Generating evidence for new high-risk medical devices

Abstract

Developers of new high-risk medical devices should plan how they will produce evidence from the earliest stage, for all the stakeholders who will need it. The audiences include regulators, health technology assessors, policy-makers, payers, clinicians and patients. ► Planning studies and data collection for the total product life cycle of a new device increases the efficiency and reduces the cost of evidence generation. Randomized controlled trials remain necessary for novel devices and indications, but other methods also exist to bolster an early evidence base. ► Regulators increasingly require real-word evidence in the longer term, especially for implanted devices. Well-planned registers, data linkage and unique device identifiers will facilitate this.

Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers

“…The uncertainties in comparative effectiveness and durability of clinical benefits remain the biggest challenge for the robust HTA and economic analysis of shoulder protheses. Research has strongly advocated improving the quality of clinical evidence, which is crucial to assure HTA bodies and payers of the clinical advantages of modern shoulder prostheses [ 55 , 56 ].…”

IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation

“…By defining the types of studies needed at different stages, IDEAL-D could guide forward planning of study methods throughout a device’s life cycle, helping to optimise speed and efficiency, and to reduce the cost of evidence generation—not only for regulation but also for health technology assessment, commissioning of services, and clinical research. 9 This would reduce the waste, cost and inefficiency associated with developing different evidence for a series of different audiences.…”

Impact of Design on Medical Device Safety

“…On the other hand, although the main content of ISO 14791 has not been Within this context, the development and establishment of strategic Coordinated Registry Networks (CRNs), which will serve as a demonstration of the National Evaluation System for Medical Devices (NESMD), has been suggested [90]. The ongoing development of CRNs for orthopedic and vascular medical devices [91][92][93] is a characteristic example of this approach. In fact, FDA has repeatedly described its "vision" to incorporate CRNs into NESMD so as to reinforce MD post-market monitoring in a way that timely identification of post-market warning signals will be translated into a facilitator of premarket MD clearance that will allow the timely management of design defaults and previously unidentified hazards.…”