Digital Innovation in Rehabilitation: why clinical evidence is a requirement (and not an option)
In the world of digital health, innovation moves fast. Every day, new technological solutions are created to improve quality of life, optimize therapeutic pathways, or make healthcare delivery more efficient. However, one crucial aspect often lags behind: clinical validation.
Many digital tools present themselves as revolutionary, but not all are supported by solid scientific data. This represents a risk not only for patients, but also for healthcare professionals and institutions considering their adoption. Without objective proof of effectiveness and safety, even the best idea risks becoming a missed opportunity [1].
The value of clinical evidence
In healthcare, every tool or device designed to support care processes must prove its reliability through objective evidence. For digital rehabilitation solutions, often dealing with delicate aspects such as movement, remote monitoring, or functional recovery, clinical evidence is even more critical.
Scientifically validating a technology means not only proving its effectiveness but also ensuring its safety, appropriateness, and usability in real clinical settings. The absence of validation represents a risk for patients and a barrier to large-scale adoption by healthcare facilities [2].
Integrated pathways
With the entry into force of the European MDR 2017/745 Regulation, the framework has become clearer but also more stringent. To place a medical device on the market, it is necessary to meet strict requirements in terms of clinical evaluation, risk management, and post-market surveillance.
This requires companies to adopt a systematic approach starting from the R&D phase, with well-structured clinical validation pathways that comply with the required ethical and scientific standards [3, 4].
In the field of digital rehabilitation, technological innovation and scientific rigor are two sides of the same coin. They cannot be treated as separate elements or as steps to be addressed at different times. Data collection and analysis, comparison with existing protocols, and the involvement of professionals and patients must be an integral part of design. This approach prevents inefficiencies, regulatory delays, and clinical risks, while also facilitating faster and more sustainable adoption in practice.
The key role of clinical research professionals and Clinical Research Organizations
Partnering with a team of professionals with solid experience in clinical trial planning and management and/or with organizations such as Contract Research Organizations (CROs) is today a strategic choice for digital health companies. These professionals and organizations not only support the design and operational execution of clinical studies, but also provide essential expertise in preparing technical documentation, managing regulatory aspects, and ultimately producing solid and reliable results [5].
Collaborating with clinical research professionals or with a qualified CRO means:
following a validated and recognized clinical research pathway,
ensuring regulatory and legal compliance throughout the certification process,
gaining a competitive advantage in market access,
strengthening credibility with regulatory bodies, clinical partners, and investors.
In line with these principles, for the clinical validation projects of the AuReha technology, DigitalRehab collaborates with Fondazione RIDE2Med, a CRO supported by a team of clinical research professionals with experience in planning and managing several hundred clinical trials and in publishing over 250 scientific articles, including in top-tier international journals.
Summary and perspectives
In today’s landscape, where healthcare digitalization is a strategic priority, scientific reliability is what distinguishes a truly innovative and effective solution from one that is unsustainable. Investing in clinical evidence is not a limitation, but a long-term competitive advantage. It is what ensures sustainability, trust, and value for all stakeholders.
This approach is at the core of DigitalRehab’s vision: every step in the design and development of our AuReha technology is supported by a rigorous validation plan, because we believe that only what is scientifically proven can truly make a difference in people’s lives.
Want to learn more about how we validate our technology?
Discover our AuReha project or contact us to find out more.
References:
- Guo C, et al. Challenges for the evaluation of digital health solutions-A call for innovative evidence generation approaches. NPJ Digit Med. 2020 Aug 27;3:110. doi: 10.1038/s41746-020-00314-2. PMID: 32904379; PMCID: PMC7453198.
- Gomis-Pastor M, et al. Clinical Validation of Digital Healthcare Solutions: State of the Art, Challenges and Opportunities. Healthcare (Basel). 2024 May 22;12(11):1057. doi: 10.3390/healthcare12111057. PMID: 38891132; PMCID: PMC11171879.
- BSI Group. (n.d.). Clinical evaluation under the EU Medical Device Regulation (MDR). Disponibile su: https://www.bsigroup.com/globalassets/localfiles/en-gb/medical-devices/whitepapers/clinical-evaluation-white-paper/clinical-evaluation-under-eu-mdr.pdf
- MDCG – Medical Device Coordination Group. (2020). MDCG 2020-1: Guidance on Clinical Evaluation (MDR) for medical device software. European Commission, Directorate-General for Health and Food Safety. Disponibile su: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf
- Singh G., Harky A., et al. (2023). Digital therapeutics in neurology. Cureus, 15(5): e39886. Disponibile su: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10256537/
