Guest Columns

1. Hazmat Regulations: What Life Sciences Companies Need To Know 9/25/2020

   It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

2. A Methodology For Developing Injection-Molded Plastic Parts For Your Medical Device 9/21/2020

   This article describes a methodology that addresses the questions that have a reputation for being “troublemakers” in the process of injected plastic product development, without compromising innovation and creativity.

3. How To Generate The Right Input Data For An Effective Quality Management Review System 9/21/2020

   This article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.

4. Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance 9/16/2020

   This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

5. 8 Steps For Reading A Lab Leader’s Mind 9/16/2020

   Do you develop products for diagnostic or clinical laboratories, such as companion diagnostics, artificial intelligence solutions, or lab automation equipment? Wouldn’t it be nice to know what your customers are thinking prior to developing and launching your product?

6. Coming To America? 8 Steps For Successful U.S. Medtech Market Entry 9/14/2020

   Despite viable technologies and products, many medtech companies seeking to enter the U.S. market are often unprepared or find themselves awash in decisions that they did not imagine confronting. After seeing dozens of these situations, I have compiled a list of risk mitigation factors that help contribute to market entry success.

7. How To Design Medical Device Test Fixtures For Maximum Repeatability 9/9/2020

   Test fixtures and inspection equipment are only useful to the extent that they produce accurate, repeatable data. In fact, flawed test fixtures that don’t produce such data can be more harmful to the program than if the test hadn’t been performed at all.

8. UDI At The Point Of Use: Should You Implement Direct Marking Now? 9/7/2020

   Looking at the FDA and MDR compliance deadlines for UDI marking can be deceiving. The intense knowledge buildup, planning, and supply chain preparation efforts necessary, along with internal procedure readiness and process changes, require a long lead time.

9. Incorporating Privacy By Design & Security By Design Into Medtech Development 9/2/2020

   Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.

10. Making FMEA More Robust With HACCP 8/27/2020

    Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.