Guest Columns

  1. Co-Designing Interactive Technology For Patients With Dementia 5/18/2022

    Using interactive light animation, this author, an industrial design engineer, was able to help create experiences of engagement and joy for patients with dementia. She shares her experiences and tips in co-designing the technology with patients and users.

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

    The EU's Medical Device Regulation 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 the safety profiles of products.

  3. 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. 

  4. 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.

  5. How Will Advanced Computing Technologies Catapult Medtech Into The Future? 5/4/2022

    There is an almost unlimited profit potential for medtech manufacturers to use advanced computing technologies such as AI, faster and smaller computing hardware, computing-driven robotics, AR/VR, and IoT to build devices that disrupt markets and improve people’s lives. This article delves into using data analytics (including AI), making more effective implantable devices, and collecting better patient data.

  6. 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.

  7. Medical Device 3D Printing & Prototyping: Lessons Learned 4/27/2022

    Nearly a decade ago, this author came up with the concept for a new medical device. In bringing that concept to fruition, he looked into 3D printing and prototyping. This article describes his process and lessons learned from the experience. Fortunately, 3D printing is now more accessible and easier to accomplish for medical device developers, so hopefully your challenges will be less of an obstacle.

  8. 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.

  9. From The Military To The Medtech Battlefield: 6 Lessons In Leadership 4/22/2022

    Since returning stateside from his time in the military as a U.S. Army Special Ops leader, Charles Fisher Jr. entered the healthcare/medtech field and currently serves as CEO of Aethlon Medical. On a recent episode of the Med Tech Gurus podcast, he shared 6 principles of leadership he learned from his military days that continue to serve him well in medtech.

  10. How Medtech Companies Can Help Make AI-assisted Surgery Possible 4/20/2022

    Future AI solutions could expand to help surgeons make better operative decisions, reduce risk and improve patient safety, and enhance performance. There are, however, significant technical and other challenges. This article examines how medtech companies can make AI-assisted surgery a reality.