical is actively defending its turf. The company's core technology, which underpins its successful thrombectomy devices, is constantly under threat from competitors looking to enter the high-value venous thromboembolism (VTE) market. Defending these patents is expensive, but losing them would be catastrophic.

A key example is the ongoing patent infringement lawsuit against Imperative Care Inc. in the U.S. District Court for the Northern District of California. This case centers on Inari Medical's patent 11,744,691, which protects a system for removing thrombus (blood clots). Importantly, Imperative Care's attempt to invalidate this patent through an inter partes review (IPR) at the Patent and Trademark Office failed in February 2025. This means the district court litigation will proceed, likely dragging on for at least another 18 months and consuming significant legal resources. We also saw a decision in October 2025 in a Delaware District Court case involving Inari Medical v. Inquis Medical, Inc., which clarified rules around pleading willful infringement and enhanced damages-a sign of how aggressively Inari Medical is using the courts to protect its IP. It's a necessary cost of doing business, but defintely a drain on resources.

Evolving State and Federal Regulations on Physician-Industry Relationships (e.g., Sunshine Act Reporting)

The regulatory environment governing how medical device companies interact with physicians is tightening, and Inari Medical is already under the microscope. Federal laws like the Anti-Kickback Statute and the Civil False Claims Act prohibit improper compensation to healthcare professionals to induce product use. The Physician Payments Sunshine Act (Open Payments) mandates transparency, requiring manufacturers to report payments and transfers of value to physicians and teaching hospitals.

A major legal cloud for Inari Medical is the civil investigative demand (CID) from the Department of Justice (DOJ) concerning its relationships with healthcare professionals. This is a serious matter. Furthermore, a class action lawsuit filed against the company alleges that a significant portion of its expenses were used to unlawfully compensate medical professionals for using their products. This suggests a systemic compliance failure, or at least a perceived one, that investors are now challenging. Legal and associated expert expenses related to these matters are recorded within Selling, General, and Administrative (SG&A) costs. For context, Inari Medical's GAAP operating expenses for Q3 2024 were $147.1 million, a substantial increase from $109.8 million in Q3 2023, with professional fees, including legal costs, being a key driver of that growth. This is the price of regulatory scrutiny.

Strict Compliance with Health Insurance Portability and Accountability Act (HIPAA) for Patient Data

As a medical device company that interacts with hospitals and patient data (often as a Business Associate), Inari Medical must maintain strict compliance with the Health Insurance Portability and Accountability Act (HIPAA). The legal requirements here are not static; they are rapidly evolving in 2025.

Key areas of focus for 2025 compliance include:

• HIPAA Security Rule Updates: Proposed updates in 2025 aim to strengthen cybersecurity, including new requirements for maintaining retrievable electronic Protected Health Information (ePHI) backups and a tighter 24-hour notification window for Business Associates activating a contingency plan.

• Reproductive Health Data: Stricter federal guidelines on the disclosure of Protected Health Information (PHI) related to reproductive health care became effective in late 2024, requiring updated HIPAA policies and staff training throughout 2025.

• AI Data Use: The increasing use of AI in healthcare requires careful management of patient data, ensuring proper licensing and consent, and avoiding the use or retention of PHI for product development or marketing without explicit notice.

Inari Medical supports its provider network with a 2025 Procedure Coding Guide and Health Economic and Market Access (HEMA) Managers, which helps clinicians with coding, billing, and documentation. This is a crucial, high-touch strategy, but it also means the company is deeply embedded in the compliance chain of its customers, increasing its own compliance burden.

Product Liability Risk Management for High-Stakes, Life-Saving Medical Devices

Inari Medical's products, like the FlowTriever and ClotTriever systems, are high-stakes, life-saving devices used in complex thrombectomy procedures. This inherently carries a high product liability risk. The company's own filings acknowledge that product liability claims are prevalent in the medical device industry, can be expensive to defend, and may result in sizable damage awards that could exceed insurance coverage.

This risk materialized with the 2024 Class I recall-the FDA's most serious classification-of the FlowTriever and ClotTriever catheters. The recall was issued due to manufacturing defects and concerns about improper usage instructions, which were linked to severe complications, including vessel damage, internal bleeding, and in some cases, death. This has led to multiple lawsuits being investigated and filed by affected patients and their families in 2025. This is a critical legal and reputational challenge that requires significant financial reserves and a robust defense strategy.

Here's a quick look at the financial context for these legal and operational risks, based on 2025 projections and recent data:

The immediate next step for the legal team is to quantify the potential financial exposure from the product liability lawsuits and the DOJ CID, and then work with Finance to ensure the reserve for legal contingencies is adequate for the rest of 2025.

Inari Medical, Inc. (NARI) - PESTLE Analysis: Environmental factors

Increasing regulatory pressure on the disposal of single-use medical devices and biohazardous waste.

The environmental cost of single-use medical devices is a critical and growing concern for the healthcare sector, directly impacting Inari Medical, Inc.'s core business. Your FlowTriever and ClotTriever systems are single-use, sterile catheters, meaning they contribute to the massive volume of hospital waste. The US healthcare industry generates approximately 6 million tons of waste annually, and while about 85% is non-hazardous, the remaining 15% is biohazardous or infectious waste requiring specialized, high-cost disposal methods like incineration or autoclaving.

This pressure is increasing on two fronts: cost and regulation. Hospitals are looking to reduce waste disposal costs, and regulators are pushing for a circular economy. The European Union's new Packaging and Packaging Waste Regulation (PPWR 2025/40), which applies from August 2026, will force manufacturers to redesign sterile packaging for recyclability by August 2030, and it introduces Extended Producer Responsibility (EPR) fees. This means Inari Medical will soon pay fees based on how difficult their packaging is to recycle.

Here is the quick math on the industry-wide challenge that Inari Medical faces:

The regulatory trend is clear: design for disposal is now a compliance and cost issue. You cannot afford to ignore this.

Demand from institutional investors for transparent Environmental, Social, and Governance (ESG) reporting.

Institutional investors, including major asset managers, are no longer treating ESG as a nice-to-have; it is a core fiduciary duty. Global ESG Assets Under Management (AUM) are forecast to grow to $53 trillion by the end of 2025. This massive capital pool prioritizes companies that disclose and manage environmental risks effectively, and Inari Medical's relatively small environmental disclosure footprint creates a transparency risk.

While Inari Medical publishes an Ethos and Sustainability Report, the lack of readily available, specific, and independently verified environmental metrics (like Scope 1 and 2 Greenhouse Gas emissions) in the public domain creates a potential discount factor. Investors are using frameworks like the Task Force on Climate-Related Financial Disclosures (TCFD) to assess risk. For a company with a projected $708 million in 2025 revenue, a failure to quantify and report key environmental metrics is a clear signal of immaturity in corporate governance.

The investment community is looking for concrete data points:

• Quantify Scope 1 and 2 emissions (direct operations).
• Establish a measurable waste reduction or recycling target.
• Link executive compensation to environmental performance metrics.

Honestly, without these numbers, you're just giving BlackRock and Vanguard an easy reason to screen you out of their dedicated ESG funds.

Need to optimize the supply chain for reduced carbon footprint and sustainable sourcing of components.

The largest environmental impact for a medical device company like Inari Medical lies in its supply chain, which falls under Scope 3 emissions (indirect emissions from the value chain). Across the entire healthcare sector, 60-70% of total greenhouse gas (GHG) emissions come from the supply chain, including manufacturing and logistics. This means your biggest environmental lever is not your Irvine headquarters, but the materials and transportation of your FlowTriever and ClotTriever components.

The complexity of securing sterile, high-quality catheter components and packaging while simultaneously demanding lower carbon footprints from suppliers is a significant operational challenge. You need to focus on two main areas:

• Logistics: Shifting from air freight to ocean freight where possible, or consolidating shipments.
• Sourcing: Requiring suppliers to provide material declarations on recycled content or lower-impact polymers.

The long-term opportunity here is to use sustainable design (circular economy principles) to reduce the material and energy intensity of each device, which can also de-risk supply chains and reduce input costs over time. This is defintely a strategic imperative, not just a compliance issue.

Compliance with global regulations like the European Union's Restriction of Hazardous Substances (RoHS) directive.

Compliance with the European Union's Restriction of Hazardous Substances (RoHS) directive (2011/65/EU) is a non-negotiable requirement for access to the European market, which is a key part of Inari Medical's international expansion strategy. RoHS restricts the use of specific hazardous materials-like lead, mercury, and cadmium-in electrical and electronic equipment (EEE). While Inari Medical's core products are mechanical catheters, the associated systems, such as the consoles or any electrical accessories used to operate the devices, fall under this directive.

Inari Medical is certified to the higher-level Medical Devices Regulation (VO (EU) 2017/745), which mandates tracking a device's complete lifecycle, including disposal. This comprehensive certification suggests an underlying compliance framework that should encompass RoHS requirements for their electrical components. However, a specific, public declaration of RoHS compliance is the standard expectation for risk mitigation. Any lapse in material declarations from a sub-component supplier could lead to a product recall, which would be a major financial and reputational hit against your projected $708 million revenue base. The compliance team needs to ensure a robust system for tracking all restricted substances down to the raw material level for every component that enters the EU.