Creation
Draft
Initial
Detailed
Accepted
Adoption
Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
Amplitude pro enterprise™ uses simple technology to capture clinical and outcome data for specific diseases, diagnosis, interventions and care pathways. Data is retained locally and available for immediate reporting and analysis.
Overview of Innovation:
The Amplitude pro enterprise™ software is a simple, tailored online platform centred around two crucial elements:
A user-friendly electronic patient portal which gives patients the freedom of completing their scores online at home, on site and via various devices and a consultant dashboard giving the clinician(s) the ability to input patient specific complexity factors and procedure data quickly and easily.

The result is representative, accurate and meaningful data that paints a clearer picture of each patient’s level of health and expected recovery. Clinicians are engaged with the clinical outcomes processes at your hospital, you get the insight required to innovate your clinical services and patients get a consistently high standard of care.

pro enterprise™ is simple, cost effective and delivers precise and accurate data, selecting scores that are identified as important to you.

The data you collect in pro enterprise™ will allow you to monitor your service delivery, identify quality issues and demonstrate levels of care. Your hospital can be confidently transparent about its activities, resulting in reassurance to your peers that you are offering the best care possible.

Amplitude specialises in the collection of electronic PROMs and clinical outcomes and we are the leading supplier of electronic PROMs to the NHS. We are accredited by NHS Digital for the electronic capture and upload of National PROMs and our platforms have achieved the highest levels of IG compliance, using data centres that are ISO27001 certified.

Amplitude's unique data exchange tool means that you enter and retain your data locally in your pro enterprise™ platform and the necessary data for clinical registries, National PROMs and NJR can be pushed to the relevant databases on your behalf.

Our systems are designed to empower clinicians in adding value to their data e.g. proper case mix adjustment, log-book, revalidation report and easy analysis and self-monitoring tools. The system automates the process of data collection via a series of reminders sent to patients via email and SMS. These reminders are triggered from the intervention data which at minimum includes procedure/intervention description and diagnosis.

Amplitude pro enterprise™ is customised and tailored to suit specific department requirements and objectives including virtual clinics, clinical outcomes and PROMs. pro enterprise™ is currently being used in T&O, Rheumatology, Urology, Cardiology and Mental Health departments.
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)
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Innovation 'Elevator Pitch':
ReferBack™ is a secure electronic specialist referral system that standardises the referral process, improves patient care, helps clinicians avoid unnecessary risk, interfaces with the BSR and saves time and money for the clinician and the NHS.
Overview of Innovation:
ReferBack™ provides a simple and secure electronic referral platform that allows medical teams to connect to specialists to assess conditions; refer critical patients and gain advice on treatment options for urgent cases. 
ReferBack™ has been developed by Amplitude in conjunction with leading spine surgeons in the UK; is endorsed by the British Association of Spine Surgeons and links directly to The British Spine Registry. 

Developed specifically for urgent spine and neuro referrals, the system is pre-populated with precise clinical questions and options that specialists require to make their assessment. 

Information is requested in structured forms and clinical questionnaires, relevant to the patients presenting problems. This allows a speedier in-put and selection of symptoms, co-morbidities, test results and observations, needed to gain a whole picture view. This process ensures thorough and consistent patient evaluations.
Patients and hospitals are no longer exposed to the consequences of unstructured and untraceable communications. All communications are tracked and traceable, so patients are not "lost" in the referral process.

ReferBack™ automatically notifies clinicians when a new referral has been received and when advice has been returned via text message, so that "downtime" between teams during any on-going communications is minimised. Communication continues until patient management decisions are agreed.

Clinical administration is simplified and reduced. Additionally, the system interfaces with the British Spine Registry (BSR), reducing the need for duplicate data entry, as the patient is on-boarded directly to the BSR. The use of an electronic emergency referral system and contribution to the BSR was highlighted as best practice recommendations in the 2019 Spinal Services GIRFT Programme National Specialty Report.

In 2016/17 the cost of medical negligence claims against spinal surgery was £135.1 million. Over 75% of these claims were due to ‘judgement / timing’ (512 claims, 52.35%), ‘interpretation of results / clinical picture’ (255 claims, 26.07%). All communications in ReferBack™ are tracked and traceable and can be used in any future litigation queries made about the quality of care received.
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: 
Digital health / Innovation and adoption
Benefit to NHS:
ReferBack™ is an electronic emergency referral system that was developed in collaboration with a leading spine surgeon, is endorsed by the British Association of Spine Surgeons and uploads directly to the British Spine Registry. It costs less than £100 per week, less than half the main competitor in the market.

From April 2019, all spine services in England are required to submit spine surgery data to the British Spine Registry in order to achieve best practice tariff, which equates to 10% of their department’s annual budget. The automated push of this data to the British Spine Registry ensures best practice tariff is achieved.

The simple to use, cloud-based software contains structured clinical questionnaires that allow fast input, ensuring complete information is captured and sent to the hub, who are then able to fully assess the patient from the outset.

Referrals use structured datasets to guide the referrer to ensure the data entered is complete and sufficiently detailed to allow the hub to properly assess the patient, resulting in thorough and consistent patient evaluations.
The system automatically notifies clinicians by SMS when a new referral has been received and when advice has been returned so that “downtime” between teams during any on-going communications is minimised, until patient management decisions are agreed. 

All communications are tracked and auditable. When a new clinician starts their shift, they can easily see any outstanding referrals and their status. The initial referral and any additional interaction between teams is documented and time stamped, helping Trusts to mitigate against future spinal litigation.

The system improves the speed of referral service being delivered ultimately improving the quality of care received by the patient. By using structured datasets, a complete picture is available from the initial referral, ensuring all information, including co-morbidities, are considered, resulting in a reduced risk of long-term complications.

In February 2019, GIRFT (Getting It Right First Time – NHS England initiative for best practice) released their Report into Spinal Services, in which they recommend the implementation of an electronic emergency referral system. ReferBack™ allows organisations to follow these GIRFT recommendations and by default, this electronic system digitises the entire referral process, reducing clinical admin and ensuring the records are accurate and less liable to mis-interpretation.
Initial Review Rating
4.40 (2 ratings)
Benefit to WM population:
ReferBack™ was trialled at Royal Devon and Exeter and at Sheffield Teaching Hospitals NHS Foundation Trust.
Both pilots offered a testing environment that was similar to environments that could easily be replicated throughout the UK including the Trusts as set up in the West Midlands. There are 7 feeder hospitals for RD&E and 9 for STH, a set-up that would be similar to the midlands-based Spine Hubs.

There are 8 Trusts identified in the 2019 GIRFT report for Spinal Services as specialised providers of complex spinal surgery in the midlands.
  • Derby Teaching Hospitals NHS Foundation Trust
  • Nottingham University Hospitals
  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHs Foundation Trust
  • The Royal Orthopaedic Hospital NHS Foundation Trust
  • University Hospitals Birmingham NHS Foundation Trust
  • University Hospitals Coventry and Warwickshire NHS Trust
  • University Hospitals of Leicester NHS Trust
  • University Hospitals of North Midlands NHS Trust
All of which take referrals from feeder hospitals and are expected to submit to the British Spine Registry to maintain best practice tariff compliance and would benefit from ReferBack™ as an electronic emergency referral system.

The software is designed for a fast deployment into NHS Spine Hubs for future users of the system. Implementation can be within a week, including system training. It is self-regulating, meaning the clinical lead at the Spinal Hub approves the registration of new clinicians using the system. There are many mandatory fields that prescribe the minimum information required by the spine specialist team to make an accurate assessment. These were outlined during the research and development stages of the system design and remain the same in all platform deployments. These are managed by the group of senior spine surgeons that make up the development steering committee.

Although originally designed for spinal services, the system can be applied to any specialty and would benefit any specialty whereby time was a crucial element to safe delivery of care. I.e. Cardiology, Neurology, Stroke, Paediatric Trauma and others.

In addition, the system is now being developed to assist referrals in oncology, whereby MDT meetings review patients from greater geographic areas than just the local Trust with no single patient management system or platform, in all referring hospitals.
 
Current and planned activity: 
ReferBack™ recently exhibited at the BASS Annual Congress and was recommended by its executive committee. Several Trusts are now taking advantage of the 1-month free trial offer available, to test the system in their environment.

We are finalising the Cranial Pathway to be added to the Spine Pathway meaning that orthopaedic and neuro / cranial referrals can all be managed in the one system.

There is continual development on the system, continually taking on board requests from the system users to improve functionality by adding areas including detailed reporting.
What is the intellectual property status of your innovation?:
Amplitude Clinical Outcomes owns the intellectual property copyright of the innovation. BASS assisted in the development of the system with the understanding that it would be sold at a cost that covers the development plus the ongoing upkeep and development. This has enabled the system to enter the market at 1/2 the cost of the existing product, that has less functionality and does not upload directly to the BSR.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Electronic wound imaging, 3D measurement, documentation, reporting, data sharing and informatics system.  An enabling technology to support objective wound assessment, quantitative outcomes monitoring and evidence-based treatment.
Overview of Innovation:
Silhouette is an easy-to-use wound imaging, 3D measurement & documentation system providing accurate wound information at the point of care to support effective clinical management of patients. Silhouette wound informatics are available as a wound assessment PDF report and on a secure web-enabled database and for easy access and sharing across the entire care team. 

The wound images and wound healing progress charts are highly visual and provide immediate and clear indication of a patient's response to treatment.

This award-winning system includes an imaging 3D camera that precisely and consistently measures the area, depth & volume of wounds to track and report healing progress. Silhouette enables wound assessment activity and wound outcomes to be monitored, providing wound information that is available instantly to key stakeholders, integrated with your EMR system. Silhouette is proven in both clinical research & clinical practice.

Silhouette supports pro-active management of wound-related risk & improves communication, helping practitioners to be more productive & effective in their delivery of wound care. Silhouette is suitable for all settings, including acute out-patient clinics, community-based care, home health & telehealth wound care.

The Silhouette system is made up of three main parts – a point of care wound camera, smart software for measuring wounds, & a wound information database:
  • The SilhouetteStar® specialized camera (pictured right) captures the wound image;
  • SilhouetteConnect® software for accurate 3D measurements of the wound based on the data acquired by SilhouetteStar (see below), together with healing progress charts & electronic wound assessment summary reports. 
  • SilhouetteCentral®, a secure Internet-accessible database that stores & consolidates the information obtained from the organisation’s SilhouetteStar + SilhouetteConnect devices, including integration with the EMR.
Unlike non-3D and traditional methods, which are imprecise & unreliable, Silhouette provides meaningful information for better clinical decisions. It is also extremely easy to use & is ready to integrate with EMR systems. Silhouette was first established in clinical research, which requires rigorous source documentation, & is now available for widespread use in clinical practice.

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 / Digital health / Person centred care
Benefit to NHS:
Silhouette is an enabling technology to support safe, cost-effective care for patients with chronic and acute wounds such as diabetic foot ulcers, pressure ulcers and leg ulcers and complex wounds.
Currently, the burden of wound care on the NHS is estimated at £3billion per annum, with unacceptable variances reported in practice standards and outcomes achieved so that thousands of patients are not receiving the standard of care that should be possible.
Silhouette technology transforms how wound status is assessed, documented and reported. Better quality of wound information available in a connected and interoperable system means that clinicians are better supported for effective and timely clinical decisions and actions. Silhouette facilitates data sharing across an entire care pathway to reduce the risks of fragmented care across silos.
Silhouette equips, empowers and enables healthcare professionals and patients to collaborate for best practice to achieve optimal wound outcomes. 
There is significant potential for the NHS to drive for cost savings, greater efficiencies and clinical effectiveness with the adoption of the Silhouette wound informatics solution.
Online Discussion Rating
5.00 (3 ratings)
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
As well as assuring patients of best practice and quality of care, patients can actively engage in their care plan and outcomes due to the highly visual nature of Silhouette wound healing data and charts displayed on the software screens.

The benefits of rapid and effective wound healing for the patient should not be underestimated. The psychological consequences of living with a chronic wound are well documented. Upton and Hender (2012) suggest that patients with chronic wounds may experience negative emotions such as:
  • Stress
  • Concern about physical symptoms
  • Lack of self-worth
  • Despair
See featured Silhouette Patient Story which demonstrate the power of Silhouette informatics in motivating a patient with a debilitating pressure ulcer to recovery.  http://www.aranzmedical.com/patient-pressure-ulcer/
Current and planned activity: 
Entec Health is an appointed distributor to ARANZ Medical for the Silhouette solution in the UK. Our partnering goals are to inform & engage NHS stakeholders on the advantages of adopting digital wound assessment & wound informatics to address the “best practice, clinical excellence & cost-effectiveness gap” in wound management. Entec has supported 5 field Silhouette evaluations in acute & community care with considerable investment of time, expertise & resource. Entec has successfully established early adopters of Silhouette across the NHS:  
Clinical Practice: King’s College Hospital London Diabetic Foot Clinic, North Bristol Trust Enablement Centre
Clinical Research: 10 NHS centres of excellence in diabetes foot care are currently using Silhouette in a multi-centre clinical trial sponsored by EdixoMed  
Planned activity: A Diabetes Foot Pathway demonstrator project supported by EMAHSN to be announced & 2 further Silhouette collaborations are in progress, information to follow.
What is the intellectual property status of your innovation?:
Product family: Silhouette Mobile, Silhouette Connect
US patent: 8,755,053
Chinese patent: ZL 200680037626.3 

Product family: Silhouette Star, Silhouette Connect
US patents: 9,179,844, 8,755,053, D662,122
Chinese patent: ZL 200680037626.3
Other patent(s) pending

Regulatory Approvals: Silhouette has the following regulatory approvals:
  • FDA 510(k) approval
  • CE Mark
  • Health Canada – Therapeutic Products Directorate
  • TGA approval (Australia)
  • WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.

Health information protocols and privacy:  Silhouette supports a variety of protocols and functionality, including:
  • HL7 patient demographic information exchange or transfer
  • DICOM image transfer
  • DICOM Encapsulated PDF report creation and transfer
Silhouette is designed to support HIPAA and HITECH compliance.
 
 
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
2 years
Ease of scalability: 
2
Regulatory Approvals:
Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.
Commercial information:
The Silhouette wound imaging, assessment and information management system is a proven, established in-market solution used across world-wide markets. The Silhouette solution is supporting wound outcomes documentation, reporting and informatics for effective and efficient wound care service delivery. Silhouette is enabling transformation of wound care pathways in acute, community and integrated care settings. Early market for Silhouette is the US with UK, Europe and Asia as emerging markets.  
Investment activity:
Entec Health, as an appointed distributor of Silhouette in the UK, has invested considerable time, effort and funds to introduce the Silhouette to the NHS/UK market since 2011. ARANZ Medical, the developer and manufacturer of Silhouette has invested significant ,funds, effort and expertise in R&D and bringing the Silhouette solution to the global market. There is continued investment in partnering with the NHS and UK healthcare provider market by Entec Health. ARANZ Medical has a commitment to on-going investment in R&D for Silhouette to ensure that the solution meets the future needs of healthcare professionals.
Regional Scalability:
The Silhouette solution is highly and easily scalable across the West Midlands region for transformation of wound care services within the NHS sector. Silhouette can help to address delivery of greater clinical effectiveness and productivity in managing patients with chronic and acute wounds, including Diabetic Foot ulcers, Pressure Ulcers, Leg Ulcers and complex wounds. Silhouette is an enterprise system designed to be interoperable and connected within the NHS/Provider IT infrastructure to enable support of multi-disciplinary care of patients across a diverse range of care settings. Silhouette can be incorporated into telehealth/teleconsultation models of service delivery to support new models of care that improve patient experience, outcomes and cost-effectiveness. 
Measures:
The target outcomes of adoption of the Silhouette solution for the Healthcare Provider Organisation are:
Quality outcomes/measure
Organisation will demonstrate objective, evidenced-based practice to support timely and appropriate treatment planning and care for delivery of optimal wound outcomes.
Measure: Silhouette wound informatics available; quantifies and reports wound healing outcomes for individual patient, patient-population, clinical pathway and treatment type. 
 
Safety outcomes/measure
Organisation will have consistent standard of wound care practice and transparency on wound care outcomes to demonstrate accountable care provision to the required safety standards.
Measure: Silhouette wound informatics available; including digital wound images, wound healing data/charts and wound assessment reports available electronically for audit and management reporting.
Cost outcomes/measure
Organisation will have wound care outcomes data available to support assessment of cost-effectiveness of wound care treatments, service delivery and wound outcomes by treatment type.
Measure: Silhouette wound outcomes and assessment activity data available; to feed into cost-planning and cost-assessment of wound care service.
People outcomes/measure
Organisation will be supported to ensure high levels of staff and patient satisfaction of wound care services through equipping and empowering with quality clinical information on wound progress. The objective wound outcomes data generated with Silhouette will enable joint, evidence-based conversations on care plan and treatment goals with patients and the multi-disciplinary care team.  
Measure: Silhouette patient and population-level reporting available; combined with patient/staff surveys before and after deployment of Silhouette.
Adoption target:
Over next 2 years, we would like to aim to partner with 6 NHS Trusts/other healthcare providers in the West Midlands region for adoption of Silhouette.
Investment sought:
The Silhouette enterprise system is a modular system and investment level is dependent on scope of deployment. An enterprise level Silhouette system based on 5 Silhouette assessment devices and SilhouetteCentral database package starts from £45,000 (net, excluding VAT) for a capital purchase plan. Data integration, IT services, project management and annual software maintenance/support fees are additional costs, dependent on requirements. Silhouette pricing can be offered as an annual subscription model or a capital purchase model to suit different budgetary requirements. 
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Innovation 'Elevator Pitch':
Electronic wound imaging, assessment & information management system.  An enabling technology to support objective wound assessment, monitoring & evidence-based treatment for patients with chronic & acute wounds such as diabetic foot ulcers.
Overview of Innovation:
Silhouette is an easy-to-use wound imaging, 3D measurement & documentation system providing accurate wound information at the point of care to support effective clinical management of patients. Silhouette wound informatics are available as a wound assessment PDF report and on a secure web-enabled database and for easy access and sharing across the entire care team. 

The wound images and wound healing progress charts are highly visual and provide immediate and clear indication of a patient's response to treatment.

This award-winning system includes an imaging 3D camera that precisely and consistently measures the area, depth & volume of wounds to track and report healing progress. Silhouette enables wound assessment activity and wound outcomes to be monitored, providing wound information that is available instantly to key stakeholders, integrated with your EMR system. Silhouette is proven in both clinical research & clinical practice.

Silhouette supports pro-active management of wound-related risk & improves communication, helping practitioners to be more productive & effective in their delivery of wound care. Silhouette is suitable for all settings, including acute out-patient clinics, community-based care, home health & telehealth wound care.

The Silhouette system is made up of three main parts – a point of care wound camera, smart software for measuring wounds, & a wound information database:
  • The SilhouetteStar® specialized camera (pictured right) captures the wound image;
  • SilhouetteConnect® software for accurate 3D measurements of the wound based on the data acquired by SilhouetteStar (see below), together with healing progress charts & electronic wound assessment summary reports. 
  • SilhouetteCentral®, a secure Internet-accessible database that stores & consolidates the information obtained from the organisation’s SilhouetteStar + SilhouetteConnect devices, including integration with the EMR.
Unlike non-3D and traditional methods, which are imprecise & unreliable, Silhouette provides meaningful information for better clinical decisions. It is also extremely easy to use & is ready to integrate with EMR systems. Silhouette was first established in clinical research, which requires rigorous source documentation, & is now available for widespread use in clinical practice.



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 / Digital health / Person centred care
Benefit to NHS:
Silhouette is an enabling technology to support safe, cost-effective care for patients with chronic and acute wounds such as diabetic foot ulcers, pressure ulcers and leg ulcers and complex wounds.

Currently, the burden of wound care on the NHS is estimated at £3billion per annum, with unacceptable variances reported in practice standards and outcomes achieved so that thousands of patients are not receiving the standard of care that should be possible.

Silhouette technology transforms how wound status is assessed, documented and reported. Better quality of wound information available in a connected and interoperable system means that clinicians are better supported for effective and timely clinical decisions and actions. Silhouette facilitates data sharing across an entire care pathway to reduce the risks of fragmented care across silos.

Silhouette equips, empowers and enables healthcare professionals and patients to collaborate for best practice to achieve optimal wound outcomes. 

There is significant potential for the NHS to drive for cost savings, greater efficiencies and clinical effectiveness with the adoption of the Silhouette wound informatics solution.
Online Discussion Rating
5.00 (2 ratings)
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
As well as assuring patients of best practice and quality of care, patients can actively engage in their care plan and outcomes due to the highly visual nature of Silhouette wound healing data and charts displayed on the software screens.

The benefits of rapid and effective wound healing for the patient should not be underestimated. The psychological consequences of living with a chronic wound are well documented. Upton and Hender (2012) suggest that patients with chronic wounds may experience negative emotions such as:
  • Stress
  • Concern about physical symptoms
  • Lack of self-worth
  • Despair
See featured Silhouette Patient Story which demonstrate the power of Silhouette informatics in motivating a patient with a debilitating pressure ulcer to recovery.  http://www.aranzmedical.com/patient-pressure-ulcer/
Current and planned activity: 
Entec Health is an appointed distributor to ARANZ Medical for the Silhouette solution in the UK. Our partnering goals are to inform & engage NHS stakeholders on the advantages of adopting digital wound assessment & wound informatics to address the “best practice, clinical excellence & cost-effectiveness gap” in wound management. Entec has supported 5 field Silhouette evaluations in acute & community care with considerable investment of time, expertise & resource. Entec has successfully established early adopters of Silhouette across the NHS:  
Clinical Practice: King’s College Hospital London Diabetic Foot Clinic, North Bristol Trust Enablement Centre
Clinical Research: 10 NHS centres of excellence in diabetes foot care are currently using Silhouette in a multi-centre clinical trial sponsored by EdixoMed  
Planned activity: A Diabetes Foot Pathway demonstrator project supported by EMAHSN to be announced & 2 further Silhouette collaborations are in progress, information to follow.
What is the intellectual property status of your innovation?:
Product family: Silhouette Mobile, Silhouette Connect
US patent: 8,755,053
Chinese patent: ZL 200680037626.3 

Product family: Silhouette Star, Silhouette Connect
US patents: 9,179,844, 8,755,053, D662,122
Chinese patent: ZL 200680037626.3
Other patent(s) pending

Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.

Health information protocols and privacy:  Silhouette supports a variety of protocols and functionality, including:
·         HL7 patient demographic information exchange or transfer
·         DICOM image transfer
·         DICOM Encapsulated PDF report creation and transfer
Silhouette is designed to support HIPAA and HITECH compliance.
 
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
2 years
Ease of scalability: 
2
Regulatory Approvals:
Regulatory Approvals: Silhouette has the following regulatory approvals:
·         FDA 510(k) approval
·         CE Mark
·         Health Canada – Therapeutic Products Directorate
·         TGA approval (Australia)
·         WAND registration (New Zealand)
ARANZ Medical is quality assured as an ISO 13485 (Medical Devices) and ISO 9001 certified company and is audited annually by a notified body.
Commercial information:
The Silhouette wound imaging, assessment and information management system is a proven, established in-market solution used across world-wide markets. The Silhouette solution is supporting wound outcomes documentation, reporting and informatics for effective and efficient wound care service delivery. Silhouette is enabling transformation of wound care pathways in acute, community and integrated care settings. Early market for Silhouette is the US with UK, Europe and Asia as emerging markets.  
Investment activity:
Entec Health, as an appointed distributor of Silhouette in the UK,  has invested considerable time, effort and funds to introduce the Silhouette to the NHS/UK market since 2011. ARANZ Medical, the developer and manufacturer of Silhouette has invested signficant funds, effort and expertise in R&D and bringing the Silhouette solution to the global market.

There is continued investment in partnering with the NHS and UK healthcare provider market by Entec Health. ARANZ Medical has a commitment to on-going investment in R&D for Silhouette to ensure that the solution meets the future needs of healthcare professionals.
 
Regional Scalability:
The Silhouette solution is highly and easily scalable across the West Midlands region for transformation of wound care services within the NHS sector. Silhouette can help to address delivery of greater clinical effectiveness and productivity in managing patients with chronic and acute wounds, including Diabetic Foot ulcers, Pressure Ulcers, Leg Ulcers and complex wounds. Silhouette is an enterprise system designed to be interoperable and connected within the NHS/Provider IT infrastructure to enable support of multi-disciplinary care of patients across a diverse range of care settings. Silhouette can be incorporated into telehealth/teleconsultation models of service delivery to support new models of care that improve patient experience, outcomes and cost-effectiveness. 
Measures:
The target outcomes of adoption of the Silhouette solution for the Healthcare Provider Organisation are:
Quality outcomes/measure
Organisation will demonstrate objective, evidenced-based practice to support timely and appropriate treatment planning and care for delivery of optimal wound outcomes.
Measure: Silhouette wound informatics available; quantifies and reports wound healing outcomes for individual patient, patient-population, clinical pathway and treatment type. 
 
Safety outcomes/measure
Organisation will have consistent standard of wound care practice and transparency on wound care outcomes to demonstrate accountable care provision to the required safety standards.
Measure: Silhouette wound informatics available; including digital wound images, wound healing data/charts and wound assessment reports available electronically for audit and management reporting.
Cost outcomes/measure
Organisation will have wound care outcomes data available to support assessment of cost-effectiveness of wound care treatments, service delivery and wound outcomes by treatment type.
Measure: Silhouette wound outcomes and assessment activity data available; to feed into cost-planning and cost-assessment of wound care service.
People outcomes/measure
Organisation will be supported to ensure high levels of staff and patient satisfaction of wound care services through equipping and empowering with quality clinical information on wound progress. The objective wound outcomes data generated with Silhouette will enable joint, evidence-based conversations on care plan and treatment goals with patients and the multi-disciplinary care team.  
Measure: Silhouette patient and population-level reporting available; combined with patient/staff surveys before and after deployment of Silhouette.
Adoption target:
Over next 2 years, we would like to aim to partner with 6 NHS Trusts/other healthcare providers in the West Midlands region for adoption of Silhouette.
Investment sought:
The Silhouette enterprise system is a modular system and investment level is dependent on scope of deployment. An enterprise level Silhouette system based on 5 Silhouette assessment devices and SilhouetteCentral database package starts from £45,000 (net, excluding VAT) for a capital purchase plan. Data integration, IT services, project management and annual software maintenance/support fees are additional costs, dependent on requirements. Silhouette pricing can be offered as an annual subscription model or a capital purchase model to suit different budgetary requirements. 
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