Duodenoscope, ECRI

510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs

By MedTech Intelligence Staff

…and other gastroenterology and urology endoscopes that have elevator channels; neurological endoscopes; arthroscopes; laparoscopes; and water-based heater-cooler systems used in operating rooms. The document also names design features that could…

…and other gastroenterology and urology endoscopes that have elevator channels; neurological endoscopes; arthroscopes; laparoscopes; and water-based heater-cooler systems used in operating rooms. The document also names design features that could…

Continue reading

Combination product, human factors

Optimize Combination Products: Select a Drug Delivery Device that Meets User Needs

By Allison Strochlic, Erin Davis

…such as arthritis, neuropathy (numbness), muscle weakness, range of motion limitations and tremor, can all affect a person’s ability to handle a device properly. Subsequently, device features may be optimized—if…

…such as arthritis, neuropathy (numbness), muscle weakness, range of motion limitations and tremor, can all affect a person’s ability to handle a device properly. Subsequently, device features may be optimized—if…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

What, No Inspection Results?

By Dr. Christopher Joseph Devine

…takeaways. One: Make sure your supplier base has skin in the game. They are the experts in their respective commodities and can identify which key features require inspection and monitoring….

…takeaways. One: Make sure your supplier base has skin in the game. They are the experts in their respective commodities and can identify which key features require inspection and monitoring….

Continue reading

magnifying glass

Scoping Out the Market

By Robert Kaminsky

…adoption Identify the product features and benefits that matter most to clinicians and patients Prioritize clinical trial endpoints to deliver data that prescribers, payers and patients most value Help craft…

…adoption Identify the product features and benefits that matter most to clinicians and patients Prioritize clinical trial endpoints to deliver data that prescribers, payers and patients most value Help craft…

Continue reading

3-D printed hip implant, electron beam melting technique

Medical Device Development’s Use of 3-D Printing: Applications and Common Processes

By Nathan Müller

…the benefit of strength and rigidity but end up costing more in materials. Hollow parts reduce the required material and lower the part cost; however, they require drainage features to…

…the benefit of strength and rigidity but end up costing more in materials. Hollow parts reduce the required material and lower the part cost; however, they require drainage features to…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Made a Design Change? Inform FDA

By Dr. Christopher Joseph Devine

…language), and voltage and power management for the new chip. Additionally, the currently marketed [DEVICE] has new features that the original device lacked, including features that enable the device to…

…language), and voltage and power management for the new chip. Additionally, the currently marketed [DEVICE] has new features that the original device lacked, including features that enable the device to…

Continue reading

Puzzle pieces

Designing Embedded Devices Firmware for Tomorrow

By Rachel Michelson

…ensure alignment with their product line features is considered. Random Numbers and Entropy Source Modern cryptography and transport protocols rely on random numbers. An OS, such as Linux, may offer…

…ensure alignment with their product line features is considered. Random Numbers and Entropy Source Modern cryptography and transport protocols rely on random numbers. An OS, such as Linux, may offer…

Continue reading

Laura Elan, UL

Increased Software Functionality Adding More Hurdles

By Maria Fontanazza

…design board and start over. That’s true for not only security but also features and functionality such as adding networking or wireless connectivity. Continuing to bolt on these types of…

…design board and start over. That’s true for not only security but also features and functionality such as adding networking or wireless connectivity. Continuing to bolt on these types of…

Continue reading

Footsteps

Remediation: Risk Priorities

By Maria Fontanazza

…aspects or features are needed to ensure effectiveness of the device and patient safety, and then implement (risk) controls to ensure that those specific performance aspects or features are preserved…

…aspects or features are needed to ensure effectiveness of the device and patient safety, and then implement (risk) controls to ensure that those specific performance aspects or features are preserved…

Continue reading

Vietnam, medtech

Vietnamese Medtech Industry on the Rise

By Ames Gross

…of 2016, including Vietnam. The system is a device that allows surgeons to correct a variety of fractures, is covered by multiple patents, and has features such as an anatomical…

…of 2016, including Vietnam. The system is a device that allows surgeons to correct a variety of fractures, is covered by multiple patents, and has features such as an anatomical…

Continue reading