Guest Columns

31. 4 Key Takeaways For Combination Products As We Move Into 2023 12/13/2022

    The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.

32. How To Close The Looming Life Sciences Data Storage Gap 12/9/2022

    Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.

33. Liquid Biopsy Early Cancer Detection Diagnostics: The Current Landscape 12/7/2022

    The most impactful driver of cancer survival in the future may not come from therapies, but rather from the diagnostic tools, especially liquid biopsies, that inform which, when, and how patients should be treated. This article provides an in-depth landscape assessment of liquid biopsies for diagnostics developers.

34. Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences 12/6/2022

    Rising interest rates, imploding cryptocurrencies, and erratic equities markets have upended assumptions about risk and returns during 2022. The “risk-free” rate has surged to more than 4% as of late November. Your pharma, biotech, or medical device company looking to raise cash needs to take the key considerations shared in this article into account.

35. The Global Cardiac Rhythm Management Market Through 2028 12/5/2022

    This article provides a market research overview on the cardiac rhythm management market (both diagnostics and medical devices) as well as the main drivers for growth.

36. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

    Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

37. How Can AI-Powered Advanced Imaging Battle Long COVID? 11/30/2022

    Long COVID is not a rare disease — over 100 million worldwide likely have it — so why do we still lack the proper infrastructure to tackle and understand it? There are two key areas that delay progress: data collection and symptom interpretation. Both can be assisted by AI-enhanced technologies.

38. The Lasting Impact Of Telehealth On Dermatology May Only Be Skin Deep 11/28/2022

    Immunological diseases received particular focus during the pandemic’s telehealth boom due to COVID-19’s disproportional effect on immunocompromised patients. Teledermatology apps saw a sharp increase in use. But is telehealth truly meeting the needs for dermatology?

39. What’s Wrong With The Medtech R&D Department? 11/22/2022

    Executives, staff members, and investors of medical device companies commonly ask, “What’s wrong with the R&D department? What’s taking so long?" This article discusses five common culprits and the common thread solution that could solve all of them.

40. FDA Vs. Congress: The Software Showdown 11/14/2022

    September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.