30 June 2026

By Natasha Edwards, Staff Systems Engineer

Drug store diagnostics, like pregnancy tests and rapid COVID-19 tests are relied on every day by consumers around the world. These devices provide fairly accurate results, but many users might find the faint lines on lateral flow assays hard to read.

For just a few dollars more, you can buy a digital pregnancy test with an LCD readout that says “Pregnant” or “Not Pregnant” in plain English. It’s the same test, with near identical accuracy, but a much more streamlined user experience.

The truth is, a digital pregnancy test is not any more chemically robust than a regular test. They do not contain microfluidics, advanced sensors, or even a computer that directly checks for hormones. Instead, they simply house a regular lateral flow test, which the device optically scans to check whether one line appeared or two, and then displays the result on a basic screen.

With the use of electronics, we can create improvements to devices that reduce user error and therefore makes rapid self-tests more similar to a more expensive point-of-care assay taken at a clinic. Added electronics can provide increased accuracy and precision, add extra usability features, and create safety mechanisms.

When Should a Medical Device Contain Electronics?

As with value-added examples like this digital pregnancy test, electronics in medical devices are often used to improve existing device designs. Even a surgical tool like a drill for a bone cannula might benefit from electronics in its kit. For instance, adding a reusable sensor that detects resistance during drilling could alert a surgeon when underlying bone density is lower than expected. They could then use less force in patients with osteoporosis, who often face higher risk of complications during placement.

 It's often more worthwhile to solve a challenge by enhancing an existing device with modern electronics than to solve the same problem without them. Doing this creates a meaningful difference for clinicians, caretakers, and patients everywhere.

There is one caveat: electronics must add value by making the device easier to use, more reliable, more integrated with other healthcare applications, or better able to solve problems When that value is real, the added cost of developing compliant electronics and their subsystems becomes worthwhile. It differentiates the product among health systems, payors, and consumers. It can earn a place in the market, and some cases, create an entirely new product category.

Understanding Electronic Medical Device Regulations

Medical devices that contain electronics are more complex, which means that while added safety is a common benefit, there are still more parts that could fail and cause injury. Thus, there are several international standards that must be met for regulatory submission depending on the device. These include IEC 60601, a list of hardware requirements for basic safety and performance, and IEC 62304, a list of life cycle requirements for software. Both of these standards are requirements for FDA and MDR medical device approvals for use in Europe and the United States.

Electronic devices must go additional regulatory hurdles in comparison to their analog counterparts. From electrical design to pre-compliance testing, the complexity that electronics add to device development requires dedicated support for risk management, software validation, and EMC testing on top of the standard verification and validation activities every medical device must undergo.

Reach Out to a Medical Device Electronics Expert

Bringing electronics into a medical device adds complexity at every stage, from design through regulatory submission. Sanner can help you navigate that complexity, from concept through compliant and manufacturable design. Reach out to start the conversation.