Swiss startup Risklick launches AI-based software for medical device clinical trials
Protocol AI accelerates clinical trial development and patient access to medical device
Risklick, a spin-off from the University of Bern, has launched its latest product, Protocol AI, for medical devices. Protocol AI is the first software of its kind and marks a turning point in the medical device industry. It uses artificial intelligence to accelerate the development of clinical trials while drastically reducing associated costs and risks. This accelerated timeline benefits patients, granting them quicker access to new treatments—potentially at a lower cost. This innovative technology has demonstrated its potential to revolutionize clinical trials for medical products and is now ready to provide millions of patients with faster access to lifesaving medical devices worldwide.
Bringing a medical device to market typically takes 3 to 7 years, with clinical investigations being the most time-consuming and costly phase, especially for high-risk medical devices. Every clinical trial begins with the development of a protocol, which serves as the cornerstone of the study and determines the trial's success or failure. Developing a protocol requires an average of six months of intensive work, where even minor errors can result in serious consequences for the clinical trial.
The medical device industry is predominantly composed of small and medium-sized enterprises (SMEs), which account for approximately 90% of the sector.
Compared to the pharmaceutical industry, the medical device sector faces less
standardization and has less clinical trial experience, coupled with growing regulatory demands that make clinical trial protocol development even more complex. These challenges significantly affect the cost, availability, and success rates of new devices, ultimately influencing patients' access to innovative solutions.
AI-based software gives patients faster access to new medical devices
To address these challenges, the spin-off from the University of Bern, Risklick, has developed Protocol AI. "We have developed a pioneering solution that reduces both the development time and costs of clinical trials, making it easier for patients to access new treatments. Our solution has already demonstrated a 50% reduction in study document development time for medicinal products, and we expect similar savings for medical devices with our tailor-made solution. Our innovative technology has the potential to improve the lives of millions of patients worldwide," says Poorya Amini, founder and CEO of Risklick.
Protocol AI is the first groundbreaking software of its kind, utilizing Natural Language Processing (NLP) and Machine Learning (ML) technologies to analyze existing clinical data, publications, and regulatory documents, thereby optimizing the study design. Protocol AI enables evidence-based decision-making and the automatic drafting of clinical trial protocols within minutes, utilizing cutting-edge Large Language Models (LLM). This provides experts with vital parameters in the world of medical devices, which is in rapid and permanent evolution.
Protocol AI allows experts to drastically reduce the development time of protocols while ensuring quality, as well as increasing the chances of success for the clinical trial. The AIbased tool accelerates and simplifies the development of new devices and treatments, paving the way for medical innovation. Protocol AI promises to revolutionize the field of clinical trials and ultimately improve the lives of millions of patients worldwide.
With Debiopharm, a leading biotechnology company in French-speaking Switzerland, and Integrated Scientific Services, ISS AG, a Swiss clinical research company with expertise in medical devices, digital medicine, and IVD, Risklick has already attracted major players from both the pharmaceutical and medical device industries as partners. They see Protocol AI as the ideal solution to the challenges of developing efficient clinical trials.
"Our investment in Risklick is a strategic enhancement to our R&D, Clinical Operations, and Regulatory Affairs workflows. Through Protocol AI, we not only accelerate the delivery of innovative treatments but also ensure more efficient trial designs and robust compliance, addressing internal challenges with cutting-edge solutions that benefit our collaborators and patients globally," says Cédric Odje, Investment Associate at Debiopharm.
"Protocol AI sets a new standard in the development of clinical investigation protocols. Faster, cost-effective, and more precise—for MedTech manufacturers, this primarily means shorter time to market," adds Bernhard Bichsel, Co-CEO Clinical Services at ISS AG.
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