Industry Perspectives - Design & Development

1. A Proactive 6-Point Approach To Security For Neurotech Developers 4/17/2025

   There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success. 

2. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

   In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

3. Struggling With GxP Systems? There's A DAP For That 4/2/2025

   A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

4. Key QMS Considerations For Your Medical Device Startup 3/17/2025

   A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and provides information to help you make the right decision for your medical device company.

5. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

   Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

6. Make It A No-Brainer: Designing For Electronic Medical Device Usability 1/14/2025

   When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple. 

7. How To Prevent Device Misuse Through Formative Studies 12/9/2024

   While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.

8. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

   FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

9. A New Approach To ISO 14971 For Better Medical Device Risk Analysis 10/23/2024

   This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

10. Ensuring Privacy & Security In Smart Medical Devices 9/10/2024

    Smart medical devices and at-home care have gathered significant momentum. This article explores how medtech companies can build privacy, security, and ethics by design within medical devices.