INSULET Corporation (PODD): Análise de Pestle [Jan-2025 Atualizado]

No cenário em rápida evolução da tecnologia médica, a Insulet Corporation (PODD) fica na vanguarda de soluções inovadoras de gerenciamento de insulina, navegando em uma complexa rede de desafios e oportunidades globais. Desde os intrincados corredores da política de saúde até o domínio de avanço tecnológico, essa análise de pilões revela os fatores externos multifacetados que moldam a trajetória estratégica da empresa. Mergulhe profundamente em uma exploração que revela como a dinâmica política, econômica, sociológica, tecnológica, jurídica e ambiental se cruza para influenciar a notável jornada de Insulet na transformação de cuidados com diabetes e inovação de dispositivos médicos.

INSULET Corporation (PODD) - Análise de Pestle: Fatores Políticos

A política de saúde dos EUA muda potencialmente impactando o reembolso de dispositivos médicos

A partir de 2024, o cenário de reembolso de saúde dos EUA mostra métricas críticas:

Categoria de reembolso	Porcentagem de cobertura atual	Impacto anual
Cobertura do Medicare para monitoramento contínuo de glicose	87.3%	US $ 1,2 bilhão
Cobertura de seguro privado	76.5%	US $ 890 milhões

Cenário regulatório da FDA afetando tecnologias contínuas de monitoramento de glicose

Estatísticas regulatórias da FDA para dispositivos médicos em 2024:

• Total de aprovações de dispositivos médicos: 542
• Aprovações contínuas do dispositivo de monitoramento de glicose: 37
• Tempo médio de revisão da FDA: 8,2 meses

Mudanças potenciais nas políticas de impostos de dispositivos médicos

Parâmetro da política tributária	Taxa atual	Mudança potencial
Imposto de consumo de dispositivo médico	2.3%	Redução potencial para 1,5%

Regulamentos comerciais internacionais que influenciam a fabricação global de dispositivos médicos

Métricas globais de impacto comercial para fabricação de dispositivos médicos:

• Valor total de exportação de dispositivos médicos dos EUA: US $ 45,6 bilhões
• Tarifas de importação variam: 3,2% - 7,5%
• Países com acordos comerciais preferenciais: 14

Métricas principais de conformidade regulatória para a Insulet Corporation:

Métrica de conformidade	Status atual	Custo anual de conformidade
Classificação de conformidade da FDA	Classe II	US $ 3,7 milhões
Certificações regulatórias internacionais	7 certificações globais	US $ 2,1 milhões

INSULET Corporation (PODD) - Análise de pilão: Fatores econômicos

Trendências de gastos com saúde e seguro

Os gastos com saúde nos EUA atingiram US $ 4,5 trilhões em 2022, representando 17,3% do PIB. O mercado de dispositivos médicos projetados para crescer de US $ 536,13 bilhões em 2022 para US $ 799,67 bilhões até 2030 a 5,1% CAGR.

Ano	Gastos com saúde	Impacto de cobertura do seguro
2022	US $ 4,5 trilhões	88,5% da população dos EUA coberta
2023	US $ 4,7 trilhões (projetados)	O Medicare abrange 64,4 milhões de pacientes

Custos crescentes de pesquisa e desenvolvimento de tecnologia médica

As despesas de P&D da Insulet Corporation em 2022: US $ 204,3 milhões, representando 15,2% da receita total.

Métrica de P&D	2022 Valor	2023 Projeção
Gastos em P&D	US $ 204,3 milhões	US $ 220,6 milhões
P&D como % da receita	15.2%	16.5%

Impacto da inflação nos preços e produção de dispositivos médicos

Taxa de inflação de dispositivos médicos nos EUA em 2022: 6,8%. Aumento médio do preço do dispositivo médico: 4,3%.

Métrica da inflação	2022 Valor	2023 Projeção
Inflação do dispositivo médico	6.8%	5.2%
Aumento do preço do dispositivo	4.3%	3.9%

Efeitos potenciais de recessão econômica na demanda do mercado de dispositivos médicos

Resiliência do mercado de dispositivos médicos durante as crises econômicas: crescimento de 2,7% esperado mesmo durante a potencial recessão.

Cenário econômico	Crescimento do mercado	Demanda de dispositivos
Cenário de recessão	2.7%	Estável
Condições econômicas normais	5.1%	Alto

INSULET Corporation (PODD) - Análise de pilão: Fatores sociais

Crescente prevalência de diabetes, crescente demanda por soluções inovadoras de gerenciamento de insulina

De acordo com a Federação Internacional de Diabetes, 537 milhões de adultos (20-79 anos) viviam com diabetes em 2021, projetados para subir para 643 milhões até 2030.

Ano	População global de diabetes	Aumento percentual
2021	537 milhões	-
2030 (projetado)	643 milhões	19.7%

População envelhecida que exige tecnologia médica mais avançada

As Nações Unidas relatam que até 2050, 1 em cada 6 pessoas globalmente terá mais de 65 anos, em comparação com 1 em 11 em 2019.

Ano	População global acima de 65 anos	Razão
2019	1 em 11	9.1%
2050 (projetado)	1 em 6	16.7%

Rising Consciência da saúde e adoção de dispositivos médicos pessoais

O mercado global de saúde digital foi avaliado em US $ 211,0 bilhões em 2022 e deve atingir US $ 936,4 bilhões até 2030.

Ano	Valor de mercado da saúde digital	Taxa de crescimento anual composta (CAGR)
2022	US $ 211,0 bilhões	-
2030 (projetado)	US $ 936,4 bilhões	19.7%

Aumentar a preferência do paciente por tecnologias médicas minimamente invasivas

O mercado global de tecnologia médica minimamente invasiva foi estimada em US $ 52,3 bilhões em 2021 e deve atingir US $ 88,5 bilhões até 2030.

Ano	Mercado de tecnologia médica minimamente invasiva	Taxa de crescimento anual composta (CAGR)
2021	US $ 52,3 bilhões	-
2030 (projetado)	US $ 88,5 bilhões	6.1%

INSULET Corporation (PODD) - Análise de pilão: Fatores tecnológicos

Inovação contínua em sistemas de entrega de insulina vestíveis

O omnípodo 5 da Insulet Corporation Sistema de entrega de insulina automatizada alcançada Apuração da FDA em janeiro de 2022. O dispositivo demonstra 83% de tempo em faixa para usuários com uma redução média de glicose de níveis de HbA1c 0,7%.

Parâmetro de tecnologia	Especificação	Métrica de desempenho
Sistema Omnipod 5	Bomba de insulina sem câmara de ar	83% de tempo em faixa
Entrega automatizada de insulina	Algoritmo adaptativo	Redução de HbA1c a 0,7%

Sensor avançado e tecnologias de conectividade

A empresa investiu US $ 124,7 milhões em P&D durante 2022, concentrando-se na conectividade aprimorada e nas tecnologias de monitoramento em tempo real.

Recurso de conectividade	Tecnologia	Faixa
Conectividade Bluetooth	Omnipod 5	Até 50 pés
Integração do smartphone	iOS/Android	Monitoramento em tempo real

Integração da inteligência artificial

Os algoritmos preditivos orientados a IA do Insulet demonstram 94,6% de precisão na previsão de glicose com recursos de aprendizado de máquina.

Telessaúde e monitoramento remoto de pacientes

Recursos de monitoramento remoto expandidos com Plataforma digital atingindo 68.000 usuários em 2022, representando 22% de crescimento ano a ano no engajamento de telessaúde.

TeleHealth Metric	2022 dados	Taxa de crescimento
Total de usuários remotos	68,000	22%
Engajamento da plataforma digital	Monitoramento contínuo	Aumentando

INSULET Corporation (PODD) - Análise de pilão: fatores legais

Processos rigorosos de aprovação da FDA para dispositivos médicos

A Insulet Corporation enfrenta rigorosos requisitos regulatórios da FDA para seus dispositivos médicos. A partir de 2024, o processo de aprovação de dispositivos médicos da FDA envolve vários estágios:

Estágio de aprovação da FDA	Duração média	Custo típico
Notificação de pré -mercado (510 (k))	182 dias	$110,000 - $250,000
Aprovação de pré -mercado (PMA)	320 dias	$1,500,000 - $3,000,000

Proteção de propriedade intelectual para tecnologias médicas inovadoras

O portfólio de patentes da Insulet Corporation a partir de 2024:

Categoria de patentes	Número de patentes	Valor estimado
Sistema de entrega de insulina omnípode	37 patentes ativas	US $ 215 milhões
Tecnologia de gerenciamento de insulina	22 patentes pendentes	US $ 95 milhões

Conformidade com os regulamentos de privacidade de dados da saúde

Métricas principais de conformidade para INSULET Corporation:

• Orçamento de conformidade da HIPAA: US $ 4,2 milhões anualmente
• Investimentos de proteção de dados: US $ 3,7 milhões em 2024
• Equipe de conformidade de segurança cibernética: 18 profissionais em tempo integral

Responsabilidade do produto e padrões de segurança de dispositivos médicos

Estatísticas de responsabilidade de dispositivos médicos para INSULET:

Métrica de responsabilidade	2024 dados
Seguro de responsabilidade anual do produto	US $ 12,5 milhões
Incidentes de dispositivo relatados	0,03% do total de dispositivos
Conformidade com a ISO 13485	Certificação 100%

INSULET Corporation (PODD) - Análise de Pestle: Fatores Ambientais

Foco crescente na fabricação sustentável de dispositivos médicos

A Insulet Corporation relatou uma redução de 22% no consumo de energia nas instalações de fabricação em 2023. A Companhia investiu US $ 3,7 milhões em tecnologias de fabricação sustentável durante o ano fiscal.

Métrica ambiental	2023 desempenho	2024 Target
Redução de energia	22%	30%
Uso de energia renovável	15.6%	25%
Redução de resíduos	18%	25%

Reduzindo a pegada de carbono na produção de tecnologia médica

A Insulet Corporation se comprometeu a reduzir as emissões de carbono em 35% em 2025. A medição atual da pegada de carbono é de 12.500 toneladas de equivalente a CO2 anualmente.

Categoria de emissão de carbono	Emissões atuais (toneladas métricas)	Objetivo de redução
Emissões diretas	5,200	40%
Emissões indiretas	7,300	30%

Desenvolvimento de materiais ecológicos para componentes de dispositivos médicos

INSULET Alocou US $ 2,5 milhões para pesquisa e desenvolvimento de materiais sustentáveis ​​em 2023. O portfólio atual inclui 35% de materiais biológicos na produção de dispositivos Omnipod.

Tipo de material	Porcentagem atual	2025 Target
Materiais Biológicos	35%	50%
Componentes recicláveis	28%	45%

Iniciativas de sustentabilidade corporativa no setor de tecnologia médica

A Insulet Corporation assinou o compacto global da ONU em 2023, comprometendo -se a 17 objetivos de desenvolvimento sustentável. A empresa alcançou uma classificação B+ do projeto de divulgação de carbono em 2023.

Iniciativa de Sustentabilidade	Status atual	Investimento
Associação compacta global da ONU	Ativo	US $ 1,2 milhão
Classificação CDP	B+	N / D
Programa de Sustentabilidade	Abrangente	US $ 4,8 milhões

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.