Certified
as a CE Class 1 Medical Device, FDA listed, being tested to EN 60601-1:2006
Why BPMpathway and not a wellbeing device?
Remote patient monitoring only works, however, if clinicians feel able to rely on the data they receive. It is self-evident that important decisions cannot be made based on the output of so-called ‘Health and Wellbeing’ devices, which have not been subjected to any rigorous, clinical validation and are more suited to consumer use once discharged from clinical care.
Unlike rival solutions from the Wellbeing industry, BPMpathway’s patented, award-winning technology has the unique combination of having been:
Validation
The sensor technology behind BPMpathway was originally validated by an independent team at Oxford Brookes University. Their study evaluated the sensor against an OMCS and, on the basis that a single sensor was being compared to a multi-camera system, the results proved to be very useable in a real-world environment.
More recently, a study to validate the accuracy of the BPMpathway sensor in post-operative total knee arthroplasty (TKA) patients has been undertaken at the Golden Jubilee National Hospital in Glasgow. The goal of the exercise was to compare the accuracy of the sensor to the gold standard in orthopaedic measurement – the OrthoPilot® Navigation System. The project leader, Mr. Duncan Whittaker MBChB, MRCS(Ed), reported:
- The BPMpathway sensor shows a high level of precision with consistent linear and repeatable results accurate to within 1 degree
- In sagittal flexion/extension, the sensor performs with a high degree of accuracy
- It provides accurate ROM feedback to the user
- Feedback from patients suggests increased compliance and motivation with physiotherapy
Military-standard data encryption
BPMpathway has multiple security layers to protect confidential patient data. All specific patient records are encrypted to AES-256, a military-grade encryption system, widely-accepted as the strongest encryption there is, used by governments, militaries, banks and other organizations across the world to protect sensitive data.
Every hospital data stack is uniquely keyed to stop the data being transferred to other locations or inappropriately accessed. The underlying server hosting layer can be configured to match any individual hospital or trust’s regulatory requirements, such as N3 or HL7 compliance.
In addition, the BPMpathway system architecture ensures that patient data is restricted to being shared between the clinician and the patient him- or herself, meaning that the patient can only ever see their own data.
Medical-grade design & manufacture
The BPMpro sensors and software used by BPMpathway have been designed and are manufactured to the highest level of medical-grade certification.
BPMpro technology uses a system architecture and software interface certified to ISO:13485 2016 and CE Class 1 Medical Device standards and which is listed with the US FDA as a Medical Class I device. BPMpathway is currently undergoing testing to EN 60601-1:2006 standards. In accordance with the developers’ quality system procedures, production sensors are sample-tested against video measurement systems.
Patents & IP
BPMpathway technology is protected by UK patent ‘Mapping of the trajectory part of anatomy of the human or animal body’ ref. GB 2530754 granted on 3rd May 2017, with over 40 unique claims relating to the measurement of the human body. International patents are pending in the US, Japan and European Union.
Further patents, including the Spinal Module UK patent application no. 1704825.7 filed 27th March 2017 and patent application no. 1704148.4 filed covering differential movement analysis, are being progressed.
‘BPMpathway’ and the BPMpro ‘Swirly’ are EU-registered trademarks.
Sustainability
270 Vision, the Company behind BPMpro technology, uses world-leading design expertise to create innovative, hi-tech, quality products and solutions, which improve the lives of our clients.
Our approach to business is guided by commitment to the following principles:
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Ethics & Transparency – As a law-abiding and socially-responsible Company, we operate with transparency and according to high standards of ethics and law in directing and managing the Company for all stakeholders. For 270 Vision, compliance means more than just legal conformity; it also encompasses ethical values such as fairness, integrity and sustainability.
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Diversity & Inclusion – We create an engaged workforce that can contribute its full potential in an inclusive work environment.
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Safe & Healthy Workforce – In co-operation with our employees, we work to maintain a safe and healthy workplace and support employees’ work-life balance.
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Supplier Relationships – We set expectations for our suppliers and work with them to conduct their operations in compliance with applicable laws and accepted standards of fairness and human decency.
Environmental Responsibility
A responsibility toward protecting the environment is one of the basic ethical values of our Company. We foster sustainable use of the earth’s resources in our products and operations, and we strive to design environmentally conscious products. We seek, therefore, to design our products to be recycled. The housing of the BPMpro sensor contains a silver-based anti-microbial technology providing lifelong protection against the threat of cross-contamination. This means that those in good condition can be reused numerous times. The sensors also incorporate efficient lithium-ion cells, which means that those that cannot be reused must be recycled in accordance with the detailed directions in our user documentation. This features the crossed-out wheeled bin symbol and a message that informs users that a product must not be disposed of in household waste, but recycled in accordance with the European Union WEEE Directive 2002/96/EC and other national legislation. Our products have minimal packaging, often reusing the packaging in which the raw materials were supplied, to reduce the amount of packaging, which in turn reduces consumer waste.
Our Commitment & Scope
This policy applies to all products developed by our organization. Staff and contractors are expected to uphold objectives under this policy to the fullest extent possible within prevailing budgets and to inform management of financial and other barriers to achieving these goals. We acknowledge we have limited influence over third parties, such as trade shows where we exhibit. While we cannot control the decisions of these parties, we commit to educate them of our policy and encourage them to align operating practices with policy objectives. Our attention to environmental, social and economic responsibility includes working within the law and voluntarily exceeding legal requirements in order to be innovative and demonstrate leadership on the issues that are important to us and our stakeholders. As we design products, work with our clients and evaluate our success, we are able to choose every day in big and small ways how our actions and words build a better quality of life for our employees, clients and suppliers.