Real-time Capacity Reactance-based Innovative Technology for Detecting Malignant Cells: An Experimental Implementation in Head and Neck Tumors.

For the market access of innovative medical devices in Germany it plays a key role whether a medical device is applied in the inpatient or in the outpatient setting. There are several possible reimbursement pathways for innovative medical devices, among them Integrated Care Models – ICM (§140 a Social Code Book). Recent research suggests ICMs as a not yet spotted potential access route for medical devices and hence faster access to innovative diagnostics and treatment methods. However, the perception among stakeholders might be quite differential. The key question within the discussion is if the ICM contracts could be an opportunity for market access which might overcome potential issues for market access through regular routes. ICMs have been evaluated systematically through a triangulated approach – the analysis of model concepts, the organizational set-ups and by semi-structured interviews with key stakeholders. In 2011, 6339 contracts exist, covering 1,9 Million insured persons. The actual number of ICM contracts is probably higher. An obligation to notify was established 2012. In total 8120 contracts could be reported in 2015 to the Federal Insurance office (BVA). There are two options for a manufacturer (outpatient setting): First, inclusion of a product within existing ICMs or second, setting up a new ICM with potential stakeholders as partners. The systematic development of treatment procedures associated to the product leading to professional case management structures, potentially supporting guideline developments and overall show a reasonable fast access to these innovative medical devices. ICM contracts are a positive addition to the regular reimbursement possibilities for innovative medical products in cross-sectoral, interdisciplinary care. The extended context of selective contracts makes the implementation of supply innovations possible by bridging the often lengthy and challenging procedures across sectors but primarily in outpatient care, were the current regular route is often still a deadlock.

In this issue of Circulation: Cardiovascular Quality and Outcomes , Xu et al present findings from a search of US patents related to bare-metal coronary stents in an effort to gain insight on how medical device innovation starts and how policies in the United States might help to promote more innovation.1 Of the 245 patents identified by their search strategy for the years 1984 to 1994, the authors report that the most frequently cited stent patents (their measure of patent importance to innovation headlined by the Palmaz and Gianturco patents) were from individual physician inventors working in academic medical centers and their small private companies. They also report a temporal trend that shows, in later years, more patents were granted to public companies. They concluded that policies aimed at supporting these entities might enhance and accelerate innovation because early innovation, in this case, was spurred by individual inventors with their small companies. Article see p 743 It is true that individual practitioners struggling with the challenges of everyday practice are an important source of new-device concepts that can possibly solve an unmet clinical need. However, the journey of successful innovation to maximized impact on public health requires that these early ideas (such as the original stiff, boxcar like tubular stent of Palmaz or the poorly scaffolding clam shell stent of Gianturco) need significant refinement through subsequent innovation (such as the later, industry-based Lau patent of the Multilink stent that …

This paper presents a framework and detailed vision for using immersive virtual reality (VR) environments to improve the design, verification, validation, and manufacture of medical devices. Major advances in medical device design and manufacture currently require extensive and expensive product cycles that include animal and clinical trials. The current design process limits opportunities to thoroughly understand and refine current designs and to explore new high-risk, high-payoff designs. For the past 4 years, our interdisciplinary research group has been working toward developing strategies to dramatically increase the role of simulation in medical device engineering, including linking simulations with visualization and interactive design. Although this vision aligns nicely with the stated goals of the FDA and the increasingly important role that simulation plays in engineering, manufacturing, and science today, the interdisciplinary expertise needed to realize a simulation-based visual design environment for real-world medical device design problems makes implementing (and even generating a system-level design for) such a system extremely challenging. In this paper, we present our vision for a new process of simulation-based medical device engineering and the impact it can have within the field. We also present our experiences developing the initial components of a framework to realize this vision and applying them to improve the design of replacement mechanical heart valves. Relative to commercial software packages and other systems used in engineering research, the vision and framework described are unique in the combined emphasis on 3D user interfaces, ensemble visualization, and incorporating state-of-the-art custom computational fluid dynamics codes. We believe that this holistic conception of simulation-based engineering, including abilities to not just simulate with unprecedented accuracy but also to visualize and interact with simulation results, is critical to making simulation-based engineering practical as a tool for major innovation in medical devices. Beyond the medical device arena, the framework and strategies described may well generalize to simulation-based engineering processes in other domains that also involve simulating, visualizing, and interacting with data that describe spatially complex time-varying phenomena.

A wide range of medical devices have significant electronic components. Compared to open-source medical software, open (and open-source) electronic hardware has been less published in peer-reviewed literature. In this review, we explore the developments, significance, and advantages of using open platform electronic hardware for medical devices. Open hardware electronics platforms offer not just shorter development times, reduced costs, and customization; they also offer a key potential advantage which current commercial medical devices lack—seamless data sharing for machine learning and artificial intelligence. We explore how various electronic platforms such as microcontrollers, single board computers, field programmable gate arrays, development boards, and integrated circuits have been used by researchers to design medical devices. Researchers interested in designing low cost, customizable, and innovative medical devices can find references to various easily available electronic components as well as design methodologies to integrate those components for a successful design.

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.

IntroductionIntegrated care (IC) is a patient-centered approach to the provision of health care that overcomes the fragmentation in the delivery of services that often occurs in older people with multiple comorbidities. Medical device innovations could help tackle this and other challenges of health systems when facing the adoption of high quality IC. Nevertheless, this should be accompanied by the right innovation funding scheme to encourage adoption.MethodsA systematic search strategy to identify payment models for IC was performed in PubMed for the period from 2014 to 2023 using the International Foundation for Integrated Care Knowledge Tree tool. This was complemented with both a gray literature search in Google and a benchmark of payment models for innovative medicines. A scoping review was then performed identifying the following information: payment scheme; advantages and disadvantages for IC; inclusion of innovation; type of IC program or initiative described (sectors and providers); population (therapeutic area); country; and whether the information was conceptual or empirical.ResultsAccording to the literature reviewed, five payment schemes used in IC were identified. However, they were rarely used in isolation; more often a mix of payment schemes was used. Based on conceptual and empirical articles, the combination of bundled payment, shared savings, and pay for performance (based on the quality of care delivered) seemed to be the most comprehensive payment scheme. However, references to inclusion of innovation were not mentioned even in this mixed system. Payment systems for innovative medicines were benchmarked for medical devices.ConclusionsA mixed system of bundled payment, shared savings, and pay for performance appears to be the most complete payment model for IC, since it counteracts the limitations of individual funding schemes. No evidence was found on how to incentivize medical device innovation in the context of IC delivery. However, inspiration from current payment schemes for innovative medicines can provide a starting point for innovative medical device schemes.

Patients need active regulatory oversight, linked to compulsory post-marketing research As therapeutic options, medical devices differ from prescription drugs in many ways, but one of the most important is their...

Two UK academies have called for an overhaul of the way medical devices are assessed for safety and performance in Europe, adding that meaningful trials could be done in the...

Products with high efficacy and low cost are desirable in all market sectors and environments, particularly in settings where resources are limited. The health sectors of developing nations are an example of this basic economic principle as constrained financial and human resources must be budgeted toward large (and often, growing) populations’ health needs. However, the cost and quality characteristics that are absolutely necessary in resource-limited settings (RLS) remain highly desirable in wealthy markets as well. Consequently, technologies and strategies designed in RLS are frequently adopted by high-income nations, a process termed “reverse innovation” [1-4]. In recent years, some medical and surgical devices designed for RLS have been adopted by high-income nations. These reverse innovations have simultaneously overcome historical barriers to medical device deployment in RLS and challenged previously held assumptions regarding the direction of information transfer between high- and low-income nations. The potential for reverse innovation has subsequently been proposed as a reason in and of itself to develop products for RLS [4]. Products that result in reverse innovation offer improved care quality and treatment outcomes at lower costs to health care systems, expand markets for manufacturers, promote bidirectional transfer of information, and strengthen global partnerships for health equity [1-4]. One country that has made investments in myriad health innovations is Rwanda, a landlocked East African nation of approximately 12 million. Within the past two decades, Rwanda’s limited resources and diverse health care needs have combined to produce health care innovations ranging from community-based service delivery pathways to novel vaccine roll-out strategies [5-10]. Rwanda’s innovative approaches to seemingly insurmountable health challenges, and the nation’s resounding successes in these initiatives, have been described in a previous article in this Globalization and Health special series [2]. In the present article, we describe our experience with medical device innovation in Rwanda through two case studies, highlighting approaches taken to accelerate development and facilitate bidirectional flow of information. We also discuss ongoing challenges to progress in the field of health technology innovation for RLS. In sharing our experiences, we add our voices to the call for health technology innovation for low- and middle-income countries (LMICs).

Background Risankizumab (RZB) has been available in our country for Crohn’s disease (CD) patients through an early access program and is now administered using an innovative medical device known as an on-body injector (OBI). We assessed the acceptability and the tolerance of RZB administration via OBI and compare its acceptability with other modalities of CD treatments, and searched for factors associated with the OBI acceptability. Methods This was a prospective, multicenter longitudinal study. All CD patients from the early access cohort treated with RZB via OBI starting in February 2024 were assessed at the time of the switch to OBI (week 0 = W0) and at W8, W16, and W24. The primary endpoint was acceptability, evaluated using a acceptability numerical scale (ANS) ranging from 0 (completely unacceptable) to 10 (perfectly acceptable). Results A total of 58 multi-refractory patients were included (mean age : 42.8 ± 13.8 years; 57.9% were women, 17.3% were smokers, 64.7% had a history of intestinal resection, and 78.2% were in PRO2-clinical remission). Therapeutic education sessions were conducted concurrently for 36.2% (21/58) of patients. OBI was applied to abdomen, thigh, or another site in 43.9%, 52.6%, and 3.5% of patients, respectively. RZB administration via OBI was well tolerated in 57.4%, with possible mild application-site pain (20.4%, mild in 90% of cases), localized erythema (22.2%), pruritus (16.7%), edema (16.7%). No factors affected the acceptability of risankizumab administration via OBI in more than 15% of patients. RZB acceptability via OBI was very high (9.5 ± 1.2) at W0, significantly better than RZB subcutaneous injections (6.98 ± 2.57; p < 0.0001). OBI acceptability remained stable over time: 9.6 ± 1.2 at W8, 9.6 ± 1.4 at W16, and 9.6 ± 0.8 at W24 (p = 0.97). OBI acceptability as a medical device was better than other injectable administration modalities for IBD treatments: IV infusions (p < 0.0001), pen injectors (p < 0.001), and syringes (p < 0.001). Overall, patients preferred OBI (64.0%), followed by oral administration (28.0%), subcutaneous injections (6.0%), and IV infusions (2.0%). When adjusted for administration frequency, RZB every 8 weeks via OBI was the most preferred method (ANS = 9.2 ± 2.0), compared to long interval subcutaneous injections (every 12, 8, or 4 weeks), more frequent injections (weekly or eow), and IV infusions every 4–8 weeks (p < 0.001 for all comparisons). Conclusion In this cohort of refractory patients, the administration of risankizumab via OBI was highly acceptable to CD patients with excellent tolerance, suggesting that this new medical device could promote the use of risankizumab in clinical practice.

Innovation in health care requires new ideas and the capital to develop and commercialize those ideas into products or services. The necessary capital is often "venture capital," but the link between public policy and the venture capital industry has not been well examined. In this paper we explore the link between venture capital and innovation in health care, and we present new descriptive data from a survey of health care venture capital fund managers. Respondents generally viewed policy levers (for example, reimbursement and regulations) as important risks to venture capital investments, potentially affecting their ability to raise capital for early-stage investment funds.

BackgroundTotal knee arthroplasty (TKA) is common, effective, and cost-effective. Innovative implants promising reduced long-term failure at increased cost are under continual development. We sought to define the implant cost and performance thresholds under which innovative TKA implants are cost-effective.MethodsWe performed a cost-effectiveness analysis using a validated, published computer simulation model of knee osteoarthritis. Model inputs were derived using published literature, Medicare claims, and National Health and Nutrition Examination Survey data. We compared projected TKA implant survival, quality-adjusted life expectancy (QALE), lifetime costs, and cost-effectiveness (incremental cost-effectiveness ratios or ICERs) of standard versus innovative TKA implants. We assumed innovative implants offered 5–70% decreased long-term TKA failure rates at costs 20–400% increased above standard implants. We examined the impact of patient age, comorbidity, and potential increases in short-term failure on innovative implant cost-effectiveness.ResultsImplants offering ≥50% decrease in long-term TKA failure at ≤50% increased cost offered ICERs <$100,000 regardless of age or baseline comorbidity. An implant offering a 20% decrease in long-term failure at 50% increased cost provided ICERs <$150,000 per QALY gained only among healthy 50–59-year-olds. Increasing short-term failure, consistent with recent device failures, reduced cost-effectiveness across all groups. Increasing the baseline likelihood of long-term TKA failure among younger, healthier and more active individuals further enhanced innovative implant cost-effectiveness among younger patients.ConclusionsInnovative implants must decrease actual TKA failure, not just radiographic wear, by 50–55% or more over standard implants to be broadly cost-effective. Comorbidity and remaining life span significantly affect innovative implant cost-effectiveness and should be considered in the development, approval and implementation of novel technologies, particularly in orthopedics. Model-based evaluations such as this offer valuable, unique insights for evaluating technological innovation in medical devices.

New therapeutic alternatives, such as innovative medical devices, are frequently the only treatment options left for patients when other efficient medical modalities are lacking or insufficient. Development of novel devices, which are safe and effective, requires understanding of complex premarket and postmarket provisions, including characteristics of clinical trials. Speeding up patient access to new technologies may imply the need to make choices in terms of extent and robustness of clinical evaluation without losing the patient safety perspective. In such situations, some challenges can readily arise due to existing methodological solutions and aspects of current legislation in the field. In this context, some challenges, occurring at various stages of the device lifecycle, will be presented in order to observe the changes and hopefully to contribute to better knowledge and improvements in the area.

This dissertation investigates peripheral arterial disease (PAD), a condition associated with high morbidity and mortality, from three perspectives: fundamental research, imaging, and regulation.<br/><br/>Part I focuses on balloon angioplasty (BA) and the resulting damage to the vascular endothelium. An ex vivo flow model was developed and validated to study this damage in pig arteries. BA was found to cause significant endothelial injury and reduced vascular function. A balloon-to-artery ratio of 1.3:1 resulted in greater damage compared to lower ratios. Two preservation methods were compared: cold static preservation (CS) caused more endothelial loss than warm perfusion (WP), but WP led to reduced vascular responsiveness. The model is therefore suitable for short-term damage assessment, but has limitations in evaluating long-term vascular function.<br/><br/>Part II introduces the length-adjusted calcium score (LACS), a method to quantify arterial calcium load in the lower limbs using contrast-enhanced CT. This score showed good agreement with established methods. When applied to patients with chronic limb-threatening ischemia (CLTI), a high LACS was significantly associated with complications such as amputations and mortality after endovascular treatment. LACS thus provides clinical value for risk stratification.<br/><br/>Part III discusses the impact of new European regulations for medical devices. These stricter rules aim to enhance patient safety through more stringent requirements and increased transparency. At the same time, innovative approaches such as 'safe-by-design' and 'production-by-manufacturability' are proposed to ensure the development of safe and innovative medical devices without hindering innovation.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries. Although device approval is currently executed by Notified Bodies in the EU, it will be advantageous in the mid-term to consider a single EU regulatory agency for devices. In the short term, steps can be taken to transform the current system into a more efficient, predictable, cost-effective, and user-friendly service. Key strategies include the following: enhancing predictability of the approval process through use of early scientific advice from regulators; establishing unique regulatory pathways for CV orphan, paediatric, and innovative devices; promoting more efficient (re)certification of essential legacy CV devices; improving transparency of sponsor interactions with Notified Bodies; expanding the roles of the Expert Panels to assist in the approval of CV devices; promoting global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions; developing an efficient system to monitor device safety; and ensuring funding for data collection platforms. Some strategies that could help include considering a pilot programme for joint approval processes of selected devices in partnership with other regions (i.e. US Food and Drug Administration); developing priority pathways for accelerated access to innovative or orphan devices; and increasing recognition of the importance of early feasibility studies in the EU.