Industry Perspectives - Design & Development

81. 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.

82. ISO 8655:2022 “Piston-Operated Volumetric Apparatus” FAQs 7/27/2022

    Read the FAQs and learn, for example, what the revision of ISO contains and the differences with the previous version. 

83. 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.

84. 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.

85. 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.

86. MDSAP Audit Approach Updated From Rev. 6 To 7 6/2/2022

    On April 15, 2022, MDSAP Audit Approach AU P0002.007 was updated from version 006 to 007. This article summarizes the changes important for medical device manufacturers to know.

87. FDA Releases Guidance On Cybersecurity In Medical Devices 5/31/2022

    The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).

88. EU MDR's Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused 5/13/2022

    The EU's MDR refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in products' safety profiles.

89. Your How-To Guide: Developing Advanced Signal Processing Software For Medical Devices 5/11/2022

    Software is rapidly emerging as a critical product differentiator in the medical device industry. While the software development life cycle described here is widely applicable to a wide range of medical devices, this article focuses on software development for cardiac devices — and more specifically, implementing advanced signal processing software into a cardiac device. 

90. What's In Store For EMRs After The Pandemic? 5/9/2022

    During the pandemic, our industry has realized that electronic medical record (EMR) systems needed some changes. This article discusses the new EMR specifics, including improved operability, advanced analytics, and smooth integration with diverse systems.