Generic - Optimised Equivalent® Orthopaedic Implants - OptiStem XTR, OptiStem CRL, OptiCup CEP, OptiCup TDT (#2229)

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Idea Description
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Innovation 'Elevator Pitch':
Optimised Equivalent® to best performing & highest volume branded orthopaedic implants (>1,000,000 patients), coupled with significant savings. Equivalent manufacture, materials, tolerances & sizes, along with operational technique & instrumentation.
Overview of Innovation:
The UK is the first country in the world to benefit from applying the principle of generics to orthopaedic products. Generic medicines have been a core part of the NHS since the 1980s, offering the same clinical outcomes for patients as originator drugs and now contributing over £12 billion in savings every year that can be reinvested into the health service (1)

With >66,000 NHS hip replacement operations performed every year (2) switching to generic hip implants from the current market leaders, the NHS could save up to £120 million by 2020 - enough to fund over 1,400 junior nurses every year (2,3,4)

This is well-timed following Lord Carter’s Review, which found that large efficiency savings can be made by all NHS hospitals – notably in orthopaedics. Some of these savings can be made by reducing the current variation in patient outcomes (5)

Evidence from over 1,000,000 hip replacement operations in published registry data shows that some of the most widely used devices with the lowest possible revision rates can be provided at a significantly reduced cost due to patent expiration. Orthimo have produced Optimised Equivalent® implants to the branded versions, providing significant cost savings without compromising patient outcomes.

The manufacturing of the Optimised Equivalent® implants are by well established suppliers with many decades of experience in manufacturing orthopaedic implants for the large Orthopaedic companies, further strengthening the equivalence value proposition. Both the surgical instruments and techniques are also equivalent.

As a further indicator of reassurance, the Department of Health recently purchased a significant quantity of Optimised Equivalent® implants through a forward buying fund, which can be obtained via NHS Supply Chain.

At a time of unprecedented cost pressures on Healthcare systems worldwide, Optimised Equivalent® implants make a valuable contribution towards maintaining high quality hip replacement services within the limited resources available.

This means patients receive the best clinical outcomes at significant cost savings for hospitals.

http://www.odep.org.uk/Product.aspx?pid=2301

http://www.beyondcompliance.org.uk/product.aspx?pid=2301

https://my.supplychain.nhs.uk/Catalogue/product/fjh10279

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 Content1
Innovation 'Elevator Pitch':
Optifit is the first clinically validated therapeutic bra and fitting system, promoting a balanced posture, reducing musculoskeletal health problems associated with larger bust sizes. Optifit provides a proven alternative to breast reduction surgery
Overview of Innovation:
The OptiFit bra and measurement system, designed by a Consultant Plastic & Reconstructive surgeon with bespoke manufacturing in the UK. www.optifitbra.com
  • Ensures an effective and comfortable ‘bespoke’ fit
  • Significantly reduces trauma and pain in Thoracic and Lumbosacral regions
  • Prevents overstretching of the suspensory ligament reducing the chance of stretch marks.
  • Preserves body shape
  • Maintains healthy posture, relieving pressure on diaphragm and balance pelvis
  • Reduces risks of tissue maceration, intertrigo and fungal growth
It is estimated that 70% of women wear the wrong size bra. The traditional alphabet bra size measurement system was initially only established for cup sizes A-D, but with 40% of British females measuring a D cup or above the same level of fit and support is not achieved in larger sizes. Failure to support the breasts can lead to many physiological conditions including back and breast pain.
 
Inappropriately sized and positioned back straps cause existing bras to slide away from the breasts reducing support. It is estimated that 70% of women wear poorly fitting bras and that 99% of women with large breasts wear the wrong size bra.  Professionally fitted bras are often as poorly fitted as ‘off the shelf products.
 
Bras that do not support the breast correctly cause many skin problems. If the weight of the breasts is mostly supported by the shoulder straps, these can dig in and cause angry red welts to develop.
Underwired bras push into the tissue leading to lesions, marks and sores.
Optifit bras do not use underwires. They hold the breast in its natural position away from the body preventing the above problems.
If the breasts are not supported away from the ribs, rubbed skin, maceration, intertrigo and fungal infections can develop underneath.
 
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Summary of interim research study findings -
  • Can help patients with Back pain
  • Can obviate need for breast reduction surgery in many patients
  • Is a cure for Inframammary intertrigo
Can potentially help patients with mastalgia especially those with associated shoulder girdle dysfunction
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 / Education, training and future workforce / Wealth creation / Clinical trials and evidence / Innovation and adoption / Person centred care
Benefit to NHS:
How best to allocate surgical resources and time within the NHS is a problem with which we wrestle and disagree constantly. Reduction mammaplasty is surgery rationed in NHS practice, yet evidence suggests that those who undergo it derive significant improvements in physical health and quality of life.
 
NHS recommends professionally fitted bras prior to Breast reduction surgery but has not evaluated their efficacy.
 
Many women do not fulfill the criteria for surgery e.g. high BMI.  Such patients have nowhere to go and are a burden on the NHS, requiring drugs for back pain, intertrigo etc. Furthermore, women with high BMI’s cannot find a properly fitted bra. The Optifit bra will help such patients and overall reduce the need for breast reduction surgery. Women seeking reduction mammaplasty often wear ill-fitting bras and are therefore likely to exacerbate some of their presenting symptoms as a result. Women may wait years from referral to surgery and symptom relief. A correctly fitted bra alleviates symptoms and may even remove the need or wish for surgery.

Savings from reduced surgical intervention and associated consultations, imaging and follow ups will be enormous, (‘21,328 procedures were carried out between 2006 and 2011, some on girls as young as 15 -which, at £5,000 each, cost taxpayers more than £106 million’. (Daily Mail July 2014)).
 
Back Pain: OptiFit should be a 1st line treatment for LBP in women with high BMI’s and/or large breasts.  A systematic review on global prevalence of LBP the highest prevalence showed women aged between 40-80 (incidence 11.9%  http://www.ncbi.nlm.nih.gov/pubmed/22231424). The OptiFit intervention would help many patients and demonstrate significant savings for the NHS
 
Intertrigo: A direct result of friction between two skin surfaces. With poorly fitted bras there is a mismatch between cup/cradle diameter and breast base.  Patients I see regularly in my clinic have had several ‘Professional’ fittings and still cannot find the correct size bra. With it’s unique design the Optifit bra remains in the inframammary crease (however large the breast and BMI may be) and it is therefore impossible to get intertrigo
 
Mastalgia: Incidence of mastalgia in the general population is reported as over 60% http://www.ncbi.nlm.nih.gov/pubmed/9240595  Most women who attend Breast Clinics with breast pain also have musculoskeletal pain related to breast size.  The 1st line of treatment for mastalgia is a professionally fitted bra
Initial Review Rating
2.60 (1 ratings)
Benefit to WM population:
The savings resulting from reduced surgical intervention and the associated consultations, imaging and follow up will be enormous, (‘21,328 procedures were carried out between 2006 and 2011, some on girls as young as 15 - which, at £5,000 each, cost taxpayers more than £106 million’. (Daily Mail July 2014)). In addition the benefits in QALY outcome measures for women will also be substantial.
 
Back Pain: We feel that this product should be recommended as a first line treatment for low back pain in women with high BMI’s and/or large breasts.  In a systematic review on the global prevalence of the low back pain in the world the highest prevalence was noted to be in women between the age of 40-80.  The incidence was found to be 11.9%  http://www.ncbi.nlm.nih.gov/pubmed/22231424 .. This simple intervention should help many patient and save the NHS on many interventions.
 
Inframammary Intertrigo:It is difficult to comment on the incidence of inframmary intertrigo in the general population as there is not ICD-10 or ICPC score.   Intertrigo is a direct result of friction between two skin surfaces.  This is due to a poorly fitted bra as there is a mismatch between the cup/cradle diameter and the breast base ( the breast base in patients with high BMIs can be several centimetres more than the cup/cradle diameter in professionally fitted bras).  The patients I see regularly in my clinic with intertrigo have had several fittings and still cannot find the correct size bra as it simply does not exist for them. With its’ unique design the optifit bra, however, stays at the inframammary crease( however large the breast and BMI may be) and it is simply not possible to get intertrigo.
 
Mastalgia: The incidence of mastalgia in the general population has been noted in studies to be over 60%.  http://www.ncbi.nlm.nih.gov/pubmed/9240595 .   Most women who attend Breast Clinics with breast pain also have musculoskeletal pain related to breast size.  The first line of treatment for mastalgia is a professionally fitted bra.
Current and planned activity: 
Ongoing research studies at University of Central Lancashire:
  • Exploring the OptiFit bra solution against fashion industry standards
  •  To determine the initial and short term biomechanical effects on posture when wearing the OptiFit bra compared to the standard or usual bra, in individuals with back or neck pain.
  • To determine the initial and short term effects on breast health, pain, activity and comfort when wearing the OptiFit bra compared to the standard or usual bra, in individuals with back or neck pain 
Required studies:
  • A community based study of incidence of inframammary intertrigo in general population resulting from poor bra fitting
  • A comparative efficacy study is required for surgical and non surgical management of symptomatic macromastia
  • Health Economics cost benefits analysis of surgical vs non surgical intervention
Further trial partners required to evaluate the product and measurement system
What is the intellectual property status of your innovation?:
Patent for Bra (GB2362560B): The granted patent has four independent claims. These are (claim 1) which covers the bra itself,  (claim 7) which covers a method of fitting a bra according to the invention, (claim 10) which covers a range of bras according to your invention and (claims 11 and 12) which cover a bra and method of making a bra respectively with particular emphasis on the back portions.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
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