Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

Tips From A Biomedical Engineer For Medical Device Innovation And Compliance

Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

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WHITE PAPERS & CASE STUDIES

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.

Leverage Apps To Reduce Line Changeover Time From 14 Days To 3

A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

Eurofins Medical Device Services Expands US Portfolio With New Ethylene Oxide Sterilisation Solution

Eurofins’ San Jose EO sterilization site offers fast, high-quality sterilization services for medical devices, ensuring compliance with FDA, cGMP, ISO 11135, and new EPA regulations.

Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

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DESIGN COMPONENTS & SERVICES

Secondary Operations Saving Time And Money

PTI has exceptional plastic joining experience, technical expertise, and responsive services in place to meet secondary assembly challenges. This experience alongside their designs for manufacturability enables PTI to provide the best methods for matching important assembly requirements and other add value services.

EMC Compliance Testing from 1 to 6 GHz: 100S1G6AB
EMC Compliance Testing from 1 to 6 GHz: 100S1G6AB

As its title would indicate, the 100S1G6AB is a solid-state amplifier ideal for testing medical devices for EMC compliance. It covers the 1 to 6 GHz frequency range and can provide up to 100 Watts of output power when used with a sweep generator.

Quality Management Systems for Medical Devices

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

Optical Sensors
Intelligent Vision Sensor (IVS) machine vision systems are high-speed, noncontact optical sensors
Miniature Single and Multi-Axis Linear Positioners: MX45S Series

This series of linear positioners/stages can be used to provide reliable linear positioning during the development and/or design of medical devices. They’re very small (45mm wide x 25mm high) and have 5mm, 15mm, and 25mm selectable travels.

Nordson - design-own-extrusion
ProtoTools™ Prototyping Tools
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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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