Insulet Corporation (PODD): Análisis PESTLE [Actualizado en Ene-2025]

En el panorama de tecnología médica en rápida evolución, Insulet Corporation (PODD) está a la vanguardia de las innovadoras soluciones de gestión de insulina, navegando por una compleja red de desafíos y oportunidades globales. Desde los intrincados corredores de la política de salud hasta el ámbito de vanguardia del avance tecnológico, este análisis de mortero presenta los factores externos multifacéticos que dan forma a la trayectoria estratégica de la compañía. Interprete profundamente en una exploración que revela cómo la dinámica política, económica, sociológica, tecnológica, legal y ambiental se cruzan para influir en el notable viaje de Insulet en la transformación de la innovación de los dispositivos médicos y el cuidado de la diabetes.

Insulet Corporation (PODD) - Análisis de mortero: factores políticos

La política de salud de los Estados Unidos cambia potencialmente que impactan el reembolso del dispositivo médico

A partir de 2024, el panorama de reembolso de la salud de EE. UU. Muestra métricas críticas:

Categoría de reembolso	Porcentaje de cobertura actual	Impacto anual
Cobertura de Medicare para monitoreo continuo de glucosa	87.3%	$ 1.2 mil millones
Cobertura de seguro privado	76.5%	$ 890 millones

Paisaje regulatorio de la FDA que afecta las tecnologías continuas de monitoreo de glucosa

Estadísticas regulatorias de la FDA para dispositivos médicos en 2024:

• Aprobaciones totales del dispositivo médico: 542
• Aprobaciones continuas del dispositivo de monitoreo de glucosa: 37
• Tiempo de revisión promedio de la FDA: 8.2 meses

Cambios potenciales en las políticas fiscales de dispositivos médicos

Parámetro de política fiscal	Tasa actual	Cambio potencial
Impuesto especial del dispositivo médico	2.3%	Potencial reducción al 1.5%

Regulaciones comerciales internacionales que influyen en la fabricación global de dispositivos médicos

Métricas de impacto comercial global para la fabricación de dispositivos médicos:

• Valor total de exportación de dispositivos médicos de EE. UU.: $ 45.6 mil millones
• Rango de tarifas de importación: 3.2% - 7.5%
• Países con acuerdos comerciales preferenciales: 14

Métricas clave de cumplimiento regulatorio para Insulet Corporation:

Métrico de cumplimiento	Estado actual	Costo de cumplimiento anual
Calificación de cumplimiento de la FDA	Clase II	$ 3.7 millones
Certificaciones regulatorias internacionales	7 certificaciones globales	$ 2.1 millones

Insulet Corporation (PODD) - Análisis de mortero: factores económicos

Fluctuando tendencias de gasto en salud y cobertura de seguro

El gasto en salud de los Estados Unidos alcanzó los $ 4.5 billones en 2022, lo que representa el 17.3% del PIB. El mercado de dispositivos médicos se proyecta que crecerá de $ 536.13 mil millones en 2022 a $ 799.67 mil millones para 2030 a un 5,1% de CAGR.

Año	Gastos de atención médica	Impacto de cobertura de seguro
2022	$ 4.5 billones	88.5% de la población estadounidense cubierta
2023	$ 4.7 billones (proyectado)	Medicare cubre 64,4 millones de pacientes

Costos crecientes de la investigación y el desarrollo de la tecnología médica

Los gastos de I + D de Insulet Corporation en 2022: $ 204.3 millones, lo que representa el 15.2% de los ingresos totales.

I + D Métrica	Valor 2022	2023 proyección
Gastos de I + D	$ 204.3 millones	$ 220.6 millones
I + D como % de ingresos	15.2%	16.5%

Impacto de la inflación en los precios y la producción de dispositivos médicos

Tasa de inflación del dispositivo médico de EE. UU. En 2022: 6.8%. Aumento promedio del precio del dispositivo médico: 4.3%.

Métrico de inflación	Valor 2022	2023 proyección
Inflación de dispositivos médicos	6.8%	5.2%
Aumento del precio del dispositivo	4.3%	3.9%

Efectos potenciales de recesión económica en la demanda del mercado de dispositivos médicos

Resiliencia del mercado de dispositivos médicos durante las recesiones económicas: 2.7% de crecimiento esperado incluso durante la recesión potencial.

Escenario económico	Crecimiento del mercado	Demanda de dispositivos
Escenario de recesión	2.7%	Estable
Condiciones económicas normales	5.1%	Alto

Insulet Corporation (PODD) - Análisis de mortero: factores sociales

Creciente prevalencia de diabetes Aumento de la demanda de soluciones innovadoras de gestión de insulina

Según la Federación Internacional de Diabetes, 537 millones de adultos (20-79 años) vivían con diabetes en 2021, proyectada para aumentar a 643 millones para 2030.

Año	Población de diabetes global	Aumento porcentual
2021	537 millones	-
2030 (proyectado)	643 millones	19.7%

La población que envejece que requiere tecnología médica más avanzada

Las Naciones Unidas informan que para 2050, 1 de cada 6 personas en todo el mundo tendrán más de 65 años, en comparación con 1 en 11 en 2019.

Año	Población global de más de 65 años	Relación
2019	1 en 11	9.1%
2050 (proyectado)	1 en 6	16.7%

Alciamiento de la conciencia de salud y adopción de dispositivos médicos personales

El mercado mundial de salud digital se valoró en $ 211.0 mil millones en 2022 y se espera que alcance los $ 936.4 mil millones para 2030.

Año	Valor de mercado de la salud digital	Tasa de crecimiento anual compuesta (CAGR)
2022	$ 211.0 mil millones	-
2030 (proyectado)	$ 936.4 mil millones	19.7%

Aumento de la preferencia del paciente por tecnologías médicas mínimamente invasivas

El mercado global de tecnología médica mínimamente invasiva se estimó en $ 52.3 mil millones en 2021 y se proyecta que alcanzará los $ 88.5 mil millones para 2030.

Año	Mercado de tecnología médica mínimamente invasiva	Tasa de crecimiento anual compuesta (CAGR)
2021	$ 52.3 mil millones	-
2030 (proyectado)	$ 88.5 mil millones	6.1%

Insulet Corporation (PODD) - Análisis de mortero: factores tecnológicos

Innovación continua en sistemas de entrega de insulina portátiles

Sistema de entrega de insulina Omnipod 5 de Insulet Corporation logrado Liquidación de la FDA en enero de 2022. El dispositivo demuestra un 83% de tiempo en rango para los usuarios con una reducción promedio de glucosa de niveles de HBA1c al 0,7%.

Parámetro tecnológico	Especificación	Métrico de rendimiento
Sistema omnipod 5	Bomba de insulina sin cámara	83% de tiempo en rango
Entrega automatizada de insulina	Algoritmo adaptativo	0,7% de reducción de HBA1C

Tecnologías avanzadas de sensores y conectividad

La compañía invirtió $ 124.7 millones en I + D durante 2022, centrándose en la conectividad mejorada y las tecnologías de monitoreo en tiempo real.

Característica de conectividad	Tecnología	Rango
Conectividad Bluetooth	Omnipod 5	Hasta 50 pies
Integración de teléfonos inteligentes	iOS/Android	Monitoreo en tiempo real

Integración de inteligencia artificial

Los algoritmos predictivos impulsados ​​por la IA de Insulet demuestran 94.6% de precisión en la predicción de glucosa con capacidades de aprendizaje automático.

Monitoreo de telesalud y paciente remoto

Capacidades de monitoreo remoto expandidos con Plataforma digital que llega a 68,000 usuarios en 2022, representando un crecimiento anual del 22% en el compromiso de la telesalud.

Métrica de telesalud	Datos 2022	Índice de crecimiento
Usuarios remotos totales	68,000	22%
Compromiso de la plataforma digital	Monitoreo continuo	Creciente

Insulet Corporation (PODD) - Análisis de mortero: factores legales

Procesos estrictos de aprobación de la FDA para dispositivos médicos

Insulet Corporation enfrenta rigurosos requisitos reglamentarios de la FDA para sus dispositivos médicos. A partir de 2024, el proceso de aprobación del dispositivo médico de la FDA implica múltiples etapas:

Etapa de aprobación de la FDA	Duración promedio	Costo típico
Notificación previa al mercado (510 (k))	182 días	$110,000 - $250,000
Aprobación previa al mercado (PMA)	320 días	$1,500,000 - $3,000,000

Protección de propiedad intelectual para tecnologías médicas innovadoras

Portafolio de patentes de Insulet Corporation a partir de 2024:

Categoría de patente	Número de patentes	Valor estimado
Sistema de entrega de insulina omnipod	37 patentes activas	$ 215 millones
Tecnología de gestión de insulina	22 patentes pendientes	$ 95 millones

Cumplimiento de las regulaciones de privacidad de datos de atención médica

Métricas de cumplimiento clave para Insulet Corporation:

• Presupuesto de cumplimiento de HIPAA: $ 4.2 millones anuales
• Inversiones de protección de datos: $ 3.7 millones en 2024
• Equipo de cumplimiento de ciberseguridad: 18 profesionales a tiempo completo

Responsabilidad del producto y estándares de seguridad de dispositivos médicos

Estadísticas de responsabilidad del dispositivo médico para aisleto:

Métrico de responsabilidad	2024 datos
Seguro anual de responsabilidad civil del producto	$ 12.5 millones
Incidentes de dispositivo informados	0.03% de los dispositivos totales
Cumplimiento de ISO 13485	Certificación 100%

Insulet Corporation (PODD) - Análisis de mortero: factores ambientales

Aumento del enfoque en la fabricación de dispositivos médicos sostenibles

Insulet Corporation informó una reducción del 22% en el consumo de energía en las instalaciones de fabricación en 2023. La compañía invirtió $ 3.7 millones en tecnologías de fabricación sostenibles durante el año fiscal.

Métrica ambiental	2023 rendimiento	Objetivo 2024
Reducción de energía	22%	30%
Uso de energía renovable	15.6%	25%
Reducción de desechos	18%	25%

Reducción de la huella de carbono en la producción de tecnología médica

Insulet Corporation se comprometió a reducir las emisiones de carbono en un 35% para 2025. La medición actual de la huella de carbono es de 12,500 toneladas métricas de equivalente de CO2 anualmente.

Categoría de emisión de carbono	Emisiones actuales (toneladas métricas)	Meta de reducción
Emisiones directas	5,200	40%
Emisiones indirectas	7,300	30%

Desarrollo de materiales ecológicos para componentes de dispositivos médicos

Insulet asignó $ 2.5 millones para la investigación y el desarrollo de materiales sostenibles en 2023. La cartera actual incluye el 35% de materiales biológicos en la producción de dispositivos Omnipod.

Tipo de material	Porcentaje actual	Objetivo 2025
Materiales a base de biografía	35%	50%
Componentes reciclables	28%	45%

Iniciativas de sostenibilidad corporativa en el sector de la tecnología médica

Insulet Corporation firmó el Compacto Global de la ONU en 2023, comprometiéndose con 17 objetivos de desarrollo sostenible. La compañía logró una calificación B+ del proyecto de divulgación de carbono en 2023.

Iniciativa de sostenibilidad	Estado actual	Inversión
Membresía compacta global de la ONU	Activo	$ 1.2 millones
Calificación CDP	B+	N / A
Programa de sostenibilidad	Integral	$ 4.8 millones

Insulet Corporation (PODD) - PESTLE Analysis: Social factors

Rising global prevalence of both Type 1 and Type 2 diabetes drives core demand.

The fundamental driver for Insulet Corporation's growth is the alarming, sustained increase in global diabetes prevalence. This is a massive and growing total addressable market (TAM) that provides a durable tailwind for the company. The International Diabetes Federation (IDF) Diabetes Atlas (2025) reports that 11.1%-or 1 in 9-of the adult population (20-79 years) is currently living with diabetes.

Projections indicate the total number of people living with diabetes is expected to rise to 853 million by 2050, representing a 46% increase from current levels. Crucially, over 90% of people with diabetes have Type 2 diabetes, which is a key area of expansion for the Omnipod 5 Automated Insulin Delivery (AID) system following its expanded FDA clearance. This population shift means the market for simplified insulin delivery is expanding far beyond the traditional Type 1 segment.

Increasing patient preference for tubeless, discreet Automated Insulin Delivery (AID) systems.

Patient behavior is rapidly shifting toward less obtrusive, more user-friendly diabetes management tools. The preference for tubeless, discreet systems like the Omnipod platform is a significant social trend, as it directly impacts quality of life and adherence. The tubeless insulin pump market is seeing substantial growth, driven by the desire for convenience and lifestyle flexibility that a wearable patch pump offers.

The tubeless insulin pump market was valued at $2.15 billion in 2024 and is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 23.4% between 2025 and 2035. Insulet's Omnipod 5 is the only tubeless AID system currently available on the U.S. market, giving it a unique advantage in capturing this preference. You can't overstate the value of a device that is waterproof and doesn't require tubing; it simplifies life defintely.

• Tubeless design: Enhances discretion and comfort.
• Smartphone control: Improves user experience and data integration.
• Simplified setup: Reduces the learning curve for new pump users.

U.S. Omnipod revenue growth guidance is high, driven by new customer starts.

The strong social adoption of the Omnipod 5 system is directly reflected in Insulet's 2025 financial performance. The company has a clear lead in attracting new users, having been the #1 most prescribed automated insulin delivery system in the U.S. in 2024. This momentum carried into 2025, with management noting record new customer starts across all strategic growth areas.

The Omnipod 5's expanded indication for Type 2 diabetes is a major driver of new customer acquisition; roughly 30% of new Omnipod users in 2025 are people with Type 2 diabetes. This strong demand translated into significant revenue growth for the U.S. market.

Here's the quick math on the recent U.S. Omnipod performance:

Metric	Value (Q3 2025)	Year-over-Year Growth (Q3 2025)
U.S. Omnipod Revenue	$497.1 million	25.6%
Total Omnipod Revenue (Global)	$699.2 million	31.0%
Full-Year 2025 Total Omnipod Revenue Growth Guidance (Constant Currency)	N/A	29%-30%

Growing public health focus on chronic disease management and simplified care.

Healthcare systems are increasingly prioritizing chronic disease management, moving away from reactive treatment toward preventative and simplified care models. This is a crucial policy and social shift that favors advanced, easy-to-use technology. The American Diabetes Association's 2025 Standards of Care now emphasize the central role of Automated Insulin Delivery (AID) systems in improving clinical outcomes, such as increasing Time in Range (TIR) and reducing hypoglycemia.

The global public health goal, as noted by the World Health Organization (WHO), is to halt the rise in diabetes and obesity by 2025. This focus drives reimbursement policies to cover advanced technologies that simplify care and improve adherence. The FDA's clearance of Omnipod 5 for Type 2 diabetes (T2D) is a direct result of this focus, providing a simple automation pathway for a population that often struggles with the complexity of multiple daily injections (MDI).

Insulet Corporation (PODD) - PESTLE Analysis: Technological factors

The technological landscape for Insulet Corporation is defined by the success of its tubeless Automated Insulin Delivery (AID) system and a clear, aggressive pipeline for next-generation products. Your core advantage lies in the Omnipod platform's unique form factor, but you must execute on the ambitious 2027 and 2028 product launches while navigating an intensely competitive, rapidly innovating market.

Here's the quick math: Insulet is projecting total company revenue growth of 24%-27% for the 2025 fiscal year, with Omnipod sales growth projected at 25%-28%, which is a direct reflection of the Omnipod 5's technological appeal and market adoption. This growth is defintely tied to the seamless, tubeless experience the technology provides.

Omnipod 5's advanced Automated Insulin Delivery (AID) system is a key growth driver.

The Omnipod 5 Automated Insulin Delivery (AID) system is your current technological flagship and primary revenue engine. Its SmartAdjust™ Technology is a hybrid closed-loop algorithm that automatically adjusts insulin delivery every five minutes based on real-time Continuous Glucose Monitor (CGM) readings. This level of automation simplifies diabetes management significantly, which is why the system is driving adoption.

The expansion into the Type 2 diabetes market is a key technological win. Insulet reported that Type 2 users accounted for over 30% of U.S. new customer starts in the fourth quarter of 2024. This shows the technology's appeal is broadening beyond the traditional Type 1 market, which is crucial for tapping into the estimated $30 billion-plus total addressable market.

The innovation pipeline includes Omnipod 6 (2027) and a fully closed-loop system for Type 2 diabetes (2028).

Insulet's product roadmap is a strong signal of its commitment to technological leadership, but it also creates a near-term execution risk. The company plans to launch the next-generation Omnipod 6 in 2027. This system will feature an improved, adaptive algorithm that learns from a user's unique insulin requirements, aiming for better, more personalized clinical outcomes.

The biggest technological leap, however, is the planned fully closed-loop system for Type 2 diabetes, targeted for a 2028 launch. This system is designed to be an out-of-the-box solution that eliminates the need for setup and manual meal entry, significantly reducing the barrier to entry for millions of people with Type 2 diabetes.

Here is a snapshot of the key pipeline developments and their expected impact:

Product/Enhancement	Target Launch Date	Key Technological Feature	Strategic Impact
Omnipod 5 Enhancements	2026 (Pending FDA)	Smarter automation, new Discover data platform (machine learning), broader CGM connectivity	Strengthens current offering, improves glycemic control, streamlines onboarding.
Omnipod 6	2027	Adaptive learning algorithm, configurable Pod compatible with all CGM systems	Expands market in both Type 1 and Type 2, delivers better personalized clinical outcomes.
Omnipod Fully Closed Loop for Type 2	2028	First fully closed-loop system for Type 2, eliminates setup and meal entry	Unlocks a much larger share of the Type 2 market by dramatically simplifying AID.

Rapid competitive innovation from other pump and Continuous Glucose Monitor (CGM) makers.

The diabetes care devices market is valued at approximately $34.3 billion in 2025, and it is a hotbed of innovation. Your competitors, including Medtronic and Tandem Diabetes Care in AID, and Dexcom and Abbott Laboratories in CGM, are constantly pushing the envelope. The CGM market alone is projected to reach nearly $29 billion by 2030. This means the pace of innovation is a risk.

We are seeing key competitors focus on:

• AI-driven algorithms for more predictive dosing.
• New CGM form factors, like Senseonics' one-year implantable Eversense 365.
• Expansion of hybrid closed-loop systems to be fully closed-loop, minimizing user input.

The primary technological risk is that a competitor launches a fully closed-loop system for Type 1 diabetes before Insulet's planned 2028 Type 2 system, or that a new, non-invasive CGM technology gains significant traction, disrupting the current sensor-based AID model.

Integration with all major CGM systems is crucial for market competitiveness.

For an AID system to be competitive, it must offer patients choice and flexibility by integrating with the most popular CGM sensors. Currently, the Omnipod 5 integrates with Dexcom G6 and G7, and the FreeStyle Libre 2 Plus CGM Sensor in certain markets.

The plan is to achieve full Continuous Glucose Monitor (CGM) integration across all major sensors by the first half of 2026, pending FDA clearance for the Omnipod 5 enhancements. This is a critical technological milestone, as it removes a major barrier for customers who prefer a specific sensor. Failure to secure these integrations quickly could cede market share to competitors who already offer broader compatibility or faster integration cycles.

Insulet Corporation (PODD) - PESTLE Analysis: Legal factors

For a medical device company like Insulet Corporation, the legal landscape isn't just a compliance checklist; it's a core operational risk that directly impacts product timelines and profitability. You need to view regulatory compliance not as a cost center, but as a necessary investment to protect the Omnipod brand's long-term value.

Extensive U.S. Food and Drug Administration (FDA) and Global Medical Device Quality Regulations

Insulet's primary legal exposure stems from the extensive U.S. Food and Drug Administration (FDA) regulations governing medical devices. The Omnipod system, a Class II or Class III device depending on its specific function, is subject to the Quality System (QS) regulation, detailed in 21 CFR Part 820. This regulation mandates strict controls over product design, manufacturing, labeling, and servicing. A failure in the QS, either by Insulet or its contract manufacturers, can lead to product recalls, injunctions, or significant fines.

The company must also comply with global equivalents, such as the Medical Device Regulation (MDR) in the European Union, which has significantly tightened post-market surveillance and clinical data requirements. Honestly, one bad FDA inspection report can halt a product launch dead in its tracks.

Complex and Evolving Data Privacy and Protection Laws (e.g., HIPAA) for Patient Data

As a provider of connected health technology, Insulet manages a vast amount of Protected Health Information (PHI), making compliance with data privacy laws critical. The Health Insurance Portability and Accountability Act (HIPAA) in the U.S. requires stringent administrative, physical, and technical safeguards for patient data. But it's not just HIPAA; global expansion means navigating the European Union's General Data Protection Regulation (GDPR) and other international standards.

The risk of a data breach or a cyberattack is a constant threat, and a failure to protect this data could result in massive financial penalties and a catastrophic loss of customer trust. The legal team has to defintely stay ahead of these evolving standards, especially as Omnipod 5 integrates with more third-party continuous glucose monitors (CGMs) and smartphone apps.

Risk of Product Liability Lawsuits or Adverse Regulatory Actions on Current Products

Any medical device carries inherent product liability risk, especially one delivering insulin where dosing errors can be life-threatening. The risk is compounded by the potential for 'off-label use,' where users or physicians use the Omnipod system in ways not explicitly cleared by the FDA, which can still expose Insulet to liability claims. The financial reports for 2025 acknowledge that significant transactions like 'legal settlements' and 'medical device corrections' are often adjusted out of non-GAAP earnings, highlighting their impact on the bottom line.

Beyond product safety, Insulet is actively engaged in protecting its core intellectual property (IP). For example, a major legal action is the ongoing trade secret misappropriation lawsuit, Insulet Corporation v. EOFlow Co., Ltd., filed in 2023, which alleges that a competitor's product copied the Omnipod's design based on stolen information. This is a multi-year, high-stakes fight to defend the moat around its proprietary patch pump technology.

Legal/Regulatory Risk Area	2025 Financial/Operational Impact	Key Legal/Regulatory Standard
Product Development & Clearance	R&D expenses increased 40.6% to $77.2 million in Q3 2025, largely funding trials for new regulatory submissions.	FDA 510(k) clearance / PMA (Pre-Market Approval), Investigational Device Exemption (IDE)
Manufacturing Quality	Risk of 'medical device corrections' and related costs, which are explicitly excluded from adjusted non-GAAP metrics.	FDA Quality System Regulation (21 CFR Part 820)
Data Privacy & Security	Risk of substantial fines and reputational damage from a breach of patient data.	HIPAA (U.S.), GDPR (EU), and evolving state/international data protection laws
Intellectual Property	Active litigation to protect core technology, such as the Insulet Corporation v. EOFlow Co., Ltd. trade secret case.	U.S. Patent Law, Trade Secret Law

Need for Continuous Clinical Trials and Regulatory Clearances for New Products

The pace of innovation in Automated Insulin Delivery (AID) systems means Insulet must constantly seek new regulatory clearances to stay competitive. This process requires significant investment in clinical trials to prove safety and efficacy for new features or products, like the planned next-generation Omnipod systems. Here's the quick math: Insulet's Q3 2025 R&D expenses of $77.2 million, a 40.6% jump year-over-year, show their commitment to this regulatory pipeline.

The company has a clear roadmap, but each step is contingent on a favorable regulatory review. You can't just ship a new product; you have to prove it's safe and effective to the FDA first. The current pipeline includes:

• Omnipod 5 enhancements: Pending FDA clearance for 2026 launch.
• Omnipod 6: Intended launch in 2027.
• Fully Closed Loop for Type 2 Diabetes: Intended launch in 2028.

The regulatory process for a new generation device like Omnipod 6 is lengthy and expensive, and any delay in clearance could give competitors a window to gain market share.

Insulet Corporation (PODD) - PESTLE Analysis: Environmental factors

You're looking at Insulet Corporation's environmental strategy, and the core challenge is clear: how do you square a life-changing, disposable product with a growing focus on sustainability? The company is tackling the medical waste issue head-on, but the sheer volume of single-use Pods means this remains a critical, high-visibility area for investors and regulators.

Here's the quick math: each Omnipod Pod is used for up to three days, creating a constant stream of plastic and electronic waste. So, Insulet Corporation has to balance its mission of simplifying life for people with diabetes with the environmental cost of a disposable device. It's a tough trade-off, but they are making measurable progress.

The disposable nature of the Omnipod Pod creates medical waste and disposal challenges.

The disposable nature of the Omnipod Pod is a significant environmental factor, as the medical device industry faces strict regulations for handling biohazardous waste. This creates a perpetual waste stream that Insulet Corporation must manage to maintain its social license to operate. To be fair, the company is actively working to shift toward a more circular business model, which means reducing resource use and recovering materials to manufacture new products. Their product design teams are defintely focused on decreasing the amount of source material used and increasing the recyclability of components.

Global product takeback programs have accepted 7.4 million used Pods for responsible disposal.

To mitigate the environmental impact of disposable Pods, Insulet Corporation has expanded its global product takeback programs. As of the latest available data, these programs have accepted 7.4 million used Pods for responsible disposal. This initiative is crucial for diverting medical waste from landfills. The company has continued its U.S. Pod takeback pilot, expanding its geographic scope from Massachusetts to include California, which shows a commitment to scaling this effort.

The company's focus on a circular economy is evident in its takeback program expansion:

• Accepted 7.4 million Pods through global takeback programs.
• Continued U.S. takeback pilot in Massachusetts and expanded to California.
• Working to increase product recyclability and divert more products from landfills.

The company met 11% of its global electricity needs with renewable energy in 2024.

Insulet Corporation is making tangible strides in its operational resilience by integrating renewable energy. For the 2024 fiscal year, the company met 11% of its annual global electricity needs with renewable energy sources. This is a key metric for investors tracking the transition to a low-carbon economy.

A major contributor to this percentage is the new manufacturing facility in Malaysia, where the company installed more than 5,700 rooftop solar panels. This solar array is designed to meet 21% of that facility's electricity needs, which is a significant step for a high-volume manufacturing site. The Malaysia facility is also designed to achieve both Green Building Index (GBI) and Leadership in Energy and Environmental Design (LEED) Silver certifications, signaling a long-term commitment to sustainable infrastructure.

Here is a summary of the operational environmental metrics:

Metric	2024 Performance (Latest Data)	Details
Global Electricity from Renewables	11% of annual global electricity needs	Met through various sources, including on-site solar.
Malaysia Facility Electricity from Solar	21% of facility's electricity needs	Powered by over 5,700 rooftop solar panels.
Facility Certification Goal	GBI and LEED Silver certifications	Target for the new, state-of-the-art Malaysia manufacturing facility.

New Omnipod 5 starter kit packaging reduced its carbon footprint by 77% compared to the original design.

The company has achieved a substantial environmental win through product packaging redesign. The redesigned U.S. Omnipod 5 starter kit packaging, which is largely paper-based and fully recyclable, resulted in a 77% estimated reduction in greenhouse gas (GHG) emissions compared to the previous design. This is a huge reduction in carbon footprint that directly addresses Scope 3 emissions (indirect emissions from the value chain).

The new packaging uses fewer and fully recyclable materials, and the U.S. kits are produced in North America, which further reduces transportation emissions by moving the supply chain closer to production. They also completed their first product and packaging Life Cycle Assessments (LCAs) in 2023 to build a foundation for future circular design efforts.

Next step: Operations team should draft a capital expenditure (CapEx) proposal by the end of Q1 2026 to expand the takeback program to all major European markets, targeting a 15% increase in Pods accepted in 2026.