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Medical Device Management in the World of Personalized Medicine

Medical devices paired with sensors can enable real-time monitoring and transmission of patient information to the cloud, improving healthcare as well as future product development.

Image by Gerd Altmann from Pixabay 

Medical device manufacturers can now supply patients with devices that are tailored specifically to their physiology. As the nature of patient care evolves, so do global regulations governing the manufacture and supply chain for these personalized medical devices. These devices require more consistent monitoring and service and thus demand greater traceability. In the current complex environment, medical device organizations are turning to cloud Enterprise Resource Planning (ERP) solutions to enable them to better manage their devices. The ability to maintain visibility at a global scale requires a solution that has the capacity to reach across oceans and borders while maintaining compliance. Medical device manufacturers require ERP solutions that can analyze vast volumes of data that can be used to enhance the patient experience and the quality of treatment. Cloud-based ERP gives medical device manufacturers the software and the tools they need to effectively manage personalized patient devices.

ERP solutions have evolved from being installed on-premise at a manufacturer’s facility to living in the cloud in order to adapt and solve the challenges posed by distance. Organizations operate on a global scale, and as their footprint expands throughout the world, so do the regulatory and compliance complexities governing their operations in various regions. Cloud-based ERP has enabled medical device manufacturers to develop more agile and responsive solutions that allow their organization to keep up with the changing nature of the industry. Regional governing bodies, like FDA, Health Canada, and European Medicines Agency, modify regional regulations and compliance expectations regularly. Recent regulation changes, such as the transition from the Medical Device Directives (MDD) and Active Implantable Medical Device Directive (AIMDD) to the Medical Device Regulation (MDR), have a direct impact on medical device management. The introduction of Unique Device Identification (UDI) allows for increased traceability of medical devices. In order for medical device manufacturers to continue operations globally, they must comply with regional requirements in each of the countries in which they operate. The cloud has allowed medtech companies to shed the one-size-fits-all approach that previously hindered the effectiveness of their ERP solutions.

Medical device manufacturers are finding that one of the most beneficial aspects of cloud-based ERP comes from the ease of gathering and sharing data and the improved decision making enabled through better analysis. Organizations can eliminate constraints posed by traditional on-premise solutions enabling businesses to operate in a more real-time capacity.

ERP solutions are feature-rich now more than ever and continue to evolve to meet the changing needs of the industry. The use of advanced technology in conjunction with an organization’s ERP solution critically impacts the relationship between the manufacturing organization and its customers. ERP companies are investigating how they can utilize IoT, machine learning and Artificial Intelligence (AI), robotic process automation (RPA), data lakes, and blockchain to enhance how their cloud software can improve patient outcomes.

Of these, Internet of Things (IoT) has been a primary focus for medical device manufacturers. Many medical devices are now paired with sensor technology to deliver real-time monitoring and transmission of patient information. This has allowed healthcare providers and medical device manufacturers to partner closely in providing thorough treatment to their patients across the globe. Traceability of the device gives the healthcare provider and manufacturer the opportunity to continuously and strategically monitor their devices. Manufacturers can trace a device to a particular customer and in turn analyze this patient information throughout the life span of the device to develop a comprehensive picture of the patient’s care. These sensors can signal when the device is malfunctioning and give the care provider an opportunity to respond quickly to preserve patient care. An ERP solution can record these malfunctions, adjustments, and repair as part of the complaint, non-conformance, and Corrective and Preventative Action (CAPA) process allowing the manufacturer to retain a comprehensive real-time Device History Record (DHR). The medical device manufacturer can gather significant data from a substantial sample of patients and analyze this data to advance R&D and develop more reliable products and treatments.

For instance, medical devices like the pacemaker can be uniquely configured to the patient and their physiology to help control the rate at which the patient’s heartbeats. These pacemakers have become so sophisticated that healthcare providers can now monitor and make real-time adjustments to a device inside a patient’s body. They monitor the patient’s heartbeat and relay the information, which allows the healthcare provider to develop a comprehensive healthcare plan. Patient mobility is no longer constrained, and cloud-based ERP allows real-time data to be gathered and analyzed regardless of the device’s location.

Medical device management has moved beyond the confines of the walls of the hospital or doctor’s office. The search for improved patient outcomes has led to the emergence of personalized medicine. The strict tracking of critical device and patient information has become integral to achieving more efficient and effective care. The maturity of cloud-based ERP, through the integration of advanced technology and improved data gathering and analysis, has helped to facilitate a boom in patient-centric care.

Michael Kolias

Michael Kolias

Michael Kolias is the director, life sciences for QAD. In that capacity, he is responsible for setting the strategic direction for the company in the life sciences vertical.

Kolias has more than 10 years of experience in the life sciences industry. Before joining QAD, Kolias was senior director of IT for Canon BioMedical. Before that, he was an IT manager at Zimmer Biomet. He has been involved in numerous ERP implementations for companies including SAP, JDE, and QAD. His focus is on delivering strategies that help organizations maximize their manufacturing and supply chain processes.

Kolias earned a BA in Economics from Ohio State University, a BS in computer science from Kent State University, and an MBA from University of Findlay. He is completing an MS in Computer Science with a focus in Computing Security from Boston University.

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