Guest Columns

41. How To Navigate Patent Eligibility Of AI-Driven Diagnostics 7/28/2022

    The uncertainty in patent eligibility has had a chilling effect on patenting life sciences and computer software inventions. AI-driven diagnostics that lie at the intersection of these two fields face particular difficulty. This article shares tips from attorneys on how diagnostics companies can tackle their patent eligibility questions with more confidence.

42. How Medtechs Can Work Best With Value Analysis Committees 7/26/2022

    Value analysis professionals are like economic traffic cops at an intersection that includes medical device manufacturer, distributor, negotiator, hospital system, clinician, and patient. Let’s explore a value analysis committee’s expectations of you, the medtech, and how you can work best with them to be successful.

43. The Top 5 Trends To Watch In The Medical Device Industry 7/21/2022

    To respond to the unprecedented challenges presented by the pandemic, medical device providers have extensively implemented disruptive innovations in areas such as cybersecurity and 5G technologies. The article shares three additional trends in the space. All five trends will continue to drive innovation moving forward.

44. Life Sciences CIO Survey Illuminates Tech Trends 7/15/2022

    Clarkston Consulting recently conducted a CIO Market Study aiming to better understand the current priorities, challenges, and goals of upper-level information technology (IT) professionals. This article delves into the survey results of the life sciences portion of the respondents.

45. 3 Lessons Learned Designing Our Digital Health App 7/15/2022

    Based on device data from our spine fusion bone growth stimulator and preliminary user interviews, our team determined that a companion app could motivate patients for better adherence. These are our 3 lessons learned in designing the digital health app.

46. Tips For Obtaining Your 510(k) FDA Clearance 7/8/2022

    This article shares tips such as knowing when to apply for your 510(k) device clearance, mapping out an application strategy, using the pre-submission process, responding to FDA rejection of your application, and more.

47. Latin America’s Landscape For Medtech Clinical Trials 7/5/2022

    This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. It also addresses critical success factors and provides recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.

48. Market Tumult And The Need For Creative Funding For Life Sciences 6/29/2022

    Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?

49. The Shifting Data Privacy Landscape For Femtech & Beyond 6/29/2022

    The lack of an overarching privacy framework for all health data has resulted in a wild west of privacy practices, with some health tech companies prioritizing consumer privacy while other companies do not. The leak of the U.S. Supreme Court’s draft decision in Dobbs v. Jackson Women’s Health Organization has reignited demand for privacy standards. This article examines what this means for femtech and health tech at large.

50. Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem 6/22/2022

    I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.