Medical Device Design

6 days ago7 min read

Takeaways from the MassMEDIC Regulatory Roundup Review

Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.

Sep 115 min read

FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers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

Jun 27, 20235 min read

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!

Apr 6, 20232 min read

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.

Dec 14, 20214 min read

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...

Sep 21, 20213 min read

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...

Sep 28, 20202 min read

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”...

Sep 5, 20171 min read

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...

Mar 17, 20173 min read

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,...

Feb 7, 20172 min read

FDA Draft Guidance - Comparative Use HF Studies in an ANDA

In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...