Because of the stringent medical device regulatory environment, the longevity and consistency of products and processes from suppliers is a primary concern of medical device manufacturers. Finding a creative way to accommodate this need, medical electronics manufacturer Emblation Microwave (Alloa, Scotland, UK) is leveraging an open, educational training platform dubbed Raspberry Pi as a robust medical controller platform to satisfy long-term device requirements.
Developed in the UK, the Raspberry Pi platform was designed as an affordable, educational platform intended to stimulate interest and enhance skills in computer science among the next generation of designers and engineers. Despite being a credit-card-sized, single-board personal computer, the platform can perform many of the same tasks as a traditional PC. For example, it is equipped with suitable networking, word-processing, graphics, and high-definition video capabilities.
Recognizing the potential of the platform to provide more than educational support, however, Emblation is exploiting such advantages as flexibility in programming options, low cost, uniformity, and longevity for use in medical device applications. “There are other options [for embedded controller systems], but the problem is that they routinely get upgraded or change in some way,” observes Eamon McErlean, technical director at Emblation. “In medical devices, you want consistency; you want to design on a platform that, over time, will be robust and not change very much. Raspberry Pi has the potential to do that.” Validation of a new controller platform to replace an obsolete unit is, after all, a time-consuming and inconvenient process, McErlean adds.
Another key advantage of Raspberry Pi, according to McErlean, is that it provides some flexibility in terms of the operating system—an important consideration for computer-controlled medical device applications. The Raspberry Pi foundation states that Fedora is the recommended distribution for the platform. However, users can replace the root partition on the secure digital card with another ARM Linux distribution, if preferred.
Although Emblation is initially employing Raspberry Pi as a control platform to support its own microwave generators, it intends to someday release the controller technology directly to medical device OEM customers. Following the model established by suppliers of medical-grade power supplies, the company states that it would potentially provide a turnkey hardware pack, consisting of a documentation and hardware pack to ensure compliance to IEC 60601 standards. Medical device manufacturers would be responsible for validating their own software, however. Applications for the controller system include imaging systems and electrosurgical products, among others.
“Raspberry Pi,” McErlean notes, “has the potential to cope with quite complex programs as well as simple programs and [features] the communications and control capabilities of a larger computer.”