Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • Why Adjusted Risk Likelihood Should Displace The Risk Priority Number

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

10 Actions To Prepare For The U.K. Conformity Assessment Process

The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the MHRA. Discover the 10 actions you should take to prepare for the U.K. Conformity Assessment process.

Implementing EU MDR and IVDR: Lessons Learned, Part 2

The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

AI/ML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval

Application of artificial intelligence (AI) and machine learning (ML) in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. By digesting the different jurisdictional AI/ML regulatory frameworks that have been released (draft or enforceable), along with personal experience with the agencies, John Giantsidis, president of CyberActa, Inc., identifies the common denominators crucial to success.

Implementing EU MDR and IVDR: Lessons Learned, Part 1

The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!

WHITE PAPERS & CASE STUDIES

Elements Of Design: Dealing With Suspect Parts

Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Medbio offers a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in in the molding process. 

Managing Cost And Speed — DFM Considerations For Plastic Medical Products

Designing a product with consideration for the manufacturing process can reduce production times and costs, as well as simplify development of transport, storage, and protection solutions.

Delivering On LSR Market Demands For Critical Cardiac Component

A global medical device company came to Donatelle for help perfecting a silicon seal component to meet the new ISO 27186:2010 standard. In this case, a seal with micro-features is needed to reliably isolate the four-pole electrical contacts between the pacemaker and defibrillator and fit inside the 6.3 mm medical device.

Reducing The Surface Friction Of Medical Devices - A New Functional Application For A Commercial Biomaterials Surface Modification Technology

Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.

DESIGN COMPONENTS & SERVICES

Until now, the only way for design engineers to increase shaft loads on precision gearheads was to specify expensive ball bearings to replace cheap sintered bearings.
With the introduction of the BX4 series of brushless DC servomotors, MicroMo once again emphasizes its position as an innovative market leader in highly integrated miniature drive systems. Using the latest production methods, some specially developed by MicroMo, the company has come up with a modular design that is limited to just a few components and entirely eliminates the need for adhesive-bonded joints.

To meet the needs of today's clinical diagnostic and bio-analytical OEMs, Parker Precision Fluidics Division offers the Series 3 Bleach Valve, a high-performance two-way and three-way miniature inert valve.  A unique and time-proven design ensures that fluids are contained within the valve, preventing damage to other components.

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.

Toshiba Imaging Systems has partnered with Dage-MTI to develop two new high definition cameras ideal for microscopy applications. Dage-MTI's RealView HD Microscope Cameras combine Toshiba Imaging's proprietary imaging technology with specially-formatted, preset values for use in critical microscopy applications.

These high speed solenoid valves can dispense microliter and nanoliter volumes at up to 1200 Hz and are ideal for high throughput screening in medical devices, as well as drug discovery. They feature a 250 million cycle (minimum) lifetime, response times as fast as 0.25ms, and operating pressures up to 120 psi.

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