Preference Testing in Medical Devices: Current Framework and Regulatory Gaps.

Preference testing is a valuable source of information that can be provided by both healthcare professionals (HCPs) and patients (users). It can be used to improve the design and development of medical devices by feeding into device usability and, ultimately, risk management. Furthermore, it can aid with selecting the most appropriate clinical endpoints to be used in the clinical evaluation of a device and increase patient engagement by incorporating patient-relevant outcomes. Preference testing is widely conducted in the food industry but is not widespread in the medical field due to limited guidelines and a lack of regulatory framework. As such, manufacturers may be unaware of the benefits of preference testing and fail to take full advantage of it, or conversely, may use inappropriate methodology and/or analyses and consequently fail to collect meaningful data. In this position paper, we aim to highlight the benefits and uses of preference testing, along with potential methods that could be used for preference testing of medical devices. A key step towards the wider implementation of preference testing in medical devices is for the publication of international standards and guidelines for the collection, assessment, and implementation of preference data into the life cycle of a medical device.

Companion Diagnostics: State of the Art and New Regulations.

Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.

Organ donation in the US and Europe: The supply vs demand imbalance.

Organ donation and transplantation remain the best and most cost-effective clinical solution for end-stage organ failure. Several agencies across the US and Europe provide legislative, regulatory, and humanitarian services to generate smoother applications in all transplantation processes and donor-recipient relationships. US and European statistics present nine types of grafts, with kidneys being the most transplanted organ worldwide. However, organ shortage, religion, underrepresented minority groups, difficulties in obtaining consent, lack of understanding, and general ethical concerns present challenging barriers to organ donation, reflecting the complexity of graft procurement and allocation. Breaking down these barriers to reduce the organ-supply imbalance requires an appropriate multifaceted approach. Some of the key areas include increasing the potential donor pool and consent rates, apt organ allocation, and improving organ health. Additionally, suitable policies and standardized guidelines for both donors and recipients, alongside educational initiatives, are needed to ensure patient safety and global awareness. Looking forward, novel and effective research plans and initiatives are needed if we are to avoid a colossal supply-demand gap.

Impact of Design on Medical Device Safety.

The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.