Commercialising Medical Innovation

“Medical Device development can be incredibly challenging. Our experience in taking early prototypes through to manufacturing has enabled some incredibly innovative companies to achieve their business goals”.
- Richard Allen, Head of Manufacturing

The Challenge

Our client PneumaCare, a University of Cambridge spin-out, had developed non-contact technology for the measurement of lung function, which did not require the patient to make forced expirations.

Their highly innovative approach used structured-light analysis to assess 3D movement of the chest.

PneumaCare asked Plextek to take their early prototype system through to manufacture, including regulatory approvals.

The Approach

We realised that development of a commercial system would involve the solution of numerous technical issues, including stereoscopic camera alignment, effect of lighting conditions, reliability and calibration.

We undertook an initial technology feasibility study, conducted an IP search and a manufacturing assessment, and recommended the most cost-effective development approach.

We assembled a multi-disciplinary team experienced in medical device development, and worked closely with PneumaCare’s founders to realise their ambition.

The Outcome

Since launching this product, PneumaCare has won numerous medical device innovation prizes and received praise from leading Respiratory and Paediatric specialists.

The Thora-3DI™ device achieved CE mark approval in Europe in 2012, and is being used in hospitals in the UK, France, Italy, Denmark, Sweden, Middle East, Hong Kong, China and Malaysia.

Following the first FDA 510(k) clearance granted in March 2016, PneumaCare is now working with its strategic partners to make the device available in the US and in other markets.

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Real-time Monitoring of Patients in Challenging Environments

"A thorough understanding of the technical issues faced in developing a novel wireless network inside a hospital environment was critical to the practical success of this project”.
- Nigel Whittle, Head of Medical & Healthcare

The Challenge

Our US-based client wanted to develop an ambulatory electrocardiogram (ECG) monitor that could record and transmit information from adult patients undergoing treatment in a hospital.

Their vision was to monitor vital signs of ambulatory patients in real-time and then transmit this data via the standard wireless medical telemetry frequencies used in hospitals.

However this poses a significant challenge as indoor wireless networks within hospitals are notoriously unreliable due to reflective surfaces, solid walls, beds and wards, which all cause interference with existing band signals.

The Approach

We determined that the system would need to reliably transmit accurate readings of heart rate determination, R-wave detection, ECG filtering and arrhythmia recognition.

In order to ensure complete reliability, our approach was to incorporate multiple antennas to ensure communication with the patient-worn telemetry packs.

A new bespoke system was developed which included radios, signal processing, software and a new secure band level for our technology, ready for adoption by hospitals.

The Outcome

The final product was a system with sufficient bandwidth to reliably monitor up to 189 patients at any given time, providing a holistic healthcare approach by allowing multiple patient monitoring.

We were able to support our client throughout the entire development cycle, from initial concept to final manufacture, providing a custom-made service that exactly matched our client’s needs.

The system was approved by The Food and Drug Administration (FDA) for use in the USA, and over one third of all US hospitals are now routinely using this monitoring system.

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Wearable Tech for early Detection & Prevention of Hearing Damage

“The ability to self-monitor will allow earphone manufacturers to provide equipment with a built-in safety feature that will provide significant reassurance to their customers”.
- Thomas Rouse, Lead Consultant, Medical & Healthcare, Plextek

The Challenge

NIHL and tinnitus have traditionally been a problem for those working in noisy environments, such as rock musicians, soldiers or construction workers, but it is also spreading fast among the music-loving younger generation.

Early intervention can be effective in mitigating the worst effects of loud music, but existing technology for testing for NIHL is generally only available in hospitals or specialised clinics.

The Approach

Plextek has developed an innovative wearable demonstrator system for early detection of NIHL, potentially allowing the subject to take immediate remedial action and thereby prevent the condition.

The technology sends auditory stimuli to the ear through standard ‘off-the-shelf’ earphones, then analyses the resulting Auditory Brainstem Response (ABR), producing a fingerprint of the ABR.

Changes in this fingerprint are predictive of the onset of hearing disorders (including ‘hidden’ hearing loss that cannot be detected by standard tests).

The Outcome

No existing technology is currently available to enable the facile detection of such damage before the person develops overt symptoms, such as the characteristic buzzing in the ears that indicates tinnitus.

The company’s solution, when integrated into commonly used in-ear consumer earphones or headphones, will remove the clinical barrier to access and could play a game-changing preventative role in the treatment of NIHL.

In addition to general consumer use, it would particularly benefit those working within high-risk environments such as building sites, the military, or music venues.

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