Industry Perspectives - Design & Development

91. 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 The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).

92. 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.

93. 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. 

94. 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.

95. Framework Methodologies For Medical Device Usability Engineering 5/2/2022

    Initial visceral impressions and intuitiveness of use impacts a user's choice of medical device. Addressing the affordance theory means understanding what a user will likely perceive and expect of a proposed design interaction. This article delves into more detail and includes discussion on user interfaces and the user experience process in designing medical devices.

96. 21 CFR 820's New Terminology & Country-Specific Terms For Medical Device Quality 4/25/2022

    The proposed revision to the U.S. Quality System Regulation (aka 21 CFR Part 820) takes a giant leap toward harmonization with other major global medical device regulations, but some U.S.-specific terms and requirements will remain in effect. This article shares the details and also discusses the impact on inspections.

97. The Importance Of Risk Documentation In Medical Device Design 4/11/2022

    Risk documents guide the design team to understand all the ways a device could fail or create a potential harm/hazard and the best way to minimize or eliminate the identified risks. This living process, when properly applied, helps ensure a device is safe, efficacious, and reliable.

98. How Do I Need To Update My QMS For FDA QMSR Amendment Compliance? 3/23/2022

    The FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices. This article describes what you need to do with your QMS in order to meet compliance.

99. FDA Seeks Public Comment On Quality Metrics Reporting Program 3/17/2022

    The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

100. Medical Device Packaging Labels 101 3/16/2022

     Medical device labels play an important role in a device’s life. They are key to market introduction and success, a company’s long-term financial viability, and to patients’ health and lives. This article provides advice for getting the label right the first time to avoid product recalls and for the best chance of product success.