Literature review: a key element in DM development

The design of a medical device is a complex stage, requiring in-depth knowledge of available technologies, unmet clinical needs, expected performance and the risks associated with the use of the product or the medical procedure performed. Here’s an update from Efor.

By Charlotte Benoit, PhD, CRO Operations Manager and clinical evaluation expert with the Efor Group

Medical state-of-the-art is an essential component of research and development (R&D) for manufacturers of medical devices or in vitro diagnostic medical devices. It is a systematic and exhaustive review of the medical and scientific literature available on a given topic. This approach, which provides a comprehensive overview of current solutions, their performance and safety profile, requires a rigorous methodology and a critical analysis of available data. This exercise is an integral part of the clinical evaluation of a device, but can also be implemented earlier, during the design phase. During this critical phase, manufacturers must also carry out a review of available standards and existing patents in order to implement the most efficient development process, adapted to both the regulatory context and the market.

Although there is no specific recommendation for drafting a state of the art in the design phase, it is advisable to follow the requirements of MEDDEV guide 2.7/1 Revision 4, which specifies the requirements for clinical evaluation. The latter details the methodology to be followed to ensure an exhaustive and objective state of the art, serving as the basis for establishing the device’s safety and performance claims.

The objectives of a state-of-the-art study differ according to the type of device being designed. When designing an innovative device, the state of the art makes it possible to identify gaps in the market and anticipate changes, so as to focus R&D efforts and position the device competitively. Indeed, it is vital to identify emerging trends and technological advances, to determine the medical needs that existing devices do not effectively address, to understand the problems that have been encountered with similar technologies, in order to develop adapted, competitive solutions that will offer a significant clinical advantage to the medical profession and to patients.
When developing a device in line with the existing one, for example to meet growing market demand, the state of the art is needed to identify existing, high-performance technologies, determine the evaluation criteria and the performance and safety benchmark to which the developed device will have to conform, thus avoiding duplication of effort.

The importance of studying similar devices

Analysis of similar devices available on the market is a major component of the state of the art. Identifying the technologies currently used in similar devices (materials, electronic components, software and mechanisms of action, etc.) with their advantages and limitations helps to guide the design.

Rigorous analysis of available data on similar devices ensures that safety and performance claims are based on sound scientific and clinical evidence. The performance and clinical benefits claimed must be measurable and quantifiable, so that their achievement can be objectively demonstrated. The performance and safety of similar devices are demonstrated through the achievement of established evaluation criteria recognized by the medical community. These same criteria should be used in preclinical or clinical studies carried out on the device under evaluation, so that its performance can be compared with similar reference devices.

The study of clinical results available on similar devices, in particular the risks, complications and undesirable effects identified, also serves as input for various elements of the technical file, such as the risk analysis or the package insert. Similarly, available publications on similar devices enable us to identify medical indications, target populations, user typology and contraindications to product use, all of which are necessary elements in the drafting of the instruction leaflet.

Finally, feedback from healthcare professionals using similar devices must also be taken into account. They may reveal problems of ergonomics, user interface or functionality that could be improved.

An ongoing process

State-of-the-art analysis must be an ongoing process, reflecting the ever-changing medical and technological environment. Manufacturers must be committed to monitoring advances in their field, and periodically re-evaluating the claims of their devices in the light of new data. This contributes to a virtuous cycle of continuous improvement, where device safety and performance are constantly optimized for the benefit of patients.

Article published by Romain Fournier in the Devicemed press review, available here.