Developing a Mobile Medical Device? FDA Is Watching
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
Tag Archives: Design
Understanding Skin and Designing Wearable Devices
Skin is an ever-changing organ. Its complexity makes it a challenge when designing wearable devices. When you design adhesives and devices that are made to stick to skin, there’s a lot to consider. Start your design with skin in mind. Learn more by reading “Meeting the challenges of skin.”
Science of Skin: Potential Problems when Sticking to the Skin of a Diabetic
Skin is a window—it can indicate our overall health. And when it’s damaged, it can hurt both psychologically and physically.
Q&A: Future for 3-D Printing Holds Promise, But Challenges Still Stand in the Way
Cost justification and lack of material compatibility continue to create hurdles, but industry stakeholders have been coming together to help drive innovation.
New Technology and Consumer Awareness Can Reduce Medical Device Security Threats
As medical devices using software and wireless communication become more ubiquitous, hackers are becoming more advanced in their methods.
Reliable Real-time Software for Medical Devices
For reliable systems, we need a different mindset.
Working with Your Component Manufacturer to Mitigate Risk
Sharing more information with design partners on device function and its inherent risks can help guide better decisions during the product development process, and keep patients safer.
Snowflake Syndrome Creates Cybersecurity Roadblocks
There are too many unique needs on the part of both manufacturers and providers. More collaboration is needed.
Biomaterials: Overview and Design Considerations
Modern technologies have taken biomaterials to another level, but hurdles remain in developing next-generation materials.
The Ultimate QA/RA Cheat Sheet
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
