Medical Device Design

FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers

Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.

FDA Guidance on the Q-Submission Program

Check out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!

FYI, Most Medical Devices Are Not Designed For Most People

Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.

Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021

I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...

FDA Final Rule on the Use of Symbols in Labeling

Introduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...

4 Examples of How COVID is Accelerating Home Use Devices

At the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...

Seeking Proposals: 2018 HFES Healthcare Symposium in Boston

I’m excited to be co-chair of the Medical and Drug-Delivery Devices track for the 2018 International Symposium, to be held March 26-28 in...

FDA/CDER Workshop Highlights

Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...

FDA Draft Guidance - Comparative Use HF Studies in an ANDA

In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...