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Insights & Innovation

Explore our latest articles, case studies and expert perspectives on the medical device industry. 

BLOG

Insights & Innovation

Explore our latest articles, case studies and expert perspectives on the medical device industry. 

BLOG

Insights & Innovation

Explore our latest articles, case studies and expert perspectives on the medical device industry. 

Uncovering Use Errors via a Known Use Problem Summary (KUPS)

Uncovering Use Errors via a Known Use Problem Summary (KUPS)

Apr 10, 2023

Known Use Problem Summary: A crucial tool for identifying and mitigating medical device use-related risks.

Medical Devices vs. Combination Products

Medical Devices vs. Combination Products

Jan 31, 2023

Key differences in human factors processes for medical devices vs. combination products: FDA perspective.

2023 FDA Labeling Draft Guidence

2023 FDA Labeling Draft Guidence

Jan 24, 2023

FDA issues draft guidance on dosage labeling for prescription drugs and biologics; comments due 3/14/2023.

Formative Evaluations Series: Early Usability Evaluations to Optimize Medical Product Design

Formative Evaluations Series: Early Usability Evaluations to Optimize Medical Product Design

Jan 3, 2023

Optimize medical device usability: Formative evaluations guide design, reduce costs, and improve outcomes.

Chinese NMPA Draft Human Factors Guidance vs. FDA 2016 Human Factors Guidance

Chinese NMPA Draft Human Factors Guidance vs. FDA 2016 Human Factors Guidance

Jul 27, 2022

Comparing NMPA and FDA human factors guidance: Key differences in medical device regulation in China vs US.

Updated FDA Guidance: Drug and Biologic Instructions for Use

Updated FDA Guidance: Drug and Biologic Instructions for Use

Jul 14, 2022

FDA updates drug and biologic IFU guidance: Key changes in content, readability, and usability requirements.

Human Factors Return on Investment Through the Lens of Medical Device Recalls

Human Factors Return on Investment Through the Lens of Medical Device Recalls

Jun 15, 2022

Medical device recalls: Rising trends, financial impacts, and how human factors engineering can mitigate risks.

A Guide to FDA 483s and Warning Letters

A Guide to FDA 483s and Warning Letters

May 31, 2022

FDA inspections, Form 483s, and warning letters: Implications for medical device manufacturers and prevention.

Best Practices for Medical Device User Training

Best Practices for Medical Device User Training

Apr 21, 2021

Medical device user training: Key findings on effective methods for healthcare providers from ClariMed study.

Applying Human Factors Engineering to Combination Products

Applying Human Factors Engineering to Combination Products

Dec 27, 2020

Key human factors considerations for combination products: Comparing CDER and CDRH FDA guidance.

Mastering FDA Guidelines: Bridging Human Factors Data for Combination Products.

Mastering FDA Guidelines: Bridging Human Factors Data for Combination Products.

Dec 15, 2020

FDA guidance on bridging human factors data for combination products: Analysis and submission tips.

Let's work together!

Contact us to discuss how we can advance your medical device development efforts together.

Let's work together!

Contact us to discuss how we can advance your medical device development efforts together.

Let's work together!

Contact us to discuss how we can advance your medical device development efforts together.