Introduction
Stakeholders are individuals or groups with a common interest in an issue or business activity. In healthcare, stakeholders have vested interests in the health system.
Health systems are complex ecosystems with diverse stakeholders with different interests and priorities.
This article explains the main stakeholders involved in most health systems and how they design and adopt health interventions. Whether developing, commercialising, procuring, or managing medical devices, it’s critical to understand how different stakeholders fit into the health system.
Who are the key health system stakeholders?
A health system includes diverse stakeholders that form a complex ecosystem of individuals, groups, or organisations vested in the process, outcome, or use of medical devices within a healthcare setting.
Every health system is different, but the main stakeholders in most settings include:
Patients receive medical care, treatment, or services from healthcare professionals due to illness, injury, or preventive healthcare needs.
Patients are central to healthcare delivery, with their needs, preferences, and outcomes guiding clinical decisions and health system design. The concept of “patient” also encompasses rights and responsibilities, including their role in informed decision-making and the importance of patient-centred care approaches. Patients are the ultimate beneficiaries of health technologies, and their needs should be considered paramount.
Carers are also essential in supporting patients by managing daily care, navigating healthcare systems, and advocating for their needs. Their insights and experiences help shape healthcare practices to address usability and patient well-being.
Patient Advocacy Groups provide collective representation to patients through input on the ethical implications of specific interventions, particularly those involving sensitive issues such as equitable access to care, patient privacy and informed consent.
Healthcare professionals, or health workers, are the individuals who deliver medical services. Health workers usually provide healthcare interventions in a healthcare providercontext. This includes healthcare facilities such as hospitals, clinics, or community-based outreach settings.
Healthcare professionals and providers are a diverse stakeholder group that includes frontline staff and back-office functions:
Front-line health workers include physicians, clinicians, nurses, technicians, community health workers (CHWs) and allied healthcare professionals.
Back-office functions include health professionals involved in administering and managing healthcare services and facilities. Large healthcare providers have Health Technology Management (HTM) departments that oversee health technology procurement, management and maintenance: Important roles include:
- Procurement professionals: are responsible for sourcing, negotiating contracts, and purchasing technologies for healthcare organisations. They ensure that technology is acquired competitively while meeting quality standards and user requirements.
- Biomedical Engineers and Technicians (BMET): are responsible for maintaining and servicing health technologies that require installation and ongoing maintenance. Their input may be sought during the procurement and management processes to assess reliability, ease of maintenance, and availability of technical support.
- Administrators: manage the resources within healthcare providers, including allocating financial and human resources to acquire and manage health technologies.
Healthcare professionals and providers are not just users of health technologies but also key contributors to their development and implementation. Their direct involvement in patient care and unique insights are crucial in ensuring that products are suitable for their intended use and compatible with existing workflows. This collaborative approach is especially important in the context of medical devices.
In the context of health technologies, economic operators are the stakeholders involved in the supply chain who ensure compliance with regulatory and market access requirements. Each economic operator plays a crucial role in the health technology lifecycle, from production to end-user delivery, ensuring safety, efficacy, and regulatory compliance at every step.
- Manufacturers are entities that design, produce, and package health products before placing them on the market. They are responsible for ensuring their products meet regulatory, quality, and performance standards.
- Authorised Representatives: Individuals or companies appointed by manufacturers outside a specific market (such as the EU) to act on their behalf regarding compliance within that market.
- Importers are companies or individuals who bring products from a manufacturer in a different country into their domestic market. They must verify that the products are correctly labelled and documented and comply with local regulations.
- Distributors are entities that store, market, and sell products within a market. They ensure appropriate handling, storage, and transportation.
- Suppliers and Subcontractors: Providers of components, materials, or services used in manufacturing, supply chain or use. They must ensure that their contributions meet quality and regulatory standards.
Regulators ensure the safety, efficacy, and quality of healthcare products and services, protecting public health. The role of a regulator is to foster trust, encourage innovation, and balance patient safety and access to medical products and services by setting and enforcing standards.
A regulatory authority may be a government or non-governmental organisation. Usually, several regulators play a role, overseeing different functions within the health system, including:
- Regulation of healthcare professionals
- Regulation of healthcare providers
- Regulation of health technology products
- Regulation of infrastructure (data management, environmental and occupational health and safety)
Payers are entities responsible for funding or reimbursing healthcare interventions, including health technologies. Payers influence access, affordability, and utilisation of healthcare services. Payers include:
- Public Health Systems: Government-funded programs such as Medicare, Medicaid (in the USA), or National Health Service (NHS) in the UK cover medical devices as part of broader healthcare services. Public payers often prioritise cost-effectiveness and public health needs.
- Private Insurance Companies: Commercial insurers reimburse for health technologies covered under their plans, influenced by clinical evidence, economic considerations and patient demand. Their coverage policies and negotiations with manufacturers impact pricing and access.
- Employer-Sponsored Plans: Employers offering health benefits may influence employees’ coverage and access to certain services.
- Out-of-pocket payers: Patients may pay directly for healthcare services or technologies not covered by insurance, especially for elective or non-essential interventions. Demand depends on affordability and perceived value.
- International Aid and NGOs: International or non-governmental organisations (NGOs) may fund or distribute devices in low-income settings or for vulnerable patient populations.
Each payer’s coverage and reimbursement criteria significantly impact the adoption and success of medical devices in different markets. Their decisions on coverage and pricing directly impact the financial sustainability of health systems and the adoption of new medical technologies.
Stakeholder influence on medical devices
Stakeholders within health systems form a complex and dynamic ecosystem, with their roles and influence shifting significantly depending on the health system’s context.
Each stakeholder group—patients, healthcare providers, regulators, payers, and policymakers—approaches health technology development, procurement, and management with unique priorities and evidence requirements. For instance, regulators focus on clinical efficacy and safety, payers emphasise cost-effectiveness and budget impact, and healthcare providers prioritise clinical utility and workflow integration. Government bodies may dominate decision-making in public health systems, whereas private systems often see a stronger influence from insurers and providers. These varying roles shape the pathways through which medical devices are assessed, approved, and adopted.
Tailoring evidence to meet the distinct needs of each stakeholder group, such as clinical data for providers or economic models for payers, is crucial for ensuring that interventions are deemed valuable and can be effectively integrated into the health system. Mapping stakeholder influence and expectations early in development can help inform product design and evidence synthesis strategies. It can also help to plan market access strategies as the evidence requirements change depending on the context of the local health system.