Clinical Evaluation of Innovative Devices
Clinical evaluation is a prerequisite for the successful launch of any new medical device. It allows a product to be tested and provides a demonstration of its performance and reliability in a real clinical environment.
The importance of clinical evaluation is underlined by the fact that in Europe, the USA and many countries worldwide it is a mandatory requirement to achieve certification. Even for the health devices which are not intended to be certificated by Health Authorities, it also demonstrates that the product has been rigorously tested for safety and efficacy, giving patients and healthcare professionals the confidence to try out a new and innovative device.
Planning for success
The foundations for a successful clinical evaluation are laid in the planning stage when we meet with clients to advise them on the best strategy to meet their goals and challenges. The KYomed INNOV team has a wealth of experience in designing clinical trials that meet clients’ development and budget targets. Our evaluations range in size from proof of concept studies involving a small number of subjects to extended clinical trials necessary to achieve Europe’s CE marking or other worldwide certification.
Clinical evaluations performed by KYomed INNOV rely on a wide range of disciplines to ensure that every aspect of the project is carefully planned. For the success of our clients’ projects, we provide a dedicated project manager who, in consultation with medical experts and health care professionals, check the operational feasibility of a study, set-up and write the clinical protocol, select investigational sites and ensure the smooth progress of the trial. The project manager will work closely with data scientists skilled in calculating the optimum sample size for a clinical trial and anticipating the different statistical analysis, regulatory experts who advise on Health Authorities requirements of specific countries, and if needed, health economics experts who evaluate the economic impact of new devices in the perspective of reimbursement application.
Integrated project management
Once planning is finalized the project manager takes charge of every operational detail involved in the clinical evaluation process: select and train the most appropriate sites to conduct the research, supervise the trial conduction and material vigilance reporting as per Good Clinical Practices and regulatory requirements, manage potential third parties and vendors providing any good or service to the trial, and issue the final clinical report.
Throughout the clinical evaluation the project manager acts as a single point of contact between the clients and the different project stakeholders to ensure an open, effective communication between all involved parties. The project manager is also responsible for the trial budget’s follow-up including the follow-up of vendors’ contracts. Clients are given direct feedback on both clinical and financial progress throughout the study.
Taking innovation to a worldwide perspective
In its approach, KYomed INNOV examines any medical innovation and medical device from a worldwide deployment perspective. Our experts have detailed knowledge of the different regulatory and market requirements of most countries. The regulatory files are compiled to meet both national laws and Professional bodies’ standards. This expertise is vital when it comes to compiling the final submission report for medical device certification at the end of the clinical evaluation process. In-depth knowledge of regulatory issues means that any specific national or regional concerns can be addressed upfront and resolved timely, paving the way for a smooth global launch of the product when it eventually comes to market.
Where usability meets clinical trials
A unique aspect of KYomed INNOV’s service is our ability to evaluate health innovations from both a clinical standpoint and user experience. Our combined clinical and usability evaluations are a highly cost- and time-effective way of putting a medical device to work in a real-life environment where aspects such as its impact on the quality of life, observance, suitability, usability and ergonomy can be tested along with its clinical efficacy. Any potential benefits of including this user experience is assessed at the planning stage of a trial by the project manager, who cooperates with KYomed INNOV UX designers, and who advises clients on the best strategy to follow.
With Health authorities placing more and more emphasis on the importance of involving patients in the evaluation process, in particular in the clinical evaluation of medical devices, this holistic approach is likely to set the benchmark for the future.