Designing Regulatory Compliance into Medical Devices

By Contributed Article | May 27, 2025

The medical device industry is constantly innovating with new materials, wireless technologies, sensors, packaging, and power devices. However, despite the ongoing advances occurring in electronics, it is critical that all equipment continues to follow regulatory compliance.

Medical equipment and medical devices are subject to stringent regulatory standards to ensure both operator and patient safety. The connectors used in medical systems are also subject to regulatory scrutiny, in addition to meeting the design requirements for moisture ingress, chemical exposure, and mechanical stresses such as vibration and shock that are part of everyday operating environments and sterilization processes. These challenges exist for medical interconnects used in the smallest devices as well as in larger equipment types.

Examples of larger medical equipment include blood analyzers, X-rays, CT scanners, ultrasound equipment, diagnostic cardiology equipment, MRI machines, heart-lung support systems, and patient-monitoring systems. Small form factor electronics include implantable medical devices such as cardioverter defibrillators, pacemakers, cochlear implants, and intrauterine devices (IUDs). Wearables are also a subset of medical technology where devices such as ECG patches, blood pressure monitoring, wearable spirometers, and smart clothing/watches can be used to track and monitor a patient’s vitals. The wide range of modalities found in medical equipment require many different types of connector technologies to support them.

Disassembled ultrasound transducer with a 128 micro-coaxial bundle containing hundreds of micro-coaxial cables for 2D arrays. This type of equipment uses the ultrasound imaging modality, where short acoustical pulses penetrate multiple interfaces and the echoes transmitted back are converted to electrical signals via the transducer to produce 2D images.

Blood analyzers use hydraulic lines and valves to move samples to various parts of the machine and mix them with various reagents to perform tests. An MRI produces a detailed 3D anatomical image by both exciting and detecting the change in the direction of the rotational axis of protons found in the water of living tissue. This is accomplished through the use of a pulsed RF current in tandem with powerful magnets that produce a strong enough magnetic field to force the protons in the body to align with that field. This allows users to observe the difference between various types of tissues based upon their magnetic properties.

Wearables leverage several micro-electro-mechanical system (MEMS) sensors and actuators and wireless technologies in miniature form factors. An example of an implantable device using MEMS is cardiac implants that control thermoresponsive actuators — such as shape-memory alloys (SMAs), a type of smart material that responds to temperature ― via an RF connection to address the recoil issue associated with stents. Implantable drug delivery microsystems can be electromagnetically actuated and wirelessly operated using a tuned RF field. Wearables often rely on MEMS sensors that use technologies such as silicon-based strain gauges to measure pressure, acceleration, or orientation to measure parameters such as heart rate, SpO2 levels, movement, and a chemical analysis of body fluids. The sheer range of technologies used to monitor, analyze, and treat patients is vast, where device form factors are constantly shrinking to better suit the application. This requires shrunken electronics where everything is designed with space in mind (e.g., traces are closer, usage of smaller SMT components).

The Internet of Medical Things

The megatrend of IoT has permeated the medical industry, opening many doors for prevention and early detection in patient care, and lowering the barriers to access many types of diagnostic equipment. Wireless technologies, such as 5G, allow for near-real-time monitoring and control to potentially detect an acute condition and perform an emergency response (e.g., defibrillation in the event of cardiac arrest). High-bandwidth communications are also necessary to send and receive large files such as imaging results. High-bandwidth, low-latency communications are critical for potential telesurgery (remote surgery) applications that use AI to interpret feedback from haptic technology used by a surgeon.

AI has the ability to truly augment medical processes for more efficiency, accuracy, and control with many potential use cases. AI can be applied for data interpretation to, for instance, list out potential diagnoses. Other applications include intelligent prostheses for the disabled, the labeling of imaging results (X-rays, MRI scans, etc.) for various exams, or to spot abnormalities or quickly identify negative exams.

A Bird’s-Eye View of Medical Connectors

As technology in medical devices evolves, so do the connectors used within them. Many medical connectors must be certified according to specific standards. This is the case for small-bore connectors (ISO 80369-1) for tubing, syringes, and other accessories that deliver fluid. Other subcategories for small-bore connectors include respiratory/breathing system connectors (ISO 80369-2), enteral and gastric connectors (ISO 80369-3), urinary collection (ISO 80369-4), limb and cuff inflation (ISO 80369-5), and more.

EDAC offers many board-to-board, wire-to-wire, and wire-to-board connectors suitable for medical device designs.

Other specific medical connector standards include the four-pole connector system (ISO 27186) used in active implantable cardiac rhythm management devices. Continue reading this article on EDAC’s site to learn more about specifying connectors for medical equipment.