week 4 compliance final

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Northeastern University *

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6000

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Information Systems

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Dec 6, 2023

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docx

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Corporate governance in the biomedical product manufacturing sector is a diverse undertaking characterized by severe regulatory compliance and the requirement for medical device innovation. Compliance Principles in Biomedical Product Manufacturing: FDA Regulations and Quality Systems: Compliance with regulatory requirements is the cornerstone of corporate governance in the biomedical product manufacturing sector. The U.S. Food and Drug Administration (FDA) governs the approval and oversight of medical devices through its Quality System Regulation (QSR), outlined in 21 CFR Part 820. This regulation establishes a framework for quality management systems, covering the entire lifecycle of medical devices, from conception to distribution (FDA, 21 CFR Part 820). Balancing Efficacy and Safety: A major part of corporate governance in this industry is striking a balance between maintaining the efficacy and safety of medical devices and facilitating access to breakthrough technologies. Because of the dynamic nature of medical devices, which are constantly improved in design, this equilibrium is on the whole difficult. (Kinsel, 2012) 21st Century Cures Act and Real-World Evidence (RWE): Real-world evidence (RWE) has been recognized as an important asset in corporate governance by the 21st Century Cures Act. RWE includes information derived from ordinary healthcare delivery, such as electronic health records (EHRs), clinical registries, and other sources. While RWE has enormous promise, it is critical to realize its limitations, which include data inconsistency and treatment choice bias. The new addition of Unique Device Identifiers (UDIs) expands RWE's value for measuring device performance in real-world scenarios. UDIs allow individual devices to be associated with patients at certain time points, making RWE a valuable resource in corporate governance. (Resnic & Matheny, 2018) Corporate Governance Challenges: Underreporting of Adverse Events: Underreporting of adverse events by doctors is a major issue in corporate governance in the biomedical product manufacturing sector. Only 0.5% of device-related adverse events are reported to the FDA, according to estimates. This underreporting restricts a thorough evaluation of device safety and performance after approval. (Kinsel, 2012) Risks of Relying on Imperfect Data: While RWE has promise, relying on incomplete clinical data for regulatory approval has inherent risks. RWE-based analyses are observational, even with sophisticated statistical modifications, and are influenced by treatment choice biases. A case in point is the examination of a device for treating hypertension, where early trials revealed promising findings, but a key FDA-mandated study yielded no clinical effect. (Resnic & Matheny, 2018)

Complex Post-Approval Studies: Traditional post-approval studies are often criticized for their small scale, inadequate controls, high costs, and limited actionable insights into device safety and performance. Corporate governance must address the challenge of designing more effective post-approval studies that offer meaningful data. (Kinsel, 2012) Although there are significant complications and special concerns, the article's concepts are actually applicable to the biopharmaceutical and medical device industries albeit with a few nuances: Clinical Trials: Clinical trials are a distinct feature of the biopharmaceutical sector, often involving extensive phases of testing in human subjects. The principles of regulatory compliance are equally stringent, but the process differs from medical device trials, making this an industry-specific consideration. ( FDA, Clinical Trials , 2020) Risk Management: Both biopharmaceutical and medical device industries employ risk management practices. The identification, assessment, and mitigation of risks are essential to ensure the safety and quality of products. In the pharmaceutical sector, Risk Evaluation and Mitigation Strategies (REMS) may be required for certain drugs, reflecting a risk-based approach (FDA, REMS). Medical device manufacturers use techniques like Failure Mode and Effects Analysis (FMEA) for risk management. ( FDA, Design Controls , 2023) Global Regulatory Harmonization: The global nature of these industries necessitates harmonization of regulatory standards. International collaboration and alignment of regulations streamline market access and reduce duplicative efforts. The International Council for Harmonisation (ICH) serves this purpose in the pharmaceutical industry, facilitating global regulatory harmonization (ICH). Similarly, the International Medical Device Regulators Forum (IMDRF) harmonizes medical device regulations worldwide. ( GHTF Study Group 2 - Post-Market Surveillance/Vigilance , 2012) Post-Market Surveillance: Post-market surveillance is a vital component in both the biopharmaceutical and medical device sectors. Monitoring the performance and safety of drugs or devices after they enter the market is crucial. Adverse event reporting, gathering RWE, and identifying safety signals are essential practices in both areas.( FDA, Drug Safety Information , 2023) Balancing Innovation and Safety: Balancing innovation with safety is a common challenge in both sectors. Biopharmaceutical companies develop new drugs and therapies, while medical device manufacturers create innovative devices. The necessity to ensure patient safety and efficacy, as mentioned in the article, is equally applicable. The principles discussed in the article, including the careful consideration of real-world evidence (RWE) and post-market surveillance, apply to both industries.

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