Medical devices play an important role in enhancing patients’ quality of life and supporting the healthcare system, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy. With its strong research base and the NHS at its core, the UK is well placed to generate the necessary high-quality evidence. But guidance is needed on the nature of evidence required, and its implementation. New approaches are needed to produce robust, appropriate evidence that can foster innovation.
A major theme of the roundtable forum was the potential to adopt methods from the engineering sector for medical devices. A transferable lesson from engineering is that engineers acknowledge that their products evolve and can fail, and therefore carry out continuous monitoring of systems in use. The framework encourages the reporting of near misses and accidents, so designs can be improved and risks mitigated. Continuous monitoring is analogous to post-market surveillance of medical devices. Furthermore, the engineering framework for assessing safety has been built with input from non-regulators, recognizing the wealth of highly relevant experience within the industrial sector. The development of a regulatory framework for medical devices would likely benefit from a similar level of dialogue to establish hazards, safety functional requirements and thresholds.
Another aspect of the value of dialogue was the development of devices that meet clinical need. Clinicians, device manufacturers and the ‘end user’ could work together to identify which devices need to be developed to meet patient need.
The value of observational studies was acknowledged where randomized controlled trials (RCTs) are not possible or appropriate. Observational studies are particularly important for demonstrating rare, catastrophic and delayed harms of treatments that are not captured by RCTs. Observational studies may be less academically rigorous than RCTs, and are prone to bias, but they can still deliver valuable information about how technologies function in real-world
settings.
It was acknowledged that a major problem with designing trials for medical devices is that devices, unlike medicines, are increasingly part of complex systems that may include software, hardware, healthcare professionals, and even operating theatres. Different components of the system can influence the outcome of a trial, such as the experience of the surgeon or the quality of the implant. However, these complex interventions are revolutionizing the way we deliver medical care and have the potential to offer enormous patient benefit. With appropriate design, meaningful trials for medical devices can and should be undertaken. Pipelines need to be established to develop this process, including specialist trial centres to develop methodologies and offer support, and clinical networks to oversee progress from early to late phase trials.
The workshop participants identified a number of steps that should be taken to improve the safety and efficacy of medical devices:
- More use should be made in the medical devices industry of hazard analysis and safety functional requirements, with active steps taken to adapt and adopt the methods used in engineering.
- The regulatory framework should specify the different levels of evidence required to ensure safety, performance and efficacy at different stages throughout the life and iterations of the medical device.
- The roles and powers of Notified Bodies, and the CE marks they verify, are in need of review. The powers, inconsistencies and lack of transparency of Notified Bodies are cause for concern, as is the current CE system, which fails to promote evidence generation. This is expected to be addressed by new EU medical devices regulations proposed by the EC.
- The regulatory framework should be prescriptive, yet responsive, ensuring the withdrawal of faulty products from the market as quickly as possible.
- The design of medical devices would benefit from a more integrated contribution from a more diverse range of stakeholders including patients, engineers, manufacturers, healthcare professionals and economists.
- Initiatives that promote best practice in the design of studies and methodologies are needed in order to bridge the evidence gap. This may include training and education programs, and the establishment of further centres of clinical research excellence.
- The NHS, with its unique patient identifier system, has the potential to facilitate the recruitment of patients into device trials. Wider adoption of the patient identifier should be promoted.
The Royal Academy of Engineering and The Academy of Medical Sciences will continue to engage with relevant bodies on these priority areas identified by the participants, in particular the first three conclusions above.
Read the full report, “Establishing High-Level Evidence for the Safety and Efficacy of Medical Devices and Systems,” a summary of a roundtable forum held on January 16, 2013 and hosted by the Royal Academy of Engineering and The Academy of Medical Sciences by clicking here.