As life expectancy continues to increase worldwide, the healthcare device market is experiencing significant growth. According to Global Market Insights, the global medical electronics market was valued at $154.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.5%, reaching approximately $298 billion by 2032. This growth reflects the rising demand for medical electronics design and device application development.
Medical electronic devices encompass a wide range of products, from wearable trackers to sophisticated medical equipment. Each device varies in terms of cost, complexity, and purpose. This diversity offers ample opportunities for tailored development based on specific requirements. However, knowing where to begin and what aspects to prioritize is crucial for successful development.
Today, we will explore the essential requirements and features of medical product development. Let’s delve into the specifics that set healthcare electronics apart from conventional electronics.
One of the primary distinctions lies in the heightened reliability and safety demands of medical devices. Since these devices support and enhance patient health, they must function flawlessly and pose no harm. Real-time data processing is another critical aspect. Medical electronics must handle health data swiftly to deliver timely interventions, potentially saving lives.
Take, for instance, a wearable device we developed—a bracelet equipped with an alert button. This ultra-low-power, BLE-enabled wearable allows patients to summon help by pressing the emergency button. The bracelet transmits the alarm signal either via Wi-Fi or Bluetooth to a nearby beacon, which forwards it to the hospital server. The server calculates the patient’s location and alerts the staff, ensuring immediate assistance. Such rapid response times are vital in emergency situations.
The global market for medical wearables is booming. By 2026, it is predicted to quadruple from its 2021 value and reach $83.9 billion. North America leads the market, accounting for roughly 40% of global wearable medical device revenue.
Another important feature of medical electronics is robust network support. If a Wi-Fi connection fails, the device seamlessly switches to a mobile network without compromising performance. User-friendly displays are equally essential—whether on a mobile app or an HMI device—to ensure that both medical professionals and patients can easily interpret the information presented.
Additional features often required in medical electronics include low power consumption, sterilization resistance, lightweight design, compact size, mobility, portability, mechanical durability, and a long-lasting appearance.
Medical electronic devices can be categorized into four major groups based on their intended use: therapeutic, diagnostic, patient monitoring, and others. The therapeutic segment dominates the market, making up nearly half of it, largely due to the aging population and the increasing need for chronic disease management. AI-driven medical electronics, including home-use devices, are propelling further growth in this area.
For example, we’ve developed an intelligent system for detecting skin cancer using a smartphone. This system combines an iOS app with a specialized smartphone lens and employs computer vision algorithms, achieving a stunning diagnostic accuracy of 80% and processing times of less than 0.1 seconds.
Medical devices are also classified into four levels of risk, determined by the U.S. Food and Drug Administration (FDA). Class I devices pose the lowest risk and account for 47% of the market, with most exempt from regulatory oversight. Class IIa and IIb devices, representing 43% of the market, involve moderate health risks and typically require a premarket notification (510(k)). High-risk Class III devices, like cochlear implants and pacemakers, require premarket approval (PMA) and face stricter design and certification standards.
When designing medical electronics, companies rely heavily on IEC standards, particularly IEC 60601-1 and IEC 60601-1-2, which specify safety and performance criteria. ISO standards, such as ISO 9001, ISO 13485, and ISO 62304, address quality management, risk management, and software lifecycle requirements. Additionally, consumer electronics must adhere to certifications like CE, UL, RoHS, or REACH.
Before embarking on a project, it’s essential to thoroughly understand the certification requirements, which vary depending on the device’s purpose and operating environment. For example, when developing an IoT healthcare system, we had to select a transformer suitable for driving AC LED lamps in humid environments. We chose a humidity-resistant FS12-1600-S2 transformer that met all the necessary criteria.
If you’re designing an embedded system, you’ll need to decide whether to use open-source or proprietary operating systems. Linux, for instance, is widely used in medical devices due to its flexibility and robustness.
Given these considerations, clients should approach outsourcing companies with a comprehensive project requirements specification. This ensures that technical specialists can focus on refining the details rather than starting from scratch.
Despite these guidelines, several risks and challenges remain. Common issues include certification hurdles, safety concerns, market failure, misdefined requirements, and software errors. To mitigate these risks, thorough preparation and expert teams are indispensable. Choosing the right programming languages and tools, along with rigorous testing, ensures reliable and secure software.
Developing medical hardware and software involves unique challenges, such as integrating new software into existing systems, ensuring uninterrupted data transfer, reducing power consumption, and miniaturizing devices. These tasks demand exceptional engineering expertise and creativity.
In conclusion, developing medical electronics and software differs significantly from consumer electronics creation. The process is more resource-intensive and time-consuming due to stringent certification requirements and the critical nature of the devices involved. Therefore, selecting highly skilled and experienced partners is paramount. At Integra Sources, we’ve successfully completed numerous healthcare projects, ranging from wearable devices to complex systems. Reach out to us to build a high-performance, safe, and innovative medical IT solution that enhances human health.
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