Medical Device Design & Development

INDUSTRY PERSPECTIVES

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.

Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis

Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

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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

Miniature Liquid Control Valves

Parker Precision Fluidics offers a wide range of miniature liquid control valves used in medical device product development.  These liquid control valves offer a broad range of specs that span a variety of medical device applications like radioactive liquids used in MRI, analytical chemistry, and clinical diagnostic applications.  Parker’s liquid control valves are ideal for these applications offering chemical resistance, non-corroding, high pressure / high flow, and rugged features.

Horn Antenna for EMC/EMI/RFI Susceptibility Testing
Horn Antenna for EMC/EMI/RFI Susceptibility Testing

Electronic medical devices need to be tested for EMC/EMI/RFI susceptibility to ensure that they remain immune to interference from cell phones, other electronic medical equipment, or other sources of RF emission. The ATH800M6G is a high-gain horn antenna covering the 0.8 to 6 GHz frequency range and has been designed for such EMC testing applications.

Overmolding And Insert Molding Capabilities
Overmolding And Insert Molding Capabilities

Proto Labs offers rapid overmolding and insert molding capabilities to produce parts from a range of thermoplastic and liquid silicone rubber materials for on-demand production, bridge tooling, pilot rune, and rapid prototyping needs. With the utilization of aluminum molds that offer cost-effective tooling, prototypes and on-demand production parts may be produced in as fast as 15 days.

Medical Device Manufacturing

With over 35 years of experience in the medical industry, PTI Engineered Plastics is poised to take on your medical device’s manufacturing process. They specialize in handling multi-part programs and medical device molding for a variety of different types of medical devices, no matter how complex.

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FitQuik® Connectors

FitQuik Connectors from Colder Products Company are high-quality fittings for leak-free tubing connections. These precision-molded fittings are designed to eliminate tubing leak points in medical devices and analytical instrumentation.

XLM Series Of LED Fiber Optic Light Modules For Medical Applications
Excelitas’ XLM Series of LED Fiber Optic Light Modules are designed to be integrated by OEMS into endoscopy, surgical microscopy, and medical headlamps and other medical applications that require bright uniform illumination. These high performance fiber optic light modules feature many advantages for medical applications including remarkable uniformity, virtually no ultraviolet or infrared emissions, maintenance-free, long-life operation, and a variable speed fan. The XLM Series offers an excellent alternative to users of xenon, metal-halide and halogen lamps.
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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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