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“Biomaterials and organic chemistry is difficult. Those who study it have acrylates of trouble.”

At Encode Health we believe in personalising healthcare and access for all. At the heart of everything we do, is keeping you, the patient, at the center of your own care…. Biomaterials have long been in use, since ancient times when Egyptians would use animal sinew for sutures and in 1892 when Sir Victor Horsley created the “Antiseptic wax” for hemostasis, made of “seven parts beeswax, one part almond oils, and 1% salicylic acid” (Wellisz T, An YH et al, February 2008), that was applied to bleeding bone edges and causing an immediate tamponade effect.  In recent years there has been a rapid increase in the use of biological materials such as cyanoacrylates (n-Butyl cyanoacrylate, 2-octyl cyanoacrylateethyl, 2-cyanoacrylate), for safer and more effective wound closure through an adhesive mechanism. The point is however, even though each compound has a similar function they are marketed and should be used for specific purposes. 

 

Tracking the types and blends of materials used for surgical implants as well as the increased needs in research and development to improve upon current tissue engineering, regenerative medicine, nanotechnologies, gene therapies and 3D printing is becoming increasingly difficult. Regulation of biomaterials is currently similar to that of medical devices. Regulating both the devices and the materials used is also becoming increasingly difficult, with minimal chances of new medical innovations getting through the regulatory process without a large amount of funding over years of trials for a singular specific type of illness use. 


Regulating the biomaterials used for “prevention rather than cure” is an area of necessary research that is growing. For such public health avenues to be explored to it’s maximum potential, preclinical populations as early as neonatal, would need to have a lifetime of follow up to ensure any abhorrent side effects do not developed in older years. Currently regenerative tissue therapies and therapeutic molecule delivery systems (e.g. cancer treatment using nanoparticles), are being explored for not only treatment of clinically presenting symptoms but also preclinical. Such research teams are having difficulty efficiently developing solution due to technological restrictions in patient data sharing across multidisciplinary teams and having to resort to physical paper based health records specifically designated to the research. This increases the length of time required to develop therapies as a single source of data that is accessible to the right people at the right time is not available.

 

If your team is developing a biomaterial and would like to engage with a team to cover not only the costs of R&D, but also develop industrial feasibility studies and clinical studies for commercialisation potential, then do not hesitate to touch base with at hello@encodehealth.com. It has been a long time in recognition that teams and institutions such as MRHA, GIRFT and Scan4Safety, see the need for validated Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs) to support much needed and long-awaited data on the relative risks and benefits of different medications and insertable devices. The Encode Healthcare passport uses SNOWMED codes to tag important clinical outcomes and “aligns the stars”, when important information is requested at a moments notice to help map out aggregate clinical pathways. 

 

References:

Compilation of International Standards and Regulatory Guidance Documents for Evaluation of Biomaterials, Medical Devices, and 3-D Printed and Regenerative Medicine Products JoAnn C. L. Schuh, Kathleen A. Funk First Published November 5, 2018  https://doi.org/10.1177/0192623318804121

 

Biomaterials and tissue engineering in the uK compiled By the Biomedical applications division of the institute of materials, minerals and mining

http://www.iom3.org/sites/default/files/biomedical_report-lr.pdf

 

Regulation of Cell-Free Biomaterial Implants N.Zhang A.Baume R.Payne J.Allickson 5 August 2016

https://www.sciencedirect.com/science/article/pii/B9780128022252000209 

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What turns us on…

What turns us on and how we competitively service you, when you need us most!

At Encode Health we believe in personalising healthcare and access for all. At the heart of everything we do, is keeping you, the patient, at the center of your own care…. This was the single most important aspect of why we turned on the switch at Encode Health. 

Since starting our efforts just before COVID-19 became an international inferno, and like a phoenix we have risen from the flames and won 3 times over in a number of competitions / grants due to our COVID-19 solution. With the Encode COVID-19 solution users can accurately capture patient information and COVID-19 test kit information in a single application to provide a GDPR compliant public health dashboard taking the onus away from clinicians, nursing staff, admin and lab technicians. 

To find out more about our COVID-19 solution: https://encodehealth.com/covid-19-solution/ 

During the Lock down The Encode Health team applied to the “Hack from Home Global Virtual Hackathon”, the anti-viral virtual hackathon. This was a collaboration of developers, designers, data scientists and making a difference against COVID-19. The international effort brought together 822 participants, from 62 countries who applied into the competition with their health technology applications. It was a positive, supportive, and impact-oriented community that even provided 147 mentors to help. The quality of the applicants was high, so the competition was elevated but also friendly and helpful towards one another. There was up to date information about the effects and pathophysiology of COVID-19 through webinars and a variety of expertly used communication tools. Here the Encode Health Solution was the first of 3 overall winners, that were assessed according to the following criteria: Problem, Capability, Viability, Presentation and Impact. 

When we applied to the OpenCovid19 competition the organising team were lovely and really wanted everyone’s solution to be impactful and help society. It really did feel like a testament to the human spirit as we all helped each other where we could. The JOGL program that helps to develop low-cost tools and methodologies that are safe and easy to use in response to the COVID-19 pandemic. This is global community of 4000+ volunteers and we were classified as experts who helped to create a solution to better prevent, detect, and treat COVID-19, as well as to help forecast the pandemic’s evolution. We won a peer reviewed section competition to help catalyze and resolve the global urgent challenge. Through a variety of efforts we had worked through in in the months between April and June, we were then able to secure a micro grant funding, from the European Research Fund. 

Throughout all of the above efforts we had the basic ideas that we wanted to provide at least 3 basic benefits to both the populous and the healthcare workers: 

  • 100% automated process of inserting patient information – reducing admin time and increasing accuracy 
  • Test results mapped to a single identity with real-time data for public health information on demographic and clinical impact 
  • Accurate forecasting dashboards implemented with Encode Healthcare passport to reduce unnecessary stock holdings and allow smart management of assets 

How we do this is a secret sauce, which has a blend of 4 patent pending IP components. We are continually looking to integrate with other hospitals and looking to the future to apply to the new XPRIZE competition to further help and partner with corporations, universities, NGOs and government – to solve this and future pandemics. 

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Encode Health response to the Cumberlege report, “First Do No Harm”

Encode Health response to the Cumberlege report, “First Do No Harm”​

Encode Health response to the Cumberlege report, “First Do No Harm”​

At Encode Health we believe in personalising healthcare and access for all. At the heart of everything we do, is keeping you, the patient, at the center of your own care.  As a community at Encode Health, we would like to say “we hear you”.

The review highlights the avoidable and harrowing accounts of how patients were adversely affected by the three treatments of hormone pregnancy tests (focusing on Primodos), the anti-epileptic medication sodium valproate and pelvic mesh implants used in women with urinary incontinence. These patients’ voices were not heard when life-changing complications occurred for them and their children.

We truly hope that the first five of nine recommendations are enacted by those who truly are inspiring and provide excellence in UK healthcare with support from the government, to redress those who were expecting better outcomes for themselves and their children. It is the sixth and seventh recommendations where Encode Health can help: 

  • The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
  • A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.

The review highlights the UK healthcare system’s technical inability to know how many people have been affected and how they were affected for the reviewed treatments. This is an ongoing issue for other treatments, with the confirming statement in the report: “The lack of such vigilant, long-term monitoring has been a predominant thread throughout our work. Its absence means that the system does not know the scale of the problems we were asked to investigate”. 

Encoding with Encode Health, any medication or device and voicing your concerns about your management, allows for a better and systematic examination of claims about performance of any treatment. This means a safer system of healthcare for you undergoing treatment and a safer warning system for those considering the same treatment after you. 

It has been a long time in recognition that teams and institutions such as MRHA, GIRFT and Scan4Safety, see the need for validated Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs) to support much needed and long-awaited data on the relative risks and benefits of different medications and insertable devices. The online yellow card system seems outdated and a live database that provides alerts and reports at a moments notice is what should be… the normal. This should happen without the need for patients and clinicians to actively insert a complex history about their treatment, but something as simple as pressing a button on your electronic health record. The Encode Healthcare passport uses SNOWMED codes to tag important clinical outcomes and “aligns the stars”, when important information is requested at a moments notice to help map out aggregate clinical pathways. 

We believe that ongoing clinical evaluation of all healthcare treatments, medication and devices should be a must and the audit process should be as easy as looking at the outcomes on a dashboard. The new Medical Device Regulations (MDR) which were set to be enforced in May of this year have still left many in the healthcare industry wondering how ongoing post market research will be implemented for their supply chains. This is particularly difficult as once a device is inserted it becomes part of a patient’s private healthcare records, so investigating possible problematic issues is costly, time consuming and requires engagement with GDPR or section 251 of the research obligations. As the UK exits the European Union it is especially worrisome as the market economics will impact medical supply chains and devices, stripping the NHS of the ability to procure the assets in the independent manner it currently does. Medication and devices that have a proven track record of safety, could be replaced very quickly as intellectual property rights may well be enforced with other countries as part of a trade deal, forcing the hand of procurement teams to buy specific products. Bad clinical outcomes are not only bad for patients, but also bad for industry reputations and so it makes economic sense to prevent ongoing issues and have the ability to audit products regularly and recall products whenever a negative clinical threshold is met. At Encode we can help the medical suppliers and providers simultaneously map out issues through our tailored dashboards and target focused interventions globally.

It is also important to note GS1 and interoperability standards to ensure that national registries at this scale can house and share unambiguous data. At Encode Health we provide the Encode Healthcare Passport as a highly secure digital identity that enables patients to identify themselves or to be identified by healthcare professionals quickly and effectively within care settings. Very importantly it enables patients to provide and control permissions to store, view and use anonymised data for research. The Encode platform has been designed to track and trace medical devices, from manufacture to patient and on through the device life-cycle. We enable real time data on implant usage, adverse incident recording and live supply chain management tools. We simplify this process and call it… ​“Encoding”​. 

As the review clearly stated: “We cannot take away their pain. But we can make sure that it doesn’t happen again. And the only way to do this is to make patients the beating heart of the healthcare system. And the shame of it is that thousands of women and children had to suffer first.” At Encode Health we hear you, and we will do our best to create a change in culture and to not let such avoidable suffering happen again.

Courses of action: The Encode community will be reaching out to the MHRA, Department of Health and Social Care, NHSDigital and others offering our services free of charge to patients immediately. We look to work with these organisations to improve upon their functions and give them tools to work with. For hospitals and other healthcare providing institutions we will be offering an Encoded device free of charge.

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