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  • Evaluating Medical Devices: How Do RCT Data and RWD Fit Together?

    Evaluating Medical Devices: How Do RCT Data and RWD Fit Together?
    The banner image talks about evaluation of medical devices using RCT and RWD

    Medical devices play a critical role in modern healthcare, aiding in diagnosing, treating, and managing various diseases and conditions. Before these devices are approved for widespread use, they undergo rigorous evaluation to ensure their safety and effectiveness. Two key sources of data used in the evaluation process are Randomized Control Trial (RCT) data and Real-World Data (RWD). While RCTs provide controlled and standardized evidence, RWD reflects the device’s performance in everyday clinical practice. Understanding how these two sources of data complement each other is essential for making informed decisions about medical device adoption and patient care.(1)

    RCTs are widely regarded as the gold standard for assessing the safety and efficacy of medical devices. These trials involve carefully designed studies where participants are randomly assigned to different treatment groups. This randomization minimizes bias and allows for the comparison of treatment outcomes. RCTs follow predefined protocols and often have strict inclusion and exclusion criteria, which helps ensure a homogeneous study population.(2,3)

    RCT data provides valuable insights into the specific device being evaluated. Researchers meticulously collect and analyze data, monitoring participant outcomes, adverse events, and treatment response. The controlled environment of RCTs allows for a detailed examination of the device’s performance, enabling researchers to draw reliable conclusions about its effectiveness. Furthermore, the blinding and randomization processes in RCTs help minimize confounding factors and enhance the internal validity of the findings.(3)

    While RCTs provide vital initial evidence, RWD offers a complementary perspective on medical device performance. RWD is collected from routine clinical practice and reflects the device’s use in diverse patient populations, various healthcare settings, and in the presence of coexisting conditions. This data is obtained from electronic health records, claims databases, registries, and other sources, providing information about a device’s long-term effectiveness and safety.(4)

    RWD captures the complexity of patient care and provides insights into how a device performs in everyday clinical practice. It helps identify potential issues that may not have emerged during the controlled setting of RCTs. RWD can uncover rare adverse events, treatment challenges in specific patient subgroups, and the durability of device efficacy over time. Additionally, it enables the evaluation of device performance in real-world settings, where factors such as operator experience and patient adherence come into play.(4,5)

    While RCTs and RWD have distinct strengths, combining these sources of information can enhance our understanding of medical device performance. RCT data establishes the initial evidence base and provides critical insights into the device’s efficacy under controlled conditions. This data is often used to support regulatory approval and guide initial clinical decisions.(4-6)

    RWD, on the other hand, supplements RCT findings by providing a broader view of device performance in diverse patient populations and real-world clinical settings. It can help identify potential risks or benefits that may not have been apparent during the controlled environment of an RCT. Moreover, RWD can inform post-market surveillance efforts, aiding in continuously monitoring device safety and effectiveness.(4)

    The integration of RCT data and RWD can help address limitations inherent in each dataset. For example, while RCTs may have limited sample sizes and shorter follow-up periods, RWD can provide insights into long-term outcomes and rare adverse events. Conversely, RWD may suffer from biases, such as confounding variables or incomplete documentation, which can be mitigated by the controlled design of RCTs.(2)

    Evaluating medical devices requires a comprehensive approach that combines the strengths of both RCT data and RWD. RCTs establish the initial evidence base, while RWD provides insights into the device’s performance in diverse patient populations and everyday clinical practice. The synergy between these two data sources is crucial for informed decision-making regarding medical device adoption, patient care, and post-market surveillance. By embracing a holistic approach to data evaluation, we can maximize the benefits and safety of medical devices, ultimately improving patient outcomes.

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    References:

    1. Ming J, He Y, Yang Y, et al. Health technology assessment of medical devices: current landscape, challenges, and a way forward. Cost Effectiveness and Resource Allocation. 2022 Dec;20(1):1-9.
    2. Tarricone R, Boscolo PR, Armeni P. What type of clinical evidence is needed to assess medical devices? Eur Respir Rev. 2016 Sep;25(141):259-65.
    3. Tarricone R, Callea G, Ogorevc M, Prevolnik Rupel V. Improving the methods for the economic evaluation of medical devices. Health Economics. 2017 Feb;26:70-92.
    4. U.S. Food and Drug Administration. FDA. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. 2023; Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices.
    5. Dhruva SS, Ross JS, Desai NR. Real-world evidence: promise and peril for medical product evaluation. Pharmacy and Therapeutics. 2018 Aug;43(8):464.
    6. Valla V, Tzelepi K, Charitou P, et al. Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices. International Journal of Digital Health. 2023 Jan 1;3(1):1.

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  • The Expanding Role of Real-World Evidence in Evaluation of Medical Devices

    The Expanding Role of Real-World Evidence in Evaluation of Medical Devices

    Concerns about the consistency of the post-marketing surveillance (PMS) for safety of medical devices is well known across the world. Only around 13% of post-marketing surveillance (PMS) clinical studies are completed on medical devices.[1] This is because new products or line extensions are launched frequently, even before full clinical trials of the parent device are conducted. This forces the manufacturers to reconsider whether a clinical study is worth funding, especially if the study timeline may result in publications reporting results on a previous generation’s technology. Furthermore, demonstration of the effectiveness of a device in clinical trials is challenging since the outcomes depend highly upon the clinician’s training and healthcare settings. In addition to this, continual and rapid changes in device design, and challenges pertaining to the use of placebo and blinding techniques, contribute to the complexity in conducting medical device trials.[2]

    Another outcome of these challenges with medical device trials is the difficulty in conducting health technology assessments (HTA) of medical devices. Most healthcare systems across the globe have implemented value analysis mechanisms to assess the clinical and economic impact of medical devices to inform policy decisions. In line with this, HTAs of medical devices are increasingly required to ensure efficacy, and safety, and also to support funding, coverage, and reimbursement decisions or price negotiations. However, the quantity of clinical evidence generated through randomized controlled trials (RCTs) of medical devices is often less, making HTA difficult.[3,4]

    These challenges with respect to the availability of clinical evidence resulted in an unmet need among device manufacturers to invest in collecting evidence from other sources. And one possible solution to these problems is in the form of harnessing the power of real-world evidence (RWD).

    With advances in technologies, modern medical devices (especially wearables) are largely connective: this means that these devices have an inherent capacity to generate RWD enabling translation to real world evidence (RWE). RWE has already been used for safety assessment in the form of PMS studies of medical devices. In addition, it has been increasingly realized that RWE may also be used to support medical device development. These include RWE used as external control of a single test group, clinical evaluations leading to modification of clinical value and registrations of the device, humanitarian device exemptions (HDE), premarket approval applications, support device reclassification petitions, and expanded labeling claims. Also, RWE on medical devices is useful in studying disease epidemiology, validating biomarkers, and refining treatment patterns. RWE can assist in surveillance and early identification of device design issues or opportunities for improvements or product extensions. RWE has the potential to reveal failure modes that are not previously diagnosed in the pre-clinical analysis thereby motivating testing advancements.[5]

    Examples of using RWE in medical device development include using existing RWD of the control device during a prospective trial for a novel device; indication expansion of drug-eluting stents; some USFDA approvals, such as those of scoliosis devices, vertebral body tethering devices, the Sapien 3 device for transcatheter aortic valve replacement (TAVR); the report on incidence rates of Microbial keratitis in pediatric contact lens users, and so on.[6]

    Realising the importance of RWE in medical devices, the USFDA developed the National Evaluation System for health Technology (NEST) in 2016, with a mission to accelerate and translate new and safe health technologies leveraging RWE throughout the lifecycle of the medical device, thereby optimizing device healthcare. NEST currently consists of 12 network collaborators representing more than 195 hospitals and 3,942 outpatient clinics, responds to the research questions of stakeholders, including medical device manufacturers, and generates crucial RWE. In 2017, the Center for Devices and Radiological Health (CDRH) of the FDA issued a guidance document on the use of RWE in supporting regulatory decisions for medical devices. In 2021, the FDA published 90 examples of regulatory submissions on medical devices using RWE from 2012 to 2019 showcasing the growing role of RWE in medical devices.[6]

    In the UK, the ratification of the Medical Device Regulation MDR 2017/745 occurred in 2021, which requires Post-Market Clinical Follow-up (PMCF) of all medical devices continually and throughout the entire lifetime of the device that indirectly contributes to the robust data that are utilized for product advancements.[7] The PMCF uses RWE to a large extent.

    There are some challenges for the adoption of RWE in medical devices, the main ones being the data quality, lack of standard endpoints in data collection, and inability to assess the incremental value of the devices when multiple medical devices are used during a single procedure. To strengthen the RWD on devices, Unique Device Identifiers (UDIs) have been mandated by the FDA for all devices, simplifying the tracking of device impacts, thereby creating a robust RWD. Modern medical devices also contribute to robust RWE generation by reducing the site visits, increasing the cohorts through Federal data networking, and reducing costs & timelines in medical product development.[6,8]

    Unlike drugs, the use of RWE in medical devices is in the embryonic stage and has the potential to boom in the coming years. With the complexities of RCTs of medical devices and the evolution of the regulatory process, making evidence requirements by regulatory bodies worldwide, manufacturers are paying more attention to their evidence generation plans for devices and diagnostics, and the benefit could be substantial.

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    References:

    1. Reynolds IS, Rising JP, Coukell AJ, et al. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2014;174(11):1773–1779.
    2. Unlocking Market Doors with Real-World Evidence [Internet]. Medical Product Outsourcing. 2019 [cited 25 May 2022]. Available from: https://www.mpo-mag.com/issues/2019-11-04/view_columns/unlocking-market-doors-with-real-world-evidence/
    3. deloitte.com. 2018 [cited 16 June 2022]. Available from: https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-medtech-iomt-brochure.pdf
    4. Pongiglione B, Torbica A, Blommestein H, de Groot S, Ciani O, Walker S et al. Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal. International Journal of Technology Assessment in Health Care. 2021;37(1).
    5. Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions [Internet]. Meddeviceonline.com. 2020 [cited 28 May 2022]. Available from: https://www.meddeviceonline.com/doc/pandemic-accelerates-expanding-role-of-real-world-evidence-in-fda-medical-device-submissions-0001
    6. gov. 2017 [cited 25 May 2022]. Available from: https://www.fda.gov/files/medical%20devices/published/Use-of-Real-World-Evidence-to-Support-Regulatory-Decision-Making-for-Medical-Devices—Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf  
    7. Real World Evidence & EU MDR Compliance [Internet]. Mantra Systems Ltd. 2022 [cited 1 June 2022]. Available from: https://www.mantrasystems.co.uk/eu-mdr-compliance/real-world-evidence
    8. Optimizing Real-World Evidence in Medical Device Development – tHEORetically Speaking [Internet]. tHEORetically Speaking. 2020 [cited 1 June 2022]. Available from: https://blogsite.healtheconomics.com/2020/01/optimizing-real-world-evidence-in-medical-device-development/

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  • What Makes Medical Devices Costly?

    What Makes Medical Devices Costly?

    Medical devices may well sound like a modern invention but they have helped us control and treat diseases for centuries. Medical gadgets play a considerable role in our lives, many of them so ubiquitous that we at times take them for granted. Some of the examples for such medical devices include clinical thermometer, hypodermic needle, spectacles, X-ray imaging, blood glucose monitor and many others.

    Sales of medical devices have grown at an annual rate of 9 percent for the past decade. It has been estimated that the total cost of quality for the medical device industry—including day-to-day quality costs as well as cost and revenue loss from non-routine events—is at $17 billion to $26 billion per year, or 12 to 18 percent of industry revenue. In a study conducted by AdvaMed, it was found out that during 23-year period from 1989 to 2011, a significant driver of changed medical practice has been the development of new medical devices—from stents to implantable defibrillators to artificial hips and knees to new imaging modalities, diagnostic tests and surgical tools.

    Further it has been documented that the average cost to bring a low-to-moderate 510(k) product from concept to market is $31 million. More than 77 percent of that, $24 million, was spent on FDA-dependent or related activities. High-risk Pre Market Approval (PMA) costs averaged $94 million, with $75 million spent on FDA-linked stages, nearly 80 percent of the total cost of bringing devices to market (average cost for FDA to review a marketing application was $870,000 and the average cost to review a 510(k) submission was $18,200).

    Manufacturers make decisions about pursuing new devices based in part on the cost of their development. Additional regulatory requirements may escalate these costs, while other incentives, such as tax breaks or market exclusivity extensions, may diminish them. The medical device industry is highly influenced by factors such as country’s GDP, regulatory environment, general healthcare expenditure, level of public spend on healthcare compared to private sector, taxation, population responsiveness of the treatment options and their reception of the certain device based therapy and reimbursement options.

    In the recent times, the medical device industry has experienced increasing pressures, including cost competitiveness, globalization and supply chain tiering. If the device development cost is too high, the eventual result may be that consumers are denied access because new products are not developed or brought to market. Access problems have led to proposals for, and the enactment of, incentives to develop medical devices for rare diseases and paediatric populations.

    In order to overcome these problems, medical device manufacturers must concentrate on the needs of the customers, product features as well as the product design. Leading companies should try hard to deliver the features their customers most value, at the lowest possible cost. While many companies invest heavily in product cost reduction, they usually do so by examining existing designs and identifying opportunities for incremental savings. Using “Design to Value” concept, companies can first work to understand the likely limits of product cost reduction. Starting with a blank sheet and using knowledge of industry best practices for materials, processing and labor costs, they can further build an estimate of the most efficient way to deliver the desired feature set.

    The Indian medical devices sector is worth about USD 3 Billion and is rising at a CAGR of 15%. The medical devices market in India is subjugated by imported products, along with products manufactured using imported material, which comprises approximately 75% of the total sales. The major players in the Indian market are: Hindustan Syringes & Medical Devices, Opto Circuits (India), Wipro GE Healthcare, 3M India, Medtronic, Johnson & Johnson, Becton Dickinson, Abbott Vascular, Bausch & Lomb, Baxter, Zimmer India, Edwards Life Sciences and many others. Although the cost of labor and production in India is significantly lower than other countries, the ultimate price of the goods is on the higher side due to multi-layer and multi-stage levy of indirect taxes. As an end result, the growth of the Indian industry, together with the medical devices industry, has been diminutive.

    In June 2015, the Times of India reported that regulators were investigating charges that imported products, such as stents and other cardiovascular implants, were marked up significantly, and that Indian patients paid between three and four times the price of the landed product.  The National Health Systems Resource Center (NHSRC) in India has submitted a new report strongly urging the National Pharmaceutical Pricing Authority (NPPA) to cap the prices of both bare metal and drug-eluting cardiovascular stents. According to the NHSRC, the deficiency of price regulation has led to consumer exploitation, especially with imported stents but according to the manufacturers the report does not consider stent quality or overall hospitalization costs.

    As per the Department of Pharmaceutical (DoP) pricing of medical devices should be different from that of drugs. It should be done in such a manner so as to ensure sufficient incentives in terms of returns on investment for the manufacturers. In Jan’ 2016, the core committee under the ministry of health had called for a meeting with the manufacturers of medical devices and stakeholders on the need for capping prices of cardiac stents and implants. The government task force has recommended that prices of medical devices, including cardiac stents and implants, be regulated under a mechanism that is distinct from medicines. The committee has taken the view that costs of medical devices should balance consumer and medical industry interests so that the volume of business provides a sufficient incentive to manufacturers.

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