While technology has revolutionized healthcare and continues to do so, there is still room for improvement in the process of manufacturing medical devices, including life-saving ones. In late June, the US Food and Drug Administration (FDA) issued a critical recall of Philips Respironics ventilators. The move followed reports linking these devices to more than 65 deaths and nearly a thousand injuries. This alarming episode demonstrated the need for an innovative approach to such a crucial stage as quality check. Phani Chandra Barla, Principal Quality Engineer at Senseonics Inc., a prestigious medical technology company that focuses on the design, development, and commercialization of glucose monitoring systems (CGM), addresses this issue in his recent research paper, “Harnessing Artificial Intelligence for Real-Time Quality Assurance in Medical Device Manufacturing,” published in The American Journal of Engineering and Technology. The study highlights the benefits of using AI and how it can reduce the risk of human errors that may jeopardize patient safety.
As a leading expert in the field, Barla knows the importance of quality assurance firsthand, as he plays a pivotal role at Senseonics Inc. in protecting consumer safety by ensuring that the company’s medical devices meet quality and safety standards. Leading a team of quality engineers and regulatory affairs specialists, he is responsible for identifying and mitigating risks related to product compliance. With more than ten years of practical experience and an international academic background, Barla has in-depth knowledge of product investigations, process validation, and quality control while ensuring compliance with strict FDA regulations. He is also certified in Six Sigma White, Yellow, and Green Belts and Project Management Essentials by the Management and Strategy Institute (MSI). Being a member of the International Association of Engineers, Barla brings a global perspective to his work and is eager to share his insights with a broad audience through publications in scientific journals, conferences, and university lectures. His commitment to innovation was recently recognized with the prestigious Cases&Faces Award. This annual international event honors outstanding ideas, projects, and individuals that promote excellence across various fields. Phani Barla won the award for Achievement in Engineering, specifically in the category of AI and Machine Learning. As an engineer constantly seeking innovative approaches, Phani is a strong advocate for AI as a solution that can enhance safety in the critical field of medical device manufacturing.
In the study, Barla pointed out the utmost importance for the industry of guaranteed quality and reliability of products to safeguard patient safety. Defects or malfunctions in medical devices can have severe consequences, ranging from compromised patient care to potential harm or even loss of life. In light of this, the detection of defects during production is critical to prevent faulty devices from reaching the market. While traditional methods that often rely on manual inspection by human operators have proven effective to some extent, they are “inherently limited by human subjectivity, fatigue, and the potential for human error,” he said.
As technologies become more advanced, so do medical devices—while this undoubtedly has a positive effect, on the other hand, it becomes more challenging for human inspectors to identify subtle defects or anomalies. Barla believes that AI has emerged as a transformative technology to overcome these limitations and enhance defect detection capabilities in the manufacturing industry.
“In this era of digital transformation, quality is no longer just about raw data, but how we process that data and extract insights from it,” he said in the study. According to Barla, the integration of AI and quality management isn’t just a concept but a reality that is reshaping modern manufacturing processes. While recent advances in healthcare using AI have sparked debates on whether AI doctors could someday replace human medical personnel, Barla believes that the complete replacement of human doctors by computers is unlikely in the near future. Instead, he emphasizes that AI tools can significantly enhance practitioners’ abilities to make more accurate clinical decisions. In the field of medical device manufacturing, which aims to improve the healthcare industry as a whole, quality control (QC) and quality assurance (QA) are currently undergoing transformation due to AI technologies.
“It would be foolish to ignore the substantial benefit that AI provides in terms of streamlining and improving testing procedures. To gain a substantial competitive edge, businesses need to know how to incorporate AI into their testing procedures,” Barla said. He added that QA teams could significantly improve their efficiency by switching from manual testing to more advanced AI-driven technologies.
The companies that develop and manufacture medical devices work non-stop, requiring resources for inventing, creating, and testing, and it is crucial to adhere to the highest quality standards and all relevant regulations, as non-compliance can result in penalties, product recalls, and damage to the company’s reputation. Barla, who is responsible for ensuring that the company’s products meet all of these standards, emphasizes that AI can take over labor-intensive tasks such as regulatory monitoring and can also predict potential issues.
“Medical device producers must adhere closely to the FDA’s strict rules. With the help of AI, not only are these regulatory standards more easily met, but the clearance procedure is also faster and more accurate. AI allows medical device companies to speed up product development without sacrificing quality or safety,” Barla said. With the ability to process large datasets and learn, AI-powered quality management systems guarantee that all stages, from medical device design and prototyping to production and post-market surveillance, are carried out to the highest quality standards, according to his research.
Barla is convinced that the application of AI will inevitably become part of modern healthcare, and to become a successful engineer in the medical device industry, one must keep a close eye on new trends in the industry. To accomplish this, he recommends participating in competitions in addition to joining professional associations. Since Barla is an industry expert, he served as a judge in the international Globee Awards in various categories in 2023 and 2024. He admitted that the experience of being the first to see the emerging technological innovations and directly impacting on their development by reviewing them in accordance with strict evaluation and scoring rules allows the judges to take part in shaping the future of the technologies. Barla added that by being involved in innovative communities such as the International Association of Engineers and the Globee Awards, he has gained insights into several important AI and machine learning developments in healthcare that are worth implementing in the work process to ensure that the quality of products meets the highest standards and is safe for people whose lives may depend on them.
