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 firstname.lastname@example.org. 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.
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
Regulation of Cell-Free Biomaterial Implants N.Zhang A.Baume R.Payne J.Allickson 5 August 2016