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Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
BUDDY® waterproof covers protect limb wound dressings in the shower and bath.
Overview of Innovation:
BUDDY® limb covers could save health professionals time when bathing patients at home, in hospital or in a care home because they can bathe normally and keep their wound dressings dry on both legs and arms, whether they be bandaged or stitched. The ability to bathe improves wellbeing and potentially allows the wound to heal more quickly. There are products on the market that cover wound dressings to keep them dry but in our opinion, none are as lightweight and gentle​.

This submission's statistics focus on the major problem of diabetic limb ulcers and skin tears.

An increasing number of (1) & (2) diabetic and (3) elderly people have (4) compromised skin and leg ulcers.

(1) https://digital.nhs.uk/data-and-information/publications/statistical/national-diabetes-audit/diabetes-prevention-programme-2017-18 “Who's affected. Venous leg ulcers are estimated to affect around 1 in 500 people in the UK, although they become much more common with age. It's estimated around 1 in 50 people over the age of 80 has one.”

(2) https://www.diabetes.org.uk/resources-s3/.../diabetes_in_the_uk_2010.pdf
In 2013, there were almost 2.9 million people in the UK diagnosed with diabetes. By 2025, it is estimated that more than 5 million people in the UK will have diabetes. ... It is estimated that 10% of people with diabetes will have a diabetic foot ulcer at some point in their lives.

(3) https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/november2018#the-uk-population-is-ageing
By 2066 there could be an additional 8.6 million people aged 65 years and over in the UK.

(4) https://www.woundcareadvisor.com/no-more-skin-tears/amp/
"A reported 1.5 million skin tears occur in institutionalised adults each year, and that does not include tears that occur at home."


Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
Similar Content3
Innovation 'Elevator Pitch':
Prep Shield has a gentle, non-restrictive central aperture to protect patient’s skin & tourniquet from damaging preparation solution leakage. Made from medical grade material & suitable for all size limbs.


 
Overview of Innovation:
Prep Shield is a disposable drape with central apertures for use in minor and major operations. Prep Shield protects the patient and tourniquet from potentially corrosive skin preparation solutions, blood, pus and other fluids.

Prep Shield is easy to use and prevents pooling of the prep solutions around or under the torniquet that could be a potential fire risk or irritant. The soft seal technology prevents seepage through to the drapes, protecting friable skin and rheumatoid patients from a potential reaction to adhesives or prep solutions.

Prep Shield can be easily removed by snipping the edge and tearing to the central aperture. 

Prep Shield is made from a flexible, lightweight, blue latex-free medical grade material, CE attested.

To view a demonstration visit: https://www.youtube.com/watch?v=RENACNX8SQE
To view the website visit: https://www.buddycover.com/prep-shield/ 

With an increasing ageing population, replacement knee surgery and lower limb amputations are becoming more prevalent.

Examples of where Prep Shield can be used:

1. 'The number of hip replacement operations on people aged under 60 has risen 76% in the last decade, NHS figures for England reveal. ... Demand for new hips across all ages has risen - there were 89,919 of the operations in 2004-05 and 122,154 in 2014-15.​'

2. 'Diabetes UK has shown that there were 26,378 lower limb amputations related to diabetes in England from 2014 to 2017, an increase of 19.4% from 2010-2013.​'
Ref:  https://www.diabetes.org.uk/about_us/news/lower-limb-amputations

3. 'There are approximately 5-6000 major lower limb amputations undertaken per year in the UK.'​
Ref:  http://www.christopherimray.co.uk/lowerlimb.htm
 
Prep Shield is available in sizes 20 to 90cm. Clean room prepared in boxes of 25 & 50, Prep Shield is significantly cheaper than other drapes @ £2.40 each, adhesive paper drapes cost £5.40 each.
 
Disposable: size 40 x 40cm non-restrictive and non-adhesive.
 
 
Stage of Development:
Close to market - Prototype near completion and final form may require additional validation/evaluation and all CE marking and regulatory requirements are in place
WMAHSN priorities and themes addressed: 
Innovation and adoption / Person centred care
Benefit to NHS:
NHS Benefits:

Prep Shield is easy to use and store. It is more cost effective and less bulky than traditional drapes. Prep Shield will keep the tourniquet protected for possible re-use.

Patient Outcomes: 

The patient's skin is protected from preparation fluids which are potentially corrosive, reducing skin irritation.

Efficieny improvements:

Prep Shield is quick and easy to use and remove
Initial Review Rating
2.40 (2 ratings)
Benefit to WM population:
Figures show increased prevalence of diabetes and its consquences in Pakistani, Bangladeshi and Indian communities. The West Midlands has the largest population of this ethnicty.  

https://digital.nhs.uk/data-and-information/publications/statistical/hea...

There were 25,312 amputations and 136,215 revascularisations, and 7543 cases were linked. The prevalence rate per 100,000 (95% confidence intervals) for amputation was 26.3 (26.0–26.6) with rates significantly higher in Northern England (North: 31.7; 31.0–32.3, Midlands: 26.0; 25.3–26.7). The odds of having an amputation with a revascularisation remained significantly higher in the North (OR 1.22; 1.13–1.33) even after controlling demographic and disease risk factors.'

Ref:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4265106/
 
Current and planned activity: 
Protoype ready, successfuly used. Lead time for production 3 weeks.  
What is the intellectual property status of your innovation?:
Trade mark and design registered.  Licensed by Joanna Winslade to QOL Limited.
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
1 year
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Woundex is a innovative breakthrough discovery, the only product in the world which efficiently works on all types skin ulcerations, and is one of the best treatments available.
Overview of Innovation:
Diabetic foot problems, such as ulcerations, infections, and gangrene, are the most common cause of hospitalization among diabetic patients. Routine ulcer care, treatment of infections, amputations, and hospitalizations cost billions of pounds every year and place a tremendous burden on the health care system.
 
This therapy will help save the psychological distress people go through when they have amputations. This treatment will reduce the monetary burden on the national health care system. It has shown good results, even on the severe cases of ulcerations.

It has no side reactions. This product can be used in all types of skin ulcerations , open wounds, burns, gangrene  and diabetic ulcers. Patients would be saved from having an amputation.
This product on application helps increase blood circulation around the wound area .It also increases and promotes tissue growth this in turn helps to heal the wound speedily.

 if it is cut, however, in some people with diabetes the skin on the feet does not heal so well and is prone to developing ulcer. This can be even after a mild injury such as stepping on a small stone in your bare feet.
There is reduced sensation of the skin on your feet. Your nerves may not work as well as normal because even a slightly high blood sugar level can, overtime damage some of your nerves. This is a complication of diabetes called peripheral neuropathy of diabetes.
Diabetic ulcers can lead to gangrene , amputation making the patient immobile.
This causes great psychological distress for the patient.
 
Diabetic foot ulcer places a big budgetary burden on the healthcare authorities. Along with treatment of foot ulcers, amputation  the cost are substantial.
The healthcare authorities have to employ multidisciplinary foot care services led by healthcare professionals, and this consist of specialists with skills in the following areas: Diabetology, Podiatry, Diabetes specialist nursing, Orthopaedic surgery, Biomechanics and orthoses, Interventional radiology, Casting and Wound care-putting an even greater financial strain on the heathcare provider.
 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Clinical trials and evidence / Innovation and adoption / Person centred care
Benefit to NHS:
Diabetes ulcer and amputations cost £1 in every £150 spent in the NHS budget. Around 15 % of all diabetes patients will suffer from diabetic ulcer and at a advanced stage amputations have to be carried out.  There are currently 150 amputations performed every week in the UK.  Patients who  have diabetic ulcers are given antibiotics as treatment to control the ulcer. These are given over many years. As you may be aware of there is a big problem of antibiotic resistance.
There will be big benefit to the NHS if they use this treatment.
Benefit to WM population:
This Treatment will benefit the WM population in big way and will eleviate the suffering diabetic ulcer patients go through.
Current and planned activity: 
The medicine is a phyto chemical spirit based solution and has to be imported from India. This medicines ingredients can only be grown in India. At the present time this product is being licenced in India
What is the intellectual property status of your innovation?:
At this stage no status
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Solesee is a foot inspection mirror designed for people with diabetes to help them see the whole of the bottom of their feet to check for cuts, grazes, dry skin & blisters. Solesee makes this much easier to achieve and encourages daily use.
Overview of Innovation:
The Solesee Foot Inspection Mirror has been specifically designed for people with diabetes to help them to see the whole of the bottom of their feet. With diabetes, people should be checking their feet every day for cuts, grazes, dry skin, blisters, changes to the colour and general condition, etc. Due to nerve and blood capillary damage caused by diabetes, people with the disease can develop peripheral neuropathy that reduces or removes any sensation or feeling in the feet.

If any break in the skin is not quickly noticed and treated, then it could become ulcerated. Ulcers are slow to heal and can quickly become infected. If this happens then the possibility of amputation is increased as the only means to treat the condition. In England alone there are over 140 diabetes relates lower limb amputations a week. Each ulcer can cost the NHS about £5,000 to treat. An amputation can cost £15,000 with the resulting rehabilitation of the patients costing a further £18,000.[Source: Diabetes UK].

Having a product like Solesee makes checking feet much easier to achieve and encourages daily use thereby helping to prevent problems occuring in the first place.  Solesee was developed, using input from both podiatrists and diabetes patients, as a result of hearing about the lack of anything simple and easy to use to check the soles of your feet every day. The key elements to Solesee are:
  • A large shatterproof mirror;
  • The mirror is set at the perfect angle to allow users to see the whole of the sole of their foot when in a seated position;
  • It folds into an iPad sized folder for easy carrying and storage
  • ​It has been designed and manufactured in the UK
  • It is design protected
A big part of what Solesee aims to do is educate people about making foot checks as regular a part of the morning and evening routine as cleaning your teeth. Part of this is consumer education through general awareness building, but it is also through getting the professional clinicians involved as they are the people who probably have most influence over the patients that they are seeing.

The National Diabetes Foot Co-ordinator for Scotland sees a clear role for clinicians to use Solesee in their clinics to not only show the patients what the soles of their feet look like (before, during & after treatment) but also to show them how to use Solesee - to encourage them to go and buy one and use it themselves.Taking ownership of their condition if you will. Wider clinical take-up and patient awareness is our key aim.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Person centred care
Benefit to NHS:
Due to nerve and blood capillary damage caused by diabetes, people with the disease can develop peripheral neuropathy that reduces or removes any sensation or feeling in their feet. As a result they are not able to feel if they have cut or damage to their feet in any way e.g.a stone in a shoe, a blister, a cut, a scold from hot bath water or burn from a radiator or open fire.

If any break in the skin is not quickly noticed and treated, then it could become ulcerated. Ulcers are slow to heal and can quickly become infected. If this happens then the possibility of amputation is increased as the only means to treat the condition.In England alone there are over 140 diabetes relates lower limb amputations a week. Each ulcer can cost the NHS about £5,000 to treat. An amputation can cost £15,000 with the resulting rehabilitation of the patients costing a further £18,000.[Source: Diabetes UK].

There are also other, hidden costs, that could manifest themselves in a wider health issue to the patient. Being incapacitated with a foot ulcer can lead to a lack of exercise, low morale, lack of social interaction (due to being housebound) and potentially a poor diet as a result. There is also the mental strain of not being able to get out and about. This can be multiplied when you consider the impact of having an amputation.

From general research and discussions with people who have diabetes, there appears to be a lack of understand about how diabetes really affects your feet. A number of people we spoke to indicated a degree of knowledge, but said they were 'happy to wait until a problem occurred' before really taking it seriously.  Other people had little idea why they should check their feet or even what to look for on their feet if they did check them.

Using Solesee to increase awareness and education, about how serious this condition is, leads to a greater chance that ulcers will not develop in the first place.  Even if a cut or ulcer did occur, the chances of getting it treated at an early enough stage are greatly increased if people are making ther own regular foot checks, especially if encouraged by professionals. A product like Solesee makes checking feet much easier and encourages daily use thereby helping to prevent problems occuring in the first place. Compare using Solesee to using a toothbrush. 30 years ago cleaning your teeth once a day was probably the norm.  Now people clean their teeth twice a day without thinking - and few people die from getting a cavity!
Initial Review Rating
2.60 (1 ratings)
Benefit to WM population:
The aim is to get every clinician, that deals with foot care related issues and education, using Solesee as part of their normal clinical practice.  Whenever a patient presents for an annual foot check or prior to/during treatment for any foot disorder, the clinician should use Solesee to show them what the sole of their foot looks like.  This can be a 'before' and 'after' treatment scenario, so the patients can see what the clinician has done.  It would also be useful for patients to know what signs of irregularity or infection they should be looking out for, if they need to change their dressings between appointments.

It can also be an means to educate patients what their feet should look and what they should be looking for prior to any issues occurring in the first place.  If there are indications that problems could occur, such as the start of dry skin or calluses, then the clinician can clearly highlight this to the patient with some advice about what they should do. 

In all the above cases the clinician should be able to recommend that the patient starts to make regular checks using a mirror, like Solesee, so they get used to seeing the bottom of their feet and what issues to be aware of and look out for.

In this way the level of education about foot related issues for people with diabetes will be raised.  The potential problems, and what that really means to the patient can be discussed in detail, and the frequency of diabetic foot related problems reduced in and around the clinics where it is practiced.

Birmingham has one of the highest incidences of diabetes in the country (according to a recent BBC Panorama programme) and as such has a lot to gain from better educating the patients about the potential foot related problems.  The cost of giving one Solesee 10,000 clinicians or patients is the equivalent to the cost of 56 individual ulcers being treated.  We would like to think that, out of 10,000 people using Solesee, that we could reduce the incidence of diabetes related ulcers by at least 56 patients!

All the above doesn't take into account the longer term benefits to the region. Reducing the incidence in ulcers will reduce days lost to sickness in industry, as well as the the other 'hidden' costs assocuated with someone who is incapacitated through not being able to walk or work.  This includes mental health related issues.
Current and planned activity: 
I have been speaking to Duncan Stang (the National Diabetes Foot Co-ordinator for Scotland) who sees a clear role for clinicians to use Solesee in their clinics to not only show the patients what the soles of their feet look like (before, during and after treatment) but also to show them how to use Solesee - to encourage them to go and buy one and use it themselves.  Taking ownership of their condition if you will.  I am in contact with Dr Jane McAdam (Head of prosthetics and podiatry at Salford University) and I am also trying to speak to Dr Paul Chadwick from Salford Royal Hospital NHS Fundation.

However I need to try and get a better access to the wider NHS and the clinicians who deal with diabetes patients on a regular basis e.g. GP's diabetes nurses, etc as well as the NHS podiatrists.  Getting professionals to use and recommend Solesee will help increase the awareness of the foot issues related to diabetes and hopefully increase the daily foot checks of patients. 
What is the intellectual property status of your innovation?:
Solesee is design protected and the brand name is a registered trade mark.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
Regional Scalability:
Scalability is simple as it is a self contained product.  Our only challenge would be to fund product production should there be a very large upswing in demand.  However this could be managed if we have POs from recognised organisations or bodies such as the NHS.
Measures:
The aim is to see a reduction in the number (percentage) of people that present themselves with a reoccurrance of a diabetic foot ulcer.  By taking a more proactive approach to daily footcare the chances of an ulcer reoccurring are significantly reduced.

To measure this, we would need a clinic to a group of patients who have previously had a diabetic foot ulcer that has been successfully treated.  They would then be split into two groups - those who are given a Solesee and shown how to use it and those that are told to check their feet but not given a Solesee to use.  The condition of their feet would be checked at the usual regular intervals over the course of a 6 month period to assess the condition of their feet.  The expected result is that group using the Solesee would see a lower reoccurance rate compared to those that were not given a Solesee to use.

We would also assess usability and product quality issues looking at both groups using more qualitative techniques.  We would want to assess how people found using Solesee on a daily basis and also what the people, who were not given a Solesee to use, did instead.

Using the approximate costs to treat an ulcer that have already been stated (to treat a foot ulcer on the NHS is about £5,000) we would look at developing a commercial case for that clinic based on the number of patients that have a diabetic foot condition, using the data produced from the trial.  This should give a firm commercial argument for investing in Solesee mirrors and prescribing them to pateints with diabetes and at a high risk of developing a foot ulcer.
Adoption target:
This is difficult to gauge as the number of people with diabetic foot conditions will vary from clinic to clinic.  To be able to price Solesee at a level that the NHS would feel is suitable, then there would need to be economies of scale as far as production is concerned.  This would mean a minimum order of about 1,000 units.
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