The Manufacturer explores how a piece of innovative wearable tech is helping the world’s 415 million-strong diabetic population cope with life-threatening complications.
Diabetes is an increasing worldwide problem. Shockingly, every 20 seconds someone in the world has part of their leg amputated due to diabetes. More than 6,000 amputations are carried out each year in the UK alone.
A common complication for those with diabetes are chronic foot ulcers, which develop because of poor blood flow and loss of feeling in the limbs, particularly the legs. This means that it’s easy for even a minor foot injury to develop and become infected.
Ulcers are slow and difficult to heal, representing a serious health injury to the diabetic, as a non-healing ulcer will allow bacteria to enter the blood steam with potentially fatal consequences. Amputation of the affected limb is often the best option to stop gangrene spreading to the rest of the body.
In December 2012, Pulseflow Technologies, a start-up without technical or manufacturing capabilities, approached family-run Morgan Innovation and Technology (IAT) with a concept that could dramatically help the healing of diabetic foot ulcers.
The resulting partnership produced the wearable tech product, PulseflowDF – a boot specifically devised to reduce pressure, shear and friction forces on the ulcer site, and promote healing to occur. The offloading device also features the periodic inflation of an air-bladder under the foot arch, which helps to maintain sufficient blood flow, a vital part of the body’s healing process.
Funding
Critical to the development of PulseflowDF, was Morgan IAT’s innovative approach to funding and R&D. Getting any idea or product to market can be difficult and costly, but particularly so in the healthcare and medical sectors.
To address this challenge, Morgan IAT has adopted a flexible funding approach which helps inventors to bridge the gap between invention and product commercialisation – often referred to as the ‘valley of death’. Every year, the company puts up to 20% of its turnover to help individuals, organisations and businesses develop new ideas.
Additionally, the company often carries out work free of charge in exchange for a share of a product’s potential, such as in the form of a royalty, a share in the IP rights or a manufacturing agreement.
Gaining UK regulatory approval
Pulseflow Technologies chose Morgan IAT as its partner to obtain CE Mark class 2A certification. Yet, the first clinical trials didn’t exactly go to plan. A metal offloader – a piece of steel that runs down the shin and connects to the sole of the boot – was failing due to the considerable pressures it was being subjected to, ending trails prematurely.
Together, Morgan IAT and Pulseflow Technologies worked on the problem, with the R&D team adjusting the size, design and structure of offloader components to vastly improve reliability. However, the project hit another hurdle.
Far from a standard piece of footwear, the complexity of PulseflowDF required the building of a bespoke test rig, something which would typically cost upwards of six figures. Once again, Pulseflow Technologies turned to Morgan IAT, who designed the necessary test rig at a competitive cost. Having produced three versions of the prototype for modification, in August 2015 just one was selected to be taken forward.
Proof of concept
The next stage was to obtain the official proof of concept that the product would work. An initial pilot study was conducted by the Royal Free Hospital, London, followed by a full proof of concept study by Professor Alexander Seifalian, Division of Surgery and Interventional Science, at the University College London, to assess the effects of PulseflowDF.
Although conducted on only a small number of volunteers, Seifalian’s study found that the pump action of PulseflowDF produced statistically significant increases in both oxygenation and flow of venous blood from the foot. The results demonstrated that improvements in blood flow – the underlying design objectives of the PulseflowDF pump system – had been successfully met.
Proof of concept proved to be the gateway to everything that the company has achieved since. With a CE Mark Class 2A approval already under its belt, the product went straight into production in September 2015.
US regulatory approval
The next step on the ladder to global commercialisation was gaining approval from the Food and Drug Administration, an essential regulatory permission needed to market a product in the United States.
This proved far more difficult than UK approvals and took some months, with the final application totalling thousands of pages. Although Pulseflow Technologies went to a specialist regulatory body in America, much of the information was predicated on work already prepared by Morgan IAT.
As Morgan IAT is an FDA approved company, it was both ready and able to manufacture the product once called upon. PulseflowDF was launched to the US at Symposium on Advanced Woundcare, Las Vegas in September 2015, with US FDA clearance achieved in December 2015, a major commercialisation milestone.
Sales of the product took off from there. The company markets the product globally via distributors, except in the US where it has a fully operational US subsidiary, Pulseflow Technologies Inc, based out of Ohio. For marketing, Pulseflow Technologies had to obtain two licences for each state, which it now holds for all 52.
PulseflowDF has seen interest and sales during 2016 from across the globe, as well as its US office, which is selling into the Veterans’ Administration network. Currently, Pulseflow Technologies has contracted distributors in Australia / New Zealand, Canada, Mexico, South America, Japan, Kuwait, Germany, Austria and Switzerland.
Since achieving FDA approval, the company has become a Durable Medical Equipment Supplier, as approved by the FDA; and in 2016, PulseflowDF was awarded the prestigious APMA seal from the American Podiatric Medical Association.
