Guest Columns

41. LATAM Medtech Leaders Podcast Summary Series: Part 1 8/5/2019

    This article is the first in a series drawing on highlights from the LATAM Medtech Leaders podcast, with guests imparting advice on topics like commercialization strategy in Latin American markets, pricing, and more.

42. Understanding Medical Diagnostic Method Patent Eligibility 7/31/2019

    Until this area of unsettled law is more fully developed, it will be important to include practical implication details in medical diagnostic patents to maximize the flexibility to claim inventions in multiple ways.

43. How To Prepare For An FDA Inspection 7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.

44. IVDs And LDTs: Evolving Visions Of FDA Oversight Under The VALID Act 7/29/2019

    The Verifying Accurate, Leading edge IVCT Development (VALID) Act represents the latest development in LDT regulation. This article examines how clinical tests have been regulated, as well as an overview of the proposed VALID Act, and where the potential legislation stands.

45. 3 Surefire Approaches To SOP Harmonization 7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

46. The Human Component Of Clinical Trial Technology Implementations 7/23/2019

    As part of our ongoing series about best-in-class approaches for rapidly assessing, prototyping, and introducing digital and other clinical trial technologies, we focus our attention in this article on the “human” component of technology-enabled transformation.

47. Will We Have Harmonized Standards By The MDR’s Date Of Application? 7/22/2019

    The EU Commission has requested that EU Standardization Organizations draft revisions to their existing standards, adapt some international standards, and issue new standards in support of the MDR and IVDR before May 26, 2020. Which standards could meet the deadline, and where are there likely to be issues?  

48. Medtech Consolidation And The Outsourcing Competitive Landscape 7/15/2019

    While consolidation may have somewhat predictable effects in most medtech markets, this trend has a distinct impact on competitors in the outsourced devices market.

49. Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods 7/11/2019

    Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives. 

50. Factors Shaping Four Major Infectious Disease In Vitro Diagnostic Markets 7/10/2019

    The HIV, hepatitis B, hepatitis C, and Treponema pallidum (or syphilis) test IVD markets represent devices that apply to multiple patient groups and scenarios. As such, the size and forecast growth trends of these markets are influenced by many different factors.