PATIENT SAFETY
care. They were the obvious choice for the project and a great partner for us. We were able to take their prototype and some injection moulding tooling and work with them to manufacture it into a finished product.” After a long development process,
Tracheseal was launched in 2012. The dedicated dressing was designed with an integrated location button which is easily located by the patient enables easy, accurate and consistent location of the tracheostomy wound. When pressed, it prevents unwanted air passage through the wound during actions such as coughing and sneezing. The dressing accelerates the healing process and offers greater patient comfort following the removal of a tracheostomy tube. The silicone oil technology provides a gentle layer to protect fragile skin. Another unique feature is the vapour-permeable, waterproof adhesive film which reduces trauma and pain during the removal of the dressing.
There are a number of clinical benefits of the dressing including quicker wound healing reducing it to as little as three days (on average this would normally take between seven to 10 days). Tracheseal also reduces the need for dressing changes preventing potential skin damage by frequent dressing removal. “Throughout the whole process our mission was to specifically address stoma closure difficulties post-decannulation but also promote faster healing and restoration of speech,” explained Claudia. “The benefits of this are improved communication between the patient and clinician and faster healing, which will ultimately free up bed space, which in the current climate means a tremendous amount to the NHS. “We wanted to improve the whole patient experience following tracheostomy tube decannulation, leading to shorter hospital stays and fewer complications.”
Customised shape designs
Since the product was launched, three customised shape designs have been designed to adapt to different patient requirements. Claudia explained that the shape options were chosen because it gives clinicians greater choice depending on the clinical needs and surgical site. The square- shaped device offers slightly more absorption of exudate (>0.50g/cm2
round absorbing (>0.25g/cm2
) with the oval and ).
dressings. They did however prefer Tracheseal as they find it so much more comfortable and effective which is wonderful news.”
The design process
During the design process, the dressing went through a number of iterations. The first product was designed using a hydrocolloid material, which was chosen for its ability to absorb higher volumes of exudate. Following feedback from clinicians and patients, P3 Medical established that the materials adhesive properties where not suitable for the specific application. The company also redesigned the button as it was too large for the elderly population and could cause irritation around the clavicle area. Simon Talbot, managing director of P3 Medical, asserted: “Having worked with the HEE in the past, they knew our strengths and thought we would be a good commercial partner. The product fitted our portfolio and our commercial strategy, so it was a good fit for us to be involved. “Our ethos is to work with healthcare professionals to bring innovative ideas to the medical device market. We have expertise in all aspects of product realisation from initial prototype right through to sales and distribution and this is what we were able to bring to the partnership. “The dressing is a perfect example of a simple but effective design that delivers benefits to patients and also to the NHS, with faster healing time meaning shorter stays in hospital. It is improving the whole patient experience following a tracheostomy.” The product has been available in the UK for 18 months in its current iteration, but Simon says it there are now plans to launch the product stateside. “The sheer size of the US makes it
Claudia said: “The soft silicon wound contact layer is non-adherent to the wound so that newly formed tissue is not traumatised when Tracheseal is changed or removed. “The purpose of the button is to prevent passage of air through the wound, which gives the patient the ability to communicate and also assists the healing process of the stoma more efficiently. It also offers the patient comfort and control over the dressing, directly improving voice quality and strength of cough. “We have also received strong feedback from patients who have been discharged from hospital and were offered alternative
The dressing is a perfect example of a simple but effective design that delivers benefits to patients and also to the NHS, with faster
healing timemeaning shorter stays in hospital. Simon Talbot, managing director P3 Medical
NOVEMBER 2018
a very attractive proposition for us and we know after speaking to clinicians in the states, there is a strong clinical need for the product,” he said. As part of the company’s strategy to roll
the product out in the US, it has located itself within the ABHI Innovation Hub, a unique partnership between the Association of British Healthcare Industries (ABHI) and the Dell Medical School at The University of Texas at Austin. The Hub offers the opportunity for P3 Medical to be part of a world-class facility and develop its US business within an ecosystem of clinicians, investors and mentors. It has also provided the infrastructure to strengthen market access and clinician engagement in Texas and beyond. “We are working with UK trade association the ABHI, who have been key in providing data on the Health Systems in the US and details of the economic climate,” said Simon. “As part of the work we are doing, they are arranging meetings with leading KOLs who all seem really interested in Tracheseal. We see being part of the Dell Medical School as an exciting collaborative opportunity to grow our US healthcare business.”
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