Newsletter | January 23, 2024

01.23.24 -- How To Operate In The AI Compliance Vacuum


How To Operate In The AI Compliance Vacuum

The rapid incorporation of AI into healthcare systems raises significant legal compliance concerns, particularly for technology developers, medtech companies, and users. Explore the implications from a range of angles, including state practice of medicine laws, the FDA’s regulation of medical devices, the HIPAA Privacy Rule, and more.

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&D Studies, Part 3

In the third and last entry in this series, we continue the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.


RFID In Medical Devices: 4 Biggest Benefits For OEMs

Go in-depth on the challenges faced by medical device original equipment manufacturers (OEMs) and how RFID technology can provide a comprehensive solution.

Transforming Manufacturing Operations For The Life Sciences

Explore key trends and challenges in manufacturing and operations, the value of modern manufacturing operations management, critical considerations on the path to digital transformation, and more.

"Be A Team" Are Not Just Words On A Wall

CEO Gary Hulecki reflects on how MTD lives in one of their core values, ‘Be a Team,’ from meetings with customers to magazine interviews to profit sharing.

Injection Molding Of Thin-Wall Cannulas

After five years of work, Accumold has developed a high-volume microinjection molding method for thin-wall cannulas, replacing the expensive and less efficient extrusion process for medical device OEMs.

Choosing The Right Primary Container And Troubleshooting Issues

Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development — and quickly uncover causes of failures.


Key Regulatory-Fueled Updates On Combination Products As We Enter 2024

Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices

The Secret To Medical Device Development Success: A Mindset For Continuous Learning

Can Aptamers In Wearable Sensors Mean A Revolution In Healthcare?

How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products


Engineering Polymer: GUR HMW-PE 1001 Datasheet

Variable Volume Dispense Pump Technical Guide

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