Medical Device Design & Development

INDUSTRY PERSPECTIVES

A Better Interpretation Of POH In ISO 24971

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

Improving Drug-Device Combination Product Co-Development

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

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WHITE PAPERS & CASE STUDIES

Life Sciences Corporation Implements eLogbooks Across 15 Sites

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

Implementing A Next-Gen MES At A Fraction Of The Cost

Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

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DESIGN COMPONENTS & SERVICES

High-Performance Batteries for Active Implants

These high-performance batteries are based on lithium-iodine or lithium-manganese dioxide. They feature high volumetric energy densities and low self-discharge. They’ve been specifically designed for use in medical implants.

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Automated Manufacturing Services for Medical Devices

Automated cells can improve quality, reduce labor, lower cycle times and increase production. At SMC, we take pride in offering industry-differentiating automation expertise. We are committed to meeting or exceeding our customers’ requirements by designing and building work cells that gain a competitive edge. Our in-house automation team will design cutting-edge automation customized to your specific program, ensuring that your requirements for quality and reliability are met time and time again.

High Flow Diaphragm Air/Gas Pumps: T2-01 Series

These high-performance and high-efficiency diaphragm pumps offer up to 66 LPM free flow. They're ideal for integration into portable aspirators, transport ventilators, and other medical devices used in respiratory or clinical diagnostics applications.

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Bionate® Thermoplastic Polycarbonate Polyurethane (PCU) Polymers

DSM Biomedical offers a proven family of highly biocompatible, medical-grade polymers for use in long term medical implants. Bionate® Thermoplastic Polycarbonate Polyurethane (PCU) polymer family is one of the most extensively tested families of biomedical polymers and is backed by a comprehensive FDA Material Master File.

Design and Development of Advanced Optical Applications

Precision Optics Corporation, or POC, was formed over 30 years ago with the purpose of designing, developing, and realizing advanced optical applications and for volume production of specialized medical optical systems.

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Medical-Grade Polyethylene Fibers: Ulteeva Purity®

DSM Biomedical offers a variety of different medical-grade Ulteeva Purity® fibers for numerous medical applications, including medical devices in orthopedic trauma, medical implants, and other uses in the human body. These medical-grade fibers are 15 times stronger than steel at a similar weight, while maintaining increased flexibility and high pliability.

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MEDICAL DEVICE DESIGN & DEVELOPMENT

Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.

Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.

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