Industry Perspectives - Design & Development
The Top 5 Trends To Watch In The Medical Device Industry
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.
Life Sciences CIO Survey Illuminates Tech Trends
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.
The Shifting Data Privacy Landscape For Femtech & Beyond
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.
MDSAP Audit Approach Updated From Rev. 6 To 7
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.
FDA Releases Guidance On Cybersecurity In Medical Devices
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 The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
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.
Your How-To Guide: Developing Advanced Signal Processing Software For Medical Devices
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.
What’s In Store For EMRs After The Pandemic?
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.
Framework Methodologies For Medical Device Usability Engineering
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.
21 CFR 820's New Terminology & Country-Specific Terms For Medical Device Quality
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.