GENERAL
How did FeelTect start?
FeelTect began its journey in BioInnovate Ireland, a needs-led innovation program involving clinical immersion in the Irish healthcare system and the Mayo Clinic, USA. It was here that the critical need was identified for a way to significantly reduce healing times and healthcare personnel workload in the treatment of VLUs, for reduced costs and improved patient outcomes. After a two-year project at the University of Galway to establish the underlying solution to this need, Tight Alright, the company was spun-out in 2020 by founders, Dr Andrew Cameron (CEO), Dr Darren Burke (CTO), and Prof. Garry Duffy.
What’s FeelTect’s mission statement?
Our mission is to disruptively improve wound care by developing connected-health solutions to realise the full potential of wound treatments and enable patients to receive individualised, optimised care, specific to their clinical and user needs.
What is FeelTect looking for in partnerships?
Wound care is a complex puzzle, and FeelTect is just one (albeit important) piece. We believe strongly in collaborations with diverse stakeholders, including healthcare professionals, providers, payers, manufacturers, patients, and even competitors, with the goal of finding mutual benefits in our shared ambition to progress wound care. Areas of interest for collaboration include clinical investigations, innovative models of care (e.g. tech-enabled service models), value- and risk-based reimbursement, new/joint product development, distribution, and strategic partnership.
SOLUTION
What does Tight Alright do?
The core function of Tight Alright is to measure and monitor sub-bandage pressure at three physiologically relevant points on the leg during different stages of compression therapy. A wearable, multi-sensor, wireless device is worn by the patient, which includes a sensing arm that remains beneath the bandage at all times and a rechargeable electronic clip that is attached to the sensing arm whenever a measurement is taken. The electronics clip wirelessly connects to a mobile app (iOS or Android) via Bluetooth to display the pressures. The mobile app also connects to a secure cloud database via the internet, allowing pressure data to be transmitted, stored, and retrieved via a remote web app dashboard.
What’s the difference between point-of-care and remote functions of Tight Alright?
At compression application, the point of care solution (wearable device and mobile app) enables targeted application of compression, helping ensure safety and efficacy. Once compression is applied, the remote monitoring solution (cloud database and web app) enables tracking of swelling reduction via pressure loss, helping identify opportunities for maintenance of efficacy (e.g. through adjustment or reapplication of compression). By accounting for the treatment delivered to each patient over time and across multiple care settings, Tight Alright empowers more stakeholders to participate in the healing journey, whilst affording tailored compression regimens to accommodate individual clinical and personal needs.
Is the device reusable?
The electronics clip is reusable throughout the duration of treatment, with battery recharging possible using the charger unit. A sensing arm can be used for up to two weeks before it is to be replaced, due to potential wear and loss of calibration over time. During application of compression, the sensing arm is placed within a disposable adhesive sheath (a packet of sheaths is provided with the sensing arm). When the bandage is changed, the disposable sheath can be thrown away with the bandage/dressing, but the sensing arm is to be retained for up to two weeks.
Is a single device used by multiple patients?
It is intended that each Tight Alright device is only assigned to one patient, allowing for remote monitoring of individual patient treatment. For example, a patient may have one electronic clip and one or more sensing arms over the course of treatment; however, for safety reasons (e.g. potential risk of infection), these should not be shared with other patients. It is possible that a patient may have different Tight Alright devices for different legs, for example in the case of bilateral wounds.
Is the transmitted data secure?
In addition to storing all data on a HIPAA compliant, GDPR compliant, HITRUST certified framework, there is no directly identifiable data collected withing the Tight Alright platform, further protecting the privacy and personal data rights of all users. All data relating to an individual patient’s compression is collated in the database via the unique identification code (UIC) of their own transmitter device. In doing so, data is anonymised at the point of capture, but relatable to individual patients upon sharing their UIC with approved users (i.e. healthcare professionals). The app is also consent-gated, meaning that remote local or remote data transmission, or remote data storage, is only possible if it is permitted by the patient on the Tight Alright mobile app.
How does the healthcare professional access a patient’s data?
Each healthcare organisation can be provided access to use FeelTect’s secure, password-protected web app. The patient takes their Tight Alright device home where they can transmit their pressure readings securely to the cloud database via the app, according to the instructions of their clinical care team. Healthcare professionals can then sign in to the web app to search for their patients’ readings on the cloud database, using the unique identifier code (UIC) of each patient’s device to search for specific patient records.
How much does Tight Alright cost?
Different combinations of hardware and software products, and assosciated services, can be supplied depending on customer needs. These may include the use of Tight Alright for clinical, research, training, or educational purposes. Please get in contact with us to tell us your needs and we’ll be happy to discuss a pricing strategy to supply you.
REGULATORY
What Class of Medical Device is Tight Alright?
CE Marking
Tight Alright is CE Marked as a Class I device (EUDAMED ID code: B-TightAlrightGK, GMDN Code 64487 – Bandage Pressure Monitor).
FDA registration
The appliance is registered with the FDA as a Class I medical device under product code “JFC”. 510(K) exempt device in the USA (device listing D485851).
MHRA registration/ UK Conformity Assessed
The Tight Alright System is registered with UKCA (UK Conformity Assessed) and in conformity with the Essential Requirements and provisions of the following EC Directives, including all amendments and national legislation implementing the Directives: Directive 93/42/EEC (Medical Devices) Classification: Class I – Bandage Pressure Monitor (GMDN Code 64487).
TGA registration (Australia)
Tight Alright Technology is now registered as a Class I device in Australia (ARTG Identifier 468745).
Can Tight Alright be used for other indications?
FeelTect’s TIght Alright technology can be used for any indication where compression therapy has been prescribed by a qualified healthcare professional.
Can Tight Alright be used for training purposes?
The Tight Alright technology can be used to train users of all experience levels on the application of targeted compression. Even highly expereinced experts can use the technology as a means of checking their skills are maintained.