Medical grade tablets have a number of unique features and use cases as compared with consumer grade tablets. This often requires a custom tablet design that tightly integrates these features and assures high reliability, security, and privacy. Consumer grade tablets usually cannot meet FDA, HIPAA, and other regulatory requirements simply through software changes and a more rugged outer package.
When used for patient monitoring and care, medical tablets and other handheld medical devices must meet FDA-mandated requirements for safety, privacy, and reliability. This extra diligence ensures trust that the medical device will not harm the patient, securely stores data, and in general performs its functions as intended.
Here are some ways in which medical grade tablets differ from consumer grade tablets. Medical grade tablets and other medical devices:
- Utilize high quality components, often manufactured in ISO 13485 certified facilities, which enable the consistent and quality construction, and supply chain traceability, required of medical devices.
- Incorporate, as an integral part of the device, specialized peripherals, such as probes. Secure fastening, as opposed to easy-to-unplug connectors such as standard USB, provide a long-lasting mechanically and electrically robust connection that minimizes failures.
- Often require enhanced Wi-Fi capability, especially when connecting the networks within hospitals and medical facilities. This entails the use of specialized Wi-Fi radios that support protocols such as the various types of Extensible Authentication Protocol (EAP) and Cisco Certified Extensions (CCX).
- Permit the use of gloved hands to operate the device effectively and without interference.
- Often have integrated barcode scanners, NFC (near field communication), and/or RFID (radio frequency identification) readers for quick scanning of patient and personnel identification, as well as medication and supplies for real time data logging and verification of treatment.
- Must be rugged, to stand up to shocks, drops, water and other liquids, and potentially harsh weather when taken outdoors. This is accomplished by using lightweight but strong materials (often composites), display assemblies built with chemically strengthened or Gorilla glass, and environmentally sealed external interfaces.
- Utilize antimicrobial layers of protection on outer surfaces to prevent the transmission of bacteria and viruses with handling.
- Include gaskets and sealed connectors that provide ingress protection from dust and liquids. These vent-less devices utilize components and special heat management techniques to withstand heat generated internally that cannot be dissipated from the case.
- May include a tethered stylus, with integrated stylus holder, which enables signature input and handwritten notetaking, as a convenience over touchscreens.
- Must meet the privacy requirements defined in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and subsequent standards defined by the US Department of Health and Human Services (HHS). In practice, this requires added provisions for securing medical data, health records, and user accounts, including the use of the latest encryption and authentication technologies, and perhaps tamper detection technologies.
- Pass stringent regulatory reviews and certifications. This includes document electronic, software, and mechanical design history and decision making. All medical devices must be approved by the FDA in the United States and obtain a CE Mark in Europe per the Medical Devices Directive. Tablets and portable handheld devices with wireless interfaces must also meet approval for FCC Part 15 specifications within the US and ETSI R&TTE within Europe.
- Utilize the principles of risk analysis and management integral to the design process. Potential failure modes are identified and rated for likelihood of occurrence, impact on occurrence, and steps for mitigation. The risk analysis in required for the medical device approval process.
Commercial tablets, such as iOS and Android devices that can be purchased in retail stores, cannot meet these requirements. The addition of rugged outer cases can increase environmental robustness, but typically do not adequately integrate and secure add-on items such as probes. The software configuration is not adequately locked down, with operating system updates that can be pushed to the device at the will of the manufacturer. There may also be limited controls on user access and the ability to install or remove software. The complete tablet’s design and test history is typically not sufficiently available to satisfy certification requirements.
Therefore, medical tablets and other medical devices are typically custom designed. Electronic circuitry is optimized for the specific application use. Components are selected for their ISO 13485 quality standards and long term availability. Peripheral components are tightly integrated into the custom device hardware, packaging, and software for robustness. Software can be fully tested for reliability. Corner cases can often be limited through the lockdown of the device and therefore can be adequately tested. HIPAA regulations can be fully satisfied through integral design.
The design of a medical grade tablet, other portable medical device, or even a Human-Machine Interface (HMI) front end to a larger medical device is a complex undertaking, and often outside the core intellectual property (IP) area of many medical device companies. In such a case, it may be cost, schedule, risk, and personnel resource efficient to procure commercial-off-the-shelf (COTS) or customized circuitry and operating system, and perhaps the entire device, from a company that specializes in its design and production.
Companies and original equipment manufacturers (OEMs) who seek to minimize cost, risk, and schedule in the development medical devices and healthcare tablets will benefit from the capabilities and expertise of SECO USA. SECO USA, incorporated in 2000, has surged to the forefront as a leading provider of low power embedded circuitry, systems, and software for industries that include medical, military and defense, transportation, instrumentation, infotainment, and more. Contact SECO USA for an evaluation of your application.