AND Technology Research, will be showcasing and unveiling its Tento+ testing dashboard at Med-Tech Innovation Expo, which could save businesses £30,000 for Class IIb submissions.
cmgirl Shutterstock
183251513
Announcement concept
Due to these cost and time savings, Tento+ could boost the medtech market significantly as more medical devices are set to enter service across the world.
The event, taking place on the afternoon of Day One (7th June) will also feature an address from guest speaker Sue Spencer, head of IVD at Qserve Group, who will run through the importance of the challenges the medtech industry faces and the role Tento+ can play.
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.
To cater for the growing 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.
At this launch event, the CEO of AND Technology Research, Dr Nicola Thorn, will be on hand to invite people/organisations looking to build and manage medtech devices to join Tento+ and use it as an effective tool to speed through the regulation process safely and easily.
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.
Tento+ offers two main benefits currently:
- Ability to find the harmonised standards that apply to your product/device
- Then easily build up the evidence to show compliance, through documenting design controls and test records.
Tento+ is built from a company (AND Technology Research) that has had to undertake the regulation process for customers time and again, for many years. Using this experience and expertise has resulted in the development of Tento+.
Attendees will be granted early access to Tento+ and can meet the creator herself, Dr Thorn, and ask any questions. As well as the product launch and demonstration, guests will be invited to have refreshments and participate in retro games.
Ultimately, Tento+’s mission is to break down the prohibitive barriers to start ups and innovators in terms of lack of guidance, extortionately high fees, and sometimes just not knowing where to start.
The mission of Tento+ is also personal. After seeing her partially sighted grandma use medical technology and assistive living technology to help her daily life, breaking down these innovation and regulation barriers is a cause close to the heart of Dr Thorn. The sooner people can benefit from life-changing medical technology, the better.
Commenting on the most recent Tento+ trial findings, CEO of ANDtr, Dr Nicola Thorn said: “The potential of Tento+ is even bigger than we originally realised when developing the dashboard. The time and cost savings are even better than we first expected.
“Many engineers struggle in navigating the regulation processes when developing a new product in the med tech sector. There are many hurdles, 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 analyse technical information, and access AI assisted advice and guidance on the regulatory process, classification, and more.”
The Tento+ product launch will be taking place from 2pm on 7th June at Med-Tech Innovation Expo at the Med-Tech Innovation Connect Lounge. AND Technology Research will be exhibiting at Med-Tech Innovation Expo on Stand C19. To register for FREE, visit www.med-techexpo.com.