Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • How To Implement Continuous Process Monitoring Of Validated Processes

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.

     

ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices

Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.

"Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap

This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

An Overview Of Bioresorbable Polymers Now Available For 3D Printing Medical Device Applications

In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S, we review how medical device companies can best evaluate current biomaterial options for the four leading 3D printing technologies.

How To Design Medical Device Test Fixtures For Maximum Repeatability

Test fixtures and inspection equipment are only useful to the extent that they produce accurate, repeatable data. In fact, flawed test fixtures that don’t produce such data can be more harmful to the program than if the test hadn’t been performed at all.

WHITE PAPERS & CASE STUDIES

  • Finding The Ideal Balance – Where Risk And Cost Of Quality Meet

    It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. These critical processes are needed to reach and maintain the optimum operating space while providing the overall value that customers seek. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

Moisture And Oxygen Risk In The Medical Device Industry

The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. For some devices the ingress of moisture or oxygen over the shelf-life of the product can impact the device performance. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.

How To Build A Resilient Supply Chain Post-COVID-19

COVID-19 put a kink in the global supply chain. And it exposed weaknesses with the power to halt the flow of business. Now, as the world takes steps to define a new business-as-usual post-pandemic, manufacturers are rethinking their supply chain.

3D Printing And Injection Molding: Same Team, Different Roles

These complementary processes can be adapted to serve countless prototyping and full-production demands, boosting medtechs’ bottom lines and speeding time to market.

Keys To Successful Design For Manufacturability

A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.

DESIGN COMPONENTS & SERVICES

Precision Optics Corporation offers models of micro-couplers with 10x magnification and 4.6x magnification. They’re able to image fiber endoscopes 1 mm or smaller, and feature focusable or fixed focus settings.

The Scepter Medical Device Polisher features automated PC control; integrated air-polish routine; 12 connector support; singlemode and multimode fiber In-line video inspection; telcordia compliant. This fiber optic polishing system is optimized for mid to high volume connector polishing.

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.

The FAULHABER Group offers a complete line of programmable motion controllers with various communication and performance features to fit your application. From the compact MCDC2805 and MCBL2805 series, (just over 2 inches square when fully enclosed), to the versatile MVP2001 series controllers with multiple interfaces like RS-485, DeviceNet, or RS-232...

The 2000S1G2z5 is a broadband amplifier designed for EMC compliance testing for medical devices. When used with a sweep generator, this air-cooled, self-contained, solid state amplifier will provide a minimum of 2000 watts of RF power and covers the 1-2.5 GHz frequency range.

The Lee MINSTAC System is made up of a variety of small, inert tubing and connection components that are designed to precisely control flow, rate, pressure, filtration and other performance factors of aggressive fluids.

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