Medical devices – whether custom handhelds, medical tablets, or placed on mobile medical carts, kept at bedsides, or used in examination rooms or labs – have become increasingly indispensable for patient monitoring, diagnostics, treatment, and real-time communication of patient data.
Medical devices utilized for direct patient care must meet stringent FDA-mandated safety and security requirements. This usually prevents off-the shelf tablets and smartphones from being leveraged, driving the creation of a custom device. Medical devices must be easy and intuitive to use, rugged, highly reliable, safe, locked down in their configurations, and perform their application.
Successful design of medical devices requires a combination of embedded processor design expertise, operating system development and modification (such as Android, Linux, or real time operating system (RTOS)), enclosure design, thermal management, specification of display and touch screen components, and the systems level expertise to optimize design decisions competing for space, limited power budgets, ruggedness, components costs, regulatory constraints, and long term availability.
At the core of a medical device is its embedded processor. SECO USA’s approach is to leverage one of our COTS single board computers and modify to meet product requirements. A display system (including LCD and touchscreen) optimal for the device is selected. Connectivity, whether Wi-Fi, Bluetooth, cellular, Ethernet, or some other interface is added. Throughout the process, we account for security, regulatory compliance, production test capability, and more.
Characteristics of Medical Devices
All medical devices must meet a stringent set of specifications that allow for high reliability, high availability, privacy laws, and potential rough handling without interruptions or degradation in functionality. Characteristics include:
- Exceptionally durable and reliable, operating with prolonged life
- Resist shocks, drops, impacts, and vibration
- Impervious to damage caused by fluids or other contaminants
- Failure modes specifically prevent bodily injury
- Resist EMI (electromagnetic interference) and comply with other electronic devices (EMC)
- Easily viewable, whether in direct sunlight, dimly lit rooms, or in complete darkness
- Operate with gloved hands, especially nitrile gloves
- Compliance with Health Insurance Portability and Accountability Act (HIPAA) for personal data privacy
- Secure and trusted operation
- Reliable operating systems, including Linux, RTOS such as VxWorks, Android
- Available for purchase for long periods of time, often 10 years or more
Medical Applications of Electronic Devices
SECO USA delivers circuitry, operating system software, and fully packaged computing systems and handheld devices for diverse medical applications such as:
- Patient monitors – bedside and portable
- Infusion pumps – handheld and body-worn
- Human-machine interface (HMI) front ends to large equipment
- Portable lab diagnostic equipment
Wide-Ranging Environmental and Compliance Requirements
Medical devices must meet FDA-mandated specifications, depending on their features and uses. SECO USA’s processes enable us to meet diverse and challenging requirements, whether technical or environmental.
- Electromagnetic compliance: FCC Part 15 (United States), Industry Canada (IC), EN55022, EN61000 (Europe)
- IEC/EN-60601 (medical device safety)
- IEC/EN-62304 (medical device software)
- FDA Class 1 and Class 2 devices
- Single device, multiple wireless interfaces: Wi-Fi (including enterprise encryption radios), 802.15.4, Bluetooth, NFC, cellular
- LTE cellular certification: PTCRB, GFC, multiple carriers including AT&T, emerging NB-IoT cellular
The SECO USA Advantage for Custom Medical Device Design
SECO USA has a broad and unique, but highly targeted set of skills and experience in the design of custom medical embedded computers and devices:
- Phased design approach: from use case analysis and product feature tradeoffs, through design, prototype, verification, and production
- In-house electronic, software, mechanical, and systems engineering that assure a highly integrated, functional, and long-term available product within fixed budgets and tight schedules
- System-level focus, understanding all use cases and requirements to optimize the product concept before commencing with design
- Supply chain management to assure on-time and long-term product availability
- Test engineering design that fully exercises a product for maximum yield and robustness
- Program management, the majority are PMP certified and highly experienced delivering real world product
- Medical Modified COTS minimizes cost, schedule, and risk through leveraging proven electronic platforms.
- ISO 9001 and ISO 13485 certified production
SECO USA is an industry leader in the design and manufacture of embedded circuit boards, custom tablets and portable electronic devices with rugged, secure, and long term operation. Discover more about the SECO USA Advantage today. Contact SECO USA for a review of your requirements and feedback on cost and schedule to get you to product.