The challenges for developers in the medical device sector [Q&A]
Across all industries developers are under pressure to deal with rapidly shifting requirements and faster turn around times.
But in highly regulated sectors like healthcare there are extra demands to ensure safety and compliance. We spoke to Roger Mazzella, senior product manager, medical at productivity platform The Qt Company to find out how developers can address these challenges while still meeting delivery times.
BN: How has the medical devices sector evolved in recent years?
RM: Over the last decade we have experienced a healthcare revolution as the medical device industry has seen significant growth and change -- like many other industries -- with the expansion of the Internet of Things (IoT). Modern healthcare provides opportunities for patient-centric design and unique consumer health experiences, from improving scheduling and appointment check-ins, to life saving treatments such as robotic-assisted surgery and everything in-between. Both patients and healthcare professionals are increasingly reliant on new medical devices to drastically improve patient recovery times, lower the cost of treatment and ultimately improve the services offered by healthcare providers and enhance patient quality of life.
Consumers expect their smartphones and other devices they use in everyday life to run without fault, but anyone who uses these devices has experienced, and understands, that these devices have faults and errors. Failures can range from small and seemingly insignificant all the way up to complete device failure. The healthcare industry requires applications and devices to function and perform at a higher standard because its top priority is patient safety. Aside from a medical device being safe, reliable, and effective, modern medical devices need to be intuitive, easy and enjoyable to use, for the sake of both patients and healthcare professionals. However, like any other high-tech device, existing medical devices commonly require software updates in order to keep pace with both changes in technology and industry. Some are even verging on being obsolete as they have been in circulation for some time. For context, if the benchmark for device UX and UI is the latest software used in Apple or Android smartphones, a number of critical medical devices are operating on something closer to Windows 95.
Connected devices are in high demand, and the Internet of Medical Things (IoMT) is no exception. Developers are playing an integral part in modernizing this industry, but introducing new products to market can be a long-winded process as many new healthcare devices are subject to the rigors of in-country certification and market clearance processes. This sub-category of the IoT was being gradually introduced to doctors’ surgeries and hospitals pre-pandemic -- as funding allowed -- enabling them to be more connected environments at a gradual pace.
BN: How has the COVID-19 pandemic exposed limitations in the medical devices sector?
RM: The outbreak of COVID-19 exposed a lot of medical devices as archaic, poorly designed and in desperate need of modernization. Ventilators, for example, were in high demand at the peak of the pandemic, exposing the fact that they were not fit for purpose when deployed en masse. Since March 2020, demand for digital products and services has grown at an unprecedented rate, and this demand has yet to waver. Our 2021 research revealed that 82 percent of respondents stated that they need to quickly introduce new smart or connected products and services in order to maintain or grow market position. When applying this to the medical device sector, the need for the rapid deployment of upgraded technology is necessary to enhance healthcare professionals' ability to save lives.
Connected devices have gone from being luxurious 'nice-to-have' items, to necessities almost overnight. The pandemic has shone a light on an industry-wide problem that has been understood for decades, with hospitals across the globe being forced to turn patients away due to unsatisfactory or unavailable supplies of the correct equipment. This has proven that connected devices are an essential part of the modern healthcare ecosystem. Crucially, therefore, there is a need to find innovative technological solutions that can help manufacturers navigate the high degree of regulation and specifications governing the medical devices sector and streamline the process of certification.
BN: What are the obstacles for digital transformation in the medical devices sector?
RM: In an ideal world, to enable truly seamless design and manufacturing of new, connected medical device, developers would be fully educated on industry guidelines and regulation. Realistically, this responsibility falls well outside their remit, and it is unreasonable to expect time-tight developers to have in-depth familiarity with various rules and specifications, especially in the world's second-most regulated industry.
However, delays caused by regulation can be somewhat alleviated during the product development and design process. Collaboration between designers and developers to streamline this phase of the product lifecycle means devices will arrive at the regulatory approval and certification process faster, helping to shorten time to market. Prior to the pandemic, initiatives like GP Connect -- a service making patient medical information available to all appropriate clinicians through connected technology systems -- were not in place. The events of the past 18 months have highlighted a need for developers to create systems that help healthcare professionals not only to streamline their processes, but also improve overall customer experience.
Another significant obstacle, and a pervasive problem, is developer well being. Connected device developers are in high demand, with 75 percent of connected device manufacturers stating that demand for developers is outstripping supply. This is unsurprising as many industries are undergoing rapid digital transformation. The medical device sector has been in the spotlight as a result of the pandemic, and as such, the true extent of the problems faced were thrown into the public eye. This added to pressures already placed on time-tight developers, causing them to be spread thinly across multiple industries.
BN: What is the role of developers in speeding up the time to market for life-saving healthcare equipment?
RM: The focus for developers should be on creating software that elevates the overall user experience in the most efficient way while prioritizing device efficacy and safety. Life-saving medical devices should be equipped with the capacity to deliver smartphone-like UX and UI for both medical staff and patients. Developers therefore have a critical role to play in the revolution of the medical device industry.
After a safe and effective device design is planned, developers should concentrate efforts on developing software that is compatible with current equipment, bringing existing medical devices up to new industry standards without the need for new products to be manufactured. When done right, this can save many hours of product design and development, with developers able to write code for existing device models, which can be equipped with touch screens to improve UX.
Upgraded user interfaces can then be linked to existing hospital infrastructure and provide connectivity for life-saving data to achieve capabilities such as monitoring symptoms and making diagnoses from remote locations. Developers have the ability to create the desired and necessary connected ecosystem, using existing products, helping to develop smart, adoptable, easy-to-use medical devices that maintain the highest safety and efficacy standards.
Image Credit: everything possible / Shutterstock