Mobile digital access via a medical grade tablet has become a high priority for healthcare organizations in 2018. This can be seen in the fact that 79.8 percent use tablets and 42.6 percent use smartphones to access the information needed to provide and coordinate care. This is according to a new HIMSS Analytics study of 129 C-suite executives, IT professionals, clinicians and department heads.
A closer look at the needs of the healthcare continuum when it comes to digital mobility shows complex variable environment conditions and specialized use case needs of the healthcare environment. Often, mobile digital tools for medical applications require a level of ruggedness and customized functions that commercial off-the-shelf (COTS) devices cannot provide.
The requirements of medical grade tablets and other medical devices are broad and challenging to meet. Today’s customizable approaches for mobile tablet technology provide a level of reliability, security, ruggedness, and agility required in the medical industry.
A medical tablet or handheld device must be reliable and secure. Whether used for direct patient treatment or simple data management during regular checkup visits, the medical tablet must properly function (including its hardware and software features), have sufficient battery charge throughout the day, and meet basic functions. The ability to lock down the tablet software, and not allow alternate uses, is critical to facilitate responsiveness, compliance with HIPAA regulations such as data privacy, and in general encourage the use of the device for medical care. In short, idiosyncrasies in tablet operation should not get in the way of its use. The avoidance of inconveniences, such as uncontrolled software updates potentially being pushed by a tablet vendor, is crucial.
No matter the challenge of the environment, an electronic medical device must work as expected and must not cause injury due to failure. It cannot be damaged through normal handling, sanitization, or accidents such as drops or liquid spills. Enclosure materials must be biocompatible. For example, they cannot cause allergic reactions in latex-sensitive people. Displays cannot shatter when subjected to impact. Devices must often withstand harsh handling wherever patients may be rescued or treated during an emergency (indoors or outdoors) or in patient examination rooms, ambulances during transport, laboratories, homes, or medical offices. In short, the device must be rugged, and ruggedness enables reliable and efficient operation.
There are many other considerations for medical tablets and devices that may not be obvious – for example supply chain integrity and availability of internal components, the need to integrate specialized peripherals and functions and be designed according to risk-managed design processes. The ability to obtain regulatory certification is critical as well.
Some medical applications, such as the use of a medical grade tablet or handheld device for direct patient monitoring or treatment may require a real-time operating system (RTOS) (to prioritize critical data and control over more auxiliary functions like display update. General purpose operating systems such as Android may not be sufficient.
The use of commercially available tablets and tablet-like devices such as smartphones is often not advisable for medical applications. In cases where the device is used for direct patient treatment, such a tablet or smartphone may not be FDA certifiable. Main concerns include the inability to fully control the software environment (such as preventing or controlling software updates) and the lack of robust patient protections from potential injury in case of failure. Other business concerns include relatively short commercial life (often two years or less), uncontrolled changes in design (which may lead to unexpected software changes or expensive rugged enclosure tooling changes to accommodate unannounced device mechanical updates such as slightly repositioning a camera, button, or display, or even changing the package dimensions. It may become necessary to expend large amounts of unexpected NRE or stock large inventories of commercial devices.
Time management and ability to get the job done in wide ranging environments is critical for all healthcare personnel. Having a versatile medical-focused rugged tablet computer increases efficiency and maximized patient care.
SECO USA designs and manufactures customized medical tablets and medical devices to meet specific use cases, feature sets, and business requirements. Successful medical device design requires the ability to optimize a broad range of conflicting parameters – technical, manufacturing, business, and regulatory. Contact SECO USA for an evaluation of our medical tablet or medical device application.