The majority of Medical Devices reach patients through procurement. Procurement is the act of obtaining goods or services, usually on a relatively large scale, i.e. by health care systems, to provide health services and products to patients.
Medical Devices are typically procured by health institutions (i.e., hospitals, clinics or laboratories), who either purchase the devices directly (e.g., through competitive tenders) or indirectly (e.g., via group purchasing organisations). As a result, manufacturers of Medical Devices typically need to demonstrate their product’s value directly to health institutions and/or payers according to the latter criteria. There are many competing frameworks for assessing the value of Medical Devices and in general, this is a space that is not harmonised across Europe. Frameworks regarding procurement of Medical Devices are equally not harmonised.
Procurement may also include the overall process from early development to implementation, which can be critically important for both health systems and manufacturers. Lately, new models that combine value-based approaches with public-private innovation partnerships and risk sharing have been introduced. There is no commonly agreed procurement model for health systems, nor is there a standard model for patient involvement. However, as these new models are being developed and implemented in value-based systems, there is an opportunity for patients to take an active role and make sure that the values reflect what is important for patients.
Figure 2 below shows a model that integrates innovation and value-creation as flexible parameters. In this model, patients can play an important role in decisions making for which value criteria should be met. This value-based approach is expected to have a greater influence on which products will be implemented and which functionalities and attributes will be prioritised for continued iterations.
Figure 2: Value and innovation-driven access model. MedTech Europe. 2021.
Patient preferences in the value assessment of Medical Devices can therefore be expressed in a variety of ways. For example, patient advocacy groups can make their preferences known to decision-makers, so that criteria improving value for patients are included at a level that is equal to typical hospital-centric criteria.
Ideally, patients should take part in decisions about which products the health system makes available., Equally important, patients should take part in procurement decisions that include innovation projects that would directly or indirectly influence patients' treatments outcomes and quality of life. Having a voice in these decisions has the potential to ensure that patient-relevant criteria are included in the agreements between manufacturers and health systems/payers, and additionally, it can also drive the focus of innovation.