Medical Device Handbook Archives - Page 5 of 5

7 ways to ensure your medical device product design isn’t biased

Correcting unintentional biases in medical device product design is a big step toward improving equity in medtech.

[Image from Pixabay]Achuta Kadambi, an assistant professor at the UCLA Samueli School of Engineering, says when looking at bias in medical devices, there’s often a lot of narrative in the media of what it is. However, it’s also important to address what it doesn’t show.

“One that doesn’t show up is that it’s a really challenging technical problem and an exciting technical problem to address,” he said, citing an example of how light doesn’t play well with darker objects like darker skin tones.

Kadambi, who recently published a column in the journal Science about achieving fairness in medical devices, says there has to be a technical passion for solving these problems. (He also discussed his views during a recent DeviceTalks Weekly podcast.)

He adds that the social impact is equally crucial …

7 ways to ensure your medical device product design isn’t biased

Correcting unintentional biases in medical device product design is a big step toward improving equity in medtech.

[Image from Pixabay]

Achuta Kadambi, an assistant professor at the UCLA Samueli School of Engineering, says when looking at bias in medical devices, there’s often a lot of narrative in the media of what it is. However, it’s also important to address what it doesn’t show.

“One that doesn’t show up is that it’s a really challenging technical problem and an exciting technical problem to address,” he said, citing an example of how light doesn’t play well with darker objects like darker skin tones.

Kadambi, who recently published a column in the journal Science about achieving fairness in medical devices, says there has to be a technical passion for solving these problems. (He also discussed his views during a recent DeviceTalks Weekly podca…

Software as a medical device: Here’s how the regulatory landscape is changing

When it comes to software as a medical device, the regulatory landscape is quite complex.

Nach Davé, Premier Research

[Image from Pixabay]

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the technology is relatively new, however, the regulatory environment is still evolving as regulators scramble to keep pace with innovation.

Health providers are increasingly deploying SaMDs to facilitate patients’ pain management, arrhythmia management, and blood glucose monitoring. Some applications require daily use by the patient — sometimes multiple times a day — while remaining compliant with good clin…

4 pain points to avoid in medtech product design

Reliability is crucial in medtech product design.

Mitch Maiman, Intelligent Product Solutions

Products designed by Intelligent Product Solutions include the AdhereTech smart pill bottle, according to IPS.Image courtesy of IPS

Medical technology product development combines the challenges of developing high-reliability commercial equipment with a regulatory landscape and discipline similar to DoD/aerospace systems.

The need for high reliability in medical technology products is obvious. Even in the lowest risk Class I devices, reliability is imperative. With Class III devices, the risk profile is so high that the highest standards of a rigorous design, verification and validation regimen are required.

Here are four unique challenges embodied in the development of technology products with medical applications:

1. The supreme need for human factors considerations

The issues around…

Could people one day get pacemakers that dissolve into the body?

Wireless, battery-free, fully implantable pacemakers made of bioresorbable components could represent the future of temporary pacing technology.

The device, seen here mounted on the heart, could benefit post-cardiac surgery patients. [Image courtesy of Rogers Lab/Northwestern University]

Flexible, dissolvable electronics could soon pave the way for temporary pacemaker wearers to avert the risks associated with surgical procedures from initial implantation to the removal of the device once its job is done.

Northwestern and George Washington universities have developed what they say is the first-ever transient pacemaker that’s not only wireless, battery-free and fully implantable — but also disappears when it’s no longer needed. Its biocompatible components can naturally absorb into the body over five to seven weeks eliminating the need for surgical removal.

In a study published on June 28 in Nature…