Guest Columns

31. 8 Best Practices For Global Medical Device Patent Protection 9/8/2022

    Medical devices demand unique intellectual property protection strategies. Preserve the valuation of your medtech during the early years of development and maximize revenue potential following regulatory approval with these eight best practices.

32. Attributable Data Integrity in Modern Biopharma Using ALCOA Principles 8/29/2022

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.

33. cGMPs For SaMDs 8/23/2022

    Unlike traditional medical devices, software as a medical device (SaMD) can blur the lines between the design and development stages and the production aspect of commercialization. So, what are the activities necessary for medtech manufacturers to be compliant with the traditional cGMP framework?

34. Medtech Cyber-Incidents: A Costlier Problem Than You Think 8/17/2022

    Harnessing advanced computing technologies gives medtech companies almost unlimited profit opportunities, but it also comes with almost unlimited liability from cyber-attacks. This article discusses different harmful events and their costly ramifications to your medtech company. Don't be underprepared for a cyber-attack.

35. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

    The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

36. Pharma Companies Are Tapping Digital Health For Improved Patient Outcomes 8/11/2022

    Smarter diagnostic tools and a growing role for remote care will be of huge importance in the new paradigm. The pharma industry, which is already growing its role in delivering hybrid solutions combining therapies with diagnostic and smart solutions and devices, could play a significant role here.

37. The Methylation Analysis Landscape In 2022 8/8/2022

    Within liquid biopsy, methylation has become a key area of interest due to its role in altering gene expression and its ability to provide information on tissue-of-origin for ctDNA. The explosion of methylation as a biomarker in oncology stems from its ability to serve as an indication for the presence of cancer early in development. This article also shares key market insights about the diagnostic companies currently working in this area.

38. Digital Health Products Can Reduce Healthcare Disparities — If We Take Action 8/8/2022

    Despite the pace of innovation in healthcare today, underrepresented populations across America are not receiving optimal care. Through digital healthcare innovations like telehealth and digital therapeutics, the industry can — and should — begin to address these disparities and shortcomings.

39. US Market Trends For Computer-Assisted & Robotics-Assisted Surgery 8/1/2022

    In coming years, the number of procedures using robotics and surgical navigation is predicted to increase at a double-digit rate year over year. This article shares the reasons for slow adoption of these technologies, recent advancements, and more.

40. Data: The Near Future Of Regulatory Info Management In Europe 7/29/2022

    Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.