Introduction: The medical profession has a very close interaction with the medical devices industry to develop cutting edge medical technology and improve existing products. There is no doubt that innovation and creativity are essential to the development and evolution of therapeutic and medical devices. This often occurs outside the laboratories of the medical device companies. The industry support of research, audits, device registries and user groups where results are reported and enhancements of products and new products developed, is important. Commentary: The Medical Technology Association of Australia (MTAA) Code of Practice facilitates ethical interactions with the profession and with others within the medical technology industry. There is a Code Complaints panel and the Code Monitoring Committee. The Code Complaints panel will hear complaints about company activities against the Code. The Code Monitoring Committee has a proactive role in examining company behaviour against the Code and is not dependent upon a complaint being received. The AMA supports the MTAA’s efforts to strengthen the Code of Practice and its compliance activities. This is industry self-regulation at work. Orthopaedic surgeons have a responsibility to ensure that their participation in collaborative efforts with medical device companies is consistent with their duties towards their patients and towards society at large. Transparency is the key. We must always disclose financial or other arrangements to peers, patients and Ethics Committees. This will improve confidence in the self-governing role of the medical profession. Our relationship with a medical device company should have the primary objective of the advancement of the health of patients. Codes of Conduct for the profession are helpful in guiding expectations and are becoming more prescriptive. Conclusion: The close and essential collaboration between the medical profession and medical device industries will always come under scrutiny. The close working relationship with the MTAA helps to ensure our collaboration with these industries is ethically robust. What matters most is that our patients get the medicines and the devices that are right for them and deliver high quality patient outcomes. We must ensure our position is unambiguous in that process

In 2009, a multidisciplinary team of orthopaedic surgeons, material scientists, and cell biologists created a consortium focused on developing novel biomaterials for cartilage regeneration. After years of hard work across scientific boundaries, the team discovered a solution that could benefit a large number of patients. However, the research team was faced with a question on how to proceed. Whether to continue the scientific path of unravelling the mysteries of cartilage regeneration or to focus on bringing the invention from bench to bedside? The latter would mean commercialisation of the invention, and for the scientists, taking a completely new career path. Taking this turn would mean risking the team members' scientific career, since running a start-up would inevitably mean lesser publications and other scientific merits in the forthcoming years. On the other hand, there was the potential to help a vast amount of patients. The team decided that the invention, a biodegradable weight-adaptive medical device for cartilage regeneration, was too promising to be left aside, so they made the choice to transform from academic researchers to entrepreneurs. Thus, Askel Healthcare Ltd was founded in March 2017. For a start-up operating in medical device sector, the company has a unique feature: the founding team is all-female. Not intentionally, but by a mere “side effect” of gathering the best talents to get the job done. The team continues to foster its strong scientific background, which is a true asset for a company focusing on tackling the big unmet medical need of cartilage regeneration

Introduction

Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in “at-risk” Birmingham Hip Resurfacing (BHR) patients, and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed if patients were not recalled.

Despite the vast quantities of published artificial intelligence (AI) algorithms that target trauma and orthopaedic applications, very few progress to inform clinical practice. One key reason for this is the lack of a clear pathway from development to deployment. In order to assist with this process, we have developed the Clinical Practice Integration of Artificial Intelligence (CPI-AI) framework – a five-stage approach to the clinical practice adoption of AI in the setting of trauma and orthopaedics, based on the IDEAL principles (https://www.ideal-collaboration.net/). Adherence to the framework would provide a robust evidence-based mechanism for developing trust in AI applications, where the underlying algorithms are unlikely to be fully understood by clinical teams.

Cite this article: Bone Joint Res 2024;13(9):507–512.

Abstract

MAGnetic Expansion Control (MAGEC) rods are used in the surgical treatment of children with early onset scoliosis. The magnetically controlled lengthening mechanism enables rod distractions without the need for repeated invasive surgery. The CE certification of these devices was suspended in March 2021 due, primarily, to performance evidence gaps in the documents provided by the manufacturer to regulators and notified bodies. MAGEC rods are therefore not permitted for use in countries requiring CE marking. This was a survey of 18 MAGEC rod surgeons in the UK about their perception of the impact of the CE suspension on the clinical management of their patients. Unsurprisingly, virtually all perceived a negative impact, reflecting the complexity of this patient group. Reassuringly, these surgeons are highly experienced in alternative treatment methods.

Cite this article: Bone Jt Open 2022;3(2):155–157.

Majority of ultra-high molecular weight polyethylene (UHMWPE) medical devices used in total joint arthroplasty are crosslinked using gamma radiation to improve wear resistance. Alternative methods of crosslinking are urgently needed to replace gamma radiation due to rapid decline in its supply. Peroxide crosslinking is a candidate method with widespread industrial applications. Oxidative stability and biocompatibility, which are critical requirements for medical device applications, can be achieved using vitamin-E as an additive and by removing peroxide by-products through high temperature melting, respectively. We investigated compression molded UHMWPE/vitamin-E/di-cumyl peroxide blends followed by high-temperature melting in inert gas as a material candidate for tibial knee inserts. Wear resistance increased and mechanical properties remained largely unchanged. Oxidation induction time was higher than most of the other clinically available formulations. The material passed the local-end point biocompatibility tests per ISO 10993. Compounds found in exhaustive extraction were of no concern with margin-of-safety values well above the accepted level, indicating a desirable toxicological risk profile. Peroxide crosslinked, vitamin-E stabilized, and high temperature melted UHMWPE has recently been cleared for clinical use in tibial knee inserts. With all the salient characteristics needed in a material that can provide superior long-term performance in total joint patients, peroxide crosslinking can replace gamma radiation crosslinking of UHMWPE for use in all total joint replacement implant including acetabular liners

In absence of available quantitative measures, the assessment of fracture healing based on clinical examination and X-rays remains a subjective matter. Lacking reliable information on the state of healing, rehabilitation is hardly individualized and mostly follows non evidence-based protocols building on common guidelines and personal experience. Measurement of fracture stiffness has been demonstrated as a valid outcome measure for the maturity of the repair tissue but so far has not found its way to clinical application outside the research space. However, with the recent technological advancements and trends towards digital health care, this seems about to change with new generations of instrumented implants – often unfortunately termed “smart implants” – being developed as medical devices. The AO Fracture Monitor is a novel, active, implantable sensor system designed to provide an objective measure for the assessment of fracture healing progression (1). It consists of an implantable sensor that is attached to conventional locking plates and continuously measures implant load during physiological weight bearing. Data is recorded and processed in real-time on the implant, from where it is wirelessly transmitted to a cloud application via the patient's smartphone. Thus, the system allows for timely, remote and X-ray free provision of feedback upon the mechanical competence of the repair tissue to support therapeutic decision making and individualized aftercare. The device has been developed according to medical device standards and underwent extensive verification and validation, including an in-vivo study in an ovine tibial osteotomy model, that confirmed the device's capability to depict the course of fracture healing as well as its long-term technical performance. Currently a multi-center clinical investigation is underway to demonstrate clinical safety of the novel implant system. Rendering the progression of bone fracture healing assessable, the AO Fracture Monitor carries potential to enhance today's postoperative care of fracture patients

Aim. The use of medical devices has grown significantly over the last decades, and has become a major part of modern medicine and our daily life. Infection of implanted medical devices (biomaterials), like titanium orthopaedic implants, can have disastrous consequences, including removal of the device. For still not well understood reasons, the presence of a foreign body strongly increases susceptibility to infection. These so-called biomaterial-associated infections (BAI) are mainly caused by Staphylococcus aureus and Staphylococcus epidermidis. Formation of biofilms on the biomaterial surface is generally considered the main reason for these persistent infections, although bacteria may also enter the surrounding tissue and become internalized within host cells. To prevent biofilm formation using a non-antibiotic based strategy, we aimed to develop a novel permanently fixed antimicrobial coating for titanium devices based on stable immobilized quaternary ammonium compounds (QACs). Method. Medical grade titanium implants (10×4×1 mm) were dip-coated in a solution of 10% (w/v) hyperbranched polymer, subsequently in a solution of 30% (w/v) polyethyleneimine and 10 mM sodium iodide, using a dip-coater, followed by a washing step for 10 min in ethanol. The QAC-coating was characterized using water contact angle measurements, scanning electron microscopy, FTIR, AFM and XPS. The antimicrobial activity of the coating was evaluated against S. aureus strain JAR060131 and S. epidermidis strain ATCC 12228 using the JIS Z 2801:2000 surface microbicidal assay. Lastly, we assessed the in vivo antimicrobial activity in a mouse subcutaneous implant infection model with S. aureus administered locally on the QAC-coated implants prior to implantation to mimic contamination during surgery. Results. Detailed material characterization of the titanium samples showed the presence of a homogenous and stable coating layer at the titanium surface. Moreover, the coating successfully killed S. aureus and S. epidermidis in vitro. The QAC-coating strongly reduced S. aureus colonization of the implant surface as well as of the surrounding tissue, with no apparent macroscopic signs of toxicity or inflammation in the peri-implant tissue at 1 and 4 days after implantation. Conclusions. An antimicrobial coating with stable quaternary ammonium compounds on titanium has been developed which holds promise to prevent BAI. Non-antibiotic-based antimicrobial coatings have great significance in guiding the design of novel antimicrobial coatings in the present, post-antibiotic era

For decades, universities and research centers have been applying modeling and simulation (M&S) to problems involving health and medicine, coining the expression in silico clinical trials. However, its use is still limited to a restricted pool of specialists. It is here proposed an easy-to-use cloud-based platform that aims to create a collaborative marketplace for M&S in orthopedics, where developers and model creators are able to capitalize on their work while protecting their intellectual property (IP), and researcher, surgeons and medical device companies can use M&S to accelerate time and to reduce costs of their research and development (R&D) processes. Digital libraries on . InSilicoTrials.com. are built on collaborations among first-rate research center, model developers, software, and cloud providers (partners). Their access is provided to life science and healthcare companies, clinical centers, and research institutes (users), offering them with several solutions for the different steps of the orthopedics and medical devices R&D process. The platform is built using the Microsoft Azure cloud services, conforming to global standards of security and privacy for healthcare, ensuring that clinical data is properly managed, protected, and kept private. The environment protects the IP of partners against the downloading, copying, and changing of their M&S solutions; while providing a safe environment for users to seamlessly upload their own data, set up and run simulations, analyze results, and produce reports in conformity with regulatory requirements. The proposed platform allows exploitation of M&S through a Software-as-a-Service delivery model. The pay-per-use pricing: 1. provide partners with a strong incentive to commercialize their high-quality M&S solutions; 2. enable users with limited budget, such as small companies, research centers and hospitals, to use advanced M&S solutions. Pricing of the M&S tools is based on specific aspects, such as particular features and computational power required, in agreement with the developing partner, and is distinct for different types of customers (i.e., academia or industry). The first medical devices application hosted on . InSilicoTrials.com. is NuMRis (Numerical Magnetic Resonance Implant Safety), implemented in collaboration with the U.S. F.D.A. Center for Devices and Radiological Health, and ANSYS, Inc. The automatic tool allows the investigation of radiofrequency (RF)-induced heating of passive medical implants, such as orthopedic devices (e.g., rods and screws), pain management devices (e.g., leads), and cardiovascular devices (e.g., stents), following the ASTM F2182-19e2 Standard Test Method. NuMRis promotes the broader adoption of digital evidence in preclinical trials for RF safety analysis, supporting the device submission process and pre-market regulatory evaluation. InSilicoTrials.com. aims at defining a new collaborative framework in healthcare, engaging research centers to safely commercialize their IP, i.e., model templates, simulation tools and virtual patients, by helping clinicians and healthcare companies to significantly expedite the pre-clinical and clinical development phases, and to move across the regulatory approval and HTA processes

AM specifically allows for cost-efficient production of patient-specific Orthopaedic medical devices with unusual designs and properties. A porous design allows to adjust the stiffness of metallic implants to that of the host bone. Beyond traditional metals, like titanium alloys, this talk will review the present state-of-the-art of directly printed absorbable metal families. Physicochemical, mechanical and biological properties of standardized design prototypes from all currently available metal families will be compared and their clinical application potential discussed. The impact of in vitro test environments on comparative corrosion behavior, post manufacturing aspects, and the recent status quo in biocompatibility testing and present knowledge gaps will be addressed

Infections are among the most diffused complications of the implantation of medical devices. In orthopedics, they pose severe societal and economic burden and interfere with the capability of the implants to integrate in the host bone, significantly increasing failure risk. Infection is particularly severe in the case of comorbidities and especially bone tumors, since oncologic patients are fragile, have higher infection rate and impaired osteoregenerative capabilities. For this reason, prevention of infection is to be preferred over treatment. This is even more important in the case of spine surgery, since spine is among the main site for tumor metastases and because incidence of post operative surgical-site infections is significant (up to 15-20%) and surgical options are limited by the need of avoiding damaging the spinal cord. Functionalization of the implant surfaces, so as to address infection and, possibly, co- adjuvate anti-tumor treatments, appears as a breakthrough innovation. Unmet clinical needs in infection and tumors is presented, with a specific focus on the spine, then, new perspectives are highlighted for their treatment

Implant manufacturers develop new products to improve existing fracture fixation methods or to approach new fracture challenges. New implants are commonly tested and approved with respect to their corresponding predecessor products, because the knowledge about the internal forces and moments acting on implants in the human body is unclear. The aim of this study was to evaluate and validate implant internal forces and moments of a complex physiological loading case and translate this to a standard medical device approval test. A finite elements model for a transverse femur shaft fracture (AO/OTA type 32-B2) treated with a locked plate system (AxSOS 3 Ti Waisted Compression Plate Broad, Stryker, Kalamazoo, USA) was developed and experimentally validated. The fractured construct was physiologically loaded by resulting forces on the hip joint from previously measured in-vivo loading experiments (Bergmann et. al). The forces were reduced to a level where the material response in the construct remained linear elastic. Resulting forces, moments and stresses in the implant of the fractured model were analysed and compared to the manufacturers’ approval data. The FE-model accurately predicted the behaviour of the whole construct and the micro motion of the working length of the osteosynthesis. The resulting moment reaction in the working length was 24 Nm at a load of 400 N on the hip. The maximum principle strains on the locking plate were predicted well and did not exceed 1 %. In this study we presented a protocol by the example of locked plated femur shaft fracture to calculate and validate implant internal loading using finite element analysis of a complex loading. This might be a first step to move the basis of development of new implants from experience from previous products to calculation of mechanical behaviour of the implants and therefore, promote further optimization of the implants’ design

Infection of implanted medical devices (biomaterials), like titanium orthopaedic implants, can have disastrous consequences, including removal of the device. These so-called biomaterial-associated infections (BAI) are mainly caused by Staphylococcus aureus and Staphylococcus epidermidis. To prevent biofilm formation using a non-antibiotic based strategy, we aimed to develop a novel permanently fixed antimicrobial coating for titanium devices based on stable immobilized quaternary ammonium compounds (QACs). Medical grade titanium implants were dip-coated in subsequent solutions of hyperbranched polymer, polyethyleneimine and 10 mM sodium iodide, and ethanol. The QAC-coating was characterized using water contact angle measurements, scanning electron microscopy, FTIR, AFM and XPS. The antimicrobial activity of the coating was evaluated against S. aureus strain JAR060131 and S. epidermidis strain ATCC 12228 using the JIS Z 2801:2000 surface microbicidal assay. Lastly, we assessed the in vivo antimicrobial activity in a mouse subcutaneous implant infection model with S. aureus administered locally on the QAC-coated implants prior to implantation to mimic contamination during surgery. Detailed material characterization of the titanium samples showed the presence of a homogenous and stable coating layer at the titanium surface. Moreover, the coating successfully killed S. aureus and S. epidermidis in vitro. The QAC-coating strongly reduced S. aureus colonization of the implant surface as well as of the surrounding tissue, with no apparent macroscopic signs of toxicity or inflammation in the peri-implant tissue at 1 and 4 days after implantation. An antimicrobial coating with stable quaternary ammonium compounds on titanium has been developed which holds promise to prevent BAI. Non-antibiotic-based antimicrobial coatings have great significance in guiding the design of novel antimicrobial coatings in the present, post-antibiotic era. Acknowledgements: This research was financially supported by the Health∼Holland/LSH-TKI call 2021–2022, project 25687, NACQAC: ‘Novel antimicrobial coatings with stable non-antibiotic Quaternary Ammonium Compounds and photosensitizer technology'

The objectives of this study are to evaluate the impact of the CoVID-19 pandemic on the development of relevant emerging digital healthcare trends and to explore which digital healthcare trend does the health industry need most to support HCPs. A web survey using 39 questions facilitating Five-Point Likert scales was performed from 1.8.2020 – 31.10.2020. Of 260 participants invited, 90 participants answered the questionnaire. The participants were located in the Hospital/HCP sector in 11.9%, in other healthcare sectors in 22.2%, in the pharmaceutical sector in 11.1%, in the medical device and equipment industry in 43.3%. The Five-Point Likert scales were in all cases fashioned as from 1 (strongly disagree) to 5 (strongly agree). As the top 3 most impacted digital health care trends strongly impacted by CoVID-19, respondents named:. - remote management of patients by telemedicine, mean answer 4.44. - shared data governance under patient control, mean answer 3.80. - new virtual interaction between HCP´s and medical industry, mean answer 3.76. Respondents were asked which level of readiness of the healthcare system currently possess to cope with the current trend impacted by CoVID-19. - Digital and efficient healthcare logistics, mean answer 1.54. - Integrated health care, mean answer 1.73. - Use of big data and artificial intelligence, mean answer 2.03. Asked if collaborative research in the form of digital data platforms for research data sharing and increasing collaboration with multi-centric consortia would have a positive impact on the healthcare sector, the agreement was high with a value of mean 4.10 on the scale. We can conclude that the impact of COVID-19 appears to be a high agreement of necessary advances in digitalization in the health care sector and in the collaboration of HCPs with the health care industry. Health care professional are unsure, in how far the national health care sector is capable of transformation in healthcare logistics and integrated health care

Abstract. Purpose. Clinical registries are an important aspect of orthopaedic research in assessing the outcomes of surgical intervention and track medical devices. This study aimed to explore the research methodology available to account for patients lost to follow-up (LTFU) specifically in studies related to arthroscopic intervention and whether the rates of patient LTFU are within the acceptable margins for survey studies. Methods. A scoping review, where a literature search for studies from nine arthroscopy registries, was performed on EMBASE, MEDLINE, and the annual reports of each registry. Inclusion criteria included studies with information on patient-reported outcome measures and being based on nine national registries identified. Exclusion criteria included review articles, conference abstracts, studies not based on registry data, and studies from regional, claims-based, or multi-centre registries. Studies were then divided into categories based on method of LTFU analysis used. Results. Thirty-six articles were identified for the final analysis. Categories for LTFU analysis included dropout analyses (n=10), referencing validation studies (n=12), contacting non-responders (n=4), and sensitivity analyses (n=1). Referencing validation studies was the most common method (n=12). Majority (n=35) of the studies exceeded the recommended maximum rates for LTFU. Conclusions. Most arthroscopy studies have rates of LTFU higher than traditionally acceptable. Therefore, any conclusions drawn from these research papers may not be sufficiently valid or free from non-response bias

The Electrospinning Company designs, develops and manufactures biomaterials for use in regenerative medical devices. Since 2012, Ann has led the growth of the company from start-up to supplier of innovative, clinical-grade product to an FDA-approved medical device, evolving the business model and adding capabilities in innovation, manufacturing, quality and alliance management. Ann will share some of the highs and lows of the journey from her perspective as a female leader of a diverse team

Electrospinning of (bio)polymers is a well acknowledged technology used by scientists all over the world to manufacture scaffolds for tissue engineering & 3D cell culture purposes. The ability to control key parameters such as fibre diameter and fibre orientation allow the generation of highly specific scaffolds that closely mimic the native extracellular matrix. Despite the popularity in the R&D lab, the technology itself has only recently seen acceptance as a method for manufacturing clinical-grade medical devices. Subsequently, never before have more electrospun materials obtained market approval (FDA/CE) and are in clinical trials. In this presentation, we share our experience as a manufacturer of clinical-grade medical devices via electrospinning and give insight into the possible applications in orthopaedics

Abstract. Objectives. Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Methods. All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO6892-1, ISO9585 and ISO12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK). Results. The mechanical tests demonstrated that the material performed to the specification for conventionally manufactured titanium alloy of this type (ISO5832-3). The toxicology review concluded that there were no significant concerns for the health of the patients identified in this evaluation and implantation of the TOKA® device would not result in a significant health risk to patients. Conclusions. Reflecting on our MHRA experience, additive manufacture of orthopaedic devices is still considered to be a ‘novel’ process by regulatory bodies, requiring additional safety evidence. Despite this, our findings demonstrate that there is no difference, mechanically or chemically, to the traditionally manufactured alloy material. We hope to support the widening use of 3D printed titanium alloy orthopaedic devices by publishing our route to regulatory approval. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

After the first big hype on additive manufacturing in medical industry the technology of 3D printing is now reaching a productive stage for some selected applications. These applications range from surgical models for visualisation to patient-specific cutting guides and 3D printed orthopaedic implants. This presentation will guide through current 3D printing applications in medical devices. We will show success stories for products in some of these fields and try to point out to a potential future of fully personalized orthopaedics in polymer and metals. A regulatory view on all aspects of 3D printing will be presented and potential hurdles to expand the full potential of medical device 3D printing