Tento+Â is on course to boost the Medtech market significantly as more medical devices are set to enter service across the world.Â
The medical device market as a whole 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 the 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%.Â
To cater to the demand for regulatory approval for new medical devices, AND Technology Research developed Tento+ to streamline the process using AI.
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 questionnaire, informs the AI algorithms to help with the classification of the device, presentation of the required quality standards, appropriate authorities, and more.
In a recent trial of five projects using Tento+, the AND Technology Research team was able to calculate how much time (and money) Tento+ can save a company when working through the medical submission regulation process.
Time is taken for projects using Tento+:Â
- 400 hours to construct tests scripts, perform tests, author construct test reports, and other key documentation for Class IIb
- 110 hours (predicted) to construct tests scripts, perform tests, author construct test reports for Class IIa
- 76 hours to construct tests scripts, perform tests, author construct test reports, and other key documentation for Class I
Previous timings without Tento+
- 550 hours to construct tests scripts, perform tests, author construct test reports, and other key documentation Class IIb
- 120 hours to construct tests scripts, perform tests, author construct test reports, and other key documentation for Class I
Assuming an hourly rate range for consultants between £150 – £200 an hour, the AND Technology Research team sees a potential saving of £30,000 for Class IIb, and £9,000 for Class I submissions.
Commenting on the findings, CEO of ANDtr, Dr. Nicola Thorn said: “The potential of Tento+ is even bigger than we originally realized when developing the dashboard. The time and cost savings are even better than we first expected.
“And when you consider the number of new and exciting innovations using Artificial Intelligence, Machine Learning, and Augmented Reality in the medtech sector, the potential could go even further – it’s certainly a key market to watch for the next decade.
“Of course, the problem we have kept seeing is how much some innovators and engineers struggle in navigating the regulation process. There are many hurdles, and so many complex considerations to make, and it bleeds businesses time and money. Tento+ is purpose-built to 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, input and analyze technical information, and access AI-assisted advice and guidance on the regulatory process, classification, and more.â€
