Guest Columns

41. "Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap 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.

42. 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?

43. 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.

44. 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.

45. 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.

46. 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.

47. 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.

48. Risk Mitigation For Homecare Devices: 4 Tips For Anticipating The Unanticipated 8/24/2020

    With the surge in home healthcare these days, designers must approach risk very differently than when devices were being designed solely for use by clinical personnel. This rise in home healthcare is driving the need for increased risk scrutiny for several reasons.

49. Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities” 8/21/2020

    How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”

50. Less Than A Year Until EU MDR: Are All Your “Economic Operators” Compliant? 8/20/2020

    Although the new requirements relating to economic operators under the EU MDR may still raise questions for manufacturers, the recent delay of the date of application by one year will give the industry additional time to get their regulatory matters in order.