What We Delivered

Key Objectives

Glyconics is an ISO 13485 certified medical diagnostic company using a novel approach to detect and monitor diseases. They are exploiting the ability of infrared light to produce a distinctive molecular ‘fingerprint’ in healthy vs non-healthy samples using a predictive algorithm in a simple point-of-care device. The technology has huge promise in the clinical management of diabetes. Working closely with the Glyconics’ team, our design challenge was to develop a game-changing, point-of-care diabetes screening tool, Glyconics-SX, prior to applying for regulatory approval and CE marking. The industrial product design brief required the medical device to be compact, easy to use by the clinician and light-weight for desktop use in independent clinical studies.

Result

Our industrial design of the non-invasive, handheld medical device, exploits the use of miniaturised infra-red (IR) spectrometry for the early diagnosis of diabetes – detecting biomarker changes in a patient’s fingernail within seconds, without the need for single use plastics. The ergonomically designed base pad features a carefully sculptured location element with gentle sloping angles to support and locate the finger, an indicator line defines the optimal nail positioning. Meanwhile, the mobile, miniaturised near-infrared (NIR) spectrometer fits neatly into a cradle with an aperture to collect good signal-to-noise measurement. A rack and pinion stage provides a smooth, fine vertical adjustment. Using the latest CAD design, DesignEdge rapidly detailed the assembly to be manufactured specifically for additive manufacturing 3D printing technology for low volume, fast turnaround aimed for primary clinical trials.

“DesignEdge is an exceptionally professional and dedicated team and we are enormously grateful. A quick note to thank all at DesignEdge for your herculean performance in getting the cradle design and production completed so unbelievably quickly. Everyone was delighted with every aspect of the device including the look and performance, all of which exceeded our expectations. DesignEdge is a tour de force and we are so pleased for all the design work you have done, not least in being so meticulous with the paperwork and tight deadlines.”

Kam PooniCEO

Transformational Non-Invasive Technology

Industrial product design for game-changing, point-of-care rapid diabetes screening

Diabetes kills prematurely more people than breast cancer and prostate cancer combined every year and is a major cause of  severe complications such as blindness, heart attack and stroke. Although early detection is recommended, mass-screening for diabetes is not implemented as it currently necessitates invasive blood sampling, tons of single-use plastics and complex, costly operations. The clinical implementation of these results – using a novel, non-invasive approach to screening – will now enable a more strategic allocation of limited healthcare resources for the management of global diabetes risk in the future.

Prof Cos, Chairman of Primary Care Diabetes Europe, “Developing non-invasive systems for population-level screening will be an important tool in reducing current barriers for mass-screening and identifying people at risk – because early detection and treatment is key to better long-term outcomes. Clearly the early detection of elevated diabetes risk requires more attention and enables prevention – this exciting new approach could shape the pivotal role that primary care plays in the management of diabetes and its long-term outcomes.”

Non-invasive desktop device

The non-invasive desktop device exploits the use of miniaturised infra-red (IR) spectrometry for the early diagnosis of diabetes – detecting biomarker changes in a patient’s fingernail within seconds and without the need for single use plastics.

Point-of-care device design

As a point-of-care device, the target users of the innovation will be retail/community pharmacists, GP surgeries, dentist surgeries, community health settings/health checks, healthcare professionals and in clinical trials.

medical-device-product-design

Ergonomic design

The product design of the wide base pad features a carefully sculptured finger location element with gentle sloping angles to support and locate the finger while an indicator line helps to define the optimal nail positioning. The miniaturised NIR spectrometer fits neatly into a cradle with an aperture to collect good signal-to-noise measurement.

Removes need for single-use plastic

Measuring non-invasively through a fingernail, the Glyconics-SXTM device and Cloud detects the presence of diabetes by analysing glycated protein in a person’s fingernail with results in under 10 seconds without the need for blood, reagents or single-use plastic consumables.