FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity considerations for medical devices to assist device manufacturers in preparing premarket submissions.

The Final Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” provides recommendations on cybersecurity device design, labeling, and documentation that the FDA recommends be included in premarket submissions…

ESD Co-Design for High-Speed SerDes in FinFET Technologies

How to Maximize the ESD Robustness of High-Performance Interface IP

By Peter de Jong for the EOS/ESD Association, Inc.

n-chip ESD protections are used to achieve the necessary robustness against ESD threats during the manufacturing and handling of the devices. For high-speed SerDes interfaces, interference by the ESD protection measures (e.g., due to added capacitive load on the I/O) can severely deteriorate performance speed. Together with the continuously decreasing ESD design window in the latest (FinFET) technologies, smart co‑design of ESD protection with the SerDes transmitter circuit has become a necessity to accomplish both speed and ESD targets.

In this article, we’ll show how parasitic elements in the driver transistors can be exploited in a co‑design style to effectively meet the ESD targets while minimally impacting speed performance. And we’ll verify the correct implementation of the ESD measures using a programmable electrical rules checking (PERC) tool.

The EU’s New Product Safety Law Will Be a Game Changer

Companies Must Prepare to Embrace the New Rules

By Rutger Oldenhuis

n April 25^th, the Council of the European Union (EU) adopted the long-awaited EU General Product Safety Regulation (GPSR). The adoption of the GPSR was the final step of the revision of the outdated EU General Product Safety Directive (Directive 2001/95/EC, or GPSD). The GPSR will enter into application on 13 December, 2024.

The ink has yet to dry, but one thing is certain: selling consumer products in the EU will never be the same. That applies both to manufacturers based in and outside the EU. In this article, I summarize the main highlights of the GPSR.

A Regulation and Not a Directive

First of all, the GPSR is a regulation and not a directive. A regulation has a direct effect in all EU Member States without the intervention of national legislators. A directive needs to be transposed into national law and often allows Member States to include deviating provisions, which obviously jeopardizes the single market principle. That is no longer possible with a regulation. The provisions of the GPSR, therefore, apply in full in all EU Member States.

Reduced-Order Modeling of Pennes’ Bioheat Equation for Thermal Dose Analysis

By Harry Alexander, James Watson, and Francesco Colella

Editor’s Note: The paper on which this article is based was originally presented at the 2023 IEEE International Symposium on Product Compliance Engineering (ISPCE), held in Dallas, TX in May 2023. It is reprinted here with the gracious permission of the IEEE. Copyright 2023, IEEE.

Introduction

Present users of wearable devices expect to be able to wear their devices for an entire day to make use of “always-on” functionalities such as step counting, heart-rate monitoring, and sleep quality tracking. This is especially true of wrist wearable devices such as smart watches and fitness trackers. In 2021, a record number of wearable devices were shipped for retail (over 530 million devices), representing a 20% increase in the number of devices shipped in 2020 [1]. As a result, more humans are maintaining longer duration contact with their powered electronic devices than ever before. Due to the necessity of direct contact between a user and a wearable device, some of the heat dissipated by the active elements of the device is transferred to the user’s skin. The objective of this study is to establish a methodology for building tractable “reduced order” models that can characterize and forecast the heat transfer between a device and a user and the potential for thermal injury. These reduced-order models can be implemented and solved efficiently in the context, for example, a control algorithm.

The Duty to Warn

Do Warnings Make a Product Safe?

By Kenneth Ross

here have been several recent articles challenging the efficacy of warnings on products. One of the articles was published on the CNBC website on July 23, 2023, and is titled: “Warning labels in the U.S. seem to be everywhere. Here’s why they may be pointless.” This article was accompanied by a lengthy video commenting on this subject.¹

The main points in the article are that people are desensitized to warning labels because they are everywhere, and warnings are the last solution to a safety hazard after design and guarding. Kip Viscusi, a law professor, said in the article that, “There’s a tendency to say things are risky [and] slap a warning on it, and that tends to dilute the impact of the other warnings that are out there.”

While it is true that some manufacturers add warning labels when they should instead design their product more safely, most manufacturers must make difficult decisions knowing that not everyone reads and follows warnings.

PRODUCT Showcase

Correlation Between Insertion Loss and Input Impedance of EMC Filters

Part 2: π and T Filters

By Bogdan Adamczyk and Jake Timmerman

his is the second of a three-article series devoted to the correlation between the insertion loss and input impedance of passive EMC filters. In the first article, [1], LC and CL filters were discussed. This article focuses on π and T filters. Analysis, simulation, and measurement results show that the frequencies at which the insertion losses of these filters are equal are the same frequencies at which the input impedances are equal. These frequencies define the regions where one filter configuration outperforms the other (with respect to the insertion loss). To determine these regions analytically, we compare the input impedances of the two filters. The next article will focus on cascaded LC and CL configurations.

INPUT IMPEDANCE TO THE π FILTER

The input impedance, _IN , to the π filter is calculated from the circuit shown in Figure 1.

Understanding Embedded On-Chip ESD Detection, Part 1

By Jeffrey C. Dunnihoo, on behalf of EOS/ESD Association, Inc.

Introduction

Electrostatic Discharge (ESD) poses a significant threat to the reliability and longevity of electronic devices. As integrated circuits (ICs) continue to shrink in size and increase in complexity, they become more susceptible to ESD damage in the factory and soft-errors and upsets in the field, especially wearable and medical devices.¹ (See Figure 1.)

Merely “increasing” ESD protection won’t solve all of these problems going forward and may even make some worse. In this 3-part series, we will introduce the growing challenges of soft-upsets and latent ESD damage and outline the benefits of embedded ESD detection as a solution to this problem.

Chip-level ESD designers have been in an arms race to achieve lower clamping voltages and higher clamping currents to prevent factory returns and failure analysis costs for the chip vendor.

Setting Up a Benchtop Conducted Emission Test

By Dr. Min Zhang

s the shift towards electrification gains momentum, an increasing number of companies are venturing into the development of products and systems used in electric vehicles or compact electric aerial vehicles like unmanned drones. These products, often referred to as electric control units (ECUs) in the automotive industry, typically operate on a DC supply voltage of less than 60 V (12V, 24V, and 48 V). Unless you’re dealing with high-power conversion, the current draw is usually below 10 A. This makes it quite feasible to establish an affordable benchtop conducted emission setup during the product’s research and development phase.

The advantage of having a pre-compliance conducted emission test setup lies in its ability to enable design engineers to identify potential design issues early on, thereby averting costly last-minute modifications. Conducted emission tests can provide reasonably accurate results and also serve as a reliable indicator of radiated emissions, as some of these emissions propagate through cable wiring.

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