Operating Devices with an Off-the-Shelf Solution

Development of a medical device is a significant challenge. Innovators with a great idea for a new technology already face an uphill battle in getting their product to market. As such, if there are obstacles to success outside a company’s expertise, they should certainly be investigated.
 
One aspect of a medical device that often reflects this need is the embedded software that is essential to many of today’s healthcare products. While some manufacturers may think they require a custom solution, specifically suited to their device, incorporating an off-the-shelf software may be all they really need.
 
With this in mind, Kim Rowe, CEO and founder of RoweBots, addressed a number of questions and concerns many device manufacturers have with regard to embedded software for their medical technology. In the following interview, Rowe shares the advantages of her company’s software solution specifically developed for healthcare systems, addresses security concerns, and discusses connectivity questions.
 
Sean Fenske: What is RoweBots? Can you give a bit of insight into the company?
Kim Rowe: RoweBots is an embedded systems company with a long history of delivering embedded products with other companies. RoweBots is now expanding into medical technology and is starting to deliver products in this area. Our first product is Unison MedicalOS.
 
Fenske: What advantages are there for medical device manufacturers in using an “off-the-shelf” OS for their product rather than a truly custom solution?
Rowe: It takes about nine different factors to deliver a volume OEM medical product. By using MedicalOS, you get eight factors and help with the ninth. MedicalOS is lean, adaptable, secure, safe, connected, cloud, complete, and cutting edge. It will soon be certified and tested for medical use and this certification will eliminate significant work for final certification.
 
Fenske: Do you encounter compatibility issues with components used in a medical device and how are these addressed?
Rowe: EMI issues must be addressed with testing of the final products. As components are used and tested with MedicalOS, they will be added to the components list. Generally, digital electronics are safe with minimal attention to EMI and most devices are not an issue; however, there are exceptions, particularly with high clock rates and these exceptions will be identified when known. 
 
Fenske: At what point do manufacturers typically approach you for assistance with the device OS?
Rowe: We see two scenarios generally. The first is during design when they realize that they need significant help with embedded software. The second scenario happens when they have tried to build a prototype and struggled, at which point they realize they need help. 
 
Fenske: What would the ideal contact point be?
Rowe: It is best not to waste time and money trying to achieve something where you will fail. It teaches you quite a bit but wastes time and money. It is best to engage early and let us help. 
 
Fenske: Do you aid in component/hardware selection for a device or make recommendations? 
Rowe: Aid for component selection is what specialized versions of Unison MedicalOS is about. By providing known sets of components that integrate easily, have software support, and are known to meet specific requirements, the hardware design and integration complexity are substantially reduced.
 
Fenske: Are you able to aid in the design of the device in any other way?
Rowe: We often get involved in the hardware design with our customers. We have considerable experience, and we can only succeed when they succeed, so we are eager to engage and help. 
 
Fenske: A critical issue gaining more attention with medical device software is security. How do you address the growing concerns with this subject?
Rowe: UnisonOS was the first RTOS to offer free security components. This was done to make security a basic feature to achieve privacy, which is mandatory for medical devices. RoweBots has always been about secure systems; it is a primary feature of all our products. This extends from communication security into data security at rest to ensure that patient data is never at risk.
 
Fenske: Can you speak more to the issue of data security? How do you ensure that?
Rowe: By encrypting data using either software or hardware provisioned algorithms, data in the file system can be protected. It is a critical element particularly for wearable devices, which can be lost and physical access is available to make data extraction much easier. 
 
Fenske: Where do you see the medical device industry lagging behind in terms of security? How is this industry compared to other industries in which you operate? 
Rowe: It is more about where it is not lagging. Medical costs are restricting budgets and thereby limiting upgrades and maintenance. By integrating maintenance in the purchase price and using the MedicalOS over the air secure upgrade capabilities, medical device companies can be part of the solution for this issue. 
 
Fenske: What about connectivity; does the medical device industry need one agreed upon communications platform to further progress functionality between devices?
Rowe: I don’t think so. Different communications protocols provide options for different use cases, making for better products. Standards for medical data exchange are good though and will help eliminate errors in data, which is provided if the standards are up to the application measurement task.
 
Fenske: Would one connectivity standard improve security of devices?
Rowe: It could, but many communications are secured to the cloud with TLS. The issue is generally to make sure layered security is provided along with this and data at rest security is used in all cases (including when the communications protocol might store messages waiting for delivery). 
 
Fenske: Do you find device manufacturers are fearful of having devices operating in the cloud? Is there a lack of understanding with this type of technology?
Rowe: Hospitals and physician’s offices are all computer based today with networks and security. Working with IT to get things secured is an issue. In general, this is an issue that can be overcome.