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Best Practices in Medical Device Development: From Concept to Regulatory Approval

Author(s) Somashekharayya Hiremath
Country United States
Abstract Invention of new medical devices requires a structured approach to navigate the path from concept ideation to approval from regulatory. This paper outlines the best practices that integrate technical feasibility, clinical relevance, and regulatory compliance to optimize the medical device lifecycle. Beginning with assessing user needs, developers must balance user requirements and market realities to establish a good business and clinical rationale.Risk management strategies, along with early adoption of recognized standards such as ISO 14971, ensure thepatient’s safety and also guides the design decisions. Concurrently, systematic application of design controls, including iterative prototyping and robust verification and validation activities, minimizes late-stage failures. The paper focuses on the importance of detailed documentation, accentuating on the creation of a Design History File (DHF) and a Device Master Record (DMR) to illustrate regulatory compliance. Additionally, it discusses clinical evaluation pathwaysranging from bench testing to clinical trialsto generate evidence supporting device efficacy and safety. Finally, an overview of the evolving global regulatory landscape is provided, focusing on harmonized guidelines that expedite approval while upholding patient protection. By synthesizing these practical insights, the paper enables medical device innovators to construct a holistic framework that aligns technical excellence with clinical and regulatory imperatives, paving the way for successful market entry.
Keywords Medical device development, regulatory approval, design controls, risk management, quality management systems (QMS), ISO 13485, ISO 14971, FDA regulations, EU MDR, clinical evaluation, verification and validation (V&V), and post-market surveillance
Field Engineering
Published In Volume 2, Issue 12, December 2021
Published On 2021-12-07
Cite This Best Practices in Medical Device Development: From Concept to Regulatory Approval - Somashekharayya Hiremath - IJLRP Volume 2, Issue 12, December 2021. DOI 10.5281/zenodo.14672971
DOI https://doi.org/10.5281/zenodo.14672971
Short DOI https://doi.org/g8z63z
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