Project Description

Clinical Trial Software

“Innovation in healthcare has at times been a very long and costly process. By embracing technology, and specifically the FileMaker Platform on iPad, we have been able to bring a bug resistant anti-microbial to hospitals in record time and at a fraction of the cost of traditional trials. We are now seeing wound care improvements that in some cases is saving limbs and dramatically changing the quality of patients’ lives” – Ian Staples, Founder, Healing Honey.

Healing Honey significantly improves chronic wound care

treatment with the help of Linear Blue

Healing Honey was formed in 2011 when former Halfords MD Ian Staples was living on an organic farm in Chile, complete with beehives. During his time at the farm he investigated why the nectar didn’t ferment in the hive when the conditions seemed perfect for fermentation to take place. Ian went on to investigate how the honey could be processed to control its natural antimicrobial qualities and make them highly potent.

Working with his son, Stuart, Ian set up Healing Honey and went about securing funding for scientific research. They have developed a turbo boosted antimicrobial, Surgihoney, which controls infection, even in the case of really tough pathogens such as highly antibiotic resistant bacteria, fungi and viruses. Once an infection is under control, the therapeutic wound healing properties of Surgihoney had the significant added benefits of pain control, wound cleaning, exudate control and the stimulation of healthy tissue development, as the starved wound tissue has access to a high energy source of nutrients from the honey.

The challenge:

Developing Surgihoney was the (relatively) easy part of the process and, once ready, Healing Honey turned its attention to how it could go about recruiting medical teams and patients to undertake a trial. This process is something that has traditionally been prohibitively difficult and expensive to anyone other than the large pharmaceutical companies.

The other challenge facing Healing Honey was how to capture and present its results in order for Surgihoney to be put to the best use in hospitals not just in the UK, but across the world.

“As we aren’t doctors, bringing in Dr Mathew Dryden, Hampshire hospital’s consultant microbiologist, was the first step to recruiting medical teams into the trial. We worked closely with him to look into all the logistics and how we could go about capturing the data” said Ian Staples, Founder, Healing Honey.

Healing Honey was also keen to test Surgihoney in environments where hospitals aren’t as advanced as the UK’s National Health Service, so paid for doctors to visit other countries and monitor progress. It was important that the technology could sync in remote areas and the same details were captured no matter where the trial was taking place.

If we hadn’t used Linear Blue and the FileMaker Platform on iPad to speed up the trial process and significantly reduce the costs, Surgihoney may still be sat in a lab somewhere. Instead it’s saving and improving lives today.

– Ian Staples, Founder, Healing Honey

The Linear Blue solution:

The simplicity of giving each nurse and doctor an iPad allowed Healing Honey to do something truly innovative. Being constrained by how things have been done before can be a real stumbling block for healthcare professionals. In order to take a different approach and deliver the best possible solution to manage the trial data, Healing Honey turned to Linear Blue in order to develop a mobile clinical trial assessment solution built on the FileMaker Platform.

Creating the clinical trial software in FileMaker preloaded onto the iPad given to medical teams, and utilising the in-built camera, enabled daily comparisons of wound improvements and allowed patients’ treatment to be easily monitored and recorded throughout the trial. The new solution was developed and live within 12 weeks meaning that patients could begin benefitting from the effects of Surgihoney within a very short timeframe.

Surgihoney has now been tested in over five countries – UK, Uganda, Ethiopia, Sudan and Tonga – by 300 patients with chronic wound care issues, in a six month programme, at less than ten per cent the cost of traditional healthcare trials.

Ian commented: “One teenage girl was in a tractor accident and in danger of losing her leg due to the infection in the wound. She is now up and walking again… on both legs. If we hadn’t used Linear Blue and the FileMaker Platform on iPad to speed up the trial process and significantly reduce the costs, Surgihoney may still be sat in a lab somewhere. Instead it’s saving and improving lives today.”

Notable benefits:

Utilising FileMaker on the iPad meant that Dr Dryden was able to undertake a trial on the effects of Surgihoney post C-section. The Department of Health initiative was carried out on 200 patients and every step was monitored through the Linear Blue solution. Infections occur between the operation and up to 14 days after but when Surgihoney was applied straight after surgery, Dr Dryden and his team saw a 60 per cent reduction in infection rates.

“The ability for doctors and nurses to not only capture medical details but also photograph the wounds in the days post op meant they could track results to a minute detail. The consistency of how results were presented also meant that healthcare teams could track, monitor and control performance on a live basis” said Ian.

The system is constantly updated following feedback from healthcare professionals using it and patients. For example, as the patients left hospital it was important for them to keep up the treatment. Instead of a nurse needing to call patients frequently to remind them to apply Surgihoney, Linear Blue adapted the FileMaker solution to include automated reminders, saving time and ensuring the best possible outcome for patients.

Surgihoney is already a CE and Canadian approved medical device. This means that it can be used in hospitals, clinics and sold in pharmacies throughout Europe and many parts of the world. The process of obtaining full global accreditation is an evolving activity.

The huge value of using the combination of the iPad and the FileMaker system has been the acceleration of the whole clinical assessment programme. The ability to see wound improvement as it happens has resulted in Surgihoney gaining enthusiastic and influential champions. These champions are the key to the product becoming a viral global wound care solution for the richest sector of the world who can always afford the very best to the poorest villager in Africa and India.