Purpose-led technology company, AND Technology Research, is announcing a new iteration of its Tento+ testing dashboard, as it aims to boost the medtech market significantly as more medical devices are set to enter service across the world.
The medical device market has undergone consistent levels of growth over the past decade and is projected to grow at a compound annual growth rate (CAGR) of 5.4% in forecast period 2021 - 2028. Currently, the World Health Organisation reports that there are an estimated 1.5 million medical devices globally, across more than 10,000 specific types. Crucially, ‘Software-as-a-medical-device’ (SaMD) now represents a market niche that is predicted to grow at a compound annual rate of 63%, considerably higher than the market growth rate.
To cater for the ever-growing demand for regulatory approval for new medical devices, AND Technology Research has developed Tento+ to streamline the process using AI, for any business, large and small.
Launching today, Tento+ is an intelligent algorithm-enabled tool to help guide and facilitate companies along the regulatory pathway; a one-stop-shop for companies looking to develop medical devices.
A knowledge base is held within Tento+, which is then used by an AI algorithm to highlight specific information to users about their unique regulatory requirements. When inputting a medical device, users can enter a target market and device type. Following this, any nomenclature is then changed, and regulatory requirements are updated.
Users can also enter a statement of use and device description which, along with a simple questionnaire, informs the AI algorithms to help with classification of the device, presentation of the required quality standards, appropriate authorities and more.
Users will also be able to capture and analyse certain technical, risk and clinical information directly in Tento+. Users will then be able to record traceability matrices, testing records and anomalies as well as risk and usability controls. From here, users can automatically generate technical documentation such as test plans, test logs and records, software decompositions and software requirements for use within submissions to regulatory bodies.
Tento+ dashboard is a purpose-built web-based tool that enables developers, project managers, and test engineers to track, manage, and organise their product development and testing journey. The dashboard provides engineers with quick insights into the progress of their project as test scripts, anomalies, and the requirements traceability matrix are all accessible in one place. Thanks to end-to-end visibility across the software testing lifecycle, development teams can now easily map and visualise the relationship and test coverage of user requirements, software function, unit, and code.
As the world scrambles to respond to new challenges brought on by COVID-19 and other global health challenges, Tento+ will serve as an example of how agile software management can bring the medical world into the future, rapidly. Increased agility removes multiple layers of obstruction to the product development process and can therefore speed up the creation of new medical technologies.
In a recent case, the platform was used successfully to accelerate the software testing of a ground-breaking 3D visualisation system developed by Norwegian start-up HoloCare. The HoloCare Studio provides clinicians with visualisation through 3D Holograms of a patient’s organs, giving better insights into both heart and liver diseases prior to life-saving surgery.
CEO of ANDtr Dr Nicola Thorn said: “The potential of Tento+ is even bigger than we originally realised when developing the platform.
“The number of new and exciting innovations using Artificial Intelligence, Machine Learning, and Augmented Reality in the medtech sector is incredible – it’s certainly a key market to watch for the next decade.
“The problem we keep seeing is how much some innovators and engineers struggle in navigating the regulation process. There are many hurdles, so many complex considerations to make, and it bleeds businesses time and money. Tento+ will change this completely, no matter what size the business is or the application of the innovation. Tento+ provides efficient and speedy management of agile testing for regulation using AI-enabled analytics to ease the journey for engineers. I like to think of Tento+ as an engineer’s new best friend. For each medical device, the user can easily access the required regulatory information, upload, and analyse technical information, and access AI assisted advice and guidance on the regulatory process, classification, and more.”
Alison Sundset, CEO of HoloCare, said: “Tento has been a real game-changer for us. It makes the whole regulatory process so much more manageable and efficient. We look forward to seeing Tento’s usage throughout the medtech industry – it is exactly what we need to speed up these processes. We’re looking forward to working with ANDtr on the next one!”
