Guest Columns

31. Combining 3 Emerging Technologies For Improved Aesthetic Devices 6/29/2023

    Patients are looking for nonsurgical and natural-looking options that still give them results comparable to what is seen with a face-lift. Three emerging technologies enable plastic surgeons to finally fight the signs of aging where they truly begin: in the muscles.

32. Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters 6/28/2023

    ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).

33. Agile Software Development In Bio/Pharma & Medical Devices, Part 1 6/27/2023

    Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.

34. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

35. Demystifying The Nuances of AI & ML For Your Regulated Medical Product 6/14/2023

    There exists an ever-growing taxonomy in the field of artificial intelligence (AI) and understanding all its nuances and branches isn’t just an exercise in vocabulary: it is paramount in deciding if AI is right for your business and end users of your medical device/medtech product.

36. A Practical Look At Data Governance In The Life Sciences 6/13/2023

    Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.

37. The Business Case for Healthcare Compliance Programs for Emerging Companies 6/9/2023

    For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead. 

38. Breeze Through Surprise Audits — Take These 5 Actions Now 6/8/2023

    Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.

39. The Landscape Of Medtech Clinical Research In El Salvador 6/6/2023

    El Salvador’s economy has transformed radically over the last half century. In recent years, the country now offers several advantages for medtech clinical research, such as a diverse patient population and a favorable regulatory environment.

40. Quality Engineers: Are You Making The Right Call? 6/1/2023

    As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?