Who are the key health technology stakeholders?
A health system includes diverse stakeholders that form a complex ecosystem of individuals, groups, or entities vested in the process, outcome, or use of medical devices within a healthcare setting. Key stakeholders typically include:
Patients: Patients are ultimately the end-users of health technologies, and their safety, comfort, and satisfaction should be considered throughout the technology’s lifecycle. Carers may also be important stakeholders in this group.
Patient Advocacy Groups: These groups may provide input on the ethical implications of using specific technologies, particularly those involving sensitive issues such as patient privacy, informed consent, and equitable access to care.
Health workers: Physicians, clinicians, nurses, and allied healthcare professionals, are not just users of health technologies, but also key contributors to their development and implementation. Their direct involvement in patient care and their 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 medical device context.
- Procurement Professionals: These individuals are responsible for sourcing, negotiating contracts, and purchasing technologies for healthcare organisations. They ensure that technology is acquired competitively while meeting quality standards and regulatory requirements.
- Biomedical Engineers and Technicians: These professionals are responsible for maintaining and servicing health technologies requiring 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.
Healthcare Providers: This includes hospitals, clinics, and other healthcare facilities using health technologies. They are interested in procuring products that meet their patient’s needs, improve healthcare outcomes, and are cost-effective.
Government: The government provides regulatory frameworks and oversight for manufacturing and using health technologies.
Regulatory Authorities: Government and non-government agencies regulate technology approval, manufacturing, and marketing and police the market.
Health Insurers and Payers: Insurers and payers may influence technology procurement and use decisions through reimbursement policies and coverage criteria. They seek cost-effective solutions that provide value-based care and improve patient outcomes.
Economic operators: In the context of medical devices, economic operators refer to the various stakeholders involved in the supply chain, who ensure their compliance with regulatory requirements and market access.
Economic operators in medical devices
Economic operators include:
- Manufacturers: Entities that design, produce, and package medical devices before placing them on the market. They are responsible for ensuring the devices meet regulatory and quality standards and performance criteria.
- Authorised Representatives: Individuals or companies appointed by manufacturers outside a specific market (such as the EU) to act on their behalf regarding regulatory and compliance matters within that market.
- Importers: Companies or individuals who bring medical devices from a manufacturer in a different country into their domestic market. They must verify that devices comply with local regulatory requirements and are correctly labelled and documented.
- Distributors: Entities that store, market, and sell medical devices within a market. They ensure that devices are appropriately handled, stored, and transported, maintaining integrity and compliance with regulatory standards.
- Suppliers and Subcontractors: Providers of components, materials, or services used in the manufacturing process of medical devices. They must ensure that their contributions meet quality and regulatory standards.
Each economic operator plays a crucial role in the lifecycle of a medical device, from production to end-user delivery, ensuring safety, efficacy, and regulatory compliance at every step.
Overall, effective collaboration among these stakeholders is essential to ensure that health technology development, procurement, and management processes result in the acquisition of safe, high-quality products that meet the needs of patients and healthcare providers while complying with regulatory requirements and budget constraints.