For medical device manufacturers, pushing a particular device through the various testing and investigation processes can prove a daunting process. Whether it’s compiling an efficient evidence base or just starting the first tentative approaches towards approval, any assistance is warmly received.
The Smart Solutions for Healthcare competition, delivered by the UK’s north-west NHS innovation hub TrusTech, promises to do just that. The aim of the competition is to find better, more cost-effective approaches for the diagnosis and treatment of patients suffering from cardiovascular disease.
TrusTech business development manager and programme director Dr Bryan Griffiths said, “The competition allows these devices to develop an evidence base and find sites for trials, while also helping the companies to handle the ethics of their respective devices.”
From the podium to the public
The competition, which attracted 50 entrants, will see the winners given the opportunity to be publicly tested, streamlining their approval and Griffiths deems this to be the perfect opportunity, adding, “Public testing can be difficult to organise, so the pivotal point is matching winners with particular investigators.”
As well as the public trials, office space in the MedTech centre in Manchester Science Park will also be provided in order to further develop the winning devices.
“The competition is independent, we merely provide the mechanism and the assessment panel is fairly rigorous.
“We try to ensure the devices are as scientifically robust as possible, so they stand up to the scrutiny they can expect in the competition and trials,” Griffiths added.
Of the 50 devices that entered the competition, four winners were announced in June 2011 and will now be put under scrutiny in a working environment.
Griffiths said, “All four of the winners provide rapid and simple ways to diagnose long-term conditions in a primary care environment, instead of specialist centres as at present. Not only do they provide significant savings on the initial testing costs, but allowing earlier diagnosis gives scope for more effective treatment and prevention. This in turn ensures better outcomes for patients and savings on longer-term care.”
Detection devices take the lead
The Liverpool-based Medalytix has developed iGrading CVD software, which could potentially provide doctors and physicians with a new way to assess a patient’s risk of cardiovascular disease by analysing a retinal image using automated algorithms. The system boasts no need for specialist staff and almost instant results, with Medalytix suggesting that it could cut the costs of the government’s over-40s health check screening programme by up to 35%.
According to the company, the quick, needleless procedure could also increase patient uptake of the screening as the current doctor’s appointment requires a blood test and takes in other aspects such as age, gender, blood pressure and weight.
Infrared to monitor blood volume
Dialog Devices, based in Loughborough, has developed the Padd device which detects peripheral arterial disease (PAD), which is effectively an obstruction of large arteries that are not within the coronary, aortic arch vasculature or brain. PAD itself can lead to acute or chronic ischemia, putting the heart under more pressure.
The Padd device can detect PAD through the use of infrared light to monitor changes in blood volume in the foot before and while raising the leg, indicating the presence of obstructed arteries. The device can be used in a primary care setting and can even provide reliable results in patients suffering from diabetes. It does not require the use of pressure cuffs, unlike other tests in use, such as the ankle brachial pressure index (ABPI).
Apnoea detection in the home
Another winner promises to allow the diagnosis of sleep apnoea in a patient’s own home, a proposal by the Cambridge-based Trillian. Patients can collect the device a GP’s surgery and simply leave it on overnight, allowing the device to conduct a sleep study and gather data. The device is returned the next day and data sent to Trillian for analysis and diagnosis. The total cost of the service is £250, one third of the £750 price hospital sleep centres have been known to charge for the same diagnosis.
Vibration at your fingertips
The fourth and final winner of the Smart Solutions for Healthcare competition, developed by the Nottingham-based McCallan Medical, is the VibraTip. The device uses vibration on the feet of diabetic patients to test for peripheral nerve damage and can provide continuous vibration, unlike tuning forks, which are traditionally used, to provide more consistent and reliable results.
The pocket-sized device costs just £6, so is inexpensive enough for patients and nurses to be equipped with.