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Why IoT and Quality Will Be Critical to Medical Device Development

Connected Medical DevicesAround the world, medical professionals risked their health to provide care for COVID-19 patients. Social distancing became a key measure to keep healthcare workers and their patients safe. Telehealth and remote care increased and became a more accepted practice. The caveat being that most medical devices do not allow for remote access to gather needed data or to make care adjustments. The spread of the virus has changed the nature of care and will require more connectivity over greater distances.

Healthcare Trends Post-Pandemic

There are two trends critical to the future of healthcare connectivity and data sharing in the post-pandemic world. First, software interoperability and second, the Internet of Things (IoT).

For years, electronic health record (EHR) interoperability has been one of the most challenging issues facing the modern healthcare industry. As the industry embraces data standards like FHIR (Fast Healthcare Interoperability Resources) to improve data exchange, users of EHR systems and the medical device makers that provide data to them will need to keep up with the latest innovations available if they want to achieve better outcomes.

IoT creates a new dimension of patient care. IoT allows for real-time remote monitoring, access to the patient’s health data, and the ability to make adjustments that improve care. It also opens new possibilities to engage the family or other caregivers in decision-making, support, and even treatment. This connectivity and sharing of data and information in the medical device arena will be critical for healthcare to improve patient health, improve operations, and generate revenue.

With a multitude of use cases, from accessing data from wearable devices in emergencies to specialty doctors seeing and treating patients in remote areas, device makers will be under pressure to deliver more quickly and with high quality. It will require device makers to understand the current needs of the market, but also envision future needs: constantly evaluating, managing, and unifying every aspect of the product lifecycle. Because lives can be at stake, focusing on quality management will continue to be critical.

Today’s Medical Device Development Requires Unified Product and Quality Processes

The current pandemic has already significantly changed how production and quality processes are handled with medical device manufacturing teams and their external supply chains. It is also changing the expectations of how devices need to operate and how they will need to be used to ensure patient and healthcare safety.

With IoT, more medical care can be provided remotely through telehealth and in-home care. This requires smart medical devices that connect through the Cloud to devices in the location of the medical provider. In facilities, bedside devices will need to be “social distance-ready” so they can be accessed and monitored remotely through wireless technologies reducing the exposure of caregivers to potential risks.

The post-pandemic reality will require medical device manufacturers to better share product design and quality information across all disciplines and teams. Quality ManagementTransparency into critical product development processes and information will be even more essential as device manufacturers innovate to meet new requirements. Some medical device companies may be challenged to work with appliances such as mobile phones, activity trackers, smartwatches, and other wireless-enabled wearable technologies. Others will need to connect with diagnostic equipment such as medical imaging machines, used to aid in diagnosis, ultrasound and MRI machines, PET and CT scanners, and x-ray machines. We may see treatment equipment such as infusion pumps, medical lasers, and LASIK surgical machines that need to be controlled and managed remotely from another room, from one facility to another, and potentially from miles away in times of a natural disaster.

This new era of medical device innovation will create even more of an imperative to have a single system to connect medical device development teams. Cloud quality management system (QMS) solutions were uniquely designed to connect teams, products, and quality processes from early development through commercialization while ensuring regulatory compliance. Sophisticated, smart devices will increase the need to have all teams working together to deliver safe and effective products to market faster than ever.

Innovative Medical Device Companies Leading the Way

With teams in different locations and suppliers in different time zones, the need for tight real-time collaboration is essential. This new paradigm makes the need for transparency and immediate communication more critical during new product development (NPD) and new product introduction (NPI). Companies that can’t reduce their reliance on distant suppliers will need a virtual system to drive a transparent and traceable product development process.

Innovative medical device companies like Kinsa, Vocera Communications, and Potrero Medical were leading the way even before the pandemic by developing smart, connected medical devices. Today, these products are critical to safely monitor and treat patients by limiting the need for direct patient interaction. These companies have unified their product and quality records in a single system of truth, Arena Quality Management System (QMS), to help successfully develop and introduce innovative, safe, and compliant devices. Arena QMS is empowering these next-generation device companies to enable better collaboration throughout product design and manufacturing.

What was already a very competitive market will become even more multifaceted in the months ahead. Medical device companies will need to continually innovate by finding new ways to leverage smart technologies to enable remote or virtual diagnostics and treatment and prevent the spread of COVID-19 or other infectious diseases. Having dispersed teams and supply chain partners working together in a single QMS system will help companies gain a competitive edge as they strive to develop and release products faster in this post-pandemic world.

The pandemic has changed how we all live, learn, and work. Whether it’s Zoom to bring people together for meetings and education or connected QMS systems to bring product development teams together, we need to improve how we interact virtually in the future. Arena Solutions provides the necessary cloud-based solutions to help today’s medical device manufacturers deliver products faster and enable smart technologies like IoT to prevent or reduce the spread of illness. Learn how companies are leading the way with Arena QMS.