Posted on November 13, 2024 by DeviceLab
Transitioning a medical device from the engineering lab to the hands of patients involves establishing robust, reliable manufacturing capabilities. What begins with prototypes handbuilt by designers culminates in optimized production, driving mass customization. Strategic planning, process development, quality systems, and supply chain integration pave the path. In this step of the process, we will explore […]
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Posted on November 6, 2024 by DeviceLab
Bringing safe and effective medical devices to patients requires proactively identifying and mitigating risks across the entire product lifecycle. A robust risk management process spanning development, manufacturing, and post-market phases provides a critical foundation for device quality and reliability. In this step of the process, we will explore the essential components of an integrated risk […]
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Posted on October 23, 2024 by DeviceLab
Transforming a medical device from concept to commercial product involves extensive product design efforts. Structured product development processes guide an invention through incremental prototypes, comprehensive testing, and design refinements to arrive at an optimized commercial device. In this installment of our medical device development processes, we explore DeviceLab’s stepwise approach to maturing medical device designs […]
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Posted on October 9, 2024 by DeviceLab
Intellectual property protection is critical in medical device innovation and commercial success. As we outline DeviceLab’s structured process for bringing new medical devices to market, intellectual property considerations permeate each step. Securing patents, managing trade secrets, and developing an IP strategy are integral to medical device development. In this section, we will explore the key […]
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Posted on September 18, 2024 by DeviceLab
Entering the medical device market requires substantial upfront investments in research and development, clinical evaluations, regulatory approvals, manufacturing capabilities, and commercialization activities. Due to these high costs and risks, having a well-defined market entry strategy is crucial for successfully launching and commercializing a new medical device. Without a robust strategy in place, companies can end […]
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Posted on September 4, 2024 by DeviceLab
The healthcare industry has undergone rapid technological innovation in recent years. The emergence of the Internet of Things (IoT) has led to connected, data-driven medical devices that are transforming patient monitoring, treatment delivery, and healthcare operations. It is estimated that the global IoT healthcare market will reach $534.3 billion by 2025. This proliferation of networked […]
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Posted on August 28, 2024 by DeviceLab
Materials are a critical component of medical device design and performance. The materials used in devices that interact with the human body have a direct impact on patient safety, device efficacy, and overall functionality. Selecting the right materials is key to mitigating risk and meeting regulatory requirements. This article covers the key considerations and criteria […]
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Posted on August 14, 2024 by DeviceLab
Medical devices play a critical role in healthcare, diagnosing conditions, treating patients, and improving quality of life. From simple bandages to complex MRI machines, medical devices encompass a wide range of products that have become essential components of modern medicine. However, successful medical device development requires navigating a complex regulatory landscape. Companies must follow structured […]
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Posted on August 9, 2024 by DeviceLab
Designing Fundus and Retinal Optical Devices Fundus and retinal optical devices are essential tools in modern ophthalmology. The retina at the back of the eye is a critical part of the visual system responsible for capturing and sending images to the brain. Diagnosing and treating retinal diseases require precise and detailed imaging, where these devices […]
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Posted on August 7, 2024 by DeviceLab
Optical devices play a crucial role in modern ophthalmology by providing detailed images of the eye, allowing for accurate diagnosis and treatment of various eye conditions. The precision and clarity of these devices, such as fundus cameras and retinal imaging systems, are essential for detecting diseases early and monitoring their progression. The design and development […]
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